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Chou R, Deyo R, Friedly J, et al. Noninvasive Treatments for Low Back Pain [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Feb. (Comparative Effectiveness Reviews, No. 169.)
Results of Literature Searches
The search and selection of articles are summarized in the literature flow diagram (Figure 2). Database searches resulted in 2,545 potentially relevant articles. After dual review of abstracts and titles, 1,310 articles were selected for full-text dual review and 156 publications were determined to meet inclusion criteria and were included in this review. Data extraction and quality assessment tables for all included studies are available in Appendixes E and F.
Key Question 1. What are the comparative benefits and harms of different pharmacological therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids, and topical/patch-delivered medications
Acetaminophen
Key Points
- For acute low back pain, one good-quality trial found no difference between acetaminophen versus placebo in pain intensity or function through 3 weeks (strength of evidence [SOE]: low for pain and function).
- For acute low back pain, a systematic review found no difference between acetaminophen versus nonsteroidal anti-inflammatory drugs (NSAIDs) in pain intensity (3 trials, pooled standard mean difference (SMD) 0.21, 95% confidence interval [CI] −0.02 to 0.43) or likelihood of experiencing global improvement (3 trials, relative risk [RR] 0.81, 95% CI 0.58 to 1.14) at ≤3 weeks, though estimates favored NSAIDs and the estimate was imprecise (SOE: insufficient)
- For chronic low back pain, no study evaluated acetaminophen versus placebo, and there was insufficient evidence from one trial to determine effects of acetaminophen versus NSAIDs (SOE: insufficient).
- There was insufficient evidence from four trials to determine effects of acetaminophen versus other interventions (SOE: insufficient).
- No study evaluated acetaminophen for radicular low back pain.
- One trial found no difference between scheduled acetaminophen, as-needed acetaminophen, or placebo in risk of serious adverse events (∼1% in each group) and a systematic review found acetaminophen associated with lower risk of side effects versus NSAIDs (3 trials, RR 0.57, 95% CI 0.36 to 0.89) (SOE: moderate).
Detailed Synthesis
The APS/ACP review29 included eight trials of acetaminophen (Appendix Tables E1, F1). One trial evaluated acetaminophen versus no treatment,30 five trials included in a systematic review31, 32 evaluated acetaminophen versus various NSAIDs,30, 33-36 and three trials evaluated acetaminophen versus other interventions (amitriptyline,37 electroacupuncture,38 and manipulation, corset, or physical therapy39). The sample size was 456 in one trial39 and ranged from 40 to 70 in the others. One trial evaluated acetaminophen for chronic low back pain,34 one mixed acute to chronic low back pain,39 and the remainder acute low back pain. No trial specifically focused on patients with radiculopathy. Acetaminophen doses were 4 g/day in 3 trials,33-35 3 g/day in 1 trial,30 2 g/day in one trial,37 and unclear in 3 trials.37-39 Duration of treatment ranged from 1 to 5 weeks. Four trials evaluated patients at 3 to 9 weeks after the completion of therapy30, 35, 38, 39 and the remainder evaluated patients at the end of therapy. Two trials34, 37 were classified as higher quality (based on meeting fewer than 6 of 11 validity criteria) and the remainder classified as lower quality. Methodological shortcomings included inadequate or unclear randomization and allocation concealment methods, unblinded design, and failure to avoid cointerventions. The APS/ACP review concluded that there was good evidence that acetaminophen was associated with moderate effects for acute and chronic low back pain, based primarily on evidence that acetaminophen and NSAIDs were associated with similar effectiveness in most trials, and trials that evaluated effects of acetaminophen for other pain conditions.
An update40, 41 to the systematic review32 of acetaminophen versus NSAIDs included one additional high-quality trial (n=371) of patients with acute pain (Table 1).42 Acetaminophen was compared against ibuprofen, a heat wrap, an unheated wrap, and placebo after a 4-day course of therapy. However, results were only reported for the comparisons of acetaminophen versus ibuprofen or heat wrap.
Table 1
Summary of systematic reviews of pharmacological treatments for low back pain.
We identified one additional good-quality trial (n=1643) of scheduled (∼4 g/day) or as-needed (up to 4 g/day) acetaminophen for up to 4 weeks versus placebo for acute low back pain (Table 2, Appendix Tables E2, F2).43 Followup was conducted through 12 weeks.
Table 2
Characteristics and conclusions of included acetaminophen trials.
Acetaminophen Versus Placebo or No Treatment
Acute Low Back Pain
One good-quality trial (n=1093) published subsequent to the systematic reviews found no differences between scheduled acetaminophen ∼4 g/day, as-needed acetaminophen up to 4 g/day, and placebo in pain, function, sleep quality, and SF-12 measures in patients with acute low back pain (∼20% with radicular symptoms) through 12 weeks.43 Differences between acetaminophen and placebo were ≤0.2 points on a 0-10 pain scale and ≤0.6 on the 0-24 Roland-Morris Disability Questionnaire (RDQ). There were also no differences in days to recovery, use of concomitant medications or health services, or hours absent from work.
A low-quality trial (n=70) included in the APS/ACP review found no differences between acetaminophen (3 g/day) versus no treatment in likelihood of recovery (54% vs. 82%, p>0.05) after a 1-week course of treatment.30 However, more patients had thoracic than lumbar back pain in this trial.
Chronic Low Back Pain
No trial evaluated acetaminophen versus placebo or no treatment for chronic low back pain.
Acetaminophen Versus NSAIDs
Acute Low Back Pain
For acute low back pain, a systematic review of low-quality trials found no difference between acetaminophen versus NSAIDs in pain intensity (3 trials, pooled SMD 0.21, 95% CI −0.02 to 0.43) or likelihood of experiencing global improvement (3 trials, RR 0.81, 95% CI 0.58 to 1.14) at ≤3 weeks, though estimates favored NSAIDs.41 Another low-quality trial (n=50) that was not included in the meta-analysis also found no differences.35
Chronic Low Back Pain
For chronic low back pain, a small (n=29), high-quality trial found diflunisal associated with higher likelihood of a patient rating of therapeutic efficacy as “good” or “excellent” versus acetaminophen after 4 weeks, but the difference was not statistically significant (62% vs. 33%, RR 1.88, 95% CI 0.77 to 4.55).34
Acetaminophen Versus Other Interventions
Acute Low Back Pain
Four trials found no clear differences between acetaminophen versus nonpharmacologic therapies (heat wrap therapy, electroacupuncture, physical therapy, corset, or spinal manipulation)38, 39, 42 or amitriptyline,37 but there was insufficient evidence to reach reliable conclusions because each comparison was only evaluated in one trial and the studies had methodological shortcomings.
Chronic Low Back Pain
No trial evaluated acetaminophen versus other interventions for chronic low back pain.
Harms
One good-quality trial found no difference between scheduled acetaminophen, as-needed acetaminophen, or placebo in risk of serious adverse events (∼1% in each group).43 A systematic review found acetaminophen associated with lower risk of side effects versus NSAIDs (3 trials, RR 0.57, 95% CI 0.36 to 0.89).41 One trial found no difference between acetaminophen versus a heat wrap in risk of systemic adverse events (4.4% vs. 6.2%, RR 0.71, 95% CI 0.23 to 2.18), with no serious adverse events in either group.42 Adverse events were not reported in other trials of acetaminophen versus other interventions.37-39
NSAIDs
Key Points
- For acute low back pain, a systematic review found NSAIDs associated with greater improvement in pain intensity versus placebo (4 studies, weighted mean difference [WMD] −8.39, 95% CI −12.68 to −4.10; chi-square 3.47, p>0.1), but four trials found no clear effects on the likelihood of achieving significant pain relief. One subsequent trial was consistent with these findings. One trial found NSAIDs associated with better function versus placebo (SOE: moderate for pain, low for function).
- For chronic low back pain, a systematic review found NSAIDs associated with greater improvement in pain versus placebo (4 trials, WMD −12.40, 95% CI −15.53 to −9.26; chi-square 1.82, p>0.5); two trials found NSAIDs associated with greater improvement in function (SOE: moderate for pain, low for function).
- For radicular low back pain, a systematic review found no difference in pain intensity between NSAIDs versus placebo (2 trials, WMD −0.16, 95% CI −11.92 to 11.59, chi-square 7.25, p<0.01) (SOE: low).
- There was insufficient evidence from two trials of an NSAID plus another intervention (skeletal muscle relaxants or massage) versus the other intervention alone to determine effectiveness (SOE: insufficient).
- There was insufficient evidence from two trials to determine the effects of NSAIDs versus doloteffin or exercise (SOE: insufficient)
- A systematic review found that most trials of one NSAID versus another found no differences in pain relief in patients with acute low back pain (15 of 21 trials) or chronic low back pain (6 of 6 trials) (SOE: moderate).
- A systematic review found NSAIDs associated with more side effects versus placebo (10 trials, RR 1.35, 95% CI 1.09 to 1.68); COX-2-selective NSAIDs were associated with lower risk of side effects versus nonselective NSAIDs (4 trials; RR 0.83, 95% CI 0.70 to 0.99). Serious harms were rare. (SOE: moderate)
Detailed Synthesis
The APS/ACP review29 included a good-quality systematic review with 51 trials of NSAIDs.31, 44 The review found nonselective NSAIDs for acute (6 trials) and chronic (1 trial) low back pain moderately more effective than placebo for outcomes related to pain and function. The APS/ACP review also found no evidence that any nonselective NSAID is superior to another for pain relief based on 24 trials, or when compared with other active interventions (e.g., other medications or passive physical modalities.) None of the trials in the systematic review evaluated a COX-2 selective NSAID.
We identified an updated version of the systematic review described above (Table 1, Appendix Tables E3, F3).41 It included 65 trials (total n=11,237) of NSAIDs versus placebo (16 trials), other active interventions (13 trials), or one type of NSAID versus another (33 trials), including five trials of COX-2 inhibitors (meloxicam, nimesulide, valdecoxib or etoricoxib) versus nonselective NSAIDs.45-49 Of the COX-2-selective NSAIDs evaluated in the trials, the only one available in the United States is meloxicam. Eleven trials investigated diclofenac sodium, eight trials ibuprofen, seven trials piroxicam, seven trials diflunisal, four trials naproxen, and 23 trials evaluated other NSAIDs. Nine trials of NSAIDs versus acetaminophen are discussed in the acetaminophen section of this report. Four trials in the systematic review of NSAIDs plus vitamin B versus NSAIDs alone are outside the scope of this review and not discussed further. Of the studies in the systematic review, 37 were conducted in patients with acute low back pain, nine in patients with chronic low back pain, and the remainder in patients with mixed or unclear duration of pain. Six studies included only patients with sciatica, 25 included low back pain without sciatica and 34 evaluated a mixed population or did not specify whether or not patients had sciatica. Treatment schedules and doses varied across studies. Medications were taken 1 to 6 times per day, and doses varied widely (i.e., ibuprofen doses ranged from 800 to 2400 mg per day, diclofenac doses ranged from 48 to 150 mg per day). Duration of treatment ranged from 1 day to 12 weeks, and followup ranged from 2 days to 6 months. 28 studies were rated high-quality by the systematic review, based on meeting at least 6 of 11 Cochrane Back Review Group criteria; the other 37 were rated low quality. Common methodological shortcomings of the low-quality studies included inadequate details regarding randomization and allocation concealment methods and cointerventions.41
We identified three additional trials (n=54 to 193) not included in the systematic review of NSAIDs for acute (including recurrent)50 or subacute51, 52 low back pain (Table 3; Appendix Tables E4, F4). One trial compared lornoxicam, diclofenac, and placebo,50 one trial an NSAID plus deep tissue massage versus deep tissue massage alone,51 and one trial an NSAID (loxoprofen sodium, diclofenac sodium, or zaltoprofen) versus exercise.52 One trial was rated good quality,52 and two were rated fair quality.50, 51 Methodological shortcomings of the fair-quality trials included inadequate description of randomization, blinding and avoidance of cointerventions.
Table 3
Characteristics and conclusions of included NSAID trials.
NSAID Versus Placebo
Acute Low Back Pain
The systematic review included 11 studies of NSAIDs versus placebo for acute low back pain;45, 53-62 studies that focused on patients with acute sciatica are discussed separately. In studies of patients without sciatica or in mixed populations with or without sciatica,45, 53, 54, 60 NSAIDs were associated with greater improvements in pain intensity versus placebo (4 studies, WMD −8.39, 95% CI −12.68 to −4.10; chi-square 3.47, p>0.1).41 Four studies reported did not report changes in mean pain intensity but reported the proportion of patients with pain relief.55, 57, 59, 61 One trial each of indomethacin, phenylbutazone, and diflunisal found no differences between the NSAID versus placebo in the likelihood of achieving pain relief.55, 57, 61 One trial found piroxicam associated with greater likelihood of pain improvement versus placebo in the subgroup of patients with moderate to severe pain at baseline (82% vs. 53%), but no clear effect in patients with mild pain (49% vs. 38%).59
Most trials did not report effects of NSAIDS on function. One trial found diclofenac and ibuprofen each associated with greater improvement in the RDQ versus placebo (p<0.001 and p=0.001, respectively).56 Pooled results from seven studies of NSAIDs versus placebo found a higher proportion of patients taking NSAIDs experienced global improvements after followup of 3 weeks or less (RR 1.19, 95% CI 1.07 to 1.33; chi-square 8.39, p>0.1).45, 55-58, 60, 61
We identified one additional trial (n=171) of lornoxicam or diclofenac versus placebo for acute low back pain or acute exacerbation of low back pain.50 Lornoxicam was associated with lower pain intensity at 3, 4, 6 and 8 hours after the first dose (p≤0.05 at each time point versus placebo), as measured on a 100 mm point visual analogue scale (VAS). There were no significant differences between lornoxicam and diclofenac for pain intensity or pain relief; function was not assessed.
Chronic Low Back Pain
The systematic review included four trials of NSAIDs versus placebo for chronic low back pain.63-66 NSAIDS were associated with greater improvement in pain from baseline to 12 weeks versus placebo (WMD −12.40, 95% CI −15.53 to −9.26; chi-square 1.82, p>0.5).41 Two of the trials found etoricoxib 60 mg 90 mg per day associated with greater improvement on the RDQ versus placebo (mean differences −2.42, 95% CI −3.87 to −0.98 and −2.06, 95% CI −3.46 to −0.65)64 and rofecoxib 25 mg or 50 mg per day associated with greater improvement versus placebo (mean differences −2.2, 95% CI −3.2 to −1.3 and −2.3, 95% CI −3.3 to −1.3).66
Radicular Low Back Pain
The systematic review found no difference in pain intensity between NSAIDs versus placebo in two trials of patients with sciatica (WMD −0.16, 95% CI −11.92 to 11.59).45, 62 Statistical heterogeneity was present (chi-square 7.25, p<0.01). One trial found no difference after 4 weeks of followup between piroxicam for 14 days versus placebo (mean difference 6.00, 95% CI −0.75 to 12.75),62 but the other trial found meloxicam associated with greater reduction in pain versus placebo after 7 days (mean difference −6.00, 95% CI −11.54 to −0.46).45 One trial included in the systematic review found indomethacin significantly more effective than placebo in the subgroup of patients with nerve root pain, but not in patients without nerve root pain.58 None of the studies assessed effects on function.
NSAIDs Plus Another Intervention Versus the Other Intervention Without NSAIDs
One trial (n=175) in the systematic review found no differences between diflunisal plus the skeletal muscle relaxant cyclobenzaprine versus cyclobenzaprine alone in global improvement at 2 or 7 days.55
One trial (n=54) of deep tissue massage plus NSAID versus deep tissue massage alone for subacute low back pain found no significant differences on the RDQ, Oswestry Disability Index (ODI), or pain intensity during rest, motion or mobility of the aching area.51
NSAIDs Versus Other Interventions
The systematic review included one trial (n=88) of rofecoxib versus doloteffin for chronic low back pain that found no difference in the likelihood of being pain free after 3 or 6 weeks.67 Studies of NSAIDs versus acetaminophen or opioids are discussed in the acetaminophen and opioids sections of this report.
One trial (n=193) of an NSAID (loxoprofen, diclofenac, or zaltoprofen) versus trunk strengthening and stretching exercises in patients with chronic low back pain was not included in the systematic review.52 It found NSAIDs associated with less improvement in quality of life measured by change ratio (improvement from baseline/baseline) on the RDQ (−0.47 versus −0.72, p=0.023) and the Japan Low Back Pain Questionnaire (−0.44 versus −0.58, p=0.021).
One NSAID Versus Another NSAID
The systematic review included thirty-three trials that compared at least two different types of NSAIDs; four evaluated injected NSAIDs which were outside the scope of the current review.41 Only two trials compared the same two NSAIDs (meloxicam versus diclofenac); both found no significant differences.45, 68 Most (15 of 21) head-to-head trials of different NSAIDs for acute low back pain found no differences in pain or function, and six head-to-head trials of different NSAIDs for chronic low back pain also found no differences.
COX-2-Selective NSAID Versus Traditional NSAID
The systematic review included 4 trials of COX-2-selective NSAIDs versus traditional NSAIDs for acute low back pain: meloxicam versus diclofenac,45 nimesulide versus diclofenac,46 nimesulide versus ibuprofen,47 and valdecoxib versus diclofenac.48 Of the COX-2-selective NSAIDs evaluated in these trials, meloxicam is the only one available in the United States. A pooled analysis of three trials, including the meloxicam trial, found no differences between the COX-2 selective and nonselective NSAIDs in pain (WMD −1.17, 95% CI −4.67 to 2.33);45, 47, 48 the fourth trial46 also found no difference.41
The systematic review included one trial of etoricoxib (not available in the United States) versus diclofenac for chronic low back pain that found no difference in pain relief.49
Harms
The systematic review included 10 trials that found NSAIDs associated with more side effects versus placebo (RR 1.35, 95% CI 1.09 to 1.68).41 It also found COX-2-selective NSAIDs were associated with lower risk of side effects versus traditional NSAIDs (4 trials; RR 0.83, 95% CI 0.70 to 0.99). Serious harms were rare in the trials.
Opioids, Tramadol, and Tapentadol
Key Points
- For chronic low back pain, a systematic review found opioids associated with greater short-term improvement in pain scores (6 trials, SMD −0.43, 95% CI −0.52 to −0.33, I2=0.0%, for a mean difference of ∼1 point on a 0−10 pain scale) and function (four trials, SMD −0.26, 95% CI −0.37 to −0.15; I2=0.0%, for a mean difference of ∼1 point on the RDQ) versus placebo; three additional trials reported results consistent with the systematic review (SOE: moderate for pain and function).
- For chronic low back pain, a systematic review found tramadol associated with greater short-term pain relief versus placebo (5 trials, SMD −0.55, 95% CI −0.66 to −0.44, I2=86%, for a mean difference of 1 point or less on a 0-10 pain scale) and function (5 trials, SMD −0.18, 95% CI −0.29 to −0.07, I2=0%, for a mean difference of ∼1 point on the RDQ); two trials not included in the systematic review reported results consistent with the systematic review findings (SOE: moderate for pain and function).
- For subacute or chronic low back pain, a systematic review included two trials that found buprenorphine patches associated with greater short-term improvement in pain versus placebo patches; effects on function showed no clear effect or were unclearly reported (SOE: low for pain, insufficient for function).
- For chronic low back pain, three trials reported inconsistent effects of opioids versus NSAIDS for pain relief, one trial found no difference in function. (SOE: insufficient for pain and function).
- For acute low back pain, one trial found no significant differences between opioids versus acetaminophen in days to return to work; pain was not reported (SOE: insufficient).
- Four trials found no clear differences among different long-acting opioids in pain or function (SOE: moderate for pain and function).
- Six trials found no clear differences between long-acting versus short-acting opioids in pain relief. Although some trials found long-acting opioids associated with greater pain relief, patients randomized to long-acting opioids also received higher doses of opioids (SOE: low).
- Short-term use of opioids was associated with higher risk versus placebo of nausea, dizziness, constipation, vomiting, somnolence, and dry mouth; risks of opioids were higher in trials that did not use an enriched enrollment and withdrawal design (SOE: moderate). Trials were not designed to assess risks of overdose, abuse, and addiction, or long-term harms.
Detailed Synthesis
The APS/ACP review included nine trials of opioid analgesics for low back pain.29 Sample sizes ranged from 36 to 683 patients. Three trials compared opioids versus placebo or acetaminophen, five trials compared sustained-release versus immediate-release opioid formulations, and two trials compared two different long-acting opioids. Only one trial assessed opioids for acute low back pain; the remainder evaluated opioids for subacute or chronic low back pain. Two trials were rated higher quality. Based on this evidence, the APS/ACP review found fair evidence that opioids are moderately more effective than placebo or no opioid for subacute or chronic low back pain, but insufficient evidence to determine effects for acute low back pain.
A recent, good-quality systematic review69 of opioids for low back pain included 16 randomized controlled trials (RCTs) (reported in 15 publications) (Table 1; Appendix Tables E5, F5).70-84 Sample sizes ranged from 55 to 981 patients. The opioids evaluated were tapentadol (1 trial), oxycodone (2 trials), long-acting oxycodone (1 trial), long-acting morphine (2 trials), extended-release hydromorphone (1 trial), extended-release oxymorphone (3 trials), combinations of oxycodone with naloxone or naltrexone (2 trials), tramadol or the combination of tramadol and acetaminophen (7 trials), and buprenorphine patches (2 trials). In many trials the dose of opioids was titrated to achieve pain relief; maximal doses ranged from 20 to 256 mg of morphine-equivalent doses per day. Tapentadol, morphine, oxymorphone, and hydromorphone were classified as “strong” opioids and analyzed together; tramadol and buprenorphine (a partial opioid agonist) were analyzed separately. Fourteen trials compared an opioid versus placebo and two trials compared an opioid versus an NSAID. The duration of treatment ranged from 2 weeks to 13 weeks following titration, and outcomes were assessed through the end of therapy in all trials. The systematic review assessed 13 trials as being at low risk of bias based on meeting ≥6 of 12 Cochrane Back Review Group criteria. Methodological shortcomings included high attrition, uncertain adherence to treatment, and uncertainty about blinding of outcome assessments. Five trials used the enriched enrollment and randomized withdrawal design described below.
We also included three trials (one higher quality85 and two lower quality36, 86) from the APS/ACP review that were not included in the systematic review and 4 additional newer trials (Table 4; Appendix Tables E8, F6).87-90 Sample sizes ranged from 36 to 302 subjects. One trial evaluated patients with acute low back pain36 and the others evaluated patients with subacute or chronic low back pain. The opioids evaluated were long-acting oxymorphone, combined oxycodone and naloxone, long-acting morphine plus oxycodone, short-acting oxycodone alone, oxycodone plus aspirin, and codeine. Two trials compared opioids versus placebo, one compared an opioid plus naproxen versus naproxen alone, and one compared opioids versus acetaminophen. Two newer trials compared tramadol plus acetaminophen versus placebo, and one compared long-acting hydrocodone versus placebo. The duration of treatment ranged from 15 days to 16 weeks, with outcomes assessed at the end of treatment. Two of the newer trials were rated good quality,87, 88 one fair quality,90 and one poor quality.89 Methodological shortcomings in the poor- and fair-quality trials included failure to describe adequate randomization methods, failure to report baseline differences, unblinded design, and high attrition. We also identified a post-hoc analysis of one of the trials included in the systematic review that stratified results according to presence of neuropathic pain.91
Table 4
Characteristics and conclusions of included opioid trials.
Of the 23 total trials, 8 employed an enriched enrollment and withdrawal design. In this design, all potential subjects receive the study drug for a period of time in a prerandomization, open label phase. Only those who benefit from the drug and tolerate side effects are then randomized to continue the active drug, or have it withdrawn and replaced with a placebo. Thus, every patient entering the trial has already demonstrated benefit from the opioid and been shown to be free of intolerable side effects at the time of randomization. This strategy can help reduce dropout rates following randomization and reduce the number of unresponsive subjects. However, it may also overestimate efficacy, and has been shown to underestimate adverse events.92
Despite frequent use of the enriched enrollment and withdrawal design, dropout rates from the trials were high. Only 2 trials had a dropout rate of less than 20 percent,86, 90 and most had rates of 30 to 60 percent.70, 72-80, 82, 84, 87, 89 The most common reasons for dropout were discontinuation due to adverse events (more common in the opioid arms than placebo) or lack of effect (more common in the placebo arms).
Another limitation of all the trials was short duration. The longest trial was 16 weeks (18).86 Many trials excluded patients with a history of substance abuse or depression, though these were groups that were more likely than others to receive opioids in clinical practice.93 Seventeen trials were industry sponsored and all involved tramadol, new long-acting preparations of older drugs, or new drug combinations.
We also included findings from a good-quality comparative effectiveness review94 of opioids for chronic noncancer pain that included three head-to-head trials of different long-acting opioids for low back pain85, 95, 96 and five trials of long-acting versus short-acting opioids,86, 97-100 and two other trials that evaluated comparisons among opioids.101, 102
Strong Opioids Versus Placebo
Subacute or Chronic Low Back Pain
Seven trials included in the systematic review69 (five rated low risk of bias70, 72, 74-76, 87) compared strong opioids versus placebo70-76, 85, 87 for subacute or chronic back pain. The opioids evaluated were extended-release tapentadol (1 trial), oxycodone (2 trials), long-acting oxycodone (1 trial), long-acting morphine (2 trials), extended release-hydromorphone (1 trial), extended-release oxymorphone (2 trials), and oxycodone with or without naltrexone (1 trial).
Strong opioids were associated with greater improvement in pain scores versus placebo (6 trials, SMD −0.43, 95% CI −0.52 to −0.33).70-72, 74-76 The findings were consistent among trials (I2=0.0%). The clinical magnitude of effects was small, typically equivalent to about 1 point on a 0-10 pain scale. Strong opioids were also associated with greater improvement in function versus placebo (4 trials, SMD −0.26, 95% CI −0.37 to −0.15; I2=0.0%). The effect was typically equivalent to about 1 point on the 24-point RDQ. Three trials not included in the meta-analysis that evaluated oxycodone, oxycodone plus naloxone, or extended-release hydrocodone reported results consistent with the findings of the systematic review.85, 87, 89
Tramadol Versus Placebo
Subacute or Chronic Low Back Pain
Five higher-quality trials of tramadol versus placebo were included in the systematic review.69 Sample sizes ranged from 254 to 386. Two trials evaluated a tramadol/acetaminophen combination77, 78 and two trials evaluated extended-release tramadol.80, 81 Doses were titrated in four trials and the fifth evaluated fixed dosing.
Tramadol was associated with greater pain relief versus placebo (5 trials, SMD −0.55, 95% CI −0.66 to −0.44, I2=86%). Effects generally averaged the equivalent of 1 point or less on a 0-10 pain scale. Although statistical heterogeneity was present, effects in all trials favored tramadol (standard mean differences ranged from −0.10 to −1.01). Tramadol was also associated with greater improvement in function versus placebo, though the average effect was smaller than for pain (5 trials, SMD −0.18, 95% CI −0.29 to −0.07, I2=0%). Four of the trials measured function using the RDQ, with a typical difference between tramadol and placebo of about 1 point. Two newer trials not included in the systematic review of tramadol plus acetaminophen versus placebo reported results consistent with the findings of the systematic review.88, 90
Buprenorphine Versus Placebo
Subacute or Chronic Low Back Pain
Two trials in the systematic review compared buprenorphine patches (titrated dose) versus placebo patches for subacute or chronic back pain (n=78 and n=541).82, 84 Both reported a statistically significant advantage of buprenorphine for pain, though the effect was smaller than the equivalent of 1 point on a 0-10 pain scale. One reported no significant difference in functional outcome;82 the other reported that buprenorphine was associated with better functional outcomes, but did not report a p value or other statistical testing.
Opioids Versus NSAIDs
Chronic Low Back Pain
Three trials in the systematic review compared opioids versus NSAIDs. Two larger trials (n=796 and n=802) of identical design (both rated higher quality) were reported in a single publication.83 They compared a fixed dose of the weak opioid tramadol (50 mg three times daily) versus a fixed dose of celecoxib (200 mg twice daily). The third was a small (n=36), older trial comparing three regimens: (1) Long acting morphine + titrated doses of oxycodone + naproxen, (2) fixed-dose short-acting oxycodone + naproxen, and (3) naproxen alone (titrated dose).86
The two trials of tramadol versus celecoxib reported the percent of patients with a reduction in pain scores of at least 30 percent on a 0-10 rating scale.83 One trial reported a statistically significant but small advantage for celecoxib (66% responders vs. 57% for tramadol). The other trial reported no statistically significant difference (65% responders for celecoxib, 60% for tramadol), though results also favored celecoxib. Functional outcomes were not reported.
The small, older trial reported greater average pain relief with both strong opioid regimens than with naproxen, by about 6-10 mm on a 100 mm visual analog scale.86 There were no significant differences in self-reported activity levels.
Opioid Versus Acetaminophen
Acute Low Back Pain
One small trial of military trainees (n=75) with acute low back pain found no differences between codeine, oxycodone plus aspirin, or acetaminophen in days to return to work (11 vs. 12 vs. 13 days, respectively).36 Pain scores were not reported.
Opioid Versus Opioid
Chronic Low Back Pain
A systematic review included three head-to-head trials of long-acting opioids for chronic low back pain.94 In the trials, patients were titrated for effective pain relief in both arms. One trial95 found no differences between oral morphine versus transdermal fentanyl and one trial85 found no differences between long-acting oxymorphone versus long-acting oxycodone in measures of pain relief or function. A third trial found long-acting morphine associated with higher likelihood of experiencing >2-point improvement on the Brief Pain Inventory versus long-acting oxycodone (55% vs. 44%, p=0.03) and greater improvement in sleep quality (mean improvement from baseline 33% vs. 17% on the Pittsburgh Sleep Quality Index, p=0.006), but had important methodological shortcomings, including open-label design, high attrition, and failure to report intention-to-treat analysis.96 One other trial found no differences between extended-release morphine versus controlled-release oxycodone in pain or function.101
Long-Acting Versus Short-Acting Opioid
Chronic Low Back Pain
A systematic review included five head-to-head trials of a long-acting versus short-acting opioid for chronic low back pain.94 Three trials found no differences between long-acting versus immediate-release preparations in pain control.97, 98, 100 In two trials, long-acting opioids were more effective than short-acting opioids for pain control, but patients who received long-acting opioids also received higher doses of opioids. One other trial also found long-acting tramadol associated with better pain relief and function than short-acting tramadol, but the dose of tramadol in the long-acting treatment arm was nearly double that of the short-acting arm.102
Harms
The systematic review found short-term use of opioids associated with higher risk versus placebo of nausea, dizziness, constipation, vomiting, somnolence, and dry mouth.69 As noted previously, a number of trials used an enriched enrollment and withdrawal design, which has been shown to underestimate risk of harms. A systematic review of opioids for chronic pain in general (not restricted to low back pain) reported nausea in 28 percent of patients randomized to opioids versus 9 percent randomized to placebo among trials that did not use an enrichment design (difference 17%, 95% CI 13 to 21), 26 versus 7 percent for constipation (difference 20%, 95% CI 15 to 25), 24 versus 7 percent for somnolence/drowsiness (difference 14%, 95% CI 10 to 18), and 15 versus 2 percent for pruritus (difference 10%, 95% CI 5 to 15).92 In trials that used an enrichment design, rates were 16 versus 8 percent for nausea (difference 7%, 95% CI 0% to 14%), 15 versus 3 percent for constipation (difference 11%, 95% CI 6 to 16), 10 versus 5 percent for somnolence/drowsiness (difference 3%, 95% CI 1 to 7), 10 versus 5 percent for dizziness/vertigo (difference 5%, 95% CI 2 to 8), and 5% versus 2 percent for pruritus (difference 3%, 95% CI 0 to 5).
The trials were not designed to assess risks of harms such as abuse and addiction, overdose, fractures, cardiovascular events, sexual dysfunction, and motor vehicle accidents. Although observational studies on risk for such harms in patients prescribed opioids specifically for low back pain is lacking, we recently reviewed evidence on the long-term risks of opioid therapy for chronic pain in general, including risks of abuse and addiction, overdose, fractures, cardiovascular events, sexual dysfunction, and motor vehicle accidents.15 Evidence from observational studies suggested an increased risk of overdose, as well as abuse and addiction, fractures, motor vehicle accidents, and sexual dysfunction, which appeared to be dose-dependent after adjusting for potential confounders.
Skeletal Muscle Relaxants
Key Points
- For acute low back pain, a systematic review found skeletal muscle relaxants superior to placebo for short-term pain relief (≥two-point or 30% improvement on a 0-10 VAS pain scale) after 2 to 4 days (4 trials; RR 1.25, 95% CI 1.12 to 1.41; I2=0%) and 5 to 7 days (3 trials; RR 1.72, 95% CI 1.32 to 2.22; I2=0%); a more recent, large (n=562) trial was consistent with the systematic review (SOE: moderate).
- For acute low back pain, a systematic review found no difference between a skeletal muscle relaxant plus an NSAID versus the NSAID alone in the likelihood of experiencing pain relief, though the estimate favored combination therapy (2 trials; RR 1.56, 95% CI 0.92 to 2.70; I2=84%); one other trial (n=197) also reported results that favored combination therapy (SOE: low).
- For chronic low back pain, evidence from three placebo-controlled trials was insufficient to determine effects, due to imprecision and inconsistent results (SOE: insufficient).
- Three trials in a systematic review found no differences in any outcome among different skeletal muscle relaxants for acute or chronic low back pain (SOE: low).
- A systematic review found skeletal muscle relaxants for acute low back pain associated with increased risk of any adverse event versus placebo (8 trials; RR 1.50, 95% CI 1.14 to 1.98) and increased risk of central nervous system events (primarily sedation) (8 trials; RR 2.04, 95% CI 1.23 to 3.37; I2=50%); one additional placebo-controlled trial was consistent with these findings (SOE: moderate).
Detailed Synthesis
The APS/ACP review29 included a good-quality systematic review of skeletal muscle relaxants103 with 22 studies.104-125 Twelve trials compared a skeletal muscle relaxant versus placebo,104-107, 109, 112, 114-116, 118, 119, 121 four compared a skeletal muscle relaxant plus an NSAID versus an NSAID alone,110, 113, 123, 125 two compared a skeletal muscle relaxant versus another active treatment,117, 124 and three compared one skeletal muscle relaxant versus another.111, 120, 122 The skeletal muscle relaxants evaluated were tizanidine (4 to 12 mg/day; 7 trials), cyclobenzaprine (30 to 40 mg/day; 4 trials), oral (dose range 100 to 200 mg/day; 3 trials) or intravenous (single 60 mg dose;1 trial) orphenadrine, carisoprodol (1400 mg/day; 2 trials), chlorzoxazone (1500 mg/day; 1 trial), dantrolene (dose not reported; 1 trial), baclofen (30 to 40 mg/day;1 trial), pridinol (8 mg IM, then oral 4 mg/day; 1 trial), tolperisone (300 mg/day; 1 trial) and meprobamate 450 mg/day; 1 trial). Duration of treatment ranged from 4 to 21 days in 21 trials, except for one trial of single dose intravenous orphenadrine.118 Only three trials followed patients after treatment had been completed.106, 123, 125 Sample sizes ranged from 20 to 405 (median n=80). Eighteen of the trials enrolled patients with acute back pain and four106, 112, 120, 121 enrolled patients with chronic back pain. The review classified 17 trials104, 105, 107-109, 111-114, 116-123, 125 as high quality based on meeting at least 6 of 11 Cochrane Back Review criteria; the other five trials were classified as low quality.106, 110, 115, 120, 124 Methodological shortcomings in most trials included inadequate reporting of randomization and allocation concealment methods; low-quality trials also did not report attrition, had unbalanced groups at baseline, and/or did not conduct intention-to-treat analyses. The APS/ACP review concluded that there was good evidence for moderate effects of skeletal muscle relaxants versus placebo for acute low back pain, but insufficient (poor) evidence to determine effects for chronic low back pain.
We identified two fair-quality trials of skeletal muscle relaxants for acute or subacute back pain published since the APS/ACP review (Table 5; Appendix Tables E7, F7).126, 127 One trial evaluated carisoprodol 1000 mg/day (250 mg three times daily) versus placebo (n=562)127 and the other (n=197) tizanidine 4 mg/day (2 mg twice daily) plus aceclofenac (an NSAID not available in the United States) 200 mg/day (100 mg twice daily) versus aceclofenac alone.126 In both studies, duration of treatment was 7 days, with no post-treatment followup. Neither trial provided information regarding methods of randomization or allocation concealment, or methods of blinding of study personnel.
Table 5
Characteristics and conclusions of included skeletal muscle relaxant trials.
Skeletal Muscle Relaxants Versus Placebo
Acute Low Back Pain
The systematic review found skeletal muscle relaxants superior to placebo for short-term pain relief (defined as at least a two-point or 30% improvement on a 0-10 VAS pain scale) after 2 to 4 days (4 trials; RR 1.25, 95% CI 1.12 to 1.41; I2=0%) and 5 to 7 days of treatment (3 trials; RR 1.72, 95% CI 1.32 to 2.22; I2=0%.)103 The review also found skeletal muscle relaxants superior to placebo for short-term improvement in global efficacy after 2 to 4 days (4 trials; RR 2.04, 95% CI 1.05 to 4.00), though heterogeneity was very high (I2=89%); the difference was no longer statistically significant after 5 to 7 days (RR 1.47, 95% CI 0.88 to 2.44; I2=34%)
A more recent fair-quality trial of carisoprodol versus placebo (n=562) was consistent with the systematic review. This trial found carisoprodol associated with greater improvements in patient-rated pain relief at day 3 (mean 1.8 vs. 1.1 on a 0 to 4 scale, p<0.0001) and day 7 (p<0.0001; data not shown.)127 Patient-rated global improvement was also greater with carisoprodol at day 3 (2.3 vs. 1.7, p<0.0001) and day 7 (p<0.0001, data not provided).
Chronic Low Back Pain
Evidence on effects of skeletal muscle relaxants versus placebo for chronic back pain is extremely limited. Of three placebo-controlled trials included in the systematic review, one small (n=20), high-quality trial112 found dantrolene associated with better pain-related outcomes versus placebo and one low-quality trial (n=69)106 found no differences between cyclobenzaprine and placebo for pain. A third, high-quality trial (n=112) found no difference between tolperisone versus placebo in global impression of efficacy after 21 days (mean 2.85 versus 2.45 on 1 to 4 scale).121
Skeletal Muscle Relaxants Plus Another Intervention Versus the Other Intervention Without Skeletal Muscle Relaxants
Acute Low Back Pain
The systematic review found no difference between a skeletal muscle relaxant plus an NSAID versus the NSAID alone in the likelihood of experiencing a 2-point or greater difference or 30 percent improvement on a 0-10 VAS after 2 to 4 days (2 trials; RR 1.56, 95% CI 0.92 to 2.70; I2=84%), though the estimate favored the combination. The combination was associated with greater likelihood of experiencing global improvement at 2 to 4 days (4 trials; RR 2.04, 95% CI 1.05 to 4.00; I2=89%); the estimate was not as strong and no longer statistically significant at 5 to 7 days (4 trials; RR 1.47, 95% CI 0.88 to 2.44; I2=34%).103
One fair-quality (n=197) trial not included in the systematic review compared tizanidine plus aceclofenac with aceclofenac alone.126 The combination was associated with greater improvement in resting pain after 3 days (mean change −3.01 vs. −1.90 on 0 to 10 VAS, p=0.0001) and 7 days (−5.88 vs. −4.35, p=0.0001).126Results for pain with movement were similar (mean change −2.94 vs. −1.81 at day 3, p=0.0001 and −6.09 vs. −3.98 at day 7, p=0.0001.) The combination was also associated with higher likelihood of experiencing a good or excellent treatment response (75% vs. 34%; RR 1.28, 95% CI 1.07 to 1.52.)
Skeletal Muscle Relaxants Versus Other Interventions
Three trials106, 128, 129 of skeletal muscle relaxants versus benzodiazepines are discussed in the benzodiazepine section of this report.
Effectiveness of One Skeletal Muscle Relaxant Versus Another Skeletal Muscle Relaxant
Three trials in the systematic review103 found no differences in any outcome between carisoprodol versus cyclobenzaprine (1 trial [n=78]),122 or tizanidine versus chlorzoxazone (1 trial [n=27]),111 for acute back pain or pridinol versus thiocolchicoside (1 trial [n=120]) for chronic back pain.120
Harms
For acute low back pain, the systematic review found skeletal muscle relaxants associated with increased risk of any adverse event versus placebo (8 trials; RR 1.50, 95% CI 1.14 to 1.98; I2=50%).103 There were no differences in risk of any adverse event between skeletal muscle relaxants plus an NSAID versus the NSAID alone (2 trials RR 1.30, 95% CI 0.62 to 2.75; I2=84%). Skeletal muscle relaxants were associated with increased risk of central nervous system events (primarily sedation) versus placebo (8 trials; RR 2.04, 95% CI 1.23 to 3.37; I2=50%), or when added to an NSAID (3 trials; RR 2.77, 95% CI 1.18 to 6.46; I2=51%). Skeletal muscle relaxants were not associated with increased risk of gastrointestinal events versus placebo (7 trials; RR 0.95, 95% CI 0.29 to 3.19; I2=50%) or when added to an NSAID (3 trials; RR 0.48, 95% CI 0.23 to 1.00; I2=50%).103
One trial published subsequent to the systematic review found no significant difference between tizanidine plus aceclofenac versus aceclofenac alone in risk of central nervous system events (drowsiness) (RR 1.19, 95% CI 0.33 to 4.29).126 One other trial found carisoprodol associated with increased risk of sedation (RR 2.92, 95% CI 1.59 to 5.37) and dizziness (RR 3.08, 95% CI 1.47 to 6.42) versus placebo, though there was no difference in withdrawals due to adverse events.127 No serious adverse events were reported in either study.126, 127
Two trials of skeletal muscle relaxants for chronic low back pain found no increase in risk of experiencing any adverse event versus placebo (RR 1.02, 95% CI 0.67 to 1.57; I2=0%).103 Other harms were not reported.
Benzodiazepines
Key Points
- For acute low back pain, there was insufficient evidence from two trials with inconsistent results to determine effectiveness of benzodiazepines versus placebo (SOE: insufficient).
- For chronic low back pain, a systematic review included two trials that found tetrazepam associated with lower likelihood of no improvement in pain at 5-7 days (RR 0.82, 95% CI 0.72 to 0.94) and at 10 to 14 days (RR 0.71, 95% CI 0.54 to 0.93) versus placebo, and lower likelihood of no overall improvement at 10 to 14 days (RR 0.63, 95% CI 0.42 to 0.97) (SOE: low).
- For acute or subacute radicular pain, one trial found no difference between diazepam 5 mg twice daily for 5 days versus placebo in function at 1 week through 1 year, or other outcomes including analgesic use, return to work, or likelihood of surgery through 1 year of followup. Diazepam was associated with lower likelihood of experiencing ≥50% improvement in pain at 1 week (41% vs. 79%, RR 0.5, 95% CI 0.3 to 0.8) (SOE: low).
- For acute low back pain, there was insufficient evidence from two trials with inconsistent results to determine effects of benzodiazepines versus skeletal muscle relaxants (SOE: insufficient).
- For chronic low back pain, one trial found no difference between diazepam versus cyclobenzaprine in outcomes related to muscle spasm (SOE: low).
- A systematic review found central nervous system adverse events such as somnolence, fatigue, and lightheadedness were reported more frequently with benzodiazepines versus placebo, though harms were not reported well; no trial was designed to evaluated risks with long-term use of benzodiazepines such as addiction, abuse, or overdose (SOE: low).
Detailed Synthesis
The APS/ACP review29 included a systematic review of skeletal muscle relaxants for low back pain103 that included eight trials of benzodiazepines.106, 128-134 The sample size was 152 in one trial;133 and ranged from 30 to 80 in the other trials. Four trials compared a benzodiazepine versus placebo,106, 130-132 one trial compared a benzodiazepine plus physical therapy versus placebo plus physical therapy,133 and three trials compared a benzodiazepine versus a skeletal muscle relaxant (carisoprodol,128 cyclobenzaprine,106 or tizanidine129). One other trial evaluated a benzodiazepine versus drugs that are not available in the United States.134 Four trials in the systematic review evaluated benzodiazepines for acute low back pain128, 129, 131, 132 and three for chronic low back pain.106, 130, 133 Two trials specifically enrolled patients with muscle spasms.106, 129 No trial focused on patients with radiculopathy; in one trial the proportion of patients with radiculopathy was 40 percent.131 Five trials evaluated diazepam106, 128, 129, 131, 132 and two trials evaluated tetrazepam (not available in the United States).130, 133 Diazepam was administered orally at doses of 5 to 10 mg three or four times daily in three trials;106, 128, 129 two trials evaluated regimens that included initial intramuscular diazepam and oral doses.131, 132 In both trials of tetrazepam, the dose was 50 mg by mouth three times daily.130, 133 The duration of therapy ranged from 6 to 14 days; two trials106, 130 evaluated patients 4 days after the completion of therapy and the others evaluated patients at the end of therapy. The review classified five trials as high quality128-131, 133 based on meeting at least 6 of 11 Cochrane Back Review group criteria; the other two trials were classified as low quality.106, 132 All trials used a blinded design. Methodological shortcomings included inadequate reporting of randomization and allocation concealment methods; some trials also did not report attrition or intention-to-treat analyses. The APS/ACP review concluded that there was fair evidence of a moderate effect of benzodiazepines for acute and chronic low back pain, based in part on evidence from populations with mixed back and neck pain, but noted that there were no reliable data on the risk of abuse of addiction.
We identified one good-quality trial (n=60) published since the APS/ACP review of diazepam 5 mg three times daily for 5 days versus placebo for acute radiculopathy due to prolapse lumbar disc (with computed tomography scan or magnetic resonance imaging confirmation) (Table 6; Appendix Tables E8, F8).135 Outcomes were evaluated through 1 year.
Table 6
Characteristics and conclusions of included benzodiapine trials.
Benzodiazepines Versus Placebo
Acute Low Back Pain
For acute nonradicular low back pain, one high-quality trial (n=50)131 included in the APS/ACP review found no differences between diazepam and placebo in likelihood of improved pain and tenderness at the end of 5 days of treatment (76% vs. 72%, RR 1.06, 95% CI 0.76 to 1.47), but a low-quality trial (n=68)132 found diazepam superior to placebo for likelihood of experiencing good or very good benefit at the end of 10 days of treatment (57% vs. 17%, RR 3.31, 95% CI 1.52 to 7.23).
Chronic Low Back Pain
For chronic nonradicular low back pain, pooled results from two high-quality trials (n=50 and 152)130, 133 included in the APS/ACP review found tetrazepam associated with lower likelihood of no improvement in pain at 5-7 days (RR 0.82, 95% CI 0.72 to 0.94) and at 10 to 14 days (RR 0.71, 95% CI 0.54 to 0.93) versus placebo, and lower likelihood of no overall improvement at 10 to 14 days (RR 0.63, 95% CI 0.42 to 0.97). In one trial, all patients also underwent physical therapy.133 One low-quality trial (n=76) found no difference between diazepam versus placebo in outcomes related to muscle spasm.106
Radicular Low Back Pain
For acute or subacute radicular pain due to herniated disc, one good-quality trial (n=60) published subsequent to the APS/ACP review found no difference between oral diazepam 5 mg twice daily for 5 days versus placebo in improvement in the RDQ (median improvement 3.0 vs. 5.0 at 1 week, p=0.67; median RDQ 2 vs. 1 at 1 year), request for additional analgesics, likelihood of improvement in neurological deficits, return to work, or likelihood of undergoing surgery through 1 year of followup.135 Diazepam was associated with lower likelihood of experiencing ≥50% improvement in pain at 1 week (41% vs. 79%, RR 0.5, 95% CI 0.3 to 0.8)
Benzodiazepines Versus Skeletal Muscle Relaxants
Acute Low Back Pain
Two high-quality trials included in the APS/ACP review evaluated diazepam versus skeletal muscle relaxants for acute low back pain.128, 129 One trial (n=30) found no differences between diazepam versus tizanidine in measures of pain relief or daily activities.129 The other trial found diazepam inferior to carisoprodol for likelihood of overall improvement (45% vs. 70%, RR 0.64, 95% CI 0.43 to 0.96) and measures of activity, sleep impairment, and overall relief at the end of a 7-day course of treatment (differences on continuous measures ranged from 12 to 19 points on a 100-point scale).128
Chronic Low Back Pain
For chronic low back pain, one trial included in the APS/ACP review found no difference between diazepam versus cyclobenzaprine in outcomes related to muscle spasm.106
Harms
In the trials of benzodiazepines included in the APS/ACP review, central nervous system adverse events such as somnolence, fatigue, and lightheadedness were reported more frequently with benzodiazepines versus placebo, though harms were not reported well.103 No trial was designed to evaluate risks with long-term use of benzodiazepines such as addiction, abuse, or overdose. Harms were not reported in one short-term trial of diazepam versus placebo published subsequent to the APS/ACP review.135
Antidepressants
Key Points
- For chronic low back pain, a systematic review found no differences in pain between tricyclic antidepressants versus placebo (4 trials; SMD −0.10, 95% CI −0.51 to 0.31; I2=32%) or SSRIs versus placebo (3 trials; SMD 0.11, 95% CI −0.17 to 0.39; I2=0%); there was also no difference between antidepressants versus placebo in function (2 trials, SMD −0.06, 95% CI −0.40 to 0.29; I2=0%) (SOE: moderate for pain, low for function).
- For chronic pain, three trials, found duloxetine associated with lower pain intensity (differences 0.58 to 0.74 on a 0 to 10 scale) and better function (differences 0.58 to 0.74 on the Brief Pain Inventory-Interference scale) versus placebo (SOE: moderate for pain and function).
- No study evaluated the effectiveness of antidepressants specifically for radicular low back pain.
- No study compared duloxetine versus a tricyclic antidepressant.
- Antidepressants were associated with higher risk of any adverse events compared with placebo, with no difference in risk of serious adverse events (SOE: moderate).
Detailed Synthesis
The APS/ACP review29 included three higher-quality systematic reviews136-138 of antidepressants for low back pain. The reviews included a total of 10 unique trials (8 placebo controlled). Based on the systematic reviews, the APS/ACP review29 concluded that that tricyclic antidepressants were slightly more effective than placebo for pain relief for chronic back pain, with no significant effects on function. There was insufficient evidence to determine the effectiveness of antidepressants for acute low back pain.
We identified a good-quality systematic review139 on antidepressants for low back pain published subsequent to the APS/ACP review (Table 1; Appendix Tables E9, F9). The review included 10 trials (n=16 to 121);140-149 seven of the trials were included in one or more of the older systematic reviews.140, 142-145, 147, 148 Only two trials required patients to have depression in addition to low back pain;144, 148 the other trials excluded patients with depression,141-143, 146 patients with depression accounted for a minority of enrollees,140, 145, 149 or depression status was not reported.147 The antidepressants assessed were tricyclic antidepressants (desipramine [3 trials], imipramine [2 trials], amitriptyline and nortriptyline [1 trial each]), selective serotonin reuptake inhibitors (paroxetine [3 trials], fluoxetine [2 trials]), tetracyclic antidepressants (maprotiline, trazodone [1 trial each]), and bupropion (1 trial.) One trial149 evaluated injectable clomipramine, an intervention which is not widely used and outside the scope of this review. All studies included a placebo arm, though three used an active placebo (either diphenhydramine,142 benztropine,141 or atropine148) meant to mimic the side effects of antidepressants without therapeutic effects on pain. One trial also compared a tetracyclic antidepressant (maprotiline) versus an SSRI (paroxetine).142 Duration of followup in the trials ranged from 10 days to 12 weeks. Nine of the trials enrolled participants with chronic pain; duration of pain was not reported in the other trial.140 Seven trials were assessed as high quality based on meeting at least 6 Cochrane Back Review Group criteria. Methodological limitations in the three lower-quality trials included inadequate description of randomization and allocation concealment methods and high rates of attrition.139
We identified five additional trials (n=60 to 404) not included in the prior systematic reviews of antidepressants for chronic low back pain (Table 7; Appendix Tables E10, F10).150-154 Three trials compared duloxetine (a serotonin-norepinephrine reuptake inhibitor) versus placebo,152-154 one trial duloxetine versus escitalopram,151 and one trial amitriptyline versus bupropion.150 One trial was rated good quality,152 three trials fair quality,151, 153, 154 and one trial poor quality.150 Methodological shortcomings in the poor- and fair-quality trials included inadequate description of randomization, allocation concealment, and blinding methods.
Table 7
Characteristics and conclusions of included antidepressant trials.
Antidepressants Versus Placebo
Chronic Low Back Pain
The systematic review found no difference between antidepressants versus placebo on pain for chronic low back pain (9 trials, SMD −0.04, 95% CI −0.25 to 0.17; I2=0%), with a point estimate close to 0 (no effect).139 In stratified analyses, there were also no differences between antidepressants versus placebo for tricyclic antidepressants (4 trials; SMD −0.10, 95% CI −0.51 to 0.31; I2=32%) or SSRIs (3 trials; SMD 0.11, 95% CI −0.17 to 0.39; I2=0%). The review also found that antidepressants were not associated with reduced depression (SMD 0.06, 95% CI −0.29 to 0.40; I2=0%) or improved function (SMD −0.06, 95% CI −0.40 to 0.29; I2=0%), but each of these outcomes was only evaluated in two trials.
One good-quality152 and two fair-quality153, 154 trials evaluated duloxetine versus placebo for chronic low back pain and were not included in the systematic review. In all three trials, duloxetine 60 mg daily was associated with better scores based on the Brief Pain Inventory-Severity Scale (differences 0.60 to 0.79 points on a 0 to 10 scale) after 12 to 13 weeks followup. Results were similar, but not statistically significant, for duloxetine 20 or 120 mg/day doses versus placebo.152 One of the trials also found 60 mg duloxetine associated with a greater likelihood of at least 50 percent improvement in pain score after 12 weeks (49% vs. 35%; RR 1.41, 95% CI 1.11 to 1.78).153
All three trials found duloxetine 60 mg daily associated with greater improvement in function versus placebo on the Brief Pain Inventory-Interference scale (mean between-group difference 0.58 to 0.74), but there were no differences on the RDQ (reported in one study; mean change from baseline −2.69 vs. −2.22; p=0.26).153 The good-quality trial found both 60 and 120 mg daily doses of duloxetine associated with greater global improvement versus placebo (mean change −0.94 vs. −1.06 vs. −0.53; p<0.05 for both comparisons), measured using the Clinical Global Impressions of Severity (CGI-S) scale, although absolute differences between the groups were small (about 0.5 point on an 0- to 7-point scale).152 Two other fair-quality trials found no differences between duloxetine and placebo in mean change in CGI-S scores.153, 154There were also few differences between duloxetine and placebo in quality-of-life outcomes, although one study found significant improvements in insomnia scores with duloxetine (mean change from baseline −1.92 versus −1.18 on the 0 to 24 Athens Insomnia Scale; p≤0.01).154
Antidepressants Plus Another Intervention Versus the Other Intervention Without Antidepressants
No study evaluated an antidepressant plus another intervention versus the other intervention alone.
Antidepressants Versus Other Interventions
One trial37 included in the APS/ACP review29 of acetaminophen versus amitriptyline is discussed in the acetaminophen section of this report.
Effectiveness of One Antidepressant Versus Another Antidepressant
Chronic Low Back Pain
Two trials included in prior reviews compared the effects of different antidepressants for chronic low back pain. One trial (n=108) found a tetracyclic antidepressant (maprotiline) superior to an SSRI (paroxetine) for pain relief after 8 weeks using the Descriptor Differential Scale (−5.41 vs. −2.34 on a 0 to 20 scale; p=0.013).142 A smaller (n=40), lower-quality trial found no difference between a tricyclic antidepressant (amitriptyline) versus an SSRI (fluoxetine) in the likelihood of experiencing at least moderate pain relief after 6 weeks (82% [14/17] vs. 78% [14/18]; RR 1.06, 95% CI 0.76 to 1.47.)155
We identified one fair-quality study (n=85) not included in prior systematic reviews that compared the effects of different antidepressants for low back pain.151, 152 It found no differences between duloxetine versus an SSRI (escitalopram) in pain, function, or quality of life. A third, poor-quality study (n=60) found no differences between a tricyclic antidepressant (amitriptyline) versus bupropion in pain after 8 weeks of use.150
Harms
The APS/ACP review29 found antidepressant use associated with a higher risk for any adverse event compared with placebo (22% vs. 14%; RR 1.73, 95% CI 1.17 to 2.55) based on an older systematic review.137 However, there were no differences between antidepressants versus placebo in rates of specific adverse events, including drowsiness (p=0.61), dizziness (p=0.84), dry mouth (p=0.55), constipation (p=0.28), or sexual dysfunction (p=0.23). The trials were not designed to assess for risk of serious adverse events.
Three recent trials found no differences between duloxetine versus placebo in risk of serious adverse events, with no deaths reported.152-154 Duloxetine was associated with increased risk of withdrawal due to adverse events (3 trials, duloxetine any dose vs. placebo [OR 2.72, 95% CI 1.74 to 4.24; I2=0%]; duloxetine 60 mg versus placebo [OR 2.52, 95% CI 1.58 to 4.03; I2=0%]). Duloxetine was also associated with increased risk of nausea (p<0.05), but there was no clear increase in risk of other specific adverse events. Trials of escitalopram versus duloxetine151 or amitriptyline versus bupropion150 found no differences in risk of adverse events.
Antiseizure Medications
Key Points
- No trial evaluated antiseizure medications for acute nonradicular low back pain.
- One trial found no difference between gabapentin (up to 3600 mg/day) versus placebo for chronic nonradicular low back pain, but did not meet inclusion criteria because it was only published as an abstract (SOE: insufficient).
- For chronic radicular low back pain, there was insufficient evidence from three poor-quality trials with inconsistent findings to determine effects of gabapentin versus placebo (SOE: insufficient).
- For chronic radicular low back pain or mixed radicular and nonradicular low back pain, two trials reported inconsistent results for effects of topiramate versus placebo (SOE: insufficient).
- For chronic radicular low back pain, two trials reported inconsistent effects of pregabalin versus placebo for pain or function (SOE: insufficient).
- For chronic radicular or nonradicular low back pain, there was insufficient evidence from one poor-quality trial to determine effects of pregabalin versus amitriptyline (SOE: insufficient).
- For chronic nonradicular low back pain, one small trial found the addition of pregabalin 300 mg/day to transdermal fentanyl associated with substantially lower pain scores than transdermal buprenorphine alone at 3 weeks (difference ∼26 points on a 0 to 100 scale, p<0.05) but the estimate was very imprecise (SOE: insufficient).
- For chronic radicular pain, one trial found pregabalin (mean 2.1 mg/kg/day) plus celecoxib associated with lower pain scores than celecoxib alone (difference 11 points on a 0-100 scale, p=0.001) after 4 weeks and one trial found no effects of adding pregabalin (titrated to 300 mg/day) to tapentadol PR versus tapentadol PR alone on pain or the SF-12 after 8 weeks (SOE: insufficient).
- Two trials of gabapentin versus placebo reported no clear differences in risk of adverse events (SOE: low).
- Two trials of topiramate versus placebo reported inconsistent effects on risk of withdrawal due to adverse events; one of the trials found topiramate associated with higher risk of sedation and diarrhea (SOE: insufficient).
- Two trials of pregabalin versus placebo reported inconsistent effects on risk of withdrawal due to adverse events, somnolence, and dizziness; one of the trials used an enrichment/withdrawal design (SOE: insufficient).
Detailed Synthesis
The APS/ACP review29 included four trials of antiseizure medications for low back pain.156-159 Two trials (n=50 and 65)157, 159 evaluated gabapentin and two trials (n=29 and 96)156, 158 evaluated topiramate. All trials compared antiseizure medications versus placebo, with one trial156 utilizing an “active” placebo (diphenhydramine). Three trials156, 157, 159 evaluated patients with radicular symptoms and one trial (of topiramate)158 evaluated a mixed population of patients with radicular or nonradicular pain.
We identified seven trials of antiseizure medications for low back pain published subsequent to the APS/ACP review (Table 8; Appendix Tables E11, F11).160-166 Sample sizes were 200 to 309 in the three largest trials160-162 and ranged from 26 to 55 in the other four trials. Six trials160-165 evaluated pregabalin and one trial166 evaluated gabapentin. Two trials compared pregabalin versus placebo160 or active placebo (diphenhydramine)163 and one trial166 compared gabapentin versus no gabapentin. Three trials compared pregabalin plus another medication (tapentadol,161 transdermal buprenorphine,164 or celecoxib165) versus the other medication without pregabalin and one trial162 compared pregabalin versus amitriptyline. The celecoxib trial also compared pregabalin alone versus celecoxib alone.165 Five trials evaluated patients with radicular symptoms,160, 161, 163, 165, 166 with two trials163, 166 focusing on patients with spinal stenosis. One trial was restricted to patients with nonradicular back pain164 and one trial enrolled a mixed population of radicular and nonradicular back pain.162
Table 8
Characteristics and conclusions of included antiseizure trials.
All of the trials, including those in the APS/ACP review, evaluated patients with chronic symptoms. Dosing of antiseizure medications varied. One trial evaluated fixed-dose pregabalin 300 mg/day in combination with transdermal buprenorphine.164 In the other pregabalin trials, doses were titrated, though titration protocols and maximum doses varied. Two trials156, 158 of topiramate titrated doses to 300 or 400 mg/day and three trials titrated gabapentin to a maximum dose that ranged from 1200 to 3600 mg/day.157, 159, 166 The duration of therapy ranged from 2 weeks to 4 months; outcomes were assessed at the end of or during therapy in all trials except for one,161 which evaluated patients 1-2 weeks after completing 8 weeks of therapy.
Three trials156, 163, 165 used a crossover design and the rest were parallel-group trials. Six trials158, 160, 161, 163-165 were rated fair quality and four156, 157, 159, 166 poor quality. Methodological shortcomings included inadequate description of randomization and allocation concealment methods and unclear blinding of outcome assessors. Additional shortcomings in the poor-quality trials included unblinded design or unclear blinding status, high attrition, and failure to perform intention-to-treat analysis. One trial of pregabalin used an enrichment/withdrawal design.160 None of the crossover trials reported results of the first intervention period and two of the crossover trials163, 165 did not assess for carryover effects, though all employed a washout period between interventions.
We excluded one trial (n=113) of gabapentin (up to 3600 mg/day) versus placebo for chronic nonradicular pain only published as an abstract.167
Antiseizure Medications Versus Placebo
Acute Low Back Pain
No trial evaluated antiseizure medications for acute nonradicular low back pain.
Chronic Low Back Pain
One trial ( n=113) of gabapentin (titrated up to 3600 mg/day) versus placebo for nonradicular low back pain was excluded because it has only been published as an abstract, but otherwise met inclusion criteria.167 It found no differences between gabapentin versus placebo in outcomes related to pain, function, or quality of life.
Radicular Low Back Pain
Two poor-quality trials included in the APS/ACP review evaluated gabapentin versus placebo for chronic radicular back pain.157, 159 One trial (n=80) found no clear differences between gabapentin (titrated up to 1200 mg/day) versus placebo in back pain at rest, back pain with movement, or leg pain (mean differences ∼0.3 to 0.5 points on a 0 to 10 scale, p for between-group differences not reported).157 The other trial (n=50), which used higher doses of gabapentin (titrated up to 3600 mg/day) found gabapentin associated with greater improvement in back pain at rest versus placebo (mean change from baseline −1.04 vs. −0.32 on a 0 to 3 scale, p<0.01).159
One subsequent poor-quality trial (n=55) of patients with chronic radicular symptoms due to spinal stenosis found gabapentin (titrated up to 2400 mg/day) associated with lower pain scores at 4 months (2.8 vs. 4.7 on 0 to 10 scale, p=0.006), increased likelihood of being able to walk >1000 m (65% vs. 21% at 4 months, p=0.001), and decreased likelihood of sensory deficit (32% vs. 63%).166 However, it was unclear if patients were blinded and attrition was not reported.
Two trials included in the APS/ACP review evaluated topiramate (titrated up to 300 or 400 mg/day) versus placebo or active placebo.156, 158 For chronic radicular or nonradicular pain, a fair-quality trial (n=96) found topiramate moderately more effective than placebo for improving Pain Rating Index scores (about 11 points on a 0 to 100 scale, p<0.001).158 Topiramate was also more effective than placebo for improving scores on all SF-36 subscales. The largest difference was on the physical function subscale (9.1 points, range 0.6 to 8.3 points for other subscales). For chronic radicular pain, a poor-quality trial (n=41)156 found topiramate more effective than diphenhydramine for improving back and overall pain, though mean differences were small (less than one point on a 0 to 10 scale). There were no statistically significant differences in leg pain, ODI scores, or SF-36 scores. Topiramate was also associated with a higher likelihood of patients reporting moderate to complete pain relief (54% vs. 24%, p=0.005).
Two fair-quality trials published subsequent to the APS/ACP review evaluated pregabalin versus placebo. One trial (n=211) that used an enrichment/withdrawal design found no differences between pregabalin (mean dose 410 mg/day) versus placebo in pain (mean change from baseline −0.16 vs. 0.05 on a 0-10 scale, p=0.33), the EQ-5D, or the RDQ.160 Pregabalin was superior for outcomes related to sleep and Hospital Anxiety and Depression Scale (HADS), but effects were small (difference in sleep quality less than 0.5 hours, and differences in HADS anxiety and depression scores ∼1 point on a 0 to 21 scale). The other, smaller (n=26) trial, which evaluated patients with neurogenic claudication due to spinal stenosis, found no differences between pregabalin (titrated to 150 mg twice daily) versus an active placebo (diphenhydramine) in the ODI, pain with ambulation, walking distance, or the Swiss Spinal Stenosis Questionnaire after 10 days.163 Pregabalin was associated with slightly worse mean RDQ at 2 weeks (13 vs. 11, p=0.01).
Antiseizure Medications Versus Another Medication
Radicular Low Back Pain
For chronic radicular pain, one fair-quality trial (n=36) found no differences between pregabalin (mean 2.1 mg/kg/day) versus celecoxib (mean 4.2 mg/kg/day) in pain scores after 4 weeks (mean 43 vs. 40 on a 0-100 scale).165
Mixed (Radicular or Nonradicular) Low Back Pain
For chronic radicular or nonradicular low back pain, one poor-quality trial (n=200) found no clear differences between pregabalin (mean dose ∼430 mg/day) versus amitriptyline (mean dose 38 mg/day) in mean pain (3.8 vs. 2.8 on 0 to 10 VAS, p>0.05) or function scores (22 vs. 17 on the ODI, p>0.05) through 14 weeks, though pregabalin was associated with greater likelihood of ≥50% improvement in pain score (RR 0.68, 95% CI 0.51 to 0.92) or >20% improvement in the ODI (RR 0.76, 95% CI 0.59 to 0.97).162
Antiseizure Medications Plus Another Medication Versus the Other Medication Alone
Chronic Low Back Pain
For chronic nonradicular low back pain, one fair-quality trial (n=44) found the addition of pregabalin 300 mg/day to transdermal buprenorphine associated with substantially lower pain scores versus transdermal buprenorphine alone at 3 weeks (difference ∼26 points on a 0 to 100 scale, p<0.05).164
Radicular Low Back Pain
For chronic radicular pain, one trial (n=36) found pregabalin (mean 2.1 mg/kg/day) plus celecoxib associated with lower pain scores versus celecoxib alone (difference 11 points on a 0-100 scale, p=0.001) after 4 weeks165 and one trial (n=309) found no effects of adding pregabalin (titrated to 300 mg/day) to tapentadol PR versus tapentadol PR alone on pain, the SF-12, the EQ-5D, or HADS anxiety or depression scores 1 to 2 weeks after an 8-week course of therapy.161 Both trials were rated fair quality.
Harms
Two trials of gabapentin versus placebo evaluated harms. In one trial, withdrawal due to adverse events occurred in 2 of 25 patients randomized to gabapentin versus none of 25 randomized to placebo.159 In the other trial, no withdrawals due to adverse events occurred, though drowsiness (6%), loss of energy (6%), and dizziness (6%) were reported with gabapentin.157 One subsequent trial of gabapentin versus placebo also reported no withdrawals, though ataxia (7%) was reported with gabapentin.166
Harms were reported in two trials of topiramate versus placebo.156, 158 One trial found topiramate associated with higher likelihood of withdrawal due to adverse events versus diphenhydramine (33% vs. 15%),156 but there was no difference between topiramate versus placebo in rates of withdrawal due to adverse events in the other (4% vs. 4%).158 Topiramate was also associated with higher rates of withdrawal due to adverse events (33% vs. 15%), sedation (34% vs. 3%) and diarrhea (30% vs. 10%) compared with diphenhydramine in one trial.156
Two trials published reported harms associated with pregabalin versus placebo.160, 163 One trial163 found pregabalin associated with greater risk of any adverse event versus diphenhydramine (active placebo) (64% vs. 35%), though the other trial160 found no difference versus inert placebo (41% vs. 42%). Serious adverse events were rare (2 events in one trial and none in the other). The trials also reported inconsistent results for somnolence and dizziness, with one trial163 reporting increased risk and the other160 no difference. In the trial that reported no differences, patients randomized to placebo were withdrawn from pregabalin after being stabilized on it (enrichment/withdrawal design).160
Three trials of pregabalin plus another drug (transdermal buprenorphine, celecoxib, or tapentadol PR) versus the other drug alone found no differences in risk of withdrawal due to adverse events or other side effects, though estimates were imprecise due to small samples.161, 164, 165
Corticosteroids
Key Points
- For acute nonradicular low back pain, two trials found no differences between a single intramuscular injection or a 5-day course of systemic corticosteroids versus placebo for pain or function (SOE: low for pain and function).
- For radicular low back pain (acute or unspecified duration) five trials consistently found no differences between systemic corticosteroids (administered a single bolus or as a short taper) versus placebo in pain or function; one trial found no effect on need for spine surgery (SOE: moderate for pain and function).
- For spinal stenosis, one trial found no differences through 12 weeks of followup between a 3-week course of prednisone versus placebo in pain intensity, the RDQ, or any SF-36 subscale (SOE: low for pain and function).
- Trials of systemic corticosteroids did not report serious adverse events, including hyperglycemia requiring medical treatment, but adverse events were not reported well in some trials (SOE: low).
Detailed Synthesis
The APS/ACP review29 included four trials of systemic corticosteroids.168-171 Three trials (n=49 to 60)168, 170, 171 evaluated systemic corticosteroids in patients with radiculopathy and one trial (n=86)169 evaluated patients with nonradicular back pain. For radiculopathy, the APS/ACP review concluded that there was consistent evidence that systemic corticosteroids were not associated with clinically significant benefits when given as a single large parenteral bolus or as a short oral or intramuscular taper.
We identified four trials172-175 of systemic corticosteroids published subsequent to the APS/ACP review and one older trial176 that was not included in the APS/ACP review (Table 9; Appendix Tables E12, F12). Three trials (n=27 to 78)173, 174, 176 evaluated patients with radicular pain, one trial (n=61) evaluated patients with spinal stenosis175 and one trial (n=67)172 evaluated patients with nonradicular pain.
Table 9
Characteristics and conclusions of included corticosteroid trials.
All of the trials were placebo-controlled. Five trials168, 169, 172-174 evaluated patients with acute low back pain (including the two trials of nonradicular back pain)169, 172 and the other four170, 171, 175, 176 did not specify the duration of symptoms. Three trials were conducted in emergency department settings,169, 172, 173 one trial in an inpatient setting,168 and in the other trials the clinical setting was not reported or mixed. The doses and mode of administration of corticosteroids varied. Three trials evaluated a single dose of parenteral (intravenous or intramuscular) methylprednisolone (150 to 500 mg, equivalent to 187.5 to 625 mg of prednisone).168, 169, 173 In the other trials, the duration of treatment ranged from 5 to 21 days. Three trials evaluated similar tapering courses of oral or intramuscular dexamethasone (64 mg for 1 day, 32 mg for 1 day, 24 mg for 1 day, 12 mg for 1 day, and 8 mg for 3 days [64 mg of dexamethasone equivalent to 400 mg of prednisone]).170, 171, 176 The other three trials evaluated different courses of oral prednisone (50 mg for 5 days,172 60 mg for 3 days, 40 mg for 3 days, and 20 mg for 3 days,174 or 1 mg/kg/day for 1 week, with a one-third dose reduction each week175). The three single-dose trials evaluated patients at 10 days to 1 month after administration; in the other trials followup ranged from within 2 days after a 5 or 7 day course of therapy171, 172 to 1 to 4 years after a 1-week course of therapy.170
Among the trials of systemic corticosteroids for radiculopathy, two trials173, 174 required a positive straight leg raise for inclusion and four others168, 170, 171, 176 required a positive straight leg raise or other signs of radiculopathy (e.g., sensory, motor, or reflex deficit). One of the latter trials also required imaging findings of a herniated disc that correlated with radicular symptoms.168 The trial of patients with spinal stenosis required presence of neurogenic claudication symptoms and imaging findings of central stenosis.175
Three trials168, 169, 173 were rated good quality, five trials fair quality,170-172, 175, 176 and one trial poor quality.174 Methodological shortcomings in the fair-quality trials included inadequate description of allocation concealment, unclear blinding of outcomes assessors, and unclear compliance to interventions. The poor-quality trial allocated patients sequentially.174
One trial (n=100) of dexamethasone versus placebo for nonradicular low back pain was excluded because it was published in German, but otherwise met inclusion criteria.177
Systemic Corticosteroids Versus Placebo
Acute Low Back Pain
Two trials evaluated the effects of systemic corticosteroids versus placebo for acute nonradicular low back pain.169, 172 The APS/ACP review included one good-quality trial (n=86) that found no differences between a single intramuscular injection of 160 mg daily methylprednisolone versus placebo in pain relief or improvement in the RDQ at 1 week or 1 month.169 A subsequent trial (n=67) also found no difference between a 5-day course of oral prednisone 50 mg daily versus placebo in measures of pain, days of work lost, or likelihood of seeking care at 5-7 days, though estimates favored the placebo group.172
One other trial (n=100) was excluded because it was published in German, but also found no effects of dexamethasone versus placebo for nonradicular pain.177
Radicular Low Back Pain
For radiculopathy, three trials included in the APS/ACP review found no differences between systemic corticosteroids (administered as a single large parenteral bolus or as a short oral or intramuscular taper) versus placebo.168, 170, 171 One good-quality trial (n=60), which was also the only trial to require imaging correlation of radicular symptoms, found a single large bolus of methylprednisolone associated with small (average 6 mm on a 0-100 scale) early improvement in leg pain versus placebo, but the benefits was no longer present after the first 3 days.168 There were no differences in the degree of pain relief, functional disability, the proportion requiring spine surgery within the first month, or medication use. In two fair-quality trials (n=33 and 49), 7-day tapering courses of either oral or intramuscular dexamethasone (initial dose 64 mg/day) were not associated with differences in overall effect or likelihood of subsequent surgery, either at the end of treatment or after 1 to 4 years of followup.170, 171
Two subsequent trials of patients with acute radicular low back pain also found no differences between systemic corticosteroids versus placebo in improvement in pain, the RDQ, return to work, use of medications, or the likelihood of seeking additional health care.173, 174 A good-quality trial (n=78)173 evaluated outcomes through 1 month after a single dose of intramuscular methylprednisolone 160 mg and one poor-quality trial (n=27)174 evaluated outcomes through 6 months after a tapering course of prednisone (initial dose 60 mg/day. One other older, fair-quality trial (n=39) that was not included in the APS/ACP review also found no difference between a tapering course of intramuscular dexamethasone (initial dose 64 mg/day) versus placebo in likelihood of experiencing “clear improvement” through 3 months.176
Spinal Stenosis
For spinal stenosis, one trial not included in the APS/ACP review found no differences through 12 weeks of followup between a 3-week course of prednisone versus placebo in pain intensity, the RDQ, or any SF-36 subscale.175
Harms
One trial reported two cases of transient hyperglycemia and one case of facial flushing following administration of a large (500 mg) intravenous methylprednisolone bolus.168 In two trials, a smaller (160 mg) intramuscular methylprednisolone injection was associated with no cases of hyperglycemia requiring medical attention, infection, or gastrointestinal bleeding.169, 173 One other older trial not included in the APS/ACP review found a tapering course of intramuscular dexamethasone (initial dose 64 mg/day) associated with increased risk of any side effect (32% vs. 5.0%, RR 6.32, 95% CI 0.84 to 47.7), but no patients in either group withdrew due to adverse events.176 Adverse events were not reported well in the other trials of systemic corticosteroids.
Topical Medications
No study evaluated topical capsaicin or lidocaine for low back pain.
Key Question 2. What are the comparative benefits and harms of different nonpharmacological noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes but is not limited to multidisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, transcutaneous electrical nerve stimulation, electrical muscle stimulation, interferential therapy, heat [various forms], and ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets, and low-level lasers
Exercise and Related Interventions: Exercise
Key Points
- For acute low back pain, a systematic review found no differences between exercise therapy versus no exercise in pain (3 trials, WMD 0.59 at intermediate term on a 0 to 100 scale, 95% CI −11.51 to 12.69) or function (3 trials, WMD at short term −2.82, 95% CI −15.35 to 9.71 and WMD 2.47 at intermediate term, 95% CI −0.26 to 5.21). For subacute low back pain, there were also no differences in pain (5 trials, WMD 1.89 on a 100-point scale, 95% CI −1.13 to 4.91) or function (4 trials, WMD 1.07, 95% CI −3.18 to 5.32). Three subsequent trials for acute to subacute low back pain reported inconsistent effects of exercise versus usual care on pain and function (SOE: low for pain and function).
- For chronic low back pain, a systematic review found exercise associated with greater pain relief versus no exercise (19 trials, WMD 10 on a 0 to 100 scale, 95% CI 1.31 to 19.09), though the effect on function was small and not statistically significant (17 trials, WMD 3.00 on a 0 to 100 scale, 95% CI −0.53 to 6.48). Results from a more recent systematic review using more restrictive criteria and additional trials not included in the systematic reviews were generally consistent with these findings (SOE: moderate for pain and function).
- For chronic low back pain, a systematic review included two trials that found motor control exercise (MCE) associated with lower pain scores in the short term (WMD −12.48 on a 0 to 100 scale, 95% CI−19.04 to −5.93), intermediate term (WMD −10.18, 95% CI −16.64 to −3.72) and at long term (WMD −13.32 95% CI −19.75 to −6.90) versus a minimal intervention. MCE was also associated with better function at short term (3 trials WMD −9.00 on 0 to 100 scale, 95% CI −15.28 to −2.73), intermediate term (2 trials WMD −5.62, 95% CI−10.46 to −0.77) and long term (2 trials, WMD −6.64, 95% CI −11.72 to −1.57) (SOE: low for pain and function).
- For nonacute low back pain, a systematic review found no clear effects of exercise therapy versus usual care on likelihood of short- or intermediate-term (∼6 months) disability, but exercise was associated with lower likelihood of work disability at long-term (∼12 months) followup (10 comparisons in 8 trials, OR 0.66, 95% CI 0.48 to 0.92) (SOE: moderate for pain and function).
- For radicular low back pain, three trials not included in the systematic reviews found effects that favored exercise versus usual care or no exercise in pain and function, though effects were small (SOE: low for pain and function).
- For chronic low back pain, a systematic review found MCE associated with lower pain intensity at short term (6 trials, WMD −7.80 on 0 to 100 scale, 95% CI −10.95 to −4.65) and intermediate term (3 trials, WMD −6.06, 95% CI −10.94 to −1.18) versus general exercise, but effects were smaller and no longer statistically significant at long-term (4 trials, WMD −3.10, 95% CI −7.03 to 0.83). MCE was also associated with better function in the short term (6 trials, WMD −4.65 on 0 to 100 scale, 95% CI −6.20 to −3.11) and long term (3 trials, WMD −4.72, 95% CI −8.81 to −0.63). One of two subsequent trials found no effect on pain, though effects on function were consistent with the systematic review (SOE: low for pain and function).
- For comparisons involving other types of exercise techniques, there were no clear differences in >20 head-to-head trials of patients with acute or chronic low back pain (SOE: moderate).
- Harms were poorly reported in trials of exercise. When reported, harms were typically related to muscle soreness and increased pain, or no harms were reported; no serious harms were reported (SOE: low).
Detailed Synthesis
The APS/ACP review29 included six systematic reviews178-184 with a total of 79 unique trials and one additional large, lower-quality trial.185 The most comprehensive systematic review in the APS/ACP review found no differences between exercise therapy versus no exercise for acute low back pain in pain (3 trials, WMD 0.59 at intermediate term on a 0 to 100 scale, 95% CI −11.51 to 12.69) or function (3 trials, WMD at short term −2.82, 95% CI −15.35 to 9.71 and WMD 2.47 at intermediate term, 95% CI −0.26 to 5.21).179 For subacute low back pain, there were also no differences in pain (5 trials, WMD 1.89 on a 100-point scale, 95% CI −1.13 to 4.91) or function (4 trials, WMD 1.07, 95% CI −3.18 to 5.32). For chronic low back pain, the APS/ACP review found good evidence that exercise is moderately superior to no exercise for pain relief (19 trials, WMD 10 on a 0 to 100 scale, 95% CI 1.31 to 19.09), though the effect on function was small and not statistically significant (17 trials, WMD 3.00 on a 0 to 100 scale, 95% CI −0.53 to 6.48). Results of the other reviews were generally consistent with these findings. Based on this evidence, the APS/ACP review concluded that there was fair evidence of no benefit for exercise versus no exercise for acute or subacute low back pain, and good evidence for moderate benefits of exercise versus no exercise for chronic low back pain.
We included three fair-quality systematic reviews of exercise for low back pain published subsequent to the APS/ACP review (Table 10; Appendix Tables E13, F13).186-188 One focused on exercise for nonspecific chronic low back pain187 one evaluated effects of exercise on work disability in patients with nonacute, nonspecific low back pain (duration >4 weeks),188 and the third focused on effects of motor control exercise (MCE), which was not addressed in the APS/ACP review and not covered well in the other reviews.186
Table 10
Summary of systematic reviews of nonpharmacological treatments for low back pain.
The first review focused on various types of exercise therapy for chronic low back pain and included 37 RCTs (n=3957).187 Shortcomings of this review included limited description of included trial characteristics (including exercise treatments) failure to report statistical heterogeneity for pooled analyses, and lack of sensitivity or subgroup analyses. The systematic review included eight trials from a previous review179 plus 29 additional trials; it excluded a number of trials in the previous review because it applied more strict criteria to define chronic low back pain (≥ 12 weeks), and only enrolled trials of patients with nonspecific low back pain. Exercise was compared against wait list/no treatment (8 RCTs), usual care (6 RCTs), back school or education (3 RCTs), and other forms of exercise therapy (11 RCTs). Exercise interventions varied and included general strengthening, stretching, or aerobic exercise; motor control and stabilization exercises; physiotherapy; multidisciplinary programs; and specific techniques such as the active trunk exercise protocol.187 Comparisons of exercise versus other active interventions (behavioral treatment, passive modalities [TENS, laser, ultrasound, massage], spinal manipulations and psychotherapy), are discussed in the sections of this report addressing those interventions. Outcomes were assessed at the end of treatment, at short term (3 months), intermediate term (6 months), and long term (>6 months). Of the 27 trials providing data for the above comparisons,189-215 11 (41%) were rated low risk of bias, based on meeting ≥6 of 11 Cochrane Back Review Group criteria.191-193, 197, 198, 201-203, 207, 209, 214, 216 Methodological flaws included failure to describe adequate randomization methods (26% of trials) or allocation concealment (48%), inadequate description of cointerventions(63%), unclear compliance with treatment (56%), failure to report intention-to-treat analysis (48%), and high or unreported attrition (33%). Given the nature of exercise interventions, blinding of patients and care providers was generally not possible; in addition, 67 percent of trials did not report blinding of outcome assessors.
The second review evaluated effects of exercise specifically on work disability in patients with nonacute (>4 weeks), nonspecific low back pain.188 It included 23 trials (n=4138), 20 of which were included in meta analyses. Sample sizes ranged from 49 to 476 and duration of low back pain varied from 4 weeks to greater than 12 months. Exercise was compared against usual care (13 RCTs, n=3181) and other forms of exercise (11 RCTs). Exercise interventions varied and included stabilization, strengthening, stretching, and mobilization, though exercise regimens were most frequently mixed. About half of the exercise interventions were administered in the context of a cognitive behavioral approach. The majority of interventions (91%) were supervised exercise conducted in an outpatient setting (77%). Nine trials206, 217-224 (39%) were rated high quality and the remainder were rated low quality, based on risk of bias criteria by Juni et al. Methodological shortcomings included detection bias in 12 trials (52%), selection bias in 9 trials (39%), and attrition bias in 8 trials (35%).
The third review included 16 trials of MCE (sample size range 30 to 346, total n=1993).186 MCE (also referred to as specific stabilization exercise) focuses on strengthening of deep muscles of the spine through a specific stabilization protocol, while reducing unwanted overactivity of other muscles.225 Methodological limitations of the review are that it did not report details regarding study quality (it reported an overall assessment only), did not report statistical heterogeneity in pooled analyses, and did not report harms. We addressed these issues through additional review and assessment of the primary studies. The review included seven trials of MCE versus various types of general exercise (including sling exercise, trunk strengthening, walking, cardiovascular and McKenzie exercises),192, 226-231 three trials of MCE versus a minimal intervention (no intervention, advice/education or placebo short-wave therapy and ultrasound),196, 232, 233 and four trials of MCE versus multimodal physical therapy (including ultrasound, electrotherapy, lumbar strengthening, passive physical therapy and general exercise).230, 234-236 Two trials evaluated MCE as part of a multimodal intervention versus other components of that intervention.237, 238 Eight trials included only chronic low back pain patients;192, 196, 226, 228-230, 232, 233 three trials also included patients with subacute low back pain, but mean duration of symptoms was 25 to 34 months.231, 234, 236 Three trials focused on patients with recurrent low back pain, with the duration of the current episode ranging from >6 weeks to >3 months.231, 235, 237 Most trials selected patients for inclusion on the basis of tests showing deficits in motor control, but the specific methods and criteria for inclusion varied. The duration of treatment ranged from 6 to10 weeks; six trials evaluated patients 10 to 28 months after the end of treatment. In two trials, MCE was administered through 20 treatment sessions (time frame not described), with followup for 180 days. The systematic review classified 10 trials as high quality, based on scoring ≥6 points on the 10 point PEDro scale192, 226, 227, 229, 230, 232-238 and six low quality.196, 227, 229, 231, 233, 234 Common methodological shortcomings included unclear or inappropriate randomization methods and unclear allocation concealment; patients and care providers generally could not be blinded. Some trials also reported discrepancies in baseline characteristics or differential attrition. Data were pooled for short term (≥6 weeks to <4 months) intermediate term (≥4 months to <8 months) and long term (≥8 months <15 months).
We identified 17 trials with sample sizes >100 of exercise for low back pain that were not included in the systematic reviews (Table 11; Appendix Tables E14, F14).239-255 Three trials evaluated exercise versus no exercise or usual care for acute to subacute low back pain,244, 254, 255 two trials compared different types of exercise for patients primarily with subacute low back pain,243, 246 four trials compared exercise versus no exercise or usual care for chronic low back pain,250-252, 256 four trials compared different types of exercise for chronic low back pain,241, 249, 251, 253 and four trials evaluated exercise versus various other interventions for radicular low back pain.239, 240, 242, 248 Exercise techniques varied but included general exercise, strengthening, the McKenzie method, exercise based on a treatment-based classification (TBC) system, the Alexander technique, periodized musculoskeletal rehabilitation, walking, MCE and others. Four trials were rated good quality,241, 242, 250, 252 seven trials fair quality,239, 240, 244, 245, 249, 253-255 and five poor quality.243, 246, 248, 251, 256 Methodological shortcomings included inadequate allocation concealment, failure to clearly described cointerventions, and failure to report compliance to treatment. Patients and people administering exercise could not be effectively blinded given the nature of the interventions.
Table 11
Characteristics and conclusions of included exercise trials.
We also identified 28 trials not included in the systematic reviews that evaluated exercise therapy for subacute to chronic low back pain, but enrolled fewer than 100 patients. Eighteen trials compared exercise versus no exercise or usual care197, 200, 257-272 and 15 compared different forms of exercise.197, 200, 258, 261, 271, 273-282 Given the number of larger trials on exercise, we did not abstract these studies in detail.
Exercise Therapy Versus Placebo, Usual Care, or No Treatment
Acute to Subacute Low Back Pain
As noted above, a systematic review included in the prior APS/ACP review found no differences between exercise therapy versus usual care for acute low back pain in pain (3 trials, WMD 0.59 at intermediate term on a 0 to 100 scale, 95% CI −11.51 to 12.69) or function (3 trials, WMD at short term −2.82, 95% CI −15.35 to 9.71 and WMD 2.47 at intermediate term, 95% CI −0.26 to 5.21).179 For subacute low back pain, there were also no differences in pain (5 trials, WMD 1.89 on a 100-point scale, 95% CI −1.13 to 4.91) or function (4 trials, WMD 1.07, 95% CI −3.18 to 5.32).
We identified three subsequent trials of exercise therapy for acute to subacute low back pain.244, 254, 255 For acute or subacute low back pain, a fair-quality trial (n=259) found the combination of exercise plus advice associated with lower pain scores versus no exercise or advice at the end of the 6-week intervention (mean difference −1.5 on a 0 to 10 scale, 95% CI −2.2 to −0.7); the difference favored exercise plus advice at 3 months (mean difference −1.1, 95% CI–2.0 to −0.3), but was smaller and no longer statistically significant at 12 months (mean difference −0.8, 95% CI −1.7 to 0.1).255 Exercise plus advice was also associated with better scores on the Patient-Specific Functional Scale (PSFS) (differences 1.1 to 1.3 on a 0 to10 scale) and on a Global Perceived Effect scale at 3 months. Differences on the RDQ tended to favor exercise plus advice (mean differences −0.9 to −1.3) but were small and not statistically different. For acute low back pain, one fair-quality trial (n=148) found six sessions of McKenzie exercise over 3 weeks associated with lower pain intensity at one (mean difference, −0.4 points on a 0 to 10 scale, 95% CI −0.8 to −0.1) and 3 weeks (−0.7, 95% CI −1.2 to −0.1) versus usual care, though effects were small.254 There were no differences in disability at either time point (mean differences −0.2 and −0.3 on the RDQ), global perceived effects (mean differences 0.3 to 0.5 on a −5 to 5 scale), or risk of developing persistent low back pain (RR 1.1, 95% CI 0.8 to 1.6).The third, fair-quality trial (n=246) found no differences between 8 weeks of trunk muscle stabilization exercise versus no treatment in patients with 8 to 12 weeks of low back pain, with outcomes measured as 6 to 24 months.244
Chronic Low Back Pain
As described above, a systematic review included in the APS/ACP review found exercise moderately superior to placebo for pain relief (19 trials, WMD 10 on a 0 to 100 scale, 95% CI 1.31 to 19.09), though the effect on function was small and not statistically significant (17 trials, WMD 3.00 on a 0 to 100 scale, 95% CI −0.53 to 6.48).179 A more recent systematic review187 that used more restrictive inclusion criteria also found exercise therapy associated with decreased pain intensity (3 trials, WMD −9.23, 95% CI −16.02 to −2.43)193, 200, 210 and better function (3 RCTs, WMD −12.35 on a 0 to 100 scale, 95% CI −23.0 to −1.69)193, 200, 210 versus usual care at the end of treatment. Effects on function were smaller but remained statistically significant at intermediate- and long-term followup (mean differences −5.23 and −3.17). Effects on pain were also smaller, and no longer statistically significant at long-term followup (mean difference −4.94, 95% CI −10.45 to 0.58).193, 203, 214
One good-quality trial (n=579) not included in the systematic review used a factorial design that randomized patients to usual care, massage, 6 sessions of Alexander, or 24 sessions of Alexander; half of the patients in each group was also randomized to exercise.252 Exercise was associated with fewer days with low back pain (in the previous 4 weeks) at 3 months (difference −6 days, 95% CI −9 to −3) versus no exercise but the effect was not significant at 12 months (difference −2 days, 95% CI −5 to 1). Effects on the RDQ also favored exercise at 3 months (mean difference −0.9, 95% CI −1.76 to 0.04) and 12 months (−1.29, 95% CI −2.25 to −0.43). There were no differences between exercise versus no exercise in the SF-36 Pain Catastrophizing Scale (PCS) at 3 or 12 months (mean differences of 3.0 and 1.9 on a 0-100 scale); exercise was associated with small positive effects on the mental component score of the SF-36 (MCS) at 3 months (mean difference 4.4, 95% CI 0.65 to 7.43 on 0 to 100 scale) that were not sustained to 12 months (mean difference, 0.9 95% CI (−2.8 to 4.6).
In the same trial, compared with usual care, 24 Alexander technique sessions were associated with fewer days with back pain at 3 months (difference −16 days, 95% CI −21 to −11) and 12 months (difference −18 days, 95% CI −23 to −13) and with better function at both time frames (mean differences on the RDQ −2.91, 95% CI 4.16 to 1.66 at 3 months and −3.4, 95% CI −4.6 to −0.03 at 12 months). The 24 session intervention was also associated with better scores on the SF-36 PCS at both time points (mean differences 7.5 and 11.3); effects on the MCS were smaller and not statistically significant (mean differences 3.4 and 4.0). Although six Alexander technique sessions were also associated with fewer low back pain days (mean differences −11 days at 3 months and −10 days at 12 months) and better scores on the RDQ (mean differences at 3 and 12 months −1.71 and −1.4, respectively) compared with usual care, effects were smaller and not as well sustained. For all outcomes, the addition of exercise to Alexander method had little impact compared with Alexander method sessions alone for all outcomes. For example, the reduction in low back pain days was similar (20 days) following 24 sessions with or without exercise, as were mean effects on the RDQ. Six sessions of Alexander plus exercise were almost as beneficial as 24 sessions without exercise with respect to effects on the number of low back pain days and function.
Two trials196, 232 included in another systematic review186 found MCE associated with lower pain scores in the short term (WMD, −12.48 on a 0 to 100 scale, 95% CI −19.04 to −5.93), intermediate term (WMD, −10.18, 95% CI −16.64 to −3.72), and at long term (WMD, −13.32 95% CI −19.75 to −6.90) versus a minimal intervention. Each trial favored MCE at all time points. MCE was also associated with lower disability at short term (3 trials, WMD −9.00 on 0 to 100 scale, 95% CI −15.28 to −2.73).196, 232, 233 Effects on disability were somewhat smaller at intermediate term (WMD −5.62, 95% CI−10.46 to −0.77) and long term (WMD, −6.64, 95% CI −11.72 to −1.57),based on two trials.196, 232 Across trials, estimates consistently favored MCE.
A poor-quality trial (n=240) not included in the systematic reviews found different intensities of periodized musculoskeletal rehabilitation (PMR) training (2, 3, and 4 days per week for 12 weeks) for chronic low back pain associated with lower pain intensity at 13 weeks versus no training (mean differences ranged from −0.74 for twice per week to −1.35 for four times per week on 0-10 scale) and better function based on the ODI (mean differences ranged from −7.3 for twice per week to −12 for four times per week, 0 to 100 scale).251 It also found training associated with better (higher) SF-36 PCS scores (mean differences ranged from 5.2 for twice per week to 10.7 for four times per week, 0 to 100 scale) and MCS scores (mean differences ranged from 7.1 for twice per week to 11.7 for four times per week, 0 to 100 scale) at 13 weeks versus no training.
We also identified two additional trials (n=100 and 105) of exercise for subacute to chronic low back pain (mean duration of symptoms not reported).250, 256 One good-quality trial found no differences between 10 weeks of supervised general exercise including back and abdomen muscle stabilization) versus avoidance of hard physical activity, at the end of treatment or at 12 months (mean differences 0.07, 95% CI −0.9 to 0.70 and 0.3, 95% CI −1.3 to 0.6 on a 0 to10 scale, respectively).250 There were also no differences on the RDQ (mean differences 0.6, 95% CI −2.2 to 1.0 and 1.2, 95% CI −3.3 to 1.0, respectively) or on the EQ5D. A poor-quality trial (n=105) found no differences between exercise versus usual care on the ODI at the end of 12 weeks of treatment (mean difference −1.9 on 0 to 100-point scale) and at 1 year (mean difference −1.8) among patients who had undergone functional multidisciplinary rehabilitation.256
A systematic review of exercise therapy for nonacute low back pain versus usual care that specifically evaluated the outcome work disability found no effects at short-term (∼4 weeks) or intermediate-term (∼6 months) followup, based on pooled analyses of high-quality studies (6 comparisons in 5 trials, OR 0.80, 95% CI 0.51 to 1.25 and 5 comparisons in 4 trials, OR 0.78, 95% CI 0.45 to 1.34, respectively).188 However, exercise, was associated with lower likelihood of work disability at long-term (∼12 months) followup (10 comparisons in 8 trials, OR 0.66, 95% CI 0.48 to 0.92).
An additional 16 trials with fewer than 100 participants compared exercise versus no exercise or usual care for chronic low back pain.197, 200, 257-267, 270-272 For pain, 11 trials reported differences favoring exercise;257, 258, 260, 261, 263, 264, 266, 267, 270-272 the other five found no differences among groups.197, 200, 259, 262, 265 Of the 12 trials that reported on function, results favored exercise in nine258, 260, 261, 263-265, 270-272 and three found no differences.197, 200, 262 Quality of life was reported by five trials, three of which favored exercise260-262 and two of which found no difference among groups.197, 200 Global improvement was reported by two studies, with results favoring exercise in one trial264 but not the other.197
Exercise Therapy Versus Advice
Subacute to Chronic Low Back Pain
Two trials not included in the systematic reviews evaluated exercise therapy versus advice for subacute to chronic low back pain.245, 268 One fair-quality trial (n=136) found no differences between 8 weeks of supervised Nordic walking or unsupervised Nordic walking versus advice to remain active at the end of treatment for pain (mean improvement 8.8, 3.4, 4.8 respectively on the 0-30 Low back pain rating scale [LBRS]) or on the functional portion of the LBRS (mean improvement 7.4, 3.2, 3.8 respectively on a 0 to 30 scale) or Patient-Specific Functional Scale (PSFS) though effects were largest with supervised Nordic walking.245 No differences between treatments were seen on the EQ-5D. One very small trial (n=21) found 4 weeks of supervised stabilization exercise associated with greater pain reduction versus advice, but there was no difference on the ODI.268
Exercise Therapy Versus Education or Back School
Chronic Low Back Pain
The systematic review187 included three trials of exercise (yoga, Pilates and MCE) versus education or back school.190, 196, 213 One small trial (n=53) found no differences between 10- to 60-minute sessions of Pilates versus back school in post intervention pain (mean difference 0.2 on a 0 to10 scale) or function (mean difference 0.8 the ODI).190 The trials of yoga213 and MCE196 are discussed in those sections of this report.
One subsequent good-quality trial (n=148) of weekly McKenzie exercises versus back school found no differences in mean pain intensity scores at the end of four weeks of treatment or at three or six months (mean differences -0.48 to -0.71 on a 0 to 10 scale).242 Exercise was associated with better function at the end of therapy (mean difference -2.37, 95% CI -3.99 to -0.76) but effects were smaller and no longer statistically significant at longer followup. Exercise was also associated with a greater likelihood of experiencing a ≥5 point improvement on the RDQ (53% vs. 30%, RR 1.8, 95% CI 1.2 to 2.7).
One other small trial (n=61) reported no differences between exercise therapy versus a single education session or between exercise versus conventional physical therapy in pain of function for subacute to chronic low back pain at 6 or 12 months.269
Radicular Low Back Pain
Three trials (n=181 to 348) predominantly enrolled patients with radiculopathy (70 to 100% of sample); the duration of symptoms varied from acute to chronic.239, 240, 248 None were included in the systematic reviews.
For subacute low back pain with radiculopathy, one fair-quality trial compared 8 weeks of symptom guided, back-related exercise versus sham (nonback related) exercise; >50 percent of the sample had lower extremity motor deficits.240 Pain scores at the end of the 8-week intervention favored exercise (mean difference −0.8, 95% CI −1.2 to −0.09, on a 0-10 scale) but effects were small. There were no differences on the RDQ or measures of health-related quality of life. Exercise was associated with greater likelihood of patients reporting being “much better” at the end of treatment (8 weeks) versus sham exercises (80% vs. 60%, RR 1.3, 95% CI 1.1 to 1.6) but effects were smaller and not statistically significant at 12 months (84% versus 76%, RR 1.1, 95% CI 1.0 to 1.3). Patient satisfaction was similar at 12 months (93.5% vs. 90.5%).240
In one fair-quality trial, the difference in median pain scores at 6 months for education plus four physical therapy sessions was 3.0 (on 0-10 scale) compared with usual care and 1.0 compared with education alone, both favoring exercise, but tests for statistical significance were not performed.239 Education plus physical therapy was also associated with better function versus usual care (mean difference in improvement on the RDQ 2.3, 95% CI 1.7 to 2.9) but not versus education alone (mean difference in improvement 0.4, 95% CI −0.26 to 1.06).
A poor-quality trial found no statistically significant differences between a maximum of 8 weeks of physical therapy, bed rest or continuation of usual activities in pain or disability at up to 6 months in patients with acute sciatica, though effects favored physical therapy.248 Mean differences between physical therapy and control groups at 6 months ranged from −1.4 to −1.0 on a 0-10 scale for pain and for the Quebec Disability Scale from −0.7 to −2.7 on a 0-100 scale. Most patients (70%) had a prior history of low back pain or sciatica.
Exercise Versus Other Active Interventions
Results for comparisons involving exercise versus other active interventions are summarized in the results sections for nonexercise interventions.
Exercise Versus Exercise
Acute and Subacute Low Back Pain
The APS/ACP review included a higher-quality systematic review183 with one higher-quality trial that found marginal differences between the McKenzie method versus flexion exercises (mean differences, 2 points on a 0 to 100 scale) for acute pain, though a second, lower-quality trial found the McKenzie method associated with large benefits on short-term (5 days) disability (mean difference, −22 points on a 0 to 100 scale, 95% CI −26 to −18).
Two subsequent poor-quality trials which primarily enrolled patients with subacute low back pain found no differences among different types of exercise.243, 246 One trial compared physical therapy based on a TBC plus graded exposure, TBC plus graded activity, and TBC only243 and one trial compared lumbar extensor strength training versus “regular” physical therapy.246 A small (n=33) trial of patients with acute low back pain found no differences between regular trunk exercises versus trunk exercises plus specific core stability core exercises through 3 months.274
Chronic Low Back Pain
The APS/ACP review29 found few trials that directly compared different types of exercise for chronic low back pain, with no clear differences. The APS/ACP review also included a meta-regression that was conducted in conjunction with a higher-quality systematic review.283 Exercise therapy factors associated with greater effects on pain in the meta-analysis were use of individually designed programs (5.4-point improvement in pain scores, 95% credible interval 1.3 to 9.5), supervised home exercise (6.1 points, 95% CI −0.2 to 12.4), group exercise (4.8 points, 95% CI 0.2 to 9.4), and individually supervised programs (5.9 points, 95% credible interval 2.1 to 9.8). High-dose exercise programs (20 or more hours of intervention time) were not superior to low-dose programs. Interventions that included additional noninvasive therapy were superior (5.1 points, 95% CI 1.8 to 8.4) to those without additional noninvasive therapy. The exercise regimens that were most effective used stretching and strengthening, though there was some overlap with other types of exercise (aerobic, mobilizing, or other specific exercise methods). The meta-regression estimated that an intervention incorporating all of the features of an effective exercise regimen would improve pain scores by 18.1 points (95% CI 11.1 to 25.0) compared with no treatment, and improve function by 5.5 points (95% CI 0.5 to 10.5) compared with no treatment. However, trials to directly confirm the incremental benefits of exercise therapies utilizing these factors are not available.
A more recent systematic review186 found MCE associated with lower pain intensity at short term (6 trials, WMD −7.80 on 0 to 100 scale, 95% CI −10.95 to −4.65)192, 226-229, 231 and at intermediate term (3 trials, WMD −6.06, 95% CI −10.94 to −1.18)192, 227, 230 versus general exercise, but effects were smaller and no longer statistically significant at long term (4 trials, WMD −3.10, 95% CI −7.03 to 0.83).192, 227, 228, 230 Individual trial estimates at all time points generally favored MCE, though most differences did not reach statistical significance. MCE was also associated with better function in the short term (6 trials, WMD−4.65 on 0 to 100 scale, 95% CI−6.20 to −3.11)192, 226-229, 231 intermediate term (3 trials, WMD −4.86 95% CI−8.59 to −1.13)192, 227, 230 and long term (3 trials, WMD −4.72, 95% CI −8.81 to −0.63).192, 227, 230 Individual trial estimates generally favored MCE at all time points, with one trial reporting a statistically significant effect.227
A subsequent trial (n=172) found no differences between MCE versus graded activity in pain at 2 (mean difference 0.0 on 0 to 10 scale, 95% CI −0.7 to 0.8), 6 (mean difference 0.0 (95% CI −0.8 to 0.8), or 12 months (mean difference 0.1 (95% CI–0.7 to 0.9).253 MCE was associated with better function at 2 (mean difference −0.8 on 0 to 24 RDQ, 95% CI −2.2 to 0.7), 6 (mean difference −0.8, 95% CI −2.3 to 0.6), and 12 months (mean difference −0.6, 95% CI −2.0 to 0.9), though differences were not statistically significant; there were no differences in Global Perceived Effect Scale scores or SF-36 mental or physical component summary scores.253
Another systematic review187 included 11 trials of other exercise therapy comparisons191, 192, 197, 199, 201, 202, 205-207, 211, 215 Results could not be pooled because of differences in the exercise regimens and comparisons evaluated. Only two trials reported statistically significant differences among groups. One low risk of bias trial (n=240) found 12 weeks of motor control exercise associated with better function and global perceived effect at 8 weeks (mean adjusted between-group difference 2.9 and 1.7, respectively) versus general exercise, but there were no differences by 6 months.192 One high risk of bias trial (n=72) found 3 months of aerobic exercise associated with greater pain relief versus lumbar flexion exercise at the end of treatment.211
Two subsequent trials that compared various forms of exercise in patients with chronic low back pain found no differences in pain relief.241, 249 One good-quality trial (n=201) compared supervised exercise focused on core strengthening versus home exercise241 and the other compared exercise therapy, a walking program or usual physical therapy.249
One poor-quality trial (n=180 for exercise groups) that evaluated different intensities of exercise found the greatest intensity of PMR training (4 days per week, 1563 repetitions) associated with greater pain relief (mean difference −0.61 95% CI −0.97 to −0.25, 0-10 scale), reduced disabilities (mean difference −4.7 on the ODI, 95% CI −7.5 to −1.9), and improved quality of life based on SF-36 PCS (mean difference 5.5, 95% CI 2.5 to 8.5, 0 to 100 scale), and MCS (mean difference 4.6, 95% CI 1.6 to 7.6 on 0-100 scale) compared with the least intense regimen (2 days per week, 564 repetitions).251
Fourteen smaller trials (n<100) also compared different forms of exercise for chronic low back pain. In four trials, results for pain favored global postural reeducation versus stabilization exercises; exercise and stabilization training versus routine exercises; periodized resistance training versus periodized aerobic exercise, or the addition of static or dynamic back endurance exercise to the McKenzie method versus the McKenzie method alone.261, 275, 280, 281 Seven other trials found no clear differences among different types of exercises in outcomes related to pain.200, 258, 271, 273, 277-279, 282 Similar results were reported for other outcomes, with most trials reporting no clear differences.
Radicular Low Back Pain
One small (n=68) trial284 of patients with spinal stenosis found no clear difference between the addition of unweighted treadmill walking versus stationary cycling to an exercise program in short-term outcomes.
Harms
Harms were poorly reported in trials of exercise.29, 186, 187 When reported, harms were typically related to muscle soreness and increased pain,232, 241, 246, 249, 255, 285 or no harms were reported.192, 230, 236, 239, 243, 250, 252 Serious harms were not reported in patients who underwent exercise therapy.248, 253
Exercise and Related Interventions: Pilates
Key Points
- For chronic low back pain, a systematic review included seven trials that found Pilates associated with small (mean difference −1.6 to −4.1 points) or no clear effects on pain at the end of treatment versus usual care plus physical activity and no clear effects on function (SOE: low for pain and function).
- For chronic low back pain, three trials found no clear differences between Pilates versus other types of exercises in pain or function (SOE: low for pain and function).
Detailed Synthesis
The previous APS/ACP review did not specifically evaluate Pilates. A systematic review on exercise therapies included in the APS/ACP review did not include any studies of Pilates.
A fair-quality systematic review published subsequent to the APS/ACP review286 included seven trials of Pilates versus usual care (sample size range17 to 86, total n=301)195, 287-292 and four trials of Pilates versus other exercise techniques (sample size range 12 to 83, total n=199) (Table 10; Appendix Tables E15; F15).293-296 The trials exclusively or primarily (∼75%)292, 293 enrolled patients with chronic low back pain. Pilates interventions varied but generally included one or three supervised mat small group classes per week plus home sessions; some included specific Pilates equipment. Usual care was generally less well described, but typically involved no specific treatment apart from medications and no restriction from regular physical activity. One study allowed both groups to continue physical therapy and regular exercise289 and another provided an educational booklet on low back pain.290 Exercise techniques in trials of Pilates versus other exercise methods included supervised stationary cycling, traditional lumbar stabilization exercises, McKenzie exercises and a generalized exercise regimen that included aerobics, stretching and strengthening. The duration of interventions in the trials ranged from four to 12 weeks. Three trials followed participants 16 to 18 weeks beyond the end of the active intervention. Most trials were conducted in Brazil, Australia and the United Kingdom and three trials were published as dissertations.289, 293, 297 Based on the 16-item McMaster Critical Review Form for Quantitative Studies, review authors classified four trials excellent (15 or 16 out of 16 points),289, 290, 294, 296 four very good (13-14 points),195, 287, 291, 292 one fair (9-10 points)293 and four poor (0-8 points).288, 295-298 Methodological shortcomings included inability to blind patients (most trials blinded outcomes assessors) and high attrition in trials with longer followup.294, 296
Pilates Versus Usual Care and Physical Activity
Chronic Low Back Pain
Seven trials195, 287-292 included in the systematic review evaluated the effects of Pilates on pain.286 Results across trials were somewhat inconsistent. Although four trials (sample sizes 22 to 86) found Pilates associated with lower pain scores versus usual care plus physical activity at the end of treatment (mean differences −1.6 to −4.1 points on a 0- to 10-point scale), three trials found no significant effects (mean differences −0.2 to −1.9 points). One trial (n=86) found smaller effects 18 weeks after the end of therapy (mean difference −0.9, 95% CI −1.9 to 0.1) that were no longer statistically significant, compared with the effects at the end of therapy (mean difference −2.2, 95% CI −2.2, 95% CI −3.2 to −1.1).290 The largest effect (−4.1, 95% CI −6.3 to −1.8 on 0−10 scale) was observed in the trial with the highest total class hours (2 hours per week for 15 weeks, n=22).287 Total hours in the other trials ranged from 12 to 24 hours of class and/or home exercise; there was no clear relationship between the intensity of treatment and estimates of effect. Trial data were not pooled.
Seven trials195, 289-292, 297, 298 included in the systematic review evaluated effects of Pilates on function.286 Most trials showed no clear beneficial effects. Two trials found no differences between Pilates versus usual care on the ODI at the end of a 6-195 or 12-week course of therapy297 (mean difference 0.0 on a 0 to 10 scale, 95% CI −8.5 to 8.5 in one trial and −7.1, 95% CI −17.6 to 3.4 in the other trial). Five trials measured disability with the RDQ. The largest, fair-quality trial (n=86) found Pilates associated with lower (better) RDQ scores at the end of a 6-week intervention of twice weekly 60-minute Pilates sessions (mean difference −2.7, 95% CI −4.4 to −1.0), but effects were smaller and no longer statistically significant at 24 weeks (mean difference,−1.4, 95% CI −3.1 to 0.0 at 24 weeks, 0 to 24 scale).290 Four smaller trials (n=20 to 39) reported inconsistent effects of Pilates at the end of 4 to 12 weeks of treatment, with two trials finding Pilates associated with better RDQ scores (mean differences −1.2, 95% CI −1.4 to −1.0292 and −2.6, 95% CI −5.2 to −0.1289) and two trials finding nonstatistically significant differences in favor of Pilates (mean differences −2.1 p>0.21, no CI reported.283 and −1.7 (95% CI −0.4 to 3.8).298
Pilates Versus Other Exercise
Chronic Low Back Pain
There were no differences between Pilates versus traditional lumbar stabilization exercises (1 trial, n=12),293 Pilates versus McKenzie and daily postural correction exercises (1 trial, n=40295), or Pilates versus general exercise (including aerobics, stretching, and strengthening) (1 trial, n=83296) in pain or function at the end of a 4- to 7-week course of treatment. One trial (n=64) found 8 weeks of Pilates (50- to 60-minute sessions 3 times a week) associated with lower pain (mean difference −1.1, 95% CI −2.1 to −0.1) and better ODI scores (difference in means −6.5%, 95% CI −11.8 to −1.1) at the end of treatment, but effects were smaller and no longer statistically significant at 24-week followup.294 Attrition was high in this trial and greater in patients randomized to cycling.
Exercise and Related Interventions: Tai Chi
Key Points
- For chronic low back pain, two trials found tai chi associated with improved pain-related outcomes versus wait list or no tai chi (mean differences 0.9 and 1.3 on a 0 to 10 scale); one trial also found tai chi associated with better function (mean difference 2.6 on the RDQ, 95% CI 1.1 to 3.7) (SOE: low for pain and function).
- For chronic low back pain, one trial found tai chi associated with lower pain intensity versus backward walking or jogging through 6 months (mean differences −0.7 and −0.8), but there were no differences versus swimming (SOE: low).
- One trial of tai chi reported a small temporary increase in back pain symptoms and one trial reported no harms (SOE: low).
Detailed Synthesis
Tai chi was not specifically evaluated in the APS/ACP review. We identified two trials of tai chi versus no treatment for chronic low back pain with no treatment (2 RCT, n=480) (Table 12; Appendix Tables E16, F16;285, 299 one of the trials also evaluated tai chi versus other exercise interventions including backward walking, jogging and swimming.299 Tai chi sessions were eighteen 40-minute sessions over 10 weeks in one trial285 and 45-minute sessions 5 days a week for 6 months in the other.299 Both trials were rated fair quality. One trial did not adequately report allocation concealment and attrition299 and adherence was unclear in both trials. The nature of the intervention precluded blinding of participants and people administering the interventions, but both trials reported blinding of outcomes assessors.
Table 12
Characteristics and conclusions of included tai chi trials.
Tai Chi Versus Wait List or No Exercise
Chronic Low Back Pain
Both trials found tai chi for chronic low back pain associated with improved pain-related outcomes versus wait list or no tai chi.285, 299 One trial (n=160) found 10 weeks of tai chi associated with lower pain intensity versus wait list (mean difference 1.3 on a 0 to 10 scale, 95% CI 07 to 1.9) and better function (mean difference 2.6 on the RDQ, 95% CI 1.1 to 3.7); the proportion of patients who experienced ≥30 percent improvement in pain intensity was 46 percent vs. 15 percent and the proportion who experienced ≥30 percent improvement in RDQ was 50 versus 24 percent.285 Similar results were seen for pain bothersomeness (mean difference 1.7, 95% CI 0.9 to 2.5; proportion with ≥30% improvement 50% vs. 18%).285 The other trial (n=188 for this comparison) found tai chi associated with lower pain intensity at 26 weeks versus no exercise (mean scores 2.7 vs. 3.6 on a 0 to 10 scale).299
Tai Chi Versus Other Exercise Interventions
Chronic Low Back Pain
One trial (n=273 for this comparison) found Tai chi associated with lower pain intensity versus backward walking or jogging at 3 months (mean differences −0.6 and −0.7 on a 0 to 10 scale, respectively) and 6 months (mean differences −0.7 and −0.8), but there were no differences versus swimming (mean differences −0.1 at both time points).299
Exercise and Related Interventions: Yoga
Key Points
- For chronic low back pain, one trial found Iyengar yoga associated with lower pain scores (24 vs. 37 on a 0-100 VAS, p<0.001) and better function (18 vs. 21 on the 0 to 100 ODI, p<0.01, on a 0 to 100 scale) versus usual care at 24 weeks (SOE: low for pain and function).
- For chronic low back pain, a systematic review found yoga associated with lower pain intensity and better function versus exercise in most trials, though effects were small and differences were not always snot statistically significant (5 trials) (SOE: low for pain and function).
- For chronic low back pain, yoga was associated with lower short-term pain intensity versus education (5 trials, SMD −0.45,- 95% CI −0.63 to −0.26; I2=0%), but effects were smaller and not statistically significant at longer-term followup (4 trials, SMD −0.28, 95% CI−0.58 to −0.02, I2=47%); yoga was also associated with better function at short-term (5 trials, SMD 0.45, 95% CI −0.65 to −0.25; I2=8%) and long-term followup (4 trials, SMD 0.39, 95% CI −0.66 to −0.11; I2=40%) (SOE: moderate for pain and function).
- Reporting of harms was suboptimal, but adverse events when reported were almost all classified as mild to moderate (SOE: low).
Detailed Synthesis
The APS/ACP review29 included three trials (n=22 to 101) of yoga for chronic low back pain.194, 207, 213 One trial evaluated Viniyoga194 and two trials Iyengar yoga;207, 213 comparator interventions were exercise or self-care. The APS/ACP review concluded that there was fair evidence that Viniyoga is moderately effective for chronic low back pain, with insufficient evidence to judge the effectiveness of other yoga styles, or the effectiveness of yoga for acute low back pain.
A good-quality systematic review300 published subsequent to the APS/ACP review included 10 trials,194, 207, 210, 213, 301-306 including the 3 trials described above (Table 10; Appendix Tables E17, F17). All trials enrolled patients with chronic (>3-month duration) low back pain, except for one small trial (n=12) which enrolled patients with back pain for >3 weeks. Sample sizes ranged from 12 to 313 (total sample=1,056). All yoga interventions included specific asanas (poses), pranayama (breathing), and relaxation, and many included meditation or mental focus practices. The most common specific yoga styles evaluated were Iyengar (5 trials) and Viniyoga (2 trials). Most trials evaluated yoga classes lasting 75 minutes once weekly with recommended home practice for 30 minutes 5 to 7 days per week, though one trial210 evaluated all-day sessions over a 1-week period. Trials generally reported starting out with simple or restorative yoga poses and progressing to more challenging poses. The duration of active intervention ranged from 1 to 24 weeks. Outcomes were assessed at the end of therapy in all trials; five trials also assessed outcomes 14 to 52 weeks after the end of therapy. Yoga was compared versus usual care (2 trials), education (7 trials), and supervised exercise therapy (3 trials). Exercise therapy interventions varied, but included stretching, strengthening, and aerobic exercise. Two trials were conducted in India,210, 302 one in the United Kingdom,301 and the remainder in the United States. Two trials213, 302 were rated high risk of bias (based on meeting fewer than 6 of 10 Cochrane Back Review Group criteria) and the remainder were rated low risk of bias; methodological shortcomings included inadequate reporting of randomization and allocation concealment methods and high attrition. Blinding of patients and caregivers was generally not possible, though 8 of the 10 trials reported blinding of outcome assessors.
We identified two additional trials307, 308 not included in the systematic review of yoga for chronic low back pain (Table 13; Appendix Tables E18; F18).307, 308 One Indian trial (n=60) compared a 60-minute class of Iyengar Yoga per week for 4 weeks (plus home practice) versus exercises (primarily strengthening exercises)307 and a US trial (n=95) compared once versus twice weekly 75-minute hatha yoga classes over 12 weeks.308 Both trials were rated fair quality; methodological shortcomings included unclear allocation concealment methods and unblinded design.
Table 13
Characteristics and conclusions of included yoga trials.
Yoga Versus Usual Care
Chronic Low Back Pain
Two trials evaluated yoga for 6 or 12 weeks versus usual care.194, 306 One trial (n=90) found Iyengar yoga associated with lower pain scores (mean 24 vs. 37 on a 0-100 VAS, p<0.001), better function (mean 18 vs. 21 on the 0 to 100 ODI, p<0.01, on a 0 to 100 scale), and better Beck Depression Inventory score (mean 5 vs.8 on 0 to 63 scale, p<0.01) at 24 weeks.306 Another trial (n=22) found yoga associated with trends towards favorable effects on the ODI and Beck Depression Inventory, but was underpowered and reported large baseline differences among groups, precluding reliable conclusions.194
Yoga Versus Exercise
Chronic Low Back Pain
Effects of yoga versus exercise on pain were reported in four trials, with somewhat inconsistent results.207, 304, 307, 309 The two most well-conducted trials evaluated a 12-week course of yoga. One trial (n=101) found yoga associated with lower pain scores at 26 weeks (mean difference between groups −1.4 on an 0 to 10 scale, 95% CI −2.5, −0.2),207 but a larger trial (n=228) found small and nonstatistically significant differences between 12 weeks of yoga versus exercise in pain scores at 6, 12, or 26 weeks and in the likelihood of experiencing a 30 or 50 percent improvement in pain.304 Another (n=80) trial found a weeklong intensive in-residence yoga program associated with lower pain scores than exercise at 1 week (3.40 vs. 4.85 on 0 to 10 scale, p<0.001).309 Another small (n=60) trial found 4 weeks of yoga associated with lower pain score versus exercise at 6 months (mean 1.8 vs. 3.8 on a 0 to 10 VAS, p=0.001).307
Effects of yoga versus exercise on back-specific disability were reported in three trials, with somewhat inconsistent effects.207, 210, 304 A large (n=228), well-conducted trial found no differences between 12 weeks of yoga versus exercise in the mean RDQ score or in the likelihood of 30 or 50 percent improvement at 6, 12, or 26 weeks,304 but another well-conducted trial (n=101) found 12 weeks of yoga associated with a better (lower) RDQ score versus exercise at 12 weeks (adjusted mean difference −1.8 on a 0 to 24 scale, 95% CI −3.5 to −0.10), though differences were not statistically significant at 6 or 26 weeks.207 One trial (n=80) found an intensive, weeklong yoga program associated with a lower (better) ODI score versus exercise at 1 week (mean 18.70 versus 35.75 on a 0 to 100 scale, p<0.01).210
One trial (n=101) found no difference between yoga versus exercise in health-related quality of life as measured by the SF-36 MCS or PCS.207 Two smaller trials found yoga associated with better health-related quality of life based on other measures of health-related qualify of life (WHO-QOL-BREF or the CDC-HRQOL-4 questionnaire).307, 310 One trial found no statistically significant differences between yoga versus exercise in the likelihood of global improvement or patient satisfaction at 6, 12, or 26 weeks, though results favored yoga, particularly at 12 weeks (RR 1.3, 95% CI 0.97 to 1.75).304 One trial (n=80) found that compared with exercise, an intensive, weeklong yoga program associated with greater improvement in the Beck Depression index (BDI) and measures of anxiety at 1 week (p≤0.001).309
Yoga Versus Education
Yoga was associated with better short-term (up to 12 weeks) mean pain scores versus education (5 trials, SMD −0.45, 95% CI −0.63 to −0.26; I2=0%) but effects were smaller and not statistically significant at longer-term (∼1 year) followup (4 trials, SMD −0.28, 95% CI −0.58 to −0.02; I2=47%).300 In the trials, differences in mean pain scores ranged from 0.37 to 2.4 on a 0 to 10 scale at 26 to 28 weeks. One of the trials included in the review (n=228) also found yoga associated with a greater likelihood of experiencing >30 percent improvement in pain at 26 weeks (RR 1.80, 95% CI 1.12 to 2.84); results also favored yoga for likelihood of >50 percent improvement, but the difference was just below the threshold for statistical significance (RR 2.13, 95% CI 0.96 to 4.73).304 Another small (n=30) trial also found yoga associated with a greater likelihood of experiencing clinically meaningful (≥ 2 points) pain relief, but the estimate was imprecise (OR 5.0, 95% CI 1.13 to 19.1).303
Yoga was associated with better back-specific disability versus education at short-term (5 trials, SMD 0.45, 95% CI −0.65 to −0.25; I2=8%) and long-term followup (4 trials, SMD 0.39, 95% CI −0.66 to −0.11; I2=40%).300 In the three largest trials, mean differences on the RDQ at 26 weeks ranged from 0.37 to 3.6 on a 0 to 24 scale, favoring yoga.207, 304, 305 The largest (n=313), fair-quality trial reported found 12 weeks of yoga associated with lower (better) RDQ scores through 12 months (mean difference −1.57, 95% CI −2.71 to −0.42).305 One trial (n=228) included in the review also found yoga associated with greater likelihood of experiencing 50 percent improvement in RDQ at 26 weeks (RR, 1.90, 95% CI 1.21 to 2.99).304 A smaller trial (n=30) also found yoga associated with greater likelihood of experiencing a ≥30 percent improvement in the RDQ, but the difference was not statistically significant (67% vs. 40%, OR 1.7, 95% CI 0.8 to 3.4).303
Yoga was also associated with better SF-12 or SF-36 scores versus education at short-term (up to 12 weeks) followup (3 trials, SMD 0.25, 95% CI 0.02 to 0.47; I2=0%), but the difference was slightly smaller and not statistically significant at longer-term followup (2 trials, SMD 0.18, 95% CI−0.05 to 0.41; I2=0%).300 In the largest trial (n=313), mean differences on the SF-12 Physical Component and Mental Component Summary Scores were small (0.42 to 2.02) and not statistically significant at any time point. 305
Yoga was associated with greater likelihood of global improvement at 12 weeks in two trials (RR 3.27, 95% CI 1.89 to 5.66; I2=0%).300 In the larger trial (n=228), a similar effect was also present at 26 weeks (RR 2.57. 95% CI 1.39 to 4.78).304 It also found yoga associated with greater likelihood of satisfaction with care through12 weeks (RR 3.95, 95% CI 1.90 to 8.21).
Once Versus Twice Weekly Yoga Classes
One fair-quality trial (n=95) compared once versus twice weekly 75-minute Hatha yoga classes for 12 weeks.308 There were no statistically significant differences in measures of pain, the RDQ, or the SF-36.
Harms
The systematic review reported adverse events from three trials.300 Reporting of adverse events was suboptimal, though adverse events were almost all classified as mild to moderate, with no clear difference in risk of serious adverse events. One trial published subsequent to the systematic review reported no adverse events307 and one trial of once versus twice weekly yoga classes reported no differences in risk of any adverse event, which were primarily musculoskeletal.308
Psychological Therapies
Key Points
- For chronic low back pain, a systematic review found progressive relaxation superior to wait list control for post-treatment pain intensity (3 trials, mean difference −19.77 on 0 to 100 VAS, 95% CI -34 to −5.20, I2=57%) and functional status (3 trials, standardized mean difference −0.88, 95% CI −1.36 to −0.39, I2=0%) (SOE: low for pain and function).
- For chronic low back pain, a systematic review found electromyography (EMG) biofeedback associated with lower pain intensity at the end of treatment (3 trials, SMD −0.80, 95% CI −1.32 to −0.28, I2=0%), with no clear effect on function (3 trials) (SOE: low for pain and function).
- For chronic low back pain, a systematic review found operant therapy associated with lower pain intensity at the end of treatment (3 trials, standardized mean difference −0.43, 95% CI −0.75 to −0.1, I2=0%), with no clear effect on function (2 trials) (SOE: low for pain and function).
- For chronic low back pain, there was insufficient evidence from two trials to determine effects of cognitive therapy versus wait list control, due to inconsistency and imprecision (SOE: insufficient).
- For chronic low back pain, a systematic review found cognitive-behavioral and other combined psychological therapy associated with greater improvements in post-treatment pain intensity compared with wait list control (5 trials, SMD −0.60, 95% CI −0.97 to −0.22, I2=40%), but effects on function were smaller and not statistically significant (4 trials, SMD −0.37, 95% CI −0.87 to 0.13, I2=50%) (SOE: low for pain and function).
- For chronic low back pain, a systematic review found no clear differences between psychological therapies versus exercise therapy in pain intensity (2 trials) or between psychological therapies plus physiotherapy versus physiotherapy alone (6 trials) in pain or function, though one small subsequent trial found combination therapy associated with greater improvements in pain and function immediately after treatment (SOE: low for pain and function).
- Ten trials found no clear differences between different psychological therapies in pain or function (SOE: moderate for pain and function).
- Harms were not well-reported, but no trial included reported any adverse events associated with psychological therapies (SOE: low).
Detailed Synthesis
The APS/ACP review29 included two high-quality systematic reviews on psychological therapies for chronic low back pain.311, 312 One review included 22 trials (6 assessed as higher quality)311 and the other included 21 trials (7 assessed as higher quality).312 Together, the two reviews included a total of 35 unique studies. Based on the systematic reviews, the APS/ACP review concluded that there was good evidence that versus no psychological therapy or wait-list control, cognitive-behavioral therapy is associated with moderate benefits, good evidence that operant therapy is associated with no effect, fair evidence that progressive relaxation is associated with substantial net benefits, and insufficient evidence to determine effects of biofeedback. Neither systematic review found any differences between one type of behavioral intervention versus another.
An updated version of one of the reviews312 included in the APS/ACP review has been published (Table 10; Appendix Tables E19, F19).313 It included 28 trials relevant to this report (total n=3090, sample sizes ranged from 18 to 409). Compared with the previous version, the updated review included seven additional trials and excluded three previously included trials. The review focused on psychological therapies conducted in an office or group setting, broadly classified into respondent (10 trials), operant (7 trials), cognitive (4 trials), and cognitive-behavioral (7 trials) treatments as well as combinations thereof (8 trials).313 Operant therapies refer to behavioral therapies that encourage healthy behaviors such as exercise and participation in usual activities, and that do not reinforce patient pain behaviors. Cognitive therapies help patients to identify and challenge maladaptive thoughts that contribute to disability and distress. Respondent therapy includes techniques such as relaxation or biofeedback, and is based on the premise that the physiological response to pain is linked to muscle tension in a negative feedback loop, and that this cycle can be interrupted by reducing muscle tension. Twelve trials compared psychological therapies versus wait list control, seven trials compared psychological therapies versus other interventions, and 10 trials compared one psychological therapy versus another. Several trials evaluated more than one type of psychological therapy. The duration and intensity of treatments were inconsistently described; when reported they varied from 35- to 120-minute sessions over 3 to 10 weeks; one trial evaluated daily 8-hour treatments over 5 weeks. Outcomes were assessed during or at the end of treatment in 25 trials and at 3 to 24 months after treatment in 21 trials.
Thirteen trials were classified as being at low risk of bias (based on meeting at least 6 of the 12 Cochrane Back Review Group criteria). Common methodological shortcomings included inadequate description of randomization and allocation concealment methods, high attrition, and dissimilar cointerventions among groups. The majority of trials used an unblinded design.313
We identified five additional trials of psychological therapies for chronic low back pain not included in the systematic review (Table 14; Appendix Tables E20; F20).314-318 One trial evaluated psychological therapy versus wait list control317 and three trials (across four publications) psychological therapies plus another noninvasive intervention versus the other intervention alone.314-316, 318 All of the trials were rated fair quality. In general, neither patients nor care providers could be blinded, compliance to treatment was low or unreported, and some trials did not report allocation concealment methodology or use of intention-to-treat analysis.315-318
Table 14
Characteristics and conclusions of included psychological therapy trials.
Respondent Therapy Versus Wait List Control
Chronic Low Back Pain
Two types of respondent therapy, progressive relaxation and biofeedback, were separately evaluated in the systematic review.
Three small trials (total n=74 patients) in the systematic review evaluated relaxation training versus placebo or wait list control for chronic low back pain.313 All were rated high risk of bias. No information was provided regarding treatment duration except that one study offered eight 45-minute sessions.319 Outcomes for pain and function favored treatment in all individual trials, as well as in pooled results. Progressive relaxation was superior to wait list control for post-treatment pain intensity (3 trials, mean difference −19.77 on 0 to 100 VAS, 95% CI −34 to −5.20, I2=57%) and functional status (3 trials, standardized mean difference −0.88, 95% CI −1.36 to −0.39, I2=0%).319-321 For function, one trial reported a 0.5-point difference in favor of progressive relaxation on a 7-point function scale319 and two trials reported a 4.8 to 11.1-point difference on the 100-point Sickness Impact Profile.320, 321 Two small studies reported post-treatment depression using the 63-point Beck Depression Inventory. One study320 (n=25) found a significant effect (14.3 points) in favor of relaxation therapy while the other trial (n=35) found no difference (1.0-point difference between groups),321 with no difference when results were pooled (2 trials, mean difference −6.80 on 0 to 63 scale, 95% CI −20 to 6.12, I2=85%).320, 321
The systematic review included four trials (3 low risk of bias) of auditory and/or visual EMG biofeedback training (plus education and breathing exercises in one study) versus wait list or placebo controls for chronic low back pain.313 The total sample was 108 patients. When described, session durations generally lasted 45 to 60 minutes and patients were offered 8 to 15 sessions over 3 to 4 weeks. EMG biofeedback was associated with lower pain intensity at the end of treatment (3 trials, SMD −0.80, 95% CI −1.32 to −0.28, I2=0%). Although results were not statistically significant in two of the three trials, they favored treatment in all three trials by 5 to 13 points on a 100-point pain scale.319, 322, 323 A fourth trial could not be pooled, but reported no effect of biofeedback on pain.324 There was no clear difference between biofeedback versus wait list control for function, with inconsistent results from three trials.319, 322, 324
Operant Therapy Versus Wait List Control
Four trials (three low risk of bias) in the systematic review compared operant therapy versus wait list control for chronic low back pain (total n=243).313 Interventions varied, but typically included behavioral therapy plus exercise, often involving spousal participation. When reported, treatments lasted 5 to 8 weeks, with sessions lasting 2 to 8 hours per day. Operant therapy was associated with lower pain intensity at the end of treatment (3 trials, standardized mean difference −0.43, 95% CI −0.75 to −0.1, I2=0%).212, 325, 326 Results favored operant therapy in all three trials (13 points on a 0 to 100 VAS scale in one trial325 or 3.3 to 3.6 points on the 78-point McGill Pain Questionnaire in two trials,212, 326 though the difference was statistically significant in only one325 of the trials. There was no difference between operant therapy versus wait list control for function at the end of treatment as measured by the Sickness Impact Profile (2 trials, mean difference −1.18 on a 100-point scale, 95% CI −3.53, 1.18, I2=0%).212, 326 Operant therapy also had no effect on depression, based on two trials.212, 325
Cognitive Therapy Versus Wait List Control
Two small trials (34 patients in each study) in the systematic review evaluated cognitive therapy versus wait list control for chronic low back pain.313 In one trial, cognitive therapy consisted of graded exposure to fearful activities plus psychological education over 13 sessions in addition to usual care;327 treatment details were not reported for the other trial.321 There was no clear difference between cognitive therapy versus wait list control in pain, though there was inconsistency between trials. One trial reported an 11-point difference on a 100-point VAS and the other reported a 0-point difference.321, 327 There was also no difference between cognitive therapy versus wait list control for function (one trial reported a 1.6-point difference in the 100-point Sickness Impact Profile and the other reported a 1.4-point difference in the Activities of Daily Living Scale). One other larger (n=156) fair-quality trial not included in the systematic review found cognitive therapy consisting of ten to fourteen 60-minute individual sessions over 18 weeks to associated with greater improvement in activity-specific pain versus wait list control (mean improvement from baseline −19.1 vs. −5.2 on the 0 to 100 Patient Specific Complaints outcome measure, p=0.018), and increased likelihood of experiencing an 18- to 24-point improvement at the end of treatment (49% vs. 26%, odds ratio 2.77, 95% CI 1.28 to 6.01).317 However, there was no effect on function as measured by the 100-point Quebec Back Pain Disability Scale (36.7 vs. 38.7).
Cognitive-Behavioral and Other Combined Psychological Therapies Versus Wait List Control
Five trials (total sample 239 patients) in the systematic review evaluated combined psychological therapies versus wait list control for chronic low back pain.313 Three trials were assessed as being at low risk of bias. Combined psychological therapy interventions varied and included education, problem solving training, coping techniques, imagery, relaxation, goal setting, cognitive pain control, and exercises. Three of the trials described these interventions as being cognitive-behavioral in nature.209, 320, 322 When reported, sessions lasted 1 to 2 hours, with 8 to 30 sessions given over 4 to 10 weeks.
Combined psychological therapy was associated with greater improvements in post-treatment pain intensity compared with wait list control (5 trials, SMD −0.60, 95% CI −0.97 to −0.22, I2=40%).209, 320-322, 326 Effects were statistically significant in two209, 320 trials and favored treatment in the other three. Specifically, two high risk of bias trials (n=22 and 39) reported a 3.8 to a 40.5-point difference between groups on a 100-point VAS pain scale;320, 321 one low risk of bias trial (n=45) found a 6.2-point difference between treatment groups in the 78-point McGill Pain Questionnaire;326 and two low risk of bias trials (n=28 and 105) reported a 7.2 to 14.8-point difference in pain outcomes (scale not reported).209, 322 There was no difference between combined psychological therapy versus wait list control in function at the end of treatment (4 trials, SMD −0.37, 95% CI −0.87 to 0.13, I2=50%).320-322, 326 Although one small (n=22) trial at high risk of bias found combined psychological therapy associated with better Sickness Impact Profile Score versus wait list control by about 10 points,320 the remaining three trials (n=28 to 45) found no differences.321, 322, 326 There was also no difference between combined psychological therapies versus wait list control on the Beck Depression Inventory (4 trials, SMD −1.92, 95% CI −6.2 to 2.3, I2=70%),209, 320-322 with only one small (n=22) trial showing an effect that favored treatment.320
Psychological Therapy Versus Usual Care
Two high risk of bias trials in the systematic review compared behavioral therapy versus usual care.313 One trial (n=100) compared 6 weeks of progressive muscle relaxation versus usual care (not otherwise described)328 and the other (n=230) compared four sessions of cognitive therapy which addressed fears and encouraged exercise and activities versus usual care (pain medications, primary care visits, and other services such as physical therapy).329 While behavioral therapy was associated with greater improvements in VAS pain scores versus usual care at the end of therapy (2 trials, mean difference −5.2 on a 0 to 100 scale, 95% CI −9.8 to −0.6, I2=20%), there was no difference at 6-month followup (2 trials, mean difference −4.3, 95% CI −9.3 to 0.7, I2=0%).328, 329 There were no differences in functional status (based on the ODI or the RDQ) at the end of therapy or at 6-month followup in either trial or when results were pooled (2 trials, SMD −0.20 at end of treatment, 95% CI −0.4 to 0.02, I2=0% and SMD −0.12 at 6 months, 95% CI −0.3 to 0.1, I2=0%), though results slightly favored behavioral therapy.328, 329
Psychological Therapy Versus Other Noninvasive Treatments
Five trials included in the systematic review209, 212, 330-332 evaluated psychological therapy versus other noninvasive treatments. The types of psychological therapies and comparator interventions varied across trials. Two trials (one low risk of bias) compared behavioral therapy versus group exercise.313 One low risk of bias trial (n=107) compared cognitive behavioral therapy with strength and aerobic physical training; both interventions were given for 3 sessions per week for 10 weeks209 and one smaller (n=39), high risk of bias trial compared operant conditioning (2 hours per week) versus group aerobic exercise (10 to 20 minutes per day, 5 days per week) for 8 weeks.212 There were no differences in pain intensity as measured by the Pain Rating Index (0-45) at the end of treatment (2 trials, mean difference −2.31, 95% CI −6.3 to 1.7, I2=0%) or at 12 months (2 trials, N=136, mean difference 0.14, 95% CI −4.4 to 4.7, I2=0%). Similarly, there were no differences in depression at the end of therapy at any time point measured through 12 months in either study or when results were pooled.209, 212
One high risk of bias trial (n=114) in the systematic review found behavioral therapy (intensive group training via 30 sessions consisting of exercise therapy, back school, and behavioral principles) associated with significantly lower pain at 6 months versus guideline-based care (approximately 13 sessions, though the number varied), although these differences were no longer statistically significant at 12 months (data not reported).332 There were no differences among groups in functional status at 6 or 12 months.
One small (n=36), high risk of bias trial included in the systematic review found no differences between ten 35-minute sessions of progressive relaxation or biofeedback training versus back education in pain (VAS and McGill Pain Questionnaire) at the end of treatment or at 3-month followup.330
One small (n=15), high risk of bias trial included in the systematic review found no differences between eight weekly 50-minute sessions of progressive relaxation versus self-hypnosis in VAS pain and depression at the end of therapy or at 3-month followup.331
Psychological Therapy Plus Another Intervention Versus the Other Intervention Alone
Nine trials evaluated the effects of adding psychological therapy to another noninvasive intervention, versus the other intervention alone. Five trials (n=20 to 116)209, 212, 333-335 in the systematic review313 compared psychological therapy plus physiotherapy or exercise therapy versus physiotherapy or exercise therapy alone. There were no differences in pain, function, or depression when measured at the end of treatment or through 4 to 6 months. Results were consistent across trials, including one low risk of bias trial.209 The systematic review also found no differences between psychological therapy plus inpatient rehabilitation versus inpatient rehabilitation alone, based on one low risk of bias (n=30)336 and two high risk of bias (n=45 and 409)337, 338 trials.313 One low risk of bias trial (n=234) in the systematic review found the additional of cognitive-behavioral therapy program to an educational intervention associated with a small, nonstatistically significant effect on pain and functional outcomes versus the educational intervention alone measured immediately after the treatment.339
Three fair-quality trials not included in the systematic review also evaluated the effects of combining psychological therapies with another noninvasive intervention.314-316, 318 One trial (n=88) found the addition of motivational enhancement to physical therapy (ten 30-minute sessions over 8 weeks) associated with no significant differences in pain, function, or quality of life versus physical therapy alone at 1 month.318 In contrast, another trial (n=54) reported the addition of cognitive behavioral therapy to physical-therapist guided exercise (three sessions per week over 12 weeks plus exercise at home twice a day five times per week) resulted in significantly better pain and RDQ scores post-treatment than physical-therapist guided exercise alone.314 Another trial (n=701) found the addition of cognitive behavioral therapy to active management advisory consult (one 15-minute session in which advice was given to remain active and use pain medication) associated with greater improvement in pain scores, the RDQ, and EQ-5D through 12-month followup, though effects on pain at 34 months were smaller and no longer statistically significant at 34 months.315, 316 Through 12 months, differences in pain scores were about 5 to 8 points and differences on the RDQ 1.0 to 1.5 points (effect sustained through 34 months).
Comparisons of Different Psychological Therapies
Ten trials in the systematic review compared one psychological therapy versus another for chronic low back pain.313 Sample sizes ranged from 16 to 90 patients. In general, trials found no differences among psychological therapies in pain or function; some trials also found no effect on measures of depression. However, methodological shortcomings in most trials (5 were rated low risk of bias), small numbers of trials for each comparison, and variability in the psychological therapy interventions evaluated within comparisons precluded strong conclusions. Four trials compared various combinations of psychological therapies (e.g., operant and respondent therapy, operant and cognitive with or without group education) versus operant therapy,326, 334, 340, 341 four trials compared various combinations of psychological therapies versus respondent therapy,320-322, 342 one trial compared different types of respondent therapy (EMG biofeedback vs. progressive relaxation),330 two trials compared cognitive therapy versus operant therapy,334, 343 one trial compared cognitive therapy versus respondent therapy (progressive muscle relaxation), and two trials compared combined psychological therapy versus cognitive therapy.321, 334 Based on pooled estimates, there were no differences between combined psychological therapies and operant therapy in pain or function. There were also no differences between combined psychological therapies and respondent therapy for pain or function. Although respondent therapy was associated with better outcomes on the Beck Depression Inventory versus combined therapy at the end of treatment (3 trials, mean difference 2.89 on 0 to 63 scale, 95% CI 0.6 to 5.2, I2=0%),320-322 the effect was smaller and no longer statistically significant at 6 months (2 trials, mean difference on 0-63 scale 1.84, 95% CI −0.4 to 4.1, I2=28%),321, 322 with no differences at either time point in one low risk of bias trial.322
Harms
None of the trials included in the systematic review or subsequent trials reported any adverse events associated with psychological therapies.
Multidisciplinary Rehabilitation
Key Points
- For chronic low back pain, a systematic review found multidisciplinary rehabilitation, versus usual care, associated with lower short-term pain intensity (9 trials, standardized mean difference −0.55, 95% CI −0.83 to −0.28, I2=72%; or ∼1.4-point mean difference on a 0- to 10-point numerical rating scale) and disability (9 trials, standardized mean difference −0.41, 95% CI −0.62 to −0.19, I2=58%; or ∼2.5-point mean difference on the RDQ); effects on long-term pain intensity and disability also favored multidisciplinary rehabilitation, but were smaller (7 trials, standard mean difference −0.21, 95% CI −0.37 to −0.04, I2=25% and 6 trials, standardized mean difference −0.23, 95% CI −0.40 to −0.06, I2=19%, respectively), with no difference in likelihood of return to work (7 trials, OR 1.04, 95% CI 0.73 to 1.47, I2=31%) (SOE: moderate for pain and function).
- For chronic low back pain a systematic review found multidisciplinary rehabilitation, versus no multidisciplinary rehabilitation, associated with lower short-term pain intensity (3 trials, standardized mean difference −0.73, 95% CI −1.22 to −0.24, I2=64%, or ∼1.7-point mean difference on a 0 to 10 numerical rating scale) and disability (3 trials, pooled standardized mean difference −0.49, 95% CI −0.76 to −0.22, I2=0%, or ∼2.9-point mean difference on the RDQ); there was insufficient evidence to assess effects on long-term outcomes (SOE: low for pain and function).
- For chronic low back pain, a systematic review found multidisciplinary rehabilitation, versus nonmultidisciplinary physical therapy, associated with lower short-term pain intensity (12 trials, standardized mean difference −0.30, 95% CI −0.54 to −0.06, I2=80%, or an approximate 0.6-point mean difference on a 0- to 10-point numerical rating scale) and disability (13 trials, standardized mean difference −0.39, 95% CI −0.68 to −0.10, I2=88%, or an approximate 1.2-point mean difference on the RDQ); multidisciplinary rehabilitation was also associated with lower long-term pain intensity (9 trials, standardized mean difference −0.51, 95% CI −1.04 to 0.01, I2=92%) and function (10 trials, standardized mean difference −0.68, 95% CI −1.19 to −0.16, I2=94%) and greater likelihood for return to work (8 trials, OR 1.87, 95% CI 1.39 to 2.53, I2=0%) (SOE: moderate).
- No study evaluated the effectiveness of multidisciplinary rehabilitation for acute low back pain or for radicular low back pain.
- Harms were poorly reported in trials of multidisciplinary rehabilitation, though no serious harms were reported (SOE: low).
Detailed Synthesis
Multidisciplinary rehabilitation, also known as interdisciplinary rehabilitation, refers to a coordinated program with both physical and biopsychosocial treatment components (at minimum) and is provided by professionals from at least two different specialties (e.g., physical therapists, occupational therapists, psychologists, physicians, and/or complementary and alternative medicine providers). The previous APS/ACP review29 identified three systematic reviews of multidisciplinary rehabilitation for chronic low back pain (>3 months duration) and one trial of multidisciplinary rehabilitation for subacute (>4 weeks and <3 months duration) low back pain.344-347 The systematic reviews were all rated high quality and included 20 unique trials. Based on the systematic reviews, the APS/ACP review concluded that there was good evidence that multidisciplinary rehabilitation interventions for chronic low back pain are moderately more effective than usual care or no multidisciplinary intervention at reducing pain and improving function, including return to work.344-347
We identified a subsequent good-quality systematic review of multidisciplinary rehabilitation that included 41 trials of multidisciplinary biopsychosocial rehabilitation (MBR) for chronic (>12 weeks) mechanical or nonspecific low back pain (Table 10; Appendix Tables E21; F21).348 Thirty-one of the trials were published after the APS/ACP review. The trials in the systematic review enrolled a total of 6,858 subjects (sample size range 20 to 542) from Europe, Iran, North America, and Australia. Sixteen trials compared MBR versus usual care; 4 trials MBR versus wait list controls; 19 trials MBR versus physical treatments (exercise plus other modalities like back school, massage, traction, and stretching); and 12 trials compared different multidisciplinary rehabilitation interventions versus one other. Trials of MBR versus surgery were included in the systematic review but outside the scope of this report. Fifteen of the MBR interventions were categorized as high-level interventions (>100 hours total and delivered on a daily basis), 15 involved low-level interventions (<30 hours and nondaily), and 11 interventions did not meet criteria for either high- or low-level interventions. Primary outcomes of pain, disability, and work were organized into short-term outcomes (<3 months), medium term-outcomes (3-12 months), and long-term outcomes (≥12 months). All of the studies had methodological shortcomings, but 13 trials were assessed by the review as low risk of bias, based on meeting ≥6 of 12 Cochrane Back Review criteria. No trial blinded providers or participants; other methodological shortcomings included failure to describe adequate randomization methods (12 trials) and failure to report intention to treat analysis (25 trials).
We identified three additional trials of multidisciplinary rehabilitation that were not included in the systematic review (Table 15; Appendix Tables E22, F22).349-351 Two trials evaluated multidisciplinary rehabilitation for subacute (<12 weeks duration) low back pain.349, 350 One good-quality trial (n=20) compared a low-intensity multidisciplinary program consisting of physician evaluation, acupuncture, chiropractic care, massage, occupational therapy, physical therapy, nutrition counseling, and as-needed psychiatric and rheumatology consults versus usual care.349 A fair-quality trial (n=70) compared a high-intensity (>100 total hours) multidisciplinary rehabilitation program including physician evaluation, physical therapy, biofeedback/pain management, group didactic sessions, case management/occupational therapy sessions, and interdisciplinary team conference for patients at high risk for chronic disabling low back pain versus usual care.350 A third, good-quality trial (n=20) evaluated multidisciplinary rehabilitation (including exercise and cognitive-behavioral therapy) versus usual care (including passive spinal mobilization and exercise) for chronic low back pain.351
Table 15
Characteristics and conclusions of included multidisciplinary rehabilitation trials.
Multidisciplinary Rehabilitation Versus Usual Care
Chronic Low Back Pain
For chronic low back pain, the systematic review found multidisciplinary rehabilitation associated with lower pain intensity versus usual care in the short term (less than 3 months) (9 trials, standardized mean difference −0.55, 95% CI −0.83 to −0.28, I2=72%; ∼1.4-point mean difference on a 0- to 10-point numerical rating scale).348 Multidisciplinary rehabilitation was also associated with better short-term disability (9 trials, standardized mean difference −0.41, 95% CI −0.62 to −0.19, I2=58%; ∼2.5-point mean difference on the RDQ). Statistical heterogeneity was present in pooled analyses. Restricting analyses to high-quality trials resulted in similar pooled estimates, though results were less precise and differences no longer statistically significant. There was substantial overlap in CIs for pooled estimates when results were stratified according to use of high versus low intensity MBR interventions. Only one trial enrolled patients with high baseline pain and disability intensity, precluding reliable conclusions regarding effects of baseline symptom intensity on estimates of effectiveness. No difference was seen in the proportion of patients working in the short term, based on two trials (OR 1.07, 95% CI 0.60 to 1.90, I2=0%). The odds ratios for return to work in the two included studies were 0.91 and 1.14.329, 352
The systematic review also found multidisciplinary rehabilitation associated with small beneficial effects on long-term back pain versus usual care (7 trials, standard mean difference −0.21, 95% CI −0.37 to −0.04, I2=25%; ∼0.5-point mean difference on a 0 to 10 numerical rating scale). Multidisciplinary rehabilitation was also associated with beneficial effects on long-term functional outcomes (6 trials, standardized mean difference −0.23, 95% CI −0.40 to −0.06, I2=19%; ∼1.4-point mean difference on the RDQ). There was no difference between multidisciplinary rehabilitation versus usual care in the likelihood of return to work long-term (7 trials, OR 1.04, 95% CI 0.73 to 1.47, I2=31%). In the included trials, odds ratios for return to work ranged from 0.48 to 2.77.
The systematic review found multidisciplinary rehabilitation associated with better short-term scores on the SF-36 mental component subscale (mean difference 15.25, 95% CI 2.05 to 28.44, I2=73%), with no effect on the SF-36 physical component subscale (mean difference 13.45, 95% CI −9.07 to 35.96, I2=94%).353, 354 However, estimates were based on only two trials with heterogeneous results (mean differences 9.4 [95% CI 2.7 to 16] and 23 [95% CI 11 to 35] on the mental component subscale and 2.5 [95% CI −1.4 to 6.4] and 26 [95% CI 15 to 36] on the physical component subscale).
Two trials evaluated multidisciplinary rehabilitation versus usual care for subacute low back pain. One trial (n=20) found MBR associated with better pain (mean 1.0 vs. 4.7) and SF-12 Physical Component Subscale scores (mean 51 vs. 44, p=0.03) through 26 weeks.349 Effects on the RDQ favored MBR at 12 weeks (3.9 vs. 11, p=0.08), but did not reach statistical significance. The second trial (n=70) found multidisciplinary rehabilitation associated with long-term (12 months) improvement in pain based on the Characteristic Pain Inventory (27 vs. 43 on a 0- to 100-point scale, p=0.001), disability days (38 vs. 102, p=0.001), return to work (91% vs. 69%, OR 4.55, p=0.027), use of opioids (27% vs. 44%, OR 0.44, p=0.020), and costs ($12,721 vs. $21,843, p<0.05) in patients at high risk for chronic disabling low back pain.350 Both trials found no differences in days in bed, days of work or school missed, and days that activity levels were reduced.
Multidisciplinary Rehabilitation Versus No Multidisciplinary Rehabilitation
Chronic Low Back Pain
The systematic review found multidisciplinary rehabilitation associated with lower short-term pain intensity versus no multidisciplinary rehabilitation (3 trials, standardized mean difference −0.73, 95% CI −1.22 to −0.24, I2=64%; ∼1.7-point mean differences on a 0 to 10 NRS).348 Although statistical heterogeneity was present, results from all trials favored multidisciplinary rehabilitation (standardized mean differences of −0.45, −0.55, and −1.20). Multidisciplinary rehabilitation was also associated with improved short-term disability (3 trials, pooled standardized mean difference −0.49, 95% CI −0.76 to −0.22, I2=0%; ∼2.9-point difference on the RDQ). There was insufficient evidence to assess effects on long-term outcomes. Work-related outcomes were also not reported.
Multidisciplinary Rehabilitation Versus Physical Therapy
Chronic Low Back Pain
The systematic review found multidisciplinary rehabilitation associated with lower short-term pain intensity versus physical therapy (12 trials, standardized mean difference −0.30, 95% CI −0.54 to −0.06, I2=80%; ∼0.6-point mean difference on a 0- to 10-point NRS).348 Multidisciplinary rehabilitation was also associated with better short-term disability (13 trials, standardized mean difference −0.39, 95% CI −0.68 to −0.10, I2=88%; ∼1.2-point mean difference on the RDQ). Statistical heterogeneity was present for both short-term pain and function, with 5 trials finding no effect on short-term pain or disability. Exclusion of high risk of bias trials and stratification by intensity of the multidisciplinary rehabilitation intervention resulted in pooled estimates that also favored multidisciplinary rehabilitation, though results were less precise and in some cases no longer statistically significant. Excluding an outlier trial with large effect sizes (e.g., 1.99 for pain vs. 0.04 to 0.65 in the other trials) eliminated statistical heterogeneity for pain and reduced statistical heterogeneity for function, and resulted in similar pooled estimates. Multidisciplinary rehabilitation was also associated with increased likelihood of working versus physical therapy at short term (3 trials, OR 1.60, 95% CI 0.92 to 2.78, I2=23%), though only one of the included trials reported a positive effect (OR 2.4, 95% CI 1.3 to 4.5, versus OR 1.1 in the other two trials).355
The systematic review also found multidisciplinary rehabilitation associated with lower long-term pain intensity versus physical therapy (9 trials, standardized mean difference −0.51, 95% CI −1.04 to 0.01, I2=92%; ∼1.2-point mean difference on a 0 to 10 NRS). Multidisciplinary rehabilitation was also associated with better long-term function (10 trials, standardized mean difference −0.68, 95% CI −1.19 to −0.16, I2=94%; ∼4.0-point difference on the RDQ). Excluding an outlier trial with very large effects in favor of multidisciplinary rehabilitation resulted in a similar pooled estimate that was no longer statistically significant. Multidisciplinary rehabilitation was associated with greater likelihood versus physical therapy for return to work (8 trials, OR 1.87, 95% CI 1.39 to 2.53, I2=0%).
Three trials found no differences between multidisciplinary rehabilitation versus physical therapy in the short or long term for quality of life measures209, 338, 356-358 and seven trials found no differences in short- or long-term depression or anxiety, or self-efficacy.209, 212, 334, 335, 338, 356-359
One subsequent small (n=20), good-quality trial reported results consistent with the systematic review.351
Harms
Harms were poorly reported in trials of multidisciplinary rehabilitation, though no serious harms were reported. One trial reported no adverse events in subjects who underwent multidisciplinary rehabilitation360 and one trial reported one case of pain due to acupuncture.349 One trial reported three cases of transitory worsening of pain and one case of mood alteration in patients undergoing multidisciplinary rehabilitation.
Acupuncture
Key Points
- For acute low back pain, a systematic review found acupuncture associated with lower pain intensity versus sham acupuncture using nonpenetrating needles (2 trials, mean difference 9.38 on a 0 to 100 VAS, 95% CI 1.76 to 17.0, I2=27%); three other trials reported effects consistent with these findings. One trial of sham acupuncture using penetrating needles to nonacupuncture points found no effect on pain. These were no clear effects on function in 5 trials (SOE: low for pain and function).
- For chronic low back pain, a systematic review found acupuncture associated with lower pain intensity versus sham acupuncture (superficial needling at acupuncture or nonacupuncture points, or nonpenetrating pressure at acupuncture points) immediately at the end of treatment (4 trials, WMD −16.76, 95% CI −33.3 to − 0.19, I2=90%) and at up to 12 weeks (3 trials, WMD −9.55, 95% CI −16.5 to −2.58, I2=40%), but there were no differences in function. Four additional trials reported results consistent with these findings (SOE: moderate for pain and function).
- For chronic low back pain, a systematic review found acupuncture associated with lower pain intensity (4 trials, SMD −0.72, 95% CI −0.94 to −0.49, I2=51%) and better function (3 trials, SMD −0.94, 95% CI −1.41 to −0.47, I2=78%) immediately after treatment versus no acupuncture. Mean effects on pain ranged from 7 to 24 points on a 0- to 100-point scale; for function one trial reported a difference of 8 points on a 0- to 100-point scale and the other two trials; two trials showed small or no clear differences at longer-term followup (SOE: moderate for pain and function).
- For acute low back pain, a systematic review found acupuncture associated with slightly greater likelihood of overall improvement versus NSAIDs at the end of treatment (5 trials, RR 1.11, 95% CI 1.06 to 1.16, I2=0%) (SOE: low).
- For chronic low back pain, a systematic review found acupuncture associated with better pain relief (3 trials, WMD −10.56 on a 0 to 100 scale, 95% CI −20.34 to −0.78, I2=0%) and improvement in function (3 trials, SMD −0.36, 95% CI −0.67 to −0.04, I2=7%) immediately postintervention (SOE: low).
- Harms of acupuncture were poorly reported in the trials, though no serious adverse events were reported (SOE: low).
Detailed Synthesis
The APS/ACP review29 included three systematic reviews361-363 with a total of 51 unique trials of acupuncture. Four trials in the systematic reviews evaluated acupuncture for acute low back pain and the remainder evaluated acupuncture for chronic low back pain. Based on the evidence in the systematic reviews, the APS/ACP review found insufficient (poor) evidence to determine effects of acupuncture for acute low back pain and fair evidence of moderate effects of acupuncture versus sham or no acupuncture for short-term pain relief in patients with chronic low back pain, though some inconsistency was noted in trials of acupuncture versus sham acupuncture, with some trials findings no effects.
We identified two fair-quality recent systematic reviews of acupuncture for low back pain; one evaluated acupuncture for acute or subacute low back pain364 and the other evaluated acupuncture for chronic low back pain (Table 10, Appendix Tables E23, F23).365
The systematic review364 on acupuncture for acute or subacute low back pain 9<12 weeks in duration) included 11 trials (9 not included in the APS/ACP review).366-374 Three trials evaluated acupuncture versus sham acupuncture (total n=148), 7 trials evaluated acupuncture versus medications including NSAIDS, muscle relaxants and analgesics (total n=966). and 1 trial compared acupuncture plus medication versus the medication alone (n=49). The acupuncture interventions ranged from a single session371, 375 to up to 12 sessions over a 4- to 6-week period. Outcomes were assessed immediately at the end of treatment in all trials; longer-term outcomes were assessed at 1 to 6 months in three trials.374, 376, 377 Five trials were rated low risk of bias,366, 371, 374-376 based on meeting at least 6 of 12 2009 Cochrane Back Group criteria. Methodological shortcomings in the 6 high-risk of bias trials included inadequate description of randomization and allocation concealment methods, unblinded design, and unclear similarity of the groups at baseline. Three sham-controlled trials had blinding of patients, providers and outcomes assessors.371, 374, 375
The systematic review365 on acupuncture for chronic low back pain included 32 trials (9 not included in the APS/ACP review).378-385 All of the trials evaluated patients with chronic low back pain for >12 weeks, with the exception of one trial that included people with subacute (>6 weeks) to chronic low back pain (up to 52 weeks).386 In addition to standard acupuncture needles applied to the body, other acupuncture techniques evaluated in the trials included electroacupuncture and auricular acupuncture. Seven trials evaluated acupuncture versus sham procedures (total sample=638 participants), 3 trials evaluated acupuncture versus medications (total sample=75 participants), and the other 22 trials compared acupuncture versus no acupuncture, usual care, TENS, exercise, inactive treatment, or another active treatment. The number of sessions ranged from 1 to 20, the duration of treatment ranged from 1 day (single treatment) to 12 weeks, and duration of followup ranged from immediately following treatment through up to 48 months. Seven of the trials378-381, 383, 387, 388 were rated low risk of bias (based on meeting all 2009 Cochrane Back Review Group criteria). Methodological shortcomings in the other trials included inadequate description of randomization and allocation concealment techniques, unblinded design, and unclear similarity of groups at baseline.
We identified three additional good-quality trials of acupuncture for acute389, 390 or chronic391 low back pain (Table 16, Appendix Tables E24, F24). One trial (n=80) compared five 30-minute sessions scalp acupuncture plus diclofenac versus sham scalp acupuncture plus diclofenac for acute low back pain; outcomes were assessed at 28 days.389 Another trial (n=270), randomized patients with acute low back pain to one of four treatment groups: true acupuncture, sham acupuncture (needles inserted at nonacupuncture points), placebo acupuncture (momentary pressure with semiblunted needle applied to back) or no acupuncture.390 Treatments were administered in five 20-minute sessions over 2 weeks, with outcomes assessed through 48 weeks. The third trial (n=130) evaluated acupuncture versus sham acupuncture for chronic low back pain.391 Patients received 12 acupuncture or sham acupuncture sessions over a 6 week time period and were followed for up to 6 months.
Table 16
Characteristics and conclusions of included acupuncture trials.
We also identified one fair-quality trial (n=236) of acupuncture performed at back pain specific acupoints or standard acupuncture performed at nonspecific acupoints (n=82) versus usual care.392 Methodological limitations included unclear allocation concealment and lack of blinding of patients and providers. Patients in the acupuncture groups received 14 daily treatments and outcomes were assessed through 24 weeks. A poor-quality trial (n=143) (due to unclear randomization and allocation concealment methods, no primary outcome identified and unclear blinding) compared the addition of daily acupuncture to an intensive inpatient 21-day rehabilitation for chronic low back pain and measured outcomes at 3 months after the end of treatment.393
Acupuncture Versus Sham Acupuncture
Acute Low Back Pain
Three low risk of bias trials in the systematic review of acupuncture for acute low back pain364 evaluated acupuncture versus a sham procedure involving nonpenetrating needles to acupuncture points.371, 374, 375 Two trials (n=40 and 60) found acupuncture associated with immediate pain relief following a single treatment, though effects were small (mean difference 9.38 on a 0 to 100 VAS, 95% CI 1.76 to 17.0, I2=27%).371, 375 The third trial (n=48) could not be pooled, but found no difference between 3 to 12 sessions of acupuncture versus sham in mean pain intensity at 3 months, though acupuncture was associated with lower scores for worst pain at 3 months (estimated marginal mean difference from baseline 18.7 on 0-100 VAS scale, 95% CI 1.5 to 36.0, p=0.034) as well as analgesic tablet use. There were no differences in function in any of the studies.
One good-quality trial (n=275) not included in the systematic review found no differences between five 20-minute sessions of acupuncture, sham (nonacupuncture points), or placebo (semiblunted needles to the back) acupuncture in the likelihood of experiencing 35 percent improvement in the RDQ at 3 weeks, though the first two were associated with greater likelihood of improvement in the RDQ versus no acupuncture (74% vs. 75% vs. 65% vs. 44%, respectively, RR 1.66, 95% CI 1.23 to 2.24 for acupuncture versus no acupuncture and RR 1.69, 95% CI 1.26 to 2.28 for sham acupuncture versus no acupuncture).390 Changes in pain intensity were not reported, and there were no clear differences between groups in the proportion of patients reporting ongoing or recurring pain at 1 year.
Another good-quality trial (n=80) not included in the systematic review found five 30-minute sessions of scalp acupuncture associated with lower pain intensity (mean improvement from baseline 4.57 vs. 3.30 on a 0-10 VAS, p=0.005) and function (mean improvement from baseline 10.8 vs. 6.6 on the RDQ, p=0.002) at 28 days versus sham acupuncture (nonpenetrating needles), though the magnitude of the difference was below the prespecified threshold for meaningful differences (<2 cm on the 10 cm VAS scale and <5 on the RDQ).389
Chronic Low Back Pain
Seven trials in the systematic review of acupuncture for chronic low back pain evaluated acupuncture versus sham acupuncture. One trial evaluated auricular electroacupuncture versus sham electroacupuncture (needles inserted but no current)394 and the other trials evaluated acupuncture to the body versus superficial needling at acupuncture points,388, 395 nonpenetrating pressure with a needling tube,396 or superficial needling at nonacupuncture points.379, 397, 398 Four trials could be included in pooled analyses.388, 395-397 Acupuncture was associated with improved pain versus sham immediately at the end of treatment (4 trials, WMD −16.76, 95% CI −33.3 to −0.19, I2=90%) and at up to 12 weeks (3 trials, WMD −9.55, 95% CI −16.5 to −2.58, I2=40%), but there were no differences on function at the end of treatment (p=0.2, data not provided) or at up to 12 weeks (p=0.76). Statistical heterogeneity was substantial and was not explained by the type of sham procedure evaluated. The three trials not included in the meta analysis due to lack of poolable data,379, 394, 398 including the trial of auricular acupuncture, reported results consistent with the meta-analysis for immediate effects. One trial that evaluated longer-term outcomes found that differences between acupuncture versus sham acupuncture were smaller and no longer statistically significant at 26 and 52 weeks.397
One good-quality trial (n=130) published subsequent to the systematic review found acupuncture (up to 12 sessions over 6 weeks) associated with lower low back pain symptom bothersomeness scores (mean change from baseline −3.4 vs. −2.3 on 0 to 10 VAS, p<0.05) and pain intensity (−3.52 vs. −2.27 on 0 to 10 VAS, p=0.008) versus sham acupuncture (semiblunt needles to nonacupuncture points) at 8 weeks, though differences were no longer present at 6-month followup.391 There was no difference in function (ODI) at any time point through 6 months.
Acupuncture Versus No Acupuncture
Chronic Low Back Pain
The systematic review of acupuncture for chronic low back pain365 included five trials of acupuncture versus no acupuncture. One trial was rated low risk of bias378 and the others unclear risk of bias.384, 397, 399, 400 The systematic review found acupuncture associated with lower pain intensity (4 trials, SMD −0.72, 95% CI −0.94 to −0.49, I2=51%)384, 397, 399, 400 and better function (3 trials, SMD −0.94, 95% CI −1.41 to −0.47, I2=78%)378, 397, 400 immediately after treatment, versus no acupuncture. Across the trials included in the meta-analyses, mean effects on pain ranged from 7 to 24 points on a 0- to 100-point scale; for function one trial reported a difference of 8 points on the Pain Disability Index397 and the other two trials378, 400 reported mean differences of 0.8 and 3.4 points on the RDQ. The low risk of bias trial found no clear differences between acupuncture versus self care alone in the RDQ at the end of treatment (mean 7.9 vs. 8.8, p=0.55) or at 1 year (mean 8.0 vs. 6.4, p=0.10) or in symptom bothersomeness scores (40 vs. 4.6 on a 0 to 10 scale at 10 weeks and 4.5 vs. 3.8 at 1 year, respectively).378 Another trial also found that effects on pain and function were much larger immediately after a 12-week course of treatment (for pain, mean difference 27 [95% CI 24 to 21] on a 0- to 100-point scale at 3 months and 2.7 [95% CI −0.3 to 5.7] at 6 months; for function, mean difference 22 points [95% CI 95% CI 19 to 25] on the 0 to 100 Hannover Functional Ability Questionnaire at 3 months and 3.7 points [95% CI 0.7 to 6.7] at 6 months).384
Acupuncture Versus Medications
Acute Low Back Pain
Five trials366-369, 373 in the systematic review of acupuncture for acute low back pain364 found acupuncture associated with slightly greater likelihood of overall improvement versus NSAIDs at the end of treatment (5 trials, RR 1.11, 95% CI 1.06 to 1.16, I2=0%). However, there was no significant difference when the analysis was restricted to two trials rated low risk of bias (pooled RR, 1.14; 95% CI 0.99, 1.30; I2=49%), although the point estimate was similar to the overall analysis and each trial reported results that favored acupuncture versus meloxicam (RR 1.07, 95% CI 1.02 to 1.11)369 or versus ibuprofen (94% vs. 75% “cured”, p<0.05).366 The three high risk of bias trials reported inconsistent effects of acupuncture versus medications on pain intensity. One trial favored acupuncture over ibuprofen368 immediately following each treatment, but two other trials found no significant differences between acupuncture versus naproxen377 or diclofenac.372
Chronic Low Back Pain
Three trials in a systematic review of acupuncture for chronic low back pain365 compared acupuncture versus medications (NSAIDs, muscle relaxants and analgesics).400-402 Two of the trials were rated high risk of bias401, 402 and the other unclear risk of bias.400 Compared with medications, acupuncture was associated with better pain relief (WMD −10.56 on a 0 to 100 scale, 95% CI −20.34 to −0.78, I2=0%) and function (SMD −0.36, 95% CI −0.67 to −0.04, I2=7%) immediately postintervention.
Acupuncture Plus Medications Versus the Medication Alone
Acute Low Back Pain
Two high risk of bias trials in the systematic review compared acupuncture plus medications versus the medication alone.372, 373 One trial (n=200) found 7 days of acupuncture plus nimesulide (an NSAID) associated with better short-term overall improvement the NSAID alone.373 The other trial (n=69) found five sessions of acupuncture plus diclofenac associated with greater short-term improvements in pain and function versus diclofenac alone at the end of treatment.372
Harms
Harms of acupuncture were poorly reported in the trials. Serious adverse events were not reported in any trial. In three trials, the most commonly reported adverse effects in people receiving acupuncture were gastrointestinal problems, changes in energy,377 mild bleeding at the needling site,371 and temporarily increased low back pain.391
Massage
Key Points
- For subacute low back pain, a systematic review included two trials that found massage associated with greater short-term (1 week) improvement in pain (SMD −0.92, 95% CI −1.35 to −0.48) and function (SMD −1.76, 95% CI −3.19 to −0.32) versus sham therapy, but there was no difference in pain or function at 5 weeks in one trial (SOE: low for pain and function).
- For chronic low back pain, one trial found no difference between foot reflexology versus usual care in pain or function, and one trial found structural or relaxation massage associated with better function (mean 2.5 to 2.9 points on the RDQ) versus usual care at 10 weeks; effects were less pronounced at 52 weeks (SOE: low for pain and function).
- For subacute to chronic low back pain, a systematic review found massage associated with better effects on short-term pain in 7 of 9 trials (mean differences −0.6 to −0.94 points on a 0 to 10 scale) and better effects on short-term function in 3 of 4 trials (SOE: moderate for pain and function).
- For subacute to chronic low back pain, a systematic review included 5 trials that generally found massage plus another intervention superior to the other intervention without massage for short-term pain, with effects somewhat stronger in trials in which massage was combined with exercise; few differences were observed for function or long-term pain. Two subsequent trials of massage plus exercise reported findings generally consistent with these findings (SOE: low).
- Comparisons of difference massage techniques were too heterogeneous and effects were too small from six trials to determine effects on pain and function (SOE: insufficient).
- Harms were not well-reported in trials of massage, though no serious adverse events were reported; two trials reported soreness during or shortly after the treatment (SOE: low).
Detailed Synthesis
The APS/ACP review29 included two good-quality systematic reviews with a total of eight unique trials of massage.403, 404 Five of the trials were rated higher quality. Based on the systematic reviews, the APS/ACP review concluded that there was fair evidence of moderate net benefits of massage for chronic or subacute low back pain.
One of the systematic reviews404 has been updated to include 13 trials (total n=1596, range 39 to 262) (Table 10; Appendix Tables E25, F25).405 The trials evaluated massage for acute (1 RCT), subacute (4 RCTs) and chronic low back pain (8 RCTs). Massage techniques were variable, and included traditional Thai massage, Swedish massage, relaxation massage methods, acupuncture massage, muscle energy technique, roptrotherapy, acupressure, foot reflexology, or combined techniques. Two trials compared massage versus sham/placebo massage, nine trials of massage versus other treatments (manipulation, exercise, relaxation, acupuncture, physiotherapy and self-care education), five trials of massage versus other interventions versus the other interventions alone, and two trials compared different massage techniques. The number of sessions, duration of sessions, and duration of treatment varied. Two of the studies included were single intervention trials; in the remainder the duration of treatment ranged from three to 10 weeks. The duration of followup ranged from immediately following treatment to 52 weeks post randomization. Six trials were rated low risk of bias (based on meeting ≥6 of 11 Cochrane Back Review group criteria). Methodological shortcomings included lack of blinding of patients and assessors and inadequate or unclearly described allocation concealment methods.
We identified eight additional trials of massage not included in the systematic review.406-413 One good-quality trial (n=401) evaluated two different types of massage (structural or relaxation) versus usual care for chronic low back pain (Table 17; Appendix Tables E26, F26).406 Patients randomized to massage received 10 weekly treatments including up to 3 home exercises from a predefined list of seven exercises, six of which were common to both treatments, as well as stretching. The relaxation massage group was also given 2.5-minute home relaxation exercises. A fair-quality trial (n=45) compared acupressure massage versus sham laser or no treatment.412 Three smaller trials (n=26 to 140) not compared different massage techniques with one another. One trial was rated as good quality,407 one fair,409 and one poor quality.408 Two fair-quality trials compared massage plus an exercise intervention to the exercise intervention alone.411, 413 One of these trials trial (n=80)411 evaluated myofascial release for subacute to chronic low back pain and the other413 evaluated Chinese massage for back pain of mixed duration. The eighth, fair-quality trial (n=32) compared massage plus traction versus traction alone in patients with chronic low back pain.410 Methodological shortcomings in the fair- and poor-quality trials included unclear randomization and allocation concealment methods, baseline group differences, and inadequate or unclear blinding.
Table 17
Characteristics and conclusions of included massage trials.
Massage Versus Sham Intervention or No Massage
Subacute Low Back Pain
The updated systematic review included two trials of massage versus sham therapy for subacute low back pain.414, 415 One low risk of bias trial (n=98) included in the prior APS/ACP review found massage moderately superior to sham laser for short- and long-term pain intensity and functional status.414 Effects of pain ranged from about 0.8 to 1.3 points on a 10-point pain scale (p<0.001) and from 1.2 to 4 points on the RDQ (p<0.001). Another, high risk of bias trial (n=60)415 compared one 30-minute session of deep cross-friction massage with the aid of a copper myofascial T-bar (roptrotherapy) applied to the lumbar pelvic region versus no massage to patients with subacute low back pain (>3 weeks and <12 weeks). In this trial, roptrotherapy was associated with less pain and improved function at 1 week compared with either no treatment or a placebo intervention (endemiology as a massage-like treatment). Mean differences in change from baseline were about 20 points for pain on a 0 to 100 scale and about 20 points on the ODI. In a pooled analysis, massage was associated with greater short-term (1 week) improvement in pain (SMD −0.92, 95% CI −1.35 to −0.48) as well as back-specific function (SMD −1.76, 95% CI −3.19 to −0.32).414, 415 However, one trial that evaluated longer-term outcomes found no statistically significant effects on pain and back-related function at 5 weeks.415
One additional fair-quality trial (n=45) found massage associated with decreased low back pain versus sham laser or no treatment at 6 weeks (0.9 vs. 4.7 vs. 5.9 on a 0 to 10 scale, respectively), but there were differences in baseline pain scores (6.4 vs. 5.7 vs. 5.0).412
Massage Versus Usual Care
Chronic Low Back Pain
One low risk of bias trial (n=243) included in the systematic review found no differences between foot reflexology versus usual care in short- or long-term pain or function.328 A recent, good quality, larger (n=401) trial406 not included in the systematic review found a 10-week course of structural or relaxation massage for chronic low back pain each associated with better RDQ scores versus usual care (differences 2.5 to 2.9 points on a 0- to 24-point scale) and better symptom bothersomeness scores (differences 1.4 and 1.7 points) at 10 weeks. Beneficial effects on function, but not symptom bothersomeness, remained present at 52 weeks for relaxation massage (but not structural massage) versus usual care, but were less pronounced (mean difference in RDQ −1.4, 95% CI −2.6 to −0.2).
Massage Versus Other Treatments
The systematic review included eight trials (5 published since the APS/ACP review) of massage other noninvasive active treatments. Massage was compared versus manipulation (1 trial),416 exercise therapy (1 trial),414 relaxation therapy (3 trials),328, 417, 418 acupuncture (1 trial),403 or physiotherapy (2 trials).419, 420 All of the trials evaluated patients with subacute to chronic low back pain. Most trials found massage superior to other treatments for short-term pain, but findings were limited by small samples, small numbers of trials for each comparison, heterogeneous massage and comparator intervention techniques, and methodological limitations in the trials. For short-term pain, results favored massage in 7 of the nine trials, though effects were small (mean differences less than 1 point on a 0 to 10 scale, range −0.6 to −0.94). The largest effect was observed in a low risk of bias trial (n=67) that found Thai massage associated with less pain versus joint mobilization 5 minutes after treatment (mean difference −0.94,95% CI −1.76 to −0.12) for chronic low back pain.416 The largest trial (n=243) found no differences between reflexology versus progressive muscle relaxation in pain (mean difference 2.90, 95% CI −12.32 to 6.52) or function (−3.60, 95% CI −11.10 to 3.90) immediately post-treatment or at 6 months.328 Other trials found massage associated with better scores on the RDQ versus acupuncture at the end of a 10-week course of treatment (n=172, mean difference in change from baseline 0.6 points, p=−0.01), with similar effects at 1 year403 versus exercise 1 month after a 1-month course of treatment (n=47, mean difference in change from baseline 4.2 points, p<0.05);414 or versus a physical therapy intervention (including exercise, manipulation, and physical modalities) at the end of a 1-month course of treatment (n=129, mean difference −4.6, 95% CI −6.4 to −2.9) through 6-month followup.419
Massage Plus Another Intervention Versus the Other Intervention Without Massage
Five trials included in the systematic review compared massage plus another intervention (exercise [2 trials],414, 421 exercise and education [1 trial],422 or usual care [2 trials]328, 423) versus the other intervention without massage; three of these trials328, 422, 423 were not in the prior APS/ACP review. Three trials were assessed as being at low risk of bias.328, 414, 421 The two studies that included usual care interventions either did not define usual care423 or included a broad range of possible treatments including no treatment, medications, physical therapy, herbal remedies and aromatherapy.328 Only one trial included patients with subacute low back pain;423 the rest included patients with subacute to chronic low back pain. The trials generally found massage plus another intervention to be superior to the treatments without massage for short-term pain, but findings were limited by small samples, few trials for each comparison, evaluation of heterogeneous massage techniques and comparator interventions, and methodological limitations in the trials. Few differences were observed for function or long-term pain. The improvement in short-term pain appeared somewhat stronger in the 3 trials in which massage was combined with either group or individual exercise.414, 421, 422
One subsequent, fair-quality trial (n=32) found massage (twice weekly 20 minute sessions) plus traction for three weeks and 32 associated with no clear effects versus traction alone in pain immediately following treatment (mean 1.9 vs. 1.4 on a 0 to 10 scale); function was not reported.410 Two other fair-quality trials (n=80 and 90) not included in the systematic review found massage plus an exercise intervention associated with small to moderate effects on short-term pain (mean difference of about 5 point on the McGill Pain Questionnaire or 1.4 on a 0 to 10 point VAS) and function (about 3 points on the 0 to 100 point Quebec Back Pain Disability Questionnaire or about 5 point on the ODI) versus the exercise intervention alone.411, 413
Comparisons of Different Types of Massage
Six trials compared different types of massage;406-409, 421, 424 two of these421, 424 were included in the systematic review.405 The massage techniques that were compared varied. Although most trials found statistically significant differences among methods, effects were small. One low risk of bias trial (n=190) found acupuncture massage superior to Swedish massage for short-term pain (mean difference about 0.8 on a 0 to 10 VAS) and function (mean difference about 7 points on the 0 to 100 Hanover Function Score Questionnaire).421 Another trial (n=268 for comparison of massage techniques) found no differences between structural versus relaxation massage on the RDQ (mean difference about 0.4 points) or symptom bothersomeness scores (mean difference about 0.3 points on a 0 to 10 scale).406 Other, smaller (n=26 to 140) trials also found small differences that favored Chinese massage with oils vs. standard massage,407 Swedish massage with oils versus Thai massage,409 traditional Thai versus Swedish massage424 and deep tissue versus standard massage.408
Harms
Harms were not well-reported in trials of massage, though no serious adverse events were reported. In two trials that reported adverse events,420, 424 soreness was noted during or shortly after the treatment. Some patients also reported a skin reaction (e.g., rash or pimples) in trials that used massage oil.
Spinal Manipulation
Key Points
- For acute low back pain, two trials (one included in a systematic review) found spinal manipulation associated with better effects on function versus sham manipulation (statistically significant in one trial); in one trial effects on pain favored manipulation but were small and not statistically significant (mean difference −0.50, 95% CI −1.39 to 0.39) (SOE: low for function, insufficient for pain).
- For chronic low back pain, a systematic review found spinal manipulation associated with small, statistically nonsignificant effects versus sham manipulation on pain at 1 month (3 trials, WMD −3.24, 95% CI −13.62 to 7.15 on a 0 to 100 scale, I2=53%); one trial reported similar results for function (SMD −0.45, 95% CI −0.97 to 0.06); one trial not included in the systematic review reported generally consistent results (SOE: low for pain, insufficient for function).
- For acute low back pain, a systematic review found no differences between spinal manipulation versus and inert treatment in pain relief at 1 week (3 trials, WMD 0.14 on a 0 to 10 scale, 95% CI −0.69 to 0.96, I2=27%), though one trial found SMT associated with better longer-term pain relief (MD −1.20 at 3 months, 95% CI 2.11 to −0.29); there were no differences in function at 1 week (2 trials, SMD −0.08, 95% CI −0.37 to 0.21, I2=0%) or at 3 months (1 trial, SMD −0.28, 95% CI −0.59 to 0.02) (SOE: low for pain and function).
- For chronic low back pain, one high-quality trial found spinal manipulation associated with greater improvement in the “main complaint” versus an inert treatment (mean difference 0.9 on a 0 to 10 scale, 95% CI 0.1 to 1.7); results from three low risk of bias trials and three additional trials not included in the systematic review were somewhat inconsistent, though some trials reported effects that favored manipulation (SOE: low).
- For acute low back pain, a systematic review found no difference between spinal manipulation versus other active interventions in pain relief at 1 week (3 trials, WMD 0.06 on a 0 to 10 scale, 95% CI −0.53 to 0.65, I2=0%), 1 month (3 trials, WMD −0.15, 95% CI −0.49 to 0.18, I2=0%), 3 to 6 months (2 trials, WMD−0.20, 95%CI −1.13 to 0.73, I2=81%), or 1 year (1 trial, MD 0.40, 95% CI −0.08 to 0.88). Findings were similar for function, with no differences observed at any time point. A subsequent trial of patients with acute or subacute low back pain found spinal manipulation associated with moderate effects versus usual care on pain and small effects on function at short-term followup, but effects were smaller and no longer statistically significant at 3 and 6 months (SOE: moderate for pain and function).
- For chronic low back pain, a systematic review found spinal manipulation associated with better short-term pain relief versus other active interventions at 1 month (10 comparisons from 6 trials, WMD −2.76 on a 0 to 100 scale, 95% CI −5.19 to −0.32, I2=27%) and 6 months (7 comparisons from 4 trials, WMD −3.07, 95% CI −5.42 to −0.71, I2=0%), though the magnitude of effects was below the small/slight threshold. There was no difference at 12 months (3 trials, WMD −0.76, 95% CI −3.19 to 1.66, I2=0%). Manipulation was also associated with greater function improvement in function versus other active interventions at 1 month (10 comparisons from 6 trials, SMD −0.17, 95% CI −0.29 to −0.06, I2=3%); effects were smaller and no longer statistically significant at 6 and 12 months. Three trials not included in the systematic reviews reported results consistent with these findings (SOE: moderate for pain and function).
- For acute low back pain, four trials in a systematic review found spinal manipulation plus either exercise or advice associated with greater improvement in function at 1 week (SMD −0.41, 95% CI −0.73 to −0.10, I2=18%) versus exercise or advice alone, but there were no differences at 1 month (3 trials, SMD −0.09, 95% CI −0.39 to 0.21, I2=37% ) or 3 months (2 trials, SMD −0.22, 95% CI −0.61 to 0.16, I2=41%) (SOE: low).
- For chronic low back pain, a systematic review found spinal manipulation plus another active treatment associated with greater pain relief at 1 month (3 trials, WMD −5.88 on a 0 to 100 scale, 95% CI −10.85 to −0.90, I2=0%), 3 months (2 trials, MD −7.23, 95% CI −11.72 to −2.74, I2=43%), and 12 months (2 trials, MD −3.31, 95% CI −6.60 to −0.02, I2=12%) versus the other treatment alone, combination therapy was also associated with better function at 1 month, (2 trials, SMD −0.40, 95% CI −0.73 to −0.07, I2=0%), 3 months (2 trials, SMD −0.22, −0.38 to −0.06, I2=33%), and 12 months (2 trials, SMD −0.21, 95% CI −0.34 to −0.09, I2=0%). One trial not included in the systematic review reported results consistent with these findings (SOE: low).
- For radicular low back pain, one good-quality trial found spinal manipulation plus home exercise and advice associated with greater improvement in leg and back pain at 12 weeks versus home exercise and advice alone (mean differences about 1 point on a 0 to 10 scale), but effects were smaller (0.3 to 0.7 points) and no longer statistically significant at 52 weeks (SOE: low).
- Harms were not reported well in most trials of spinal manipulation. No serious adverse events were reported and most adverse events were related to muscle soreness or transient increases in pain (SOE: low).
Detailed Synthesis
The APS/ACP review29 included 12 systematic reviews361, 425-436 with a total of 69 individual trials of spinal manipulation versus sham, an inactive treatment, or another active treatment for acute and chronic low back pain.16 The APS/ACP review concluded that there was fair evidence that spinal manipulation was associated with moderate benefits for acute and chronic low back pain.
One of the reviews of spinal manipulation in the APS/ACP review was subsequently updated as separate good-quality reviews for acute low back pain437 and chronic low back pain (Table 10; Appendix Tables E27, F27)438 The acute low back pain review included 19 randomized trials; eight of these trials were not included in the APS/ACP review.439-446 Sample sizes ranged from 36 to 323 participants (total sample=2674). About half of the trials restricted inclusion to patients with acute low back pain,442-445, 447-451 four included patients with a mix of acute and subacute back pain439, 441, 446, 452 and six included patients with acute to chronic low back pain.440, 453-457
A separate review438 included 26 trials (sample sizes 29 to 1,334, total sample=6070 participants) of spinal manipulation for chronic low back pain; 18 of these trials were not included in the prior Cochrane review.185, 192, 196, 402, 458-471 Only eight trials restricted inclusion to patients with symptoms longer than 3 months.192, 196, 402, 458, 460, 464, 465, 467, 470 The remainder permitted inclusion of patients with nonchronic symptoms, but the mean duration of back pain was generally months to years in duration.
Six studies of acute low back pain were rated as low risk of bias441-443, 445, 446, 453 and nine studies of chronic low back pain were rated as low risk of bias.185, 192, 461, 462, 469, 472-474 Methodological shortcomings in the high risk of bias studies included unblinded design, unclear allocation concealment methods, incomplete followup, selective reporting of outcomes and in one study475 significant baseline differences among groups.
In the trials included in the systematic reviews, spinal manipulation was compared against a wide variety of interventions, including various sham or inert therapies (placebo antiedema gel, detuned short-wave diathermy, bed rest, detuned ultrasound, corset and transcutaneous muscle stimulation, sham SMT), or another active intervention (acupuncture, back school, educational back booklet with or without additional counseling, exercise therapy, myofascial therapy, massage, pain clinic, pharmacological/analgesic therapy, short-wave diathermy, standard medical care [including analgesic therapy and advice/reassurance], standard physiotherapy, and ultrasound). The primary type of thrust technique used in the spinal manipulation interventions also varied. High-velocity low-amplitude (HVLA) thrust was used in most studies, though a combination of manipulation and mobilization or other mobilization techniques such as flexion-distraction or the Maitland method were used in 8 trials and unspecified types of SMT were used in 14 trials.
The number and frequency of manipulation treatments also varied among trials that reported this information. Approximately half of the acute low back pain trials did not report number of treatments, but those that did reported 1 and 10 treatment sessions. For chronic low back pain trials, the average maximum number of treatments allowed was 8 and the average duration of treatment 7 weeks in trials that provided this information. In both acute and chronic low back pain trials, followup ranged from 2 weeks to 2 years, with approximately half of the studies only reporting short-term outcomes (<3 months). One study of SMT for acute low back pain only measured the immediate effect of treatment, 2 days after the end of treatment.446
We identified 16 additional trials published subsequent to the updated reviews, 8 of which were trials for chronic low back pain,241, 476-482two for acute or subacute low back pain483-485, one for mixed duration low back pain466 one for radicular low back pain.486 (Table 18; Appendix Tables E28, F28). We also included 3 trials that were excluded from the systematic reviews because they enrolled patients with sciatica/radiculopathy.487-489 Two studies were poor quality487, 488 and one was good quality.489 These additional trials varied in terms of the comparators including epidural steroid injections,487 chemonucleolysis,488 McKenzie,466, 481 physical therapy,478 active exercise241, 486 usual care,483 and inactive or sham treatments including detuned ultrasound,476 simulated manipulation,489 side lying,477 and light massage.480 The duration of treatment ranged from a single treatment479 on 1 day to 18 sessions over a period of 9 months.
Table 18
Characteristics and conclusions of included spinal manipulation trials.
Spinal Manipulation Versus Sham Therapy
Acute Low Back Pain
The systematic review of spinal manipulation for acute low back pain437 included one high risk of bias trial (n=192) of SMT versus sham SMT.444 It found no differences between seven sessions of high velocity low amplitude thrust SMT over 2 weeks versus sham adjustments at 1-month followup (MD −0.50, 95% CI −1.39 to 0.39 for pain; SMD −0.35, 95% CI −0.76 to 0.06, function).
One additional poor-quality study not included in the systematic review485 (n=100) compared three treatments: SMT (up to 2 treatments over a 3-day period) with placebo diclofenac, sham SMT with diclofenac, and sham SMT with placebo diclofenac. Results at 7 to 9 days post treatment favored SMT with placebo diclofenac versus the sham SMT with diclofenac (mean improvement from baseline on RDQ 7.71 vs. 4.75, p=0.01) and versus sham SMT with placebo diclofenac (data not provided), but effects were small.
Chronic Low Back Pain
The systematic review of manipulation for chronic low back pain included three high risk of bias trials of SMT versus sham SMT.459, 464, 490 The SMT interventions in these trials ranged from four to seven treatment sessions over 2 weeks to 5 months. There was no difference between SMT versus sham SMT in pain at 1 month (3 trials, WMD −3.24, 95% CI −13.62 to 7.15 on a 0 to 100 scale, I2=53%). Two of the trials (n=64 and 19)459, 490 reported a nonsignificant effects in favor of SMT, while the third trial (n=65)464 reported a nonsignificant effect that favored sham SMT. One trial that reported 3- and 6-month outcomes464 reported nonsignificant effects that favored sham SMT. This was also the only trial to report function; it found a small benefit favoring SMT at 1 month (SMD −0.45, 95% CI −0.97 to 0.06) but there were no differences at 3 or 6 months.
Two additional trials compared SMT versus a sham SMT procedure for chronic low back pain.479, 482 A good-quality trial (n=148) found no difference between a single treatment of region-specific SMT versus sham SMT (nonregion-specific HVLA) immediately following the procedure.479 One additional fair-quality trial (n=94) compared two different SMT protocols (12 sessions of SMT over 1 month and 12 sessions of SMT over 1 month plus maintenance SMT for 9 months) versus sham manipulation for chronic low back pain.482 Both SMT groups were superior to sham at 1 month (mean difference 5.0 on a 0-100 scale, p<0.05), with no difference between active SMT interventions. At 10 months, maintenance SMT was associated with small improvements in both pain (16.3 difference on a 0-100 scale, p<0.05) and function (18.1 difference on ODI, p<0.05) compared with either 1 month of SMT or sham manipulation.
Spinal Manipulation Versus an Inactive Treatment
Acute Low Back Pain
Seven trials included in the systematic review of manipulation for acute low back pain437 compared SMT versus inert interventions (an educational booklet,453 detuned ultrasound and cold packs,447 detuned ultrasound,443 detuned short-wave diathermy,491 antiedema gel spread,456 bed rest,456 and short-wave diathermy450, 452). Two trials were rated low risk of bias.443, 453 There were no differences between SMT versus inactive treatments for pain relief at 1 week (3 trials, MD on 0-10 scale 0.14, 95% CI −0.69 to 0.96, I2=27%),447, 452, 453 one trial found SMT associated with better longer-term pain relief (MD −1.20 at 3 months, 95% CI 2.11 to −0.29).453 There were no differences between SMT versus inert interventions in function at 1 week (2 trials, SMD −0.08, 95% CI −0.37 to 0.21, I2=0%)447, 453 or at 3 months (1 trial, SMD −0.28, 95% CI −0.59 to 0.02).453
Chronic Low Back Pain
The systematic review of manipulation for chronic low back pain438 included four trials of SMT versus inert interventions (antiedema gel [1 trial], detuned short-wave diathermy [1 trial], detuned ultrasound [1 trial], or corset and transcutaneous muscle stimulation [1 trial]).456, 474, 475, 492 One trial (n=76) was rated low risk of bias.474 It found SMT associated with greater improvement in the “main complaint” (mean difference 0.9 on a 0 to 10 scale, 95% CI 0.1 to 1.7) versus detuned therapy at 12 months. Effect also favored SMT for function at 12 months, though the difference was not statistically significant (mean difference 0.6, 95% CI −0.1 to 1.3). Effects at earlier time points were smaller not statistically significant. Three high risk of bias trials found no clear differences between SMT versus various inert interventions in pain or other outcomes.456, 475, 492
Three additional trials (n=42, 40, 111 and 400)476, 477, 480 not included in the systematic review also compared SMT versus other inactive treatments for chronic low back pain. One of the trials was rated good quality480 and two were rated fair quality.476, 477 The inactive comparators were detuned ultrasound,476 side lying without SMT,477 and light massage for 5 minutes.480 One trial evaluated effects of a single treatment session immediately after treatment.477
The good-quality trial480 compared 6, 12, or 18 sessions of SMT versus light massage. All patients underwent 18 sessions of therapy; at each session they also received hot packs and low-intensity ultrasound and for sessions in which they did not undergo SMT, they received 5 minutes of light massage instead. At the primary outcome of 12 weeks, both those receiving either 12 or 18 sessions of SMT demonstrated statistically significant, but modest improvements in pain over those receiving light massage only; 12 sessions was associated with slightly greater improvement versus light massage only (MD 8.6 on a 0 to100 scale, 95% CI 3.2, 14.0) than 18 sessions (MD 6.1, 95% CI 1.0 to 11.2). Although 12 sessions of SMT were superior to light massage only for function at 6 weeks (mean difference 7.5 on a 0 to 100 scale, 95% CI 1.7 to 13.3), effects were small. Differences were smaller and not statistically significant at 12 and 24 weeks. Eight sessions of SMT were superior to light massage only at 52 weeks for pain (mean difference 7.6, 95% CI 0.8 to 9.2) and function (mean difference 8.8, 95% CI 3.3 to 14.4). Effects on the SF-36 physical and mental component scales and EuroQoL were small and did not show any clear differences between the SMT treatments versus light massage only.
One fair-quality trial found SMT associated with greater pain relief versus side lying with SMT (−11 versus −2.2 on a 0 to 100 scale, p=0.04).477 The third trial found 8 sessions of SMT over 4 to 8 weeks associated with greater pain relief at 6 months versus detuned ultrasound, though the difference was not statistically significant based on a prespecified p-value of <0.025 due to multiple comparisons (mean difference −1.24 on 0-10 scale, 95% CI −2.37 to −0.30, p=0.032).476 SMT was associated with greater improvement in the ODI (mean difference −7.14, 95% CI −12.8 to −1.52, p=0.013).
Spinal Manipulation Versus Another Active Treatment
Acute or Subacute Low Back Pain
Eight trials in the systematic review compared SMT versus another active intervention (exercise;439, 451 physical therapy [according to McKenzie principles];448, 452, 453, 456, 457 massage;454 standard general practitioner [GP] care consisting primarily of prescription [diclofenac or codeine] or nonprescription medication (paracetamol), or both;451, 456 or back school452, 456). One trial was rated as a low risk of bias.453 There were no differences between SMT versus other active interventions in pain relief (0-10 scale) at 1 week (3 trials, MD 0.06, 95% CI −0.53 to 0.65; I2=0%), 1 month (3 trials, MD −0.15, 95% CI −0.49 to 0.18; I2=0%), 3 to 6 months (2 trials MD −0.20, 95% CI −1.13 to 0.73, I2=81%), or 1 year (1 trial, MD 0.40, 95% CI −0.08 to 0.88). Findings were similar for function, with no differences observed at any time point. Among the trials included in the pooled analyses, the active comparators were exercise or physical therapy in all trials except for one, which evaluated back school.452 The only low risk of bias trial453 compared SMT (n=122) versus physical therapy/McKenzie (n=133) versus a minimal intervention (an educational booklet). This trial found no differences between SMT versus physical therapy/McKenzie in pain at 1 week (mean difference 0.20 on a 0 to 10 scale, 95% CI −0.56 to 0.96) or 1 month (mean difference −0.40, 95% CI −0.96 to 0.16), or in function (SMD 0.07 at 1 week, 95% CI −0.18 to 0.33 and SMD −0.09 at 1 month, 95% CI −0.34 to 0.16).
One subsequent good-quality trial (n=112) found manual thrust SMT for acute or subacute low back pain associated with greater effects on pain and the ODI versus mechanical assisted manipulation or usual care at the end of four weeks of treatments (mean differences in pain scores -1.4 to -1.7 point and on the ODI -6.5 to -8.1 points), but differences were smaller and no longer statistically significant at 3 or 6 months.484
Chronic Low Back Pain
Fifteen studies in the systematic review of SMT for chronic low back pain compared SMT with another active intervention.185, 192, 460-463, 465, 466, 468-473, 475 Eight trials were rated low risk of bias. The comparators were acupuncture (1 trial), back school, (2 trials), educational back booklet with or without additional counseling (2 trials), exercise therapy (9 trials), myofascial therapy (1 trial), massage (1 trial), pain clinic (1 trial), pharmaceutical/analgesic therapy only (2 trials), short-wave diathermy (1 trial), and standard medical care, including analgesic therapy and advice/reassurance (4 trials), standard physiotherapy (5 trials), and ultrasound (1 trial).
Based on trials rated low risk of bias, SMT was associated with better short-term pain relief versus other interventions at 1 month (10 comparisons from 6 trials, WMD −2.76 on a 0 to 100 scale, 95% CI −5.19 to −0.32, I2=27%) and 6 months (7 comparisons from 4 trials, WMD −3.07, 95% CI −5.42 to −0.71, I2=0%), though effects were small. Effects on pain relief were even smaller and no longer statistically significant at 12 months in three trials (3 trials, WMD −0.76, 95% CI −3.19 to 1.66, I2=0%).185, 192, 463 For functional status, SMT was associated with greater functional improvement versus other active interventions at 1 month, though effects were small (10 comparisons from 6 trials, SMD −0.17, 95% CI −0.29 to −0.06, I2=3%); as for pain, effects on function were even smaller and no longer statistically significant at 6 and 12 months (8 comparisons from 6 trials, SMD −0.12, 95% CI −0.23 to 0.00, I2=0% and 9 comparisons from 5 trials, SMD −0.06, 95% CI −0.16 to 0.05, I2=0%, respectively). Exercise and physical therapy were the most commonly evaluated active comparators in the trials included in the meta-analyses; results from this subgroup of trials appeared consistent with the overall estimates.
Three additional trials compared SMT versus other active treatments for chronic low back pain.241, 478, 481 One good-quality trial (n=301) found no clear differences between 12 weeks of SMT versus supervised or home exercise in pain or function.241 Effects were small (differences 0.1 to 0.6 points on a 0 to 10 pain scale and 0.2 to 1.3 points on the RDQ) and not statistically significant. A good-quality trial (n=350) found SMT (maximum of 15 sessions over 12 weeks) associated with worse function at 12 months versus exercise (mean difference 1.5 on the RDQ, 95% CI 0.2 to 2.9), though the effect was small.481 Results for pain also favored exercise, but the difference was not statistically significant (mean difference 2.8 on 0 to 100 scale, 95% CI −0.2 to 5.8). A fair-quality trial (n=210) found SMT (20-minute sessions once a week for 4 to 6 weeks) associated with greater pain relief and improvement in function versus back school or physical therapy (fifteen 1-hour sessions over 3 weeks); differences were less than 1 point on 0-10 pain scale and less than 5 points on the RDQ.478
Low Back Pain Of Mixed Duration
One fair-quality trial (n=134)466 of patients with acute to chronic low back pain that was not included in the systematic reviews found no differences between SMT (3 to 7 session) versus McKenzie exercise (3 to 7 sessions) in pain or function, though SMT was associated with better effects versus advice (one 45- to 60-minute session) on the RDQ (MD −3, 95% CI −6 to 0).
Spinal Manipulation Plus Other Active Treatment Versus the Active Treatment Without Manipulation
Acute Low Back Pain
Four trials in the systematic review of SMT for acute low back pain compared SMT plus another intervention (one trial each of advice on posture, exercise, and avoidance of occupational distress,455 analgesic medication (parecetamol, diclofenac, or dihydrocodeine),445 exercise,440 or physiotherapy442). One trial was rated low risk of bias.445 It found no differences between SMT plus analgesics versus analgesics alone at 1 week or at 3 to 6 months in pain relief (MD 0.84 on a 0 to 100 scale, 95% CI −0.04 to 1.72 and MD 0.65, 95% CI −0.32 to 1.62, respectively). Two high risk of bias trials440, 455 found SMT plus either exercise or advice associated with greater improvement in function at 1 week (SMD −0.41, 95% CI −0.73 to −0.10, I2=18%) versus exercise or advice alone, but there were no differences in function at 1 month (3 trials, SMD −0.09, 95% CI −0.39 to 0.21, I2=37% ) or 3 months (2 trials, SMD −0.22, 95% CI −0.61 to 0.16, I2=41%).
Chronic Low Back Pain
The systematic review of spinal manipulation for chronic low back pain.438 included five studies185, 462, 464, 467, 493 of SMT plus another active treatment versus the other active treatment alone. Two trials were rated low risk of bias.185, 462 The comparators were extension exercises,467 best care + exercise,185 myofascial therapy,462 or usual care.464 Combination therapy with SMT was more effective versus active treatment without SMT for pain relief at 1 month (3 trials, MD −5.88 on a 0 to 100 scale, 95% CI −10.85 to −0.90, I2=0%),462, 464, 467 3 months (2 trials, MD −7.23, 95% CI −11.72 to −2.74, I2=43%),185, 464 and 12 months (2 trials, MD −3.31, 95% CI −6.60 to −0.02, I2=12%).185, 467 Combination therapy with SMT was also more effective versus active treatment without SMT on function at 1 month, (2 trials, SMD −0.40, 95% CI −0.73 to −0.07, I2=0%), 3 months (2 trials, SMD −0.22, −0.38 to −0.06, I2=33%), and 12 months (2 trials, SMD −0.21, 95% CI −0.34 to −0.09, I2=0%). Results from the two trials rated low risk of bias were consistent with the pooled estimates.
One fair-quality trial (n=91) not included in the systematic review found SMT (2 sessions once a week for 4 weeks) plus standard medical therapy associated with lower pain intensity (mean difference 1.2 on a 0 to 10 scale, 95% CI 0.2 to 2.3) and better function (mean difference 4.0 on the RDQ, 95% CI 1.3 to 6.7) at the end of therapy versus standard medical care alone for chronic low back pain.483
Radicular Low Back Pain
One fair-quality trial (n=192) of patients with subacute to chronic back-related leg pain (n=192) found SMT plus home exercise and advice associated with greater improvement in leg and back pain at 12 weeks versus home exercise and advice alone (mean differences about 1 point on a 0 to 10 scale), but effects were smaller (0.3 to 0.7 points) and no longer statistically significant at 52 weeks.486
Harms
As in the prior APS/ACP review, we found that harms were poorly reported in trials of SMT. For chronic low back pain, ∼two-thirds of trials did not report adverse events.438 When reported, adverse events in patients undergoing SMT were limited to muscle soreness, stiffness, and/or transient increase in pain. None of the studies reported any serious complications in either the experimental or control group.
Physical Modalities: Ultrasound
Key Points
- For chronic low back pain, a systematic review found no difference between ultrasound versus sham ultrasound in pain at the end of treatment (3 trials, mean difference −7.12 on 0 to 100 scale, 95% CI −18.0 to 3.75, I2=77%) and two trials found no effects on pain 4 weeks after the end of treatment. Evidence from 5 trials was too inconsistent to determine effects on function, though a larger, good-quality trial found no effect on the RDQ (SOE: low for pain, insufficient for function).
- For chronic low back pain, a systematic review found no differences between ultrasound versus no ultrasound in pain (2 trials, mean difference −2.16, 95% CI −4.66 to 0.34, I2=0%) or back-specific function (2 trials, mean difference −0.41, 95% CI −3.14 to 2.32), but estimates were imprecise (SOE: low for pain and function).
- For chronic low back pain, evidence from 3 trials was insufficient to determine effects of ultrasound plus exercise versus exercise alone on pain or function, due to imprecision and methodological shortcomings (SOE: insufficient).
- For radicular low back pain due to spinal stenosis, a small trial found no differences between ultrasound plus exercise versus sham ultrasound plus exercise in back pain, leg pain, or the ODI after 3 weeks of therapy (SOE: insufficient)
- There was insufficient evidence from three small trials with methodological shortcomings to determine effects of ultrasound versus other interventions (SOE: insufficient).
- For radiculopathy, there was insufficient evidence from two small trials with methodological shortcomings to determine effects of ultrasound versus other interventions (SOE: insufficient).
- No study evaluated the effectiveness of ultrasound for acute nonradicular low back pain.
- One trial found no differences between ultrasound versus sham ultrasound in risk of any adverse event (6.0% vs. 5.9%, RR 1.03, 95% CI 0.49 to 2.13) or serious adverse events (1.3% vs. 2.7%, RR 0.48, 95% CI 0.12 to 1.88) (SOE: low).
Detailed Synthesis
The APS/ACP review29 included three small (n=15 to 73) trials of therapeutic ultrasound for low back pain.494-496 All trials had methodological shortcomings. One trial (n=73) found ultrasound associated with a higher likelihood of being pain-free versus sham ultrasound or analgesics (41% vs. 12% vs. 6.8%, p<0.001 for ultrasound versus placebo), but used a quasi-randomized design (alternate allocation).495 In addition, all patients were placed on bed rest, a treatment no longer recommended. One small (n=10) trial of patients with chronic low back pain found ultrasound moderately superior to sham ultrasound after 10 treatment sessions, but had high loss to followup and did not perform intention-to-treat analysis.494 The third trial (n=36), which was published in 1960, found no difference between ultrasound and sham ultrasound for low back pain of unspecified duration in pain improvement after 1 month of therapy.496 The APS/ACP review concluded that there was insufficient evidence to determine effects of ultrasound.
We identified one good-quality systematic review published since the APS/ACP review (Table 10; Appendix Tables E29, F29).497 It included seven trials, including one of the trials described above494 and six subsequent trials.465, 494, 498-502 All trials enrolled patients with chronic nonradicular low back pain. Sample sizes ranged from 15 to 120 subjects. One trial was published in Croatian.502 All studies evaluated 1 MHz continuous ultrasound at intensities from 1 to 2.5 W/cm2, applied for 5 to 10 minutes or based on Gray's formula. The number of sessions ranged from 6 to 18. The review focused on outcomes immediately following the prescribed ultrasound treatment course; two trials also evaluated patients 4 weeks501 and 6 months465 after the end of treatment. Four trials evaluated ultrasound versus sham ultrasound,494, 498, 501, 502 two trials ultrasound versus no ultrasound,499, 500 and three trials ultrasound versus other treatments (spinal manipulation,465 electrical stimulation,499 and phonophoresis500). In all of the trials except for one,494 patients in all treatment groups also underwent exercise therapy. Although all trials had methodological shortcomings, two trials498, 501 were classified by the systematic review as being at low risk of bias, based on meeting six or more of 12 risk of bias criteria. Patients were blinded to receipt of ultrasound in four trials,494, 498, 501, 502 care providers were blinded in none of the trials, and intention-to-treat analysis was reported in two trials.498, 501
The largest randomized trial (n=455) of ultrasound was published after the systematic review (Table 19; Appendix Tables E30, F30).503 It compared ultrasound versus sham ultrasound for chronic nonradicular low back pain and evaluated patients 4 weeks after the end of treatment. About 20 percent of patients also underwent exercise therapy. The trial used a 2 × 2 factorial design in which patients were also randomized osteopathic manual treatment versus no manual treatment; there was no interaction between the ultrasound and manual treatment interventions. We also identified three small trials of ultrasound that were not included in the systematic review. One fair-quality trial (n=30) compared ultrasound versus low-level laser therapy for back pain ≥3 weeks,504 one fair-quality trial (n=45) compared ultrasound plus exercise, sham ultrasound plus exercise, and no treatment for spinal stenosis,505 and one poor-quality trial (n=60) of ultrasound versus traction or low-level laser therapy for acute radiculopathy due to herniated disc.506
Table 19
Characteristics and conclusions of included ultrasound trials.
Ultrasound Versus Sham Ultrasound
Chronic Low Back Pain
The systematic review found no difference between ultrasound versus sham ultrasound in pain at the end of treatment (3 trials, mean difference −7.12 on 0 to 100 scale, 95% CI −18.0 to 3.75, I2=77%).497 Statistical heterogeneity was high, with one trial498 reporting an effect favoring ultrasound (mean difference −20.0, 95% CI −31.1 to −8.81) and two trials501, 502 reporting no effect (mean difference −4.10 and 0.90). Ultrasound was associated with better functional status at the end of treatment than sham ultrasound (3 trials, standardized mean difference −0.45, 95% CI −0.84 to −0.05, I2=0%).497 Although statistical heterogeneity was not present, only one501 of the trials reported a statistically significant effect (standardized mean difference −0.71, 95% CI −1.30 to −0.13 [∼8 points on a 0 to 100 scale], versus −0.26 and −0.20, or [∼5 points on a 0 to 100 scale] in the other two trials).494, 498 One additional good-quality trial not included in the systematic review found no differences between ultrasound versus sham ultrasound on the RDQ (median 3 vs. 4, p=0.76) or the SF-36 General Health score (72 vs. 72, p=0.53) at the end of treatment.503
Two trials of ultrasound versus sham ultrasound reported no effects on pain 4 weeks after the end of treatment.501, 503 In a fair-quality trial,501 there was no difference in pain scores (28 vs. 26, p=0.48) and in a good-quality trial503 there was no difference in the likelihood of experiencing ≥30 percent (RR 1.02, 95% CI 0.86 to 1.20) or ≥50% (RR 1.09, 95% CI 0.88 to 1.35) improvement in pain. Results were inconsistent for function. The fair-quality trial501 found that ultrasound was superior to sham ultrasound on the Functional Rating Index (23 vs. 30, p=0.04), but the good-quality trial503 found no effect on the RDQ (median 3 vs. 3, p=0.93).
Ultrasound Plus Exercise Versus Exercise Alone
Chronic Low Back Pain
The systematic review497 found no differences between ultrasound plus exercise versus exercise alone in pain (mean difference −2.16 on a 0 to 10 scale, 95% CI −4.66 to 0.34, I2=0%) or back-specific function (mean difference −0.41 on the ODI, 95% CI −3.14 to 2.32); pooled estimates favored ultrasound but were imprecise and were based on only two trials with methodological shortcomings.499, 500 Neither individual trial found a statistically significant effect on either outcome.
Mixed Duration Low Back Pain
A small (n=30), fair-quality trial found no differences between ultrasound plus exercise versus sham ultrasound plus exercise in back pain, leg pain, or the ODI after 3 weeks of therapy in patients with low back pain for ≥3 weeks.504
Radicular Low Back Pain
A small (n=45), fair-quality trial found no differences between ultrasound plus exercises versus sham ultrasound plus exercise in back pain, leg pain, the ODI, or paracetamol use after 3 weeks of therapy in patients with spinal stenosis.505
Ultrasound Versus Other Interventions
Chronic Low Back Pain
Three nonblinded trials compared ultrasound versus other interventions.465, 499, 500 In one trial, ultrasound, versus spinal manipulation, was associated with worse pain at the end of treatment (mean difference −16.4 on 0 to 100 scale, −26.8 to −6.1), though the difference was not as pronounced 6 months after the end of treatment (−1.4, 95% CI −2.7 to −0.1).465 Spinal manipulation was also associated with better ODI scores at the end of treatment (mean difference −7.8, 95% CI −13.2 to −2.4), with similar findings 6 months after the end of treatment. One trial each found no differences between ultrasound versus electrical stimulation499 or ultrasound versus phonophoresis500 in pain or function.
Mixed Duration Low Back Pain
A small (n=30), fair-quality trial of patients with low back pain ≥3 weeks found ultrasound associated with higher pain intensity (median 4 vs. 3 on a 0 to 10 VAS, p<0.001) and worse function (median 16 vs. 12 on the ODI, p<0.001) versus high-intensity laser therapy after three weeks of treatment.504
Radicular Low Back Pain
A small (n=60), poor-quality trial found no differences between ultrasound versus traction or low-level laser therapy for acute radiculopathy in back or leg pain or function as measured by the RDQ or modified ODI.506
Harms
Harms were only reported in one good-quality trial of therapeutic ultrasound. This trial found no difference between ultrasound versus sham ultrasound in risk of any adverse event (6.0% vs. 5.9%, RR 1.03, 95% CI 0.49 to 2.13) or serious adverse events (1.3% vs. 2.7%, RR 0.48, 95% CI 0.12 to 1.88).503
Physical Modalities: Transcutaneous Electrical Nerve Stimulation
Key Points
- For acute or subacute low back pain, evidence from single trials with methodological shortcomings was too limited to permit reliable conclusions regarding effectiveness (SOE: insufficient).
- For chronic low back pain, a systematic review found no differences between transcutaneous electrical nerve stimulation (TENS) versus sham TENS in pain intensity (4 trials, WMD −4.47 on a 0 to 100 scale, 95% CI −12.84 to 3.89) or function (2 trials, WMD −1.36 on a 0 to 100 scale, 95% CI −4.38 to 1.66) at short-term followup; most trials found no effect on pain or function at the end of a course of treatment (SOE: low for pain and function).
- For chronic low back pain, a systematic review found no differences between TENS versus acupuncture for short- (4 trials; SMD 0.15, 95% CI −0.33 to 0.63) or long-term pain (2 trials; SMD 0.32, 95% CI −0.33 to 0.96). Evidence for TENS versus other interventions was too limited to permit reliable conclusions (SOE: low for TENS vs. acupuncture).
- Evidence on harms associated with TENS was limited, but suggests an increased risk of skin site reactions without an increased risk of serious adverse events (SOE: low).
Detailed Synthesis
The APS/ACP review29 included a good-quality systematic review507 of TENS versus sham that included one good-quality trial,508 and one poor-quality trial.509 The first (good quality) trial (n=145) compared 4 weeks of treatment with followup 2 months after treatment cessation.508 The second trial (n=30) compared 2 weeks of TENS versus sham, with no post-treatment followup, and was rated poor quality due to lack of blinding, unclear allocation concealment, and incomplete outcome data.509 The APS/ACP review also included evidence from systematic reviews of acupuncture,363 massage,510 spinal manipulation,426 traction, and superficial heat and cold511 that each included one to five trials of TENS versus these interventions. The APS/ACP review concluded that there was insufficient to determine the effects of TENS for acute or chronic low back pain.
We identified a more recent good-quality systematic review of TENS versus sham TENS512 that included the good-quality trial described above508 and four other trials (Table 10; Appendix Tables E31, F31).508, 513-516 The poor-quality study discussed above509 was not included, presumably because there was no post-treatment followup. The studies enrolled between 50 and 324 patients with chronic low back pain. Duration of treatment ranged from 2 to 8 weeks in five trials508, 513, 514, 516 and duration of followup ranged from 2 to 11 weeks in three trials;508, 513, 516 duration of followup was not reported in one crossover study.515 One trial also included an exercise comparison group and one trial513 included a PENS comparison group. Three trials were classified as higher-quality508, 514, 516 based on meeting at least six of eleven Cochrane Back Review Group criteria; common methodological shortcomings were failure to repeat adequate allocation concealment techniques, unblinded design or unclear blinding status, and failure to report intention-to-treat analysis.
We identified three other trials of TENS for chronic low back pain that compared TENS versus sham TENS517, 518 or interventional therapy519 (Table 20; Appendix Tables E32, F32). Two fair-quality trials (n=236517 and n=21518), one of which included patients with or without radicular symptoms517 evaluated TENS (3 months or 5 weeks of treatment) versus sham TENS. The third, good-quality trial (n=150), evaluated 2 weeks of TENS treatment versus interferential therapy.519 All three trials only evaluated outcomes at the end of treatment.
Table 20
Characteristics and conclusions of included transcutaneous electrical nerve stimulation (TENS) trials.
TENS Versus Sham TENS
Chronic Low Back Pain
For chronic low back pain, a good-quality trial (n=145) included in the APS/ACP review found no differences between TENS versus sham TENS in pain, functional status, or other outcomes after 4 weeks of treatment or 11 weeks total followup.508 A smaller (n=30) trial included in the APS/ACP review found TENS associated with decreased pain versus sham TENS (WMD −33.6, 95% CI −52.3 to −14.0), but only evaluated outcomes immediately after a 60-minute treatment session.509
A systematic review which included the good-quality trial described above and three other trials published subsequent to the APS/ACP review found no statistically significant differences between TENS versus sham TENS in pain scores at followup ranging from 2 weeks to 3 months (4 trials, WMD −4.47, 95% CI −12.84 to 3.89).512 There was also no difference between TENS versus sham in disability (2 trials, WMD −1.36, 95% CI −4.38 to 1.66.)
Two trials (n=21 and n=236) that were not included in the systematic review reported results that were generally consistent.517, 518 Both trials found no differences between TENS versus sham TENS on any outcome after 6 weeks of treatment, including mean pain scores,518 patient satisfaction, and functional improvement.517 However, after 3 months of treatment, one of the trials, which enrolled patients with radicular or nonradicular low back pain, found TENS associated with greater likelihood of experiencing improvement ≥50 percent from baseline in VAS score versus sham for both lumbar (RR 3.71, 95% CI 1.69 to 8.18) and radicular pain (RR 2.26, 95% CI 1.13 to 4.51).517 However, mean changes in pain scores were not reported, there were no statistically significant differences between TENS versus sham TENS on other 3-month outcomes, including function, quality of life, and patient satisfaction, and the trial did not report outcomes following the end of treatment. Estimates of effect were somewhat stronger in subgroups of patients with radicular symptoms or a neuropathic pain component, but estimates were imprecise, with overlapping CIs.
TENS Versus Other Interventions
Acute Low Back Pain
Evidence on effectiveness of TENS for acute or subacute low back pain was limited. For acute low back pain, one small fair-quality trial (n=20) found acupuncture superior to TENS for pain (mean difference 21 on a 0 to 100 VAS score, 95% CI 4.13 to 38).520
Chronic Low Back Pain
For chronic low back pain, the APS/ACP review found no difference between TENS versus acupuncture in short- (4 trials; SMD 0.15, 95% CI −0.33 to 0.63) or long-term pain (2 trials; SMD 0.32, 95% CI −0.33 to 0.96)363 or between TENS versus gentle ice massage (1 trial),521 though the quality of evidence was fair to poor for both comparisons.29 Evidence for TENS versus other interventions was limited and mixed. Based on one trial traction was superior to TENS,522 and minimal ice massage was inferior in one trial523 with no difference in another trial. 521
A systematic review512 published subsequent to the APS/ACP review included one trial of TENS versus exercise508 and one trial of TENS versus PENS513 for chronic low back pain. Each review reported no statistically significant differences in pain or disability. One trial not included in prior reviews of TENS versus interferential therapy found no differences in pain or disability, though for one measure (the McGill Pain Questionnaire pain rating index) interferential therapy was superior to TENS (mean change from baseline −17.66 vs. −25.34, p>0.05).519
Harms
The APS/ACP review found limited evidence on harms from trials of TENS, though there was no clear difference between active versus sham TENS in likelihood of minor skin irritation at the application site. In one trial published since the APS/ACP review, active TENS was associated with greater likelihood of application skin site reactions versus sham TENS (9% vs. 3%; RR 3.73, 95% CI 1.07 to 13).517 There were no significant differences in risk of other harms, including withdrawals due to adverse events (3% vs. 0.8%; RR 3.05, 95% CI 0.32 to 29) and serious adverse events (4% vs. 5%; RR 0.73, 95% CI 0.24 to 22), though event rates were low and estimates imprecise.
Physical Modalities: Electrical Muscle Stimulation
Key Points
- There was insufficient evidence from five RCTs to determine effects of electrical muscle stimulation plus exercise versus exercise alone or versus other interventions, due to methodological limitations and imprecision (SOE: insufficient).
- There was insufficient evidence to determine harms of electrical muscle stimulation (SOE: insufficient).
Detailed Synthesis
The APS/ACP review did not evaluate effects of electrical muscle stimulation for low back pain. We identified five trials on the effects of electrical muscle stimulation for low back pain (Table 21; Appendix Tables E33, F33).492, 499, 524-526 The sample size ranged from 28 to 80 in four trials and was 164 in the fifth trial.492 Four trials enrolled patients with chronic low back pain and the fifth trial492 enrolled patients with back pain of 3 weeks to 6 months in duration. Two trials compared electrical muscle stimulation plus exercise versus exercise,499, 524 one trial electrical muscle stimulation plus exercise versus sham stimulation plus exercise,525 and three trials electrical muscle stimulation versus other interventions (ultrasound,499 TENS or sham TENS,526 and massage, manipulation, or lumbar supports492), with or without exercise. The duration of stimulation sessions ranged from 15 minutes to at least 8 hours, the number of sessions ranged from 2 to 60, and the duration of treatment ranged from 2 days to 2 months. The technical parameters of the stimulation varied. Outcomes were assessed at the end of 2 days to 8 weeks of therapy in four trials and at 6 months (4 months after the end of therapy) in the fifth trial.525 One trial was rated fair quality492 and the other four poor quality. Methodological shortcomings included unclear randomization and allocation concealment methods, unblinded design, and lack of intention-to-treat analysis. In two trials, some subscales of the SF-36 were analyzed as mean differences and others as median differences without a rationale.499, 524
Table 21
Characteristics and conclusions of included electrical muscle stimulation trials.
Electrical Muscle Stimulation Plus Exercise Versus Sham Stimulation Plus Exercise
Chronic Low Back Pain
One poor-quality (n=55) trial found no differences between 2 months of therapy with electrical muscle stimulation plus exercise versus sham stimulation plus exercise in subscales of the Low Back Pain Outcome Instrument or the SF-36 mental health subscale after 2 or 6 months.525 Although the trial reported some differences as statistically significant, this does not appear to be possible based on the mean scores and standard deviations (e.g., for the Low Back Pain Outcome Instrument Expectations Met subscale, scores of 2.71[standard deviation 0.77] vs. 2.56 [0.71] were reported as having a p<0.05). The trial reported very high (>50%) attrition at 6 months.
Electrical Muscle Stimulation Plus Exercise Versus Exercise Alone
Chronic Low Back Pain
Two poor-quality trials (n=41 and n=68) each found electrical muscle stimulation plus exercise superior to exercise for pain at the end of a 6- or 8-week course of therapy.499, 524 Differences in pain scores averaged 2.9 and 1.5 points on a 0-10 VAS scale. Effects on the ODI were mixed (differences 12.6 and 1.6 points). Electrical muscle stimulation was superior to exercise on some SF-36 subscales.
Electrical Muscle Stimulation Versus Other Interventions
Acute/Subacute Low Back Pain
One fair-quality trial (n=164) found no difference between electrical muscle stimulation (at least 8 hours/day) versus manipulation, massage, or lumbar support in improvement in pain (range −9.6 to −24 on a 0-100 VAS) after a 3-week course of therapy.492
Chronic Low Back Pain
One poor-quality crossover trial (n=24) found no difference between electrical muscle stimulation versus TENS or sham TENS in pain scores after a 2-day course of therapy (39.7 vs. 40.6 vs. 44.8 on a 0-100 VAS scale).526 However, the combination of electrical muscle stimulation plus TENS was more effective than sham TENS (36.3 vs. 44.8, p=0.02). Another poor-quality trial (n=59) found no differences between electrical muscle stimulation plus exercise versus ultrasound plus exercise in the pain scores (0.4 vs. 0.9 on 0-10 VAS) or the ODI (6.80 vs. 8.60) after a 6-week course of therapy.499
Harms
One trial of electrical muscle stimulation reported no adverse treatment effects.526 The other trials did not report harms.
Physical Modalities: Percutaneous Electrical Nerve Stimulation
Key Points
- There was insufficient evidence from seven trials to determine effects of percutaneous electrical nerve stimulation (PENS) versus sham, PENS plus exercise versus exercise alone, or PENS versus other interventions, due to methodological limitations, inconsistency and imprecision (SOE: insufficient).
- Harms were poorly reported in trials of PENS (SOE: insufficient).
Detailed Synthesis
Percutaneous electrical nerve stimulation (PENS) involves the application of an electrical nerve stimulus via needles placed at the dermatomal levels corresponding to the pain (rather than at acupuncture sites). The APS/ACP review29 included four trials (n=34 to 64) of percutaneous electrical nerve stimulation (PENS) for low back pain.513, 527, 528 Two trials compared PENS versus sham PENS,513, 527 one trial compared PENS plus physical therapy versus sham PENS plus physical therapy,528 three trials compared PENS versus TENS,513, 527, 529 and one trial compared PENS versus exercise.513 Two trials enrolled patients with nonradicular low back pain,513, 528 one trial enrolled patients with radicular back pain,527 and one trial did not specify presence or absence of radicular symptoms.529 All trials enrolled patients with chronic low back pain; although the trial of radicular back pain enrolled patients with symptoms for >6 weeks, the mean duration was 21 months.513 PENS was administered two or three times weekly for 2 to 8 weeks, with each session 15 to 45 minutes in duration. Outcomes were assessed at the end of treatment in two trials,513, 527 and 8 weeks529 or 3 months528 after the end of treatment. The APS/ACP review concluded that there was insufficient evidence to determine the effectiveness of PENS for acute or chronic low back pain.
We also identified three trials not included in the APS/ACP review (Table 22; Appendix Tables E34, F34). One trial (n=200) compared PENS (two 30-minute sessions weekly for 6 weeks), PENS plus supervised and home exercise, control (minimal) PENS plus exercise, and control PENS alone. One trial (n=112) compared PENS (three 30-minute sessions weekly for 3 weeks) versus dry needling for chronic low back pain.530 The other trial (n=75) compared different durations of PENS therapy (15, 30, or 45 minutes 3 times a week for 2 weeks) versus sham PENS (insertion of needles without stimulation).531 Outcomes were assessed at the end of treatment in both trials.
Table 22
Characteristics and conclusions of included percutaneous electrical nerve stimulation (PENS) trials.
Among all trials, two trials were rated fair quality528, 532 and the rest were rated poor quality. Methodological shortcomings included inadequate description of randomization and allocation concealment methods, failure to report attrition, unblended or unclearly blinded design and failure to report intention-to-treat analysis. Three trials with a crossover design had a 1 week washout between treatments, but did not evaluate for potential carryover effects.513, 527, 531
PENS Versus Sham PENS
Chronic Low Back Pain
For chronic non-radicular low back pain, one fair-quality trial (n=200) found no difference between PENS versus a control (minimal) PENS intervention in pain, function, quality of life, or other outcomes at the end of a 6-week course of therapy or through 6-month followup.532 One poor-quality trial (n=60) of patients with nonradicular low back pain513 found PENS superior to sham PENS for pain at the end of a 3-week course of therapy. The difference in mean pain scores in was about 2 points (p<0.05) on a 0-10 VAS scale. PENS was also associated with greater improvement in SF-36 physical and mental component summary scores, but effects were small (less than 7 points on a 0 to 100 scale for the physical component and <3 points for the mental component). PENS was also associated with better quality of sleep and decreased opioid use.
One poor-quality trial (n=75) not included in the APS/ACP review found PENS administered for varying durations (15, 30, or 45 minutes) similarly effective versus sham PENS for pain relief.531 Differences ranged from 3.4 to 3.9 points on a 0-10 VAS scale at the end of a 2-week course of treatment. Although the three PENS interventions were also more effective than sham PENS on the SF-36 physical and mental component scores, sleep quality, and use of nonopioid analgesics, there was some evidence of a dose threshold effect, with the 15-minute intervention associated with smaller effects than the 30- and 45-minute interventions.
Radicular Low Back Pain
One poor-quality trial (n=64) of patients with radiculopathy527 found PENS superior to sham PENS for pain at the end of a 3-week course of therapy. The difference in mean pain scores in was about 2 points (p<0.05) on a 0-10 VAS scale. PENS was also associated with greater improvement in SF-36 physical and mental component summary scores, but effects were small (less than 7 points on a 0 to 100 scale for the physical component and <3 points for the mental component). PENS was also associated with better quality of sleep and decreased opioid use.
PENS Plus Exercise Therapy Versus Sham PENS Plus Exercise Therapy
Chronic Low Back Pain
For chronic nonradicular back pain, one fair-quality trial (n=34) included in the APS/ACP review found PENS plus physical therapy superior to sham PENS plus physical therapy for pain.528 The difference in the Multidimensional Pain Inventory pain severity score was about 1 point (0 to 6 scale) 3 months after an 8-week course of treatment. Physical therapy consisted of exercise, physical modalities, manual therapies, and education to meet patient goals. There were no differences on the RDQ, Geriatric Depression Scale, or Pittsburgh Sleep Quality Index. However, a fair-quality trial published subsequent to the APS/ACP review found no differences between PENS plus exercise therapy versus control (minimal) PENS plus exercise therapy in pain, the RDQ, or other outcomes through 6-month followup after a 6-week course of treatment.532
PENS Versus TENS
Chronic Low Back Pain
Three trials included in the APS/ACP review evaluated PENS versus TENS for chronic low back pain.513, 527, 529 Two poor-quality trials (n=40 and 60) each found PENS superior to TENS for pain, though effects may not be sustained. In one trial, the difference was 2.1 points on a 0-10 VAS scale at the end of a 3-week course of therapy.513 In the other, the difference was 17 points on a 0-100 VAS scale at the end of an 8-week course of therapy (p<0.01), but the difference was smaller (6 points) and no longer statistically significant 8 weeks later.529 Effects of therapy consisting of 4 weeks of PENS followed by 4 weeks of TENS were similar to effects of 8 weeks of TENS. PENS was also superior to sham TENS on measures of function, but neither trial reported standardized measures of back-specific function. In one trial, PENS was superior to sham PENS on the SF-36 physical and mental component summary scores, though effects were small (differences of 4.66 and 1.7 points, respectively).513
Radicular Low Back Pain
One poor-quality trial (n=64) of patients with radicular back pain included in the APS/ACP review found PENS superior to sham PENS for pain at the end of a 3-week course of therapy (difference 1.3 points on a 0-10 scale, p<0.01).527 PENS was also superior to sham PENS on the SF-36 physical and mental component scores, though effects were small (5.7 and 2.1 points, respectively).
PENS Versus Other Interventions
Chronic Low Back Pain
For chronic low back pain, one poor-quality trial (n=60) included in the APS/ACP review found a 3-week course of PENS more effective than a minimal exercise intervention (flexion and extension while seated) for pain (mean difference 2.1 points on a 0-10 VAS), level of activity, and quality of sleep.513 PENS was also more effective than exercise on the SF-36 physical and mental component scores, but differences were small. A fair-quality trial (n=200) published subsequent to the APS/ACP review found no difference between PENS versus control (minimal) PENS plus exercise in pain, the RDQ, or other outcomes through 6 months followup after a 6-week course of treatment.532
One poor-quality trial (n=112) published subsequent to the APS/ACP review of patients with chronic nonradicular back pain found no differences between a 3-week course of PENS versus dry needling in pain, the ODI, and sleep quality at the end of treatment.530
Harms
Harms were poorly reported in trials of PENS therapy. One trial reported no treatment-related adverse events, though one patient withdrew due to worsening low back pain.532
Physical Modalities: Interferential Therapy
Key Points
- There was insufficient evidence from four trials to determine effects of interferential therapy versus other interventions, or interferential therapy plus another intervention versus the other interventions lone, due to methodological limitations and imprecision (SOE: insufficient).
- No study evaluated harms of interferential therapy (SOE: insufficient).
Detailed Synthesis
The APS/ACP review29 included three trials (n=151 to 240) of interferential therapy for low back pain.533-535 No trial compared interferential therapy versus sham therapy. One trial each compared interferential therapy versus spinal manipulation533 or traction.535 One of these trials also compared interferential therapy versus the combination of interferential therapy plus spinal manipulation.533 The third trial compared interferential therapy applied to the painful area versus to the area of the spinal nerve, each in combination with a self-care book, as well as against the self-care book alone.534 The trials focused on patients with nonradicular low back pain. The duration of symptoms was 4 to 12 weeks in two trials533, 534 and unspecified (mainly chronic) in the third.535 The trials varied in the number (range 3 to 10) and duration (10 to 30 minutes) of interferential therapy sessions and in technical parameters. Outcomes were assessed at 3 to 12 months (1 week to 10 months following the end of therapy). All of the trials were rated poor quality; methodological shortcomings included failure to blind patients or care providers, high attrition, and failure to perform intention-to-treat analysis; one trial534 also reported potentially important baseline differences. The APS/ACP review concluded that there was insufficient to determine the effectiveness of interferential therapy for acute or chronic low back pain.
One trial (n=62) published subsequent to the APS/ACP review evaluated interferential therapy versus superficial massage for chronic low back pain (Table 23; Appendix Tables E35, F35).536 Interferential therapy was administered for 30 minutes in 20 sessions over 10 weeks, with outcomes assessed at the end of therapy. The trial was rated fair quality; methodological shortcomings included unblinded design and failure to report use of cointerventions and compliance to assigned therapies.
Table 23
Characteristics and conclusions of included interferential therapy trials.
Interferential Therapy Versus Other Interventions
The two poor-quality trials included in the APS/ACP review found no differences between interferential therapy versus spinal manipulation for subacute low back pain533 or interferential therapy versus traction535 for low back pain of unspecified duration (primarily chronic) on pain, function, or other outcomes.
One subsequent, fair-quality trial (n=62) found interferential therapy associated with greater improvement from baseline in pain (0-10 VAS, difference −1.06, 95% CI −1.91 to −0.22) and the RDQ (0-24, difference −3.01, 95% CI −4.53 to −1.47) versus superficial massage at the end of a 10-week course of therapy, though effects on the ODI were not statistically significant (0-100, difference −5.20, 95% CI −10.82 to 0.42) and longer-term effects were not assessed.536 There were no statistically significant differences on seven of eight SF-36 subscales. The superficial massage intervention appeared to be designed as a sham or subtherapeutic control treatment.
Interferential Therapy Plus Another Intervention Versus the Other Intervention Alone
One poor-quality trial found a 3-week course of interferential therapy applied to the paraspinal area (near the target spinal nerve) plus a back self-care book associated with greater improvement in the RDQ (0-24, −6.0 vs. −4.0, p<0.05) after 3 months, though there were no differences in the McGill Pain Rating Index or the EQ-5D.534 However, effects on the RDQ are difficult to interpret as there were baseline differences (median 9.0 vs. 5.0) and scores at 3 months were identical (1.0 vs. 1.0). There were no differences between interferential therapy applied to the painful area plus a self-care book versus the self-care book alone. One of the trials described above no differences between the combination of interferential therapy plus spinal manipulation versus manipulation alone.533
Harms
No trial of interferential therapy reported harms.
Physical Modalities: Superficial Heat or Cold
Key Points
- For acute or subacute low back pain, a systematic review found a heat wrap more effective than placebo for pain relief at 5 days (2 trials, mean difference 1.06 on a 0 to 5 scale, 95% CI 0.68 to 1.45) and disability at 4 days (mean difference −2.10 on the RDQ, 95% CI −3.19 to −1.01). Two subsequent trials also found a heat wrap associated with decreased pain intensity at 3 to 4 days (differences 16 to 20 points on a 0- to 100-point VAS) or increased pain relief at 8 hours (difference ∼1.5 points on a 0 to 5 scale). Another trial found a heat wrap during emergency transport associated with substantially lower pain intensity versus an unheated blanket upon arrival to the hospital (SOE: moderate for pain and function).
- For acute low back pain, one higher-quality trial found heat plus exercise associated with greater pain relief at day 7 (mean difference 1.40 on 0 to 10 scale, 95% CI 0.69 to 2.11) and on the RDQ (mean difference −3.20 on the RDQ, 95% CI −5.42 to −0) versus exercise without heat (SOE: low).
- One fair-quality trial found heat plus an NSAID associated with better pain scores versus an NSAID without heat at day 15, based on the McGill Pain Questionnaire (scoring methods unclear) (SOE: insufficient).
- For acute or subacute low back pain, a systematic review included one trial that found heat more effective for pain relief than acetaminophen (mean difference 0.90 on a 0 to 10 scale, 95% CI 0.50 to 1.30) or ibuprofen (0.65, 95% CI 0.25 to 1.05) after 1 to 2 days of treatment; the heat wrap was also associated with greater improvement on the RDQ (mean differences 2.00 on a 0 to 24 scale, 95% CI 0.86 to 3.14 and 2.20, 95% CI 1.11 to 3.29, respectively) (SOE: low for pain and function).
- For acute low back pain, a systematic review included one trial that found no clear differences between heat versus exercise in pain relief or function (SOE: low).
- No study compared superficial cold versus placebo or no cold treatment.
- For acute low back pain, one small trial with methodological shortcomings found cold plus naproxen associated with better pain scores versus naproxen alone, based on the McGill Pain Questionnaire (methods for scoring unclear). (SOE: insufficient).
- There was insufficient evidence from three trials to determine effects of heat versus cold, due to methodological limitations and imprecision (SOE: insufficient).
- Heat was not associated with increased risk of skin flushing versus no heat or placebo in two trials; no serious adverse events were reported with use of heat (SOE: low).
Detailed Synthesis
The APS/ACP review29 included a good-quality systematic (Cochrane) review511 of nine controlled clinical trials on the effects of heat or cold on low back pain. An updated version of the review was published in 2011, but included no additional trials (Table 2; Appendix Tables E36, F36).537 Of the studies included in the systematic review, five were randomized parallel-group trials.42, 538-541 The other four used alternate allocation or did not describe the allocation method;521, 542-544 one was a parallel group trial542 and the other three used a crossover design.521, 543, 544 Four trials evaluated hot packs or heated wraps versus placebo or nonheated wraps,42, 539-541, 544 one trial heat plus exercise versus heat or exercise alone,538 one trial heat versus ibuprofen or acetaminophen,42 and two trials hot packs versus ice massage.542, 543 One trial521 compared ice massage versus TENS and is discussed in the TENS section of this report. The sample sizes ranged from between 36 and 371 participants with acute pain (1 trial); mixed acute and subacute pain (4 trials); chronic (3 trials) or mixed acute pain; and subacute and chronic (1 trial) pain. Duration of treatment was generally 1 week or less, with followup no longer than 1 or 2 days after the end of treatment. In one trial, treatment duration was 25 to 27 minutes, with immediate post-treatment followup.541
The systematic review rated the five RCTs42, 538-541 higher quality, based on meeting at least 6 of 11 Cochrane Back Review Group criteria,545 and the remaining studies were rated lower quality.521, 542-544 All studies had methodological limitations, including unblinded design and failure to adequately report methods of randomization and allocation concealment.511 Four trials reported funding by manufacturers of heat wraps.
We identified two fair-quality trials (n=30 and 51) published subsequent to the systematic review of heat therapy (4 hours daily for 4 days, 8 hours for 1 day) versus no heat therapy (Table 24; Appendix Tables E37, F37).546, 547 One trial547 enrolled patients with acute low back pain and the other546 included patients with acute or subacute low back pain. Methodological shortcomings included inadequate description of randomization and allocation concealment methods and nonblinded design; one trial546 also had high (21%) attrition. Both trials were funded by a manufacturer of heat wraps. We also identified a fair-quality trial (n=87) that compared superficial heat (hot water bottle 20 minutes twice daily for 1 week) plus naproxen 500 mg bid, superficial cold (ice 20 minutes twice daily for 1 week) plus naproxen, or naproxen alone for acute low back pain548 and a small (n=43), poor-quality trial of patients with acute low back pain in an occupational health setting evaluated3 days of heat-wrap therapy plus education versus education only through 14 days.549 Methodological shortcomings included inadequate description of randomization and allocation concealment, failure to report attrition, and unblinded design.
Table 24
Characteristics and conclusions of included superficial heat or cold trials.
Heat Versus Placebo
Acute or Subacute Low Back Pain
For acute or subacute low back pain, the systematic review511 found a heat wrap more effective versus placebo for short-term pain relief (mean difference at 5 days 1.06 on a 0 to 5 scale, 95% CI 0.68 to 1.45) and improvement in disability (mean difference at 4 days −2.10 on the RDQ, 95% CI −3.19 to −1.01) based on pooled results from two trials.539, 540 Effects on pain intensity were about 10-13 points on a 0- to 100-point scale in one trial and about 0.7 to 1 point on a 0- to 10-point scale in the other trial, and effects on the RDQ were about 2-3 points in both trials. One other trial that could not be pooled found a heat wrap applied during emergency transport associated with substantial lower pain intensity upon arrival at the hospital versus an unheated blanket (mean difference from baseline −32.3 vs. 0.8 on a 0 to 100 VAS).541 A fourth trial did not report effects on pain or disability.544
A small, fair-quality trial (n=38) not included in the systematic review found a heat wrap for acute or subacute low back pain associated with decreased pain versus no heat wrap after 3 (mean 31 versus 57 on a 0 to 100 VAS; p=0.02 [data estimated from graph]) or 4 days (27 versus 47; p=0.04); effects at 1 to 2 days also favored the heat wrap, but were smaller and not statistically significant.546 The heat wrap was also associated with lower likelihood of waking in the night due to pain at day 2 (7% [1/15] versus 53% [8/15]; RR 0.13, 95% CI 0.02 to 0.88); no patients in the heat wrap group reported night waking on days 3 and 4 (compared with 67% and 59% of no heat wrap patients) Another fair-quality trial (n=51) found a heat wrap for acute low back pain associated with increased pain relief versus oral placebo, but only evaluated outcomes after 8 hours of treatment (mean pain relief score 3.0 vs. 1.5 on 0 [very poor] to 5 [excellent] scale).547
Heat Versus Another Intervention Versus the Other Intervention Without Heat
One higher-quality trial (n=100) included in the systematic review found heat plus exercise for acute low back pain superior to exercise alone for pain relief at day 7 (mean difference 1.40 on 0 to 10 scale, 95% CI 0.69 to 2.11). Effects were smaller (mean differences 0.50 to 0.80) on days 2 and 4 and not statistically significant.538 Heat plus exercise was also superior to exercise alone at day 7 (mean difference −3.20 on the RDQ, 95% CI −5.42 to −0.0), but not at day 2 (0.60, 95% CI −0.79 to 1.99) or day 4 (−1.20, 95% CI −3.14 to 0.74).
Two trials not included in the systematic review compared heat versus another intervention versus the other intervention without heat. A fair-quality trial (n=58) found a hot water bottle for 20 minutes plus naproxen 500 mg twice daily associated with better scores on the McGill Pain Questionnaire (scoring methods unclear).548 A poor-quality trial (n=43) found 3 days of heat wrap therapy plus education associated with decreased pain intensity at day 3 (mean difference −2.05, 95% CI −3.34 to −0.76 on a 0 to 10 pain scale) through day 14 (mean difference −1.63, 95% CI −2.92 to −0.34) as well as on the RDQ (difference −2.37, 95% CI −5.62 to 0.85 at day 4 and −4.02, 95% CI −7.82 to −0.24 at day 14), versus education without heat wrap.549
Heat Versus Other Active Treatments
For acute or subacute pain, the systematic review537 included one higher-quality trial (n=371) that found heat more effective for pain relief than acetaminophen (mean difference 0.90 on a 0 to 10 scale, 95% CI 0.50 to 1.30) or ibuprofen (0.65, 95% CI 0.25 to 1.05) after 1 to 2 days of treatment.42 The heat wrap was also associated with greater improvement on the RDQ versus acetaminophen (mean difference 2.00 on a 0 to 24 scale, 95% CI 0.86 to 3.14) and ibuprofen (2.20, 95% CI 1.11 to 3.29).42
One higher-quality trial (n=100) included in the systematic review found small, nonstatistically significant differences favoring heat versus exercise in pain relief (mean difference 0.40 on a 0 to 10 scale at days 1 to 2, 95% CI −0.15 to 0.95; mean difference 0.30 at day 7, 95% CI −0.68 to 1.28) and function (mean difference −0.70 on the RDQ at day 4, 95% CI −2.09 to 0.69; mean difference −0.90 at day 7, 95% CI −2.84 to 1.04).538
Cold Versus Placebo
No study compared cold versus placebo or no cold.
Cold Versus Another Intervention Versus the Other Intervention Without Cold
A fair-quality trial (n=58) found ice for 20 minutes plus naproxen 500 mg twice daily associated with better scores based on the McGill Pain Questionnaire (scoring methods unclear).548
Cold Versus Other Active Treatments
One lower-quality trial included in the systematic review537 found no differences between ice massage versus TENS (see the TENS section of this report.)521
Heat Versus Cold
Two lower-quality trials (n=117 and 36) included in the systematic review537 evaluated heat versus cold.542, 543 One trial found no difference between hot packs versus ice massage for back pain of mixed duration (treatment duration and followup not reported)542 and one trial found ice massage superior to hot packs for chronic pain following two 20-minute treatments.543 One fair-quality trial (n=58) not included in the systematic review found a hot water bottle twice daily for 1 week associated with no clear differences versus ice twice daily through 2 weeks, based on the McGill Pain Questionnaire (scoring methods unclear).548
Harms
The only adverse events reported in the systematic review537 were from two trials that found no difference between heat wrap versus no heat or placebo in the risk of skin flushing at the application site in two trials of heat wrap versus no heat/placebo (5% [6/128] versus 0.8% [1/130]; RR 6.09, 95% CI 0.74 to 50; Appendix Table E36).539, 540 No serious adverse events were reported. One trial not included in the systematic review reported two cases of headache with heat, versus no cases in the oral placebo group.547
Low-Level Laser Therapy
Key Points
- For acute low back pain, there was insufficient evidence from one trial to determine effectiveness of low-level laser therapy versus sham laser, due to serious methodological shortcomings and imprecision (SOE: insufficient).
- For chronic low back pain, three of four trials found low-level laser therapy more effective than sham laser for pain, though methods for assessing pain and duration of followup varied; two trials found low-level laser therapy more effective than sham laser for function, with small magnitude of effects (SOE: low for pain and function).
- For acute or subacute low back pain, one trial found low-level laser therapy plus an NSAID associated with lower pain intensity versus sham laser plus an NSAID or the NSAID alone (mean differences 9 to 14 points on a 0 to 100 VAS); effects on the ODI also favored combination treatment but were smaller (differences <6 points) (SOE: low).
- For chronic low back pain, there was insufficient evidence from three trials to determine effects of low-level laser therapy plus exercise versus the other sham laser plus exercise alone, due to methodological shortcomings and inconsistency (SOE: insufficient).
- There was insufficient evidence to determine effects of low-level laser therapy versus another intervention, due to methodological shortcomings and imprecision (SOE: insufficient).
- There was insufficient evidence to determine effects of different wavelengths of low-level laser therapy or different doses, due to methodological limitations and imprecision (SOE: insufficient).
- Harms were not well-reported in trials of low-level laser therapy, but no serious adverse events and no harms were reported (SOE: low)
Detailed Synthesis
Low level laser therapy involves administration of a single wavelength of light (usually from 632 to 904 nm) that does not emit heat but may affect underlying connective tissues and have potential anti-inflammatory effects. The APS/ACP review29 included seven trials550-556 of low-level laser therapy for low back pain. Four trials were conducted in patients with chronic low back pain, one trial in patients with acute low back pain, and two trials did not specify the duration of symptoms. The APS/ACP review found insufficient evidence to determine effectiveness of low-level laser therapy versus sham or other interventions, due to variability across trials in terms of laser types and doses, outcomes, duration of followup, and inconsistency in results. A recent systematic review557 included six550-555 of the trials included in the APS/ACP review plus one additional trial (Table 2).558 We also identified five recently published trials not included in prior reviews (Table 25; Appendix Tables E38, F38).559-563
Table 25
Characteristics and conclusions of included low-level laser therapy trials.
In total, after excluding one poor-quality trial with uninterpretable findings,556 10 trials assessed low-level laser therapy for low back pain.550-555, 558-563 Laser wavelengths ranged from 830 to 10600 nm and five of the trials used a 904 nm laser.551, 552, 555, 560, 562 Duration of treatment ranged from 1 day to 6 weeks, followup was from 1 day to 1 year, and there were 6 to 20 laser treatment sessions (1 trial555 did not report the treatment protocol and 1 trial553 assessed outcomes after a single treatment). Five trials compared laser versus sham550-553, 559 and two trials compared different laser doses, either with555 or without562 a sham group. The other five trials compared laser plus another treatment (heat, exercise, or NSAID) versus the other treatment, either alone or in combination with sham laser.554, 558, 560, 561, 563 Sample sizes in nine of the trials ranged from 20 to 120 and in the tenth (largest) study was 546.560 Patients had chronic low back pain in seven trials550-552, 554, 558, 559, 563 and acute low back pain in three trials.555, 560, 562 One trial enrolled both subacute and chronic pain patients561 and one trial did not report the duration of pain.553 Two trials560, 561 were rated good quality, two554, 555 poor quality, and eight trials fair quality. Methodological limitations in the fair- and poor-quality studies included inadequate reporting of treatment allocation, unblinded design, use of cointerventions, unclear or low compliance, and high or unclear attrition.
Low-Level Laser Therapy Versus Sham or Placebo
Acute Low Back Pain
One poor-quality trial (n=120) of patients with acute low back pain compared two different laser wavelengths versus sham.555 A higher proportion of patients in both active laser groups reported effective (undefined) treatment versus sham, with no difference among active groups, but point estimates were very imprecise. The number of treatments given in each group was not reported.
Chronic Low Back Pain
Three fair-quality trials550, 552, 553 included in the APS/ACP review found laser more effective than sham treatment for pain and disability. All three trials (n=41 to 71)550, 552, 553 reported significant differences between laser and sham for pain outcomes, though duration of followup (range 1 day to 6 months) and methods for assessing pain varied among the trials. One trial found a higher proportion of laser-treated patients reported >60% pain relief after 2 weeks of treatment (71% [27/38] vs. 36% [12/33]; RR 1.95, 95% CI 1.19 to 3.21)552 and another found laser associated with higher likelihood of “effective” (undefined) treatment (94% [15/16] vs. 48% [12/25]; RR 1.95, 95% CI 1.27 to 2.99).553 The third trial reported significantly different mean pain VAS scores (scale 0 to 100) between laser and sham after 4 weeks (19.1 vs. 35.1; mean difference −16.00, 95% CI −27.95 to −4.05).550 One additional fair-quality trial (n=60) published subsequent to the APS/ACP review found no difference in improvement in VAS pain scores between laser versus sham laser after 2 weeks of treatment (0-10 scale, difference -0.3, 95% CI -1.0 to 0.3).559
One trial included in the APS/ACP review and one subsequent trial found low-level laser therapy associated with significantly better ODI scores versus sham (14.7 vs. 22.9; mean difference −8.20, 95% CI −13.44 to −2.96550 and mean difference in improvement -0.3, 95% CI -0.6 to -0.1 [scale unclear]559).
Low-Level Laser Therapy Plus Another Intervention Versus the Other Intervention Without Low-Level Laser Therapy
Acute or Subacute Low Back Pain
Two good-quality trials (n=80 and 546)560, 561 assessed low-level laser therapy for acute or subacute low back pain. The larger trial found low-level laser therapy plus an NSAID, versus sham laser plus an NSAID or the NSAID alone, associated with improved pain (mean change −30.0 vs. −15.7 vs. −20.8 on 0 to 100 VAS), function (mean change −12.0 vs. −6.5 vs. −10.0 on the ODI) and the SF-36 physical component score (−4 vs. −2 vs. −3 on a 0 to 100 scale) after 3 weeks of treatment, although differences in disability and quality of life scores were small (<6 points on the ODI and 1 to 2 points on the SF-36 physical component score).560 The smaller (n=80) trial found no difference between low-level laser therapy plus heat versus sham plus heat in pain (mean change from baseline −4.0 vs. −4.15 on 0 to 10 VAS; p=0.07) or disability (RDQ mean change from baseline -6.0 vs. −5.65; p=0.39; ODI mean change from baseline −8.2 vs. −8.7; p=0.15); patient global assessment of pain was significantly worse with laser versus sham (mean change from baseline −3.0 vs. −4.7; p=0.006.)561
Chronic Low Back Pain
Four trials compared low-level laser therapy plus another intervention versus the other intervention alone for chronic low back pain.551, 558, 561, 563 A good-quality trial (n=40) found laser plus heat associated with smaller improvements versus sham laser plus heat in pain scores (mean change −3.35 versus −3.95 on a 0 to 10 scale; p=0.03) and physician global assessment of pain (mean change −3.15 versus −4.05; p=0.01) at 3 weeks,561 but differences were small (less than 1 point on a 0 to 10 scale).564 Low-level laser therapy plus heat was associated with greater improvement in the RDQ (mean change −6.7 vs. −4.65 on a 0 to 24 scale; p>0.05) and modified ODI (mean change −9.6 vs. −6.2 on a 0 to 50 scale; p>0.05) versus sham laser plus heat.
Three fair-quality trials compared low level laser therapy plus exercise versus sham laser plus exercise for chronic low back pain.551, 558, 563 The one small trial (n=20) found no differences in pain (mean change −1.3 vs. −1.2 on 0 to 7.5 scale; p=0.5) or the RDQ (mean change −1.8 vs. −3.0, p=0.9) at 1-month followup.551 However, two other trials (n=54 and 100) found the combination associated with lower pain intensity (2.4 vs. 4.3 at 12 weeks; p=0.0005558 and 2.68 vs. 4.08 at 3 weeks on a 0 to 10 VAS563) and disability (16.8 vs. 24.1 on the 0 to 50 modified ODI; p=0.0001558).
Low-Level Laser Therapy Versus Other Interventions
The APS/ACP review included two poor-quality trials of low-level laser therapy versus other interventions, though one was uninterpretable due to methodologic and reporting limitations.556 The other trial (n=75) found no differences between low-level laser therapy versus exercise in pain (mean change −4.2 vs. −3.60 on 0 to 10 VAS) or disability (mean change −16.4 vs. −16.9 on modified ODI).554 A trial not included in the APS/ACP review found no difference between low-level laser therapy versus sham laser plus exercise for pain (4.4 vs. 4.3 on 0 to 10 VAS; p=0.87) or disability (20.8 vs. 24.1 on modified ODI; p=0.06).
Low-Level Laser Therapy Versus Low-Level Laser Therapy
One fair-quality trial (n=66) found no differences between 904 nm laser therapy at doses of 0.1, 1.0, and 4.0 joules per point (corresponding to 0.4, 4.0, and 16.0 joules daily) in pain scores after 2 weeks of followup, but 16.0 joules daily was associated with better functional outcomes related to walking (p=0.007), sitting (p=0.005), and standing (p=0.013) versus the lower doses.562 A poor-quality trial (n=120) found no difference between 904 nm versus 10600 nm low-level laser therapy in the likelihood of experiencing complete resolution of pain at 1-month followup (95% vs. 83%; RR 1.15; 95% CI 0.98 to 1.35.)555
Harms
Harms were not well-reported in trials of low-level laser therapy. The APS/ACP review29 reported no harms associated with low-level laser therapy. Three subsequent trials described no adverse events (including local adverse events), without providing further data.558, 560, 562 One trial reported two withdrawals due to worsening pain across groups.562
Short-Wave Diathermy
Key Points
- For back pain of mixed duration, there was insufficient evidence from five RCTs to determine effects of short-wave diathermy versus sham diathermy, due to methodological limitations and imprecision (SOE: insufficient).
- No study evaluated harms of short-wave diathermy.
Detailed Synthesis
The APS/ACP review29 included three trials (n=24 to 400) of short-wave diathermy for low back pain.450, 475, 565 Two trials475, 565 compared short-wave diathermy versus sham diathermy and all three trials compared short-wave diathermy versus other interventions (exercises,565 traction,565 or manipulation450 , 475). The trials focused on patients with nonradicular low back pain. One trial enrolled patients with acute (<3 weeks) back pain,450 one trial patients with low back pain for 2 to 12 months,(Gibson) and the third patients with back pain for >1 week.565 The trials varied in the number of sessions (6, 12, or not specified); only one trial565 specified the duration of each session (20 minutes). Outcomes were assessed at the end of a 2-week course of therapy in two trials450, 565 and at 12 weeks (8 weeks after the end of therapy) in the third trial.475 Two trials475, 565 were rated fair quality and one trial450 poor quality; methodological shortcomings included unclear randomization and allocation concealment methods, failure to blind care providers and outcome assessors, and failure to report use of cointerventions and compliance. The poor-quality trial also did not blind patients. The APS/ACP review found insufficient evidence to determine effects of short-wave diathermy for acute or chronic low back pain.
Two trials (n=97 and 102) published subsequent to the APS/ACP review evaluated short-wave diathermy versus sham diathermy for chronic low back pain (Table 26; Appendix Tables E39, F39).566, 567 Short-wave diathermy was administered for 15 minutes in 18 sessions over 6 weeks, with outcomes assessed at the end of therapy. Both trials were rated poor quality; methodological shortcomings included unclear randomization and allocation concealment methods, failure to report attrition, lack of intention-to-treat analysis, and failure to blind caregivers and outcome assessors.
Table 26
Characteristics and conclusions of included diathermy trials.
Short-Wave Diathermy Versus Sham Diathermy
Mixed Duration Low Back Pain
Two fair-quality trials included in the APS/ACP review found no difference between 2 weeks of short-wave diathermy versus sham diathermy. In one trial of patients with low back pain for 2 to 12 months, short-wave diathermy was not superior to sham diathermy in median pain scores, the proportion free of pain, or the proportion with work or activity limitations through 12 weeks, with some trends favoring sham therapy.475 In a trial of patients with back pain for >1 week, there was no difference in the likelihood of a positive global response at the end of therapy (39% vs. 37%, RR 1.05, 95% CI 0.74 to 1.50).565
Two subsequent, poor-quality trials each found short-wave diathermy for chronic low back pain associated with better pain scores at the end of a 6-week course of therapy.566, 567 However, in addition to the methodological shortcomings in the trials, they also used a nonstandardized method to assess pain (sum of Lattinen's score plus tenderness score plus 0-10 VAS). Other outcomes were not assessed.
Short-Wave Diathermy Versus Other Interventions
Mixed Duration Low Back Pain
Two fair-quality trials included in the prior APS/ACP review found no differences between a 2-week course of short-wave diathermy versus spinal manipulation475 in pain, use of analgesics, or work or activity limitations through 12 weeks or versus extension exercises or traction565 in the likelihood of a positive global effect at the end of therapy. A small (n=24), poor-quality trial of patients with acute low back pain found short-wave diathermy associated with a lower likelihood of being “fully restored” than spinal manipulation at the end of a 2-week course of therapy (25% vs. 92%, RR 0.27, 95% CI 0.10 to 0.74).450
Harms
No trial of short-wave diathermy reported harms.
Lumbar Supports
Key Points
- For acute or subacute low back pain, there was insufficient evidence from five trials to determine effects of lumbar supports versus no lumbar supports or an inactive treatment, due to methodological shortcomings and inconsistent results (SOE: insufficient).
- For chronic low back pain, there was insufficient evidence from two trials to determine effects of lumbar supports versus no lumbar supports, due to methodological shortcomings and inconsistent results (SOE: insufficient).
- For back pain of mixed duration, one trial found an inextensible but not extensible lumbar support associated with greater improvement in function versus no lumbar support, but effects were small. There was no clear effect on function (SOE: low).
- For acute or subacute low back pain, one trial found no differences between a lumbar support plus an education program versus an education program alone in pain or function after 1 year (SOE: low for pain and function).
- For chronic low back pain, one trial found no difference between a lumbar support plus exercise (muscle strengthening) versus exercise alone in short-term (8 weeks) or long-term (6 months) pain or function (SOE: low for pain and function).
- Three trials found no clear differences between lumbar supports versus other active treatments in pain or function (SOE: low for pain and function).
- There was insufficient evidence from 3 trials to determine comparative effects of different types of lumbar supports for chronic low back pain or back pain of mixed duration, due to heterogeneous comparisons, methodological shortcomings and imprecision (SOE: insufficient).
- Trials reported no harms associated with use of lumbar supports (SOE: low).
Detailed Synthesis
The APS/ACP review29 included a good-quality systematic review44 with six trials39, 568-572 of lumbar supports for low back pain. Sample sizes ranged from 19 to 456 subjects. One of the trials was classified as high quality.569 The APS/ACP review concluded that there was insufficient evidence to determine effects of lumbar supports for acute or chronic low back pain.
An updated version of the systematic review573 with two additional trials574, 575 (eight total) has since been published (Table 2; Appendix Tables E40, F40). Six trials compared lumbar supports versus no lumbar supports,39, 568, 569, 571, 572, 575 three trials lumbar supports versus other active interventions (e.g., spinal manipulation therapy, exercise, massage),39, 568, 569, 575 and two trials compared different types of lumbar supports570, 574 The types of lumbar supports included flexible and semi-rigid corset made of various materials and a pneumatic lumbar support. Duration of treatment ranged from 3 weeks to 2 months. Trials evaluated patients at the end of treatment; three trials39, 568, 574 also evaluated patients 6 to 16 months after the end of treatment. Three trials enrolled patients with chronic pain570, 574, 575 and four enrolled patients with low back pain of mixed duration;39, 568, 569, 572 one trial571 did not report the duration of pain. Sample sizes ranged from 19 to 456 (total n=1,361). All of the studies except for one569 were rated lower quality by the systematic review, based on meeting at least 5 of 10 Cochrane Back Review Group criteria.545 Methodological shortcomings in the trials included failure to describe adequate randomization and allocation concealment methods, lack of blinding of outcome assessors, inadequate or unclear compliance, and possible differential use of cointerventions.573
We identified three trials (n=50, 98 and 217) published since the updated Cochrane review of lumbar supports versus no support for subacute,576 chronic, 577 or mixed duration low back pain578 and one trial (n=433) of lumbar supports plus education versus education alone for acute or subacute low back pain579 (Table 27; Appendix Tables E41, F41). One of the trials also compared two types of lumbar supports (inextensible [stiffer] versus extensible).578 Treatment duration was 2 weeks, 3 months, or 6 months in three trials, with followup up through the end of treatment. The fourth trial did not report treatment duration, but followed patients for 1 year. All four trials were rated fair quality; methodological limitations included unclear allocation concealment methods, unclear compliance and unblended design.
Table 27
Characteristics and conclusions of included lumbar support trials.
Lumbar Support Versus No Lumbar Support or an Inactive Therapy
Acute or Subacute Low Back Pain
The systematic review573 included four trials of lumbar supports versus no lumbar support or an inactive therapy (light massage)569 for acute or subacute low back pain. Meta-analysis was not performed due to clinical heterogeneity. One higher-quality trial (n=164)569 and two lower-quality trials (n=334 and 456)39, 568 found no difference between lumbar supports versus no lumbar support in pain. The fourth, a lower-quality trial (n=216), found lumbar supports associated with higher likelihood of improvement in pain (95% [106/111] vs. 77% [79/103]; RR 1.25, 95% CI 1.11 to 1.40).572 Only one trial evaluated function using standardized measures; it found no differences between a corset versus light message on the RDQ or ODI.569 Evidence on return to work was mixed in two lower-quality trials one trial found no difference between lumbar support versus no support in time to return to work,568 while the other trial found lumbar supports associated with greater likelihood of return to work at 3 weeks (85% [94/111] vs. 67% [70/105]; RR 1.27, 95% CI 1.09 to 1.49).572 Two lower-quality trials (n=790) reported no difference in measures of global improvement.39, 568
A fair-quality trial (n=217) published subsequent to the systematic review evaluated lumbar supports versus no lumbar support for subacute low back pain.576 It found lumbar supports associated with greater improvement in pain after 30 days (mean change −26.8 vs. −21.3; p=0.04) and 90 days (mean change −41.5 vs. −32.0; p=0.002) of use. Lumbar supports were also associated with greater improvement in function, based on the EIFEL score (mean change −5.4 vs. −4.0 at 30 days on a 0 to 24 scale; p=0.02 and −7.6 vs. −6.1 at 90 days; p=0.02).
Mixed Duration Low Back Pain
One fair-quality trial (n=98) of patients with acute to chronic low back pain found an inextensible lumbar support associated with better scores on the ODI (mean difference 9.4, 95% CI 2.2 to 16.6) and the Patient Specific Activity Scale (mean difference -1.4 on a 0 to 10 scale, 95% CI -2.3 to -0.4) and greater likelihood of ≥50 percent improvement in the ODI (RR 3.40, 95% CI 1.07 to 10.8) versus no lumbar support after 2 weeks of therapy among patients who also underwent physical therapy.578 Effects on pain were small (<1 point on a 0-10 NRS) and were not statistically significant. Differences between an extensible lumbar support versus no lumbar support were smaller and did not reach statistical significance.
Chronic Low Back Pain
One lower-quality trial (n=79)575 of lumbar supports versus no support for chronic pain found no differences in pain or functional outcomes after 2 months of treatment.573 A small trial (n=50) published since the systematic review found use of lumbar supports associated with better pain and functional outcomes versus no lumbar support at 1 month (p<0.01; no data reported) based on assessment using the Japanese Orthopedic Association criteria, but effects were not sustained after 3 and 6 months of use.577
Lumbar Support Plus Another Intervention Versus the Other Intervention Without Lumbar Support
Acute and Subacute Low Back Pain
One fair-quality trial (n=433) published subsequent to the systematic review found no differences between a lumbar support plus an education program versus an education program alone in pain or function after 1 year, in patients with acute or subacute work-related back pain.579
Chronic Low Back Pain
One small, lower-quality trial (n=63) included in the systematic review found no difference between a lumbar support plus exercise (muscle strengthening) versus exercise alone in short-term (8 weeks) or long-term (6 months) pain or function.574
Lumbar Support Versus Other Treatments
Acute, Subacute, or Chronic Low Back Pain
The systematic review included one higher-quality (n=164)569 and two lower-quality (n=334 and 456) trials39, 568of lumbar supports versus other active treatments.573 None of the trials found a significant difference among lumbar supports and other treatments, including traction, spinal manipulation, exercise, physiotherapy or TENS, and pain outcomes. For function, results from the higher-quality trial were mixed,569 with the lumbar support associated with better function versus spinal manipulation or transcutaneous muscle stimulation based on the RDQ, but no difference based on the ODI. There were no differences between lumbar supports and other active treatment for either time to return to work (1 trial) or global improvement (2 trials).573
One Type of Lumbar Support Versus Another
Chronic or Mixed Duration Low Back Pain
For chronic low back pain, one trial (n=79; lower quality) included in the systematic review573 found no differences between a flexible versus semi-rigid corset in pain or functional outcomes after 2 months of use.575 Another, small (n=19), lower-quality trial included in the systematic review found a lumbar support plus nonsupportive corset associated with greater improvement in short-term pain and back-specific function after 8 weeks followup versus the nonsupportive corset alone.570
A fair-quality trial (n=98) of patients with back pain of mixed duration found no clear differences between an inextensible versus extensible lumbar support in pain or the ODI after 2 weeks, though effects on the ODI favored the inextensible support (difference 4.1 points, 95% CI -2.8 to 11.1).578
Traction
Key Findings
- For low back pain with or without radicular symptoms, a systematic review included 13 trials that found no clear differences with inconsistent effects of traction versus placebo, sham, or no treatment in pain, function, or other outcomes, though two trials reported favorable effects on pain in patients with radicular back pain (SOE: insufficient for pain and function).
- For low back pain with or without radicular symptoms, a systematic review included five trials that found no clear differences between traction versus physiotherapy versus physiotherapy alone (SOE: low).
- For low back pain with or without radicular symptoms, a systematic review included 15 trials of traction versus other interventions that found no clear between traction versus other active interventions in pain or function (SOE: low for pain and function).
- A systematic review included five trials that found no clear differences between different types of traction (SOE: low).
- Eleven trials of traction in a systematic review reported no adverse events or no difference in risk of adverse events versus placebo or other interventions. Three subsequent trials reported findings consistent with the systematic review (SOE: low).
Detailed Synthesis
The APS/ACP review29 included a large, good-quality systematic review580 with 23 trials of traction versus sham or no treatment, sham versus other interventions, or one type of traction versus another. The review was subsequently updated to include 32 trials with 2,762 patients (Table 2; Appendix Tables E42, F42).581 Thirteen trials compared traction versus placebo, sham traction, or no treatment; 15 trials compared traction versus other active treatments (including exercise [6 trials], heat therapy [2 trials], or other passive physical modalities [7 trials]); and five trials compared one type of traction versus another. Ten trials assessed participants with chronic pain and participants with subacute pain were included in one trial. In the remaining trials, duration of pain was mixed (17 trials) or not clearly reported (5 trials). Of the 32 included trials, 23 enrolled populations with radicular low back pain. Among the other nine studies, eight enrolled a mixed population with radicular and nonradicular pain and one enrolled only patients with nonradicular low back pain. Duration of followup ranged from 1 week to 1 year. Only three studies460, 582, 583 reported outcomes beyond 6 months followup. Sixteen of the 32 included trials were judged to have a low risk of bias (i.e., quality score ≥6/12.)
We also identified three trials (in four publications) not included in the updated systematic review (Table 28; Appendix Tables E43, F43).584-587 Each trial (n=24 to 80) compared combination treatment with traction plus another active intervention versus the active intervention alone. None of the trials clearly stated the duration of low back pain in study participants, but inclusion criteria for two trials584-586 required 3 months or more of pain at baseline (subacute/chronic) and the third587 required no more than 6 months of pain at baseline (acute/subacute). Two trials compared 10 weeks of traction in combination with usual care (infrared lamp and stretching584, 585or hot packs and interferential therapy586) versus usual care alone. The third trial compared inversion traction plus physiotherapy with physiotherapy alone.587 Study participants received treatment for 10 weeks in two trials584-586 and for 4 weeks in the third,587 with respective followup of 6 months and 56 weeks. Two trials were rated fair quality584-586 and one poor quality.587 Methodological shortcomings included unblinded design and in the case of the poor-quality study,587 inadequate description of randomization and allocation concealment techniques, and incomplete followup.
Table 28
Characteristics and conclusions of included traction trials.
Traction Versus Placebo, Sham, or No Treatment
Low Back Pain With or Without Radiculopathy
Although the updated systematic review included 13 trials of traction versus placebo, sham, or no treatment, few studies reported data suitable for meta-analysis.581 For low back pain with or without radiation, two trials found traction associated with lower pain scores at 3- to 5-week followup (2 trials; mean difference VAS −18.49, 95% CI −24.12 to −12.87) but not at longer followup (6 weeks to 1 year). There were also no significant differences between traction versus placebo, sham or no treatment in functional status, global improvement, or return to work after 3 weeks to 6 months, though evidence was limited to one to four trials for each outcome. Among the trials not included in meta-analyses, there was no significant difference at 3- to 5-week followup in pain,582, 588 functional status,588 or global improvement.588, 589
Traction Plus Another Intervention Versus Another Intervention Alone
Low Back Pain With or Without Radiculopathy
The systematic review found few differences between traction plus another intervention versus the other intervention alone in pain, function, or global improvement for nonradicular or radicular low back pain based on five trials. All five trials compared traction plus physiotherapy versus physiotherapy alone, though evidence was limited to one to two trials for outcome and time point.581
Two trials published subsequent to the systematic review evaluated traction plus an active “usual care” intervention (infrared lamp and stretching or hot packs and interferential therapy) versus the usual care intervention alone.584-586 One trial (n=80) found traction associated with better pain scores at 10 weeks (mean difference −1.20 on a 0 to 10 scale, 95% CI −1.87 to −0.53) and 6 months (mean difference −0.90, 95% CI −1.41 to −0.39) and improved function (mean difference in ODI scores −1.60 on 0 to 100 scale at 6 weeks, 95% CI −1.41 to −0.39 and −3.30 at 6 months, 95% CI −4.57 to −2.03).584, 585 The other trial (n=64) found traction associated with better pain scores (mean difference −2.20 on 0 to 100 scale, 95% CI −2.79 to −1.62) and function (mean difference −8.10 on the ODI, 95% CI −9.60 to −6.60) at 6 months, though the differences were small.586 A small (n=24), poor-quality trial of traction plus physiotherapy versus physiotherapy alone for radicular low back pain found no differences in pain, disability, or quality-of-life scores after 4 weeks of treatment and 6 weeks of followup, though traction was associated with lower likelihood of back surgery (23% vs. 82%; RR 0.28, 95% CI 0.10 to 0.79.)587
Traction Versus Other Active Treatments
Low Back Pain With or Without Radiculopathy
Although the updated systematic review included 15 trials of traction versus other active interventions, few of the included trials provided data suitable for inclusion in meta-analysis.581 The review found no differences between traction versus other active treatments in two trials of low back pain with radicular symptoms (followup at 1 to 16 weeks) or in four trials of patients with low back pain with or without radicular symptoms (followup at 1 year) in pain, functional status, and global improvement. We identified no trial published subsequent to the systematic review on traction versus other active treatments.
One Type of Traction Versus Another
Low Back Pain With or Without Radiculopathy
Five trials included in the updated systematic review compared different types of traction.581 For low back pain of varying duration with or without radicular symptoms, one trial (n=26) found no difference between static versus intermittent traction in the likelihood of experiencing global improvement after 1 to 2 weeks (risk difference −0.08, 95% CI −0.46 to 0.30)590 and one trial (n=67) found autotraction superior to mechanical traction (risk difference 0.53, 95% CI 0.32 to 0.73.)591 For radicular low back pain, there were no differences among different types of traction (autotraction versus manual or mechanical traction [2 trials] and water versus land-based traction [1 trial]) in pain scores (3 trials; mean difference 6.58, 95% CI −2.77 to 16) or likelihood of global improvement (1 trial; risk difference −0.16, 95% CI −0.40 to 0.09.)
Harms
Eleven (of 32) studies included in the updated systematic review581 reported adverse events; of those, four reported no events in either group. In the other seven trials, most found no difference between traction versus placebo or other treatments in risk of adverse events (including aggravation or worsening of symptoms), or with one type of traction versus another. However, one trial found inversion traction associated with increased likelihood of worsened pain versus conventional traction, although the estimate was imprecise (79% [11/14]) versus 15% [2/13]; RR 5.00, 95% CI 1.39 to 19.) Three trials published subsequent to the updated systematic review did not report adverse events584-586 or reported no adverse events.587
Taping
Key Points
- For chronic low back pain, three trials found no differences between a Kinesio Taping® versus sham taping in back-specific function after 5 to 12 weeks; effects on pain were inconsistent (SOE: low for function, insufficient for pain).
- For chronic low back pain, there was insufficient evidence from 1 trial to determine effects of Functional Fascial Taping plus exercise versus sham taping plus exercise, due to methodological limitations and imprecision (SOE: insufficient).
- For chronic low back pain, two trials found no differences between Kinesio Taping® versus exercise therapy in pain or function (SOE: low for pain and function).
- No trial of taping reported harms.
Detailed Synthesis
The APS/ACP review did not evaluate taping for low back pain. We identified six trials on the effects of taping (Table 29; Appendix Tables E44, F44).592-597 Sample sizes ranged from 20 to 60 in five trials and was 148 in the fifth trial.597 Five trials evaluated Kinesio Taping®592, 593, 595-597 and one trial Functional Fascial Taping.594 Three trials of Kinesio Taping592, 593, 597 and the trial of Functional Fascial Taping®594 evaluated a sham taping (taping applied without tension) comparison. In the Functional Fascial Taping trial, patients in both groups also received instruction in home trunk flexion exercises. Among the Kinesio Taping trials, one trial595 compared Kinesio Taping versus exercise therapy without Kinesio Taping, one trial 596 compared Kinesio Taping versus exercise therapy or the combination of taping and exercise, and one trial592 compared Kinesio Taping plus physical therapy (hot pack, ultrasound, and TENS) versus sham taping plus physical therapy. The five trials of Kinesio Taping enrolled patients with chronic low back pain and the trial of Functional Fascial Taping enrolled patients with back pain for >6 weeks, though the median duration was 32 to 39 weeks. The taping techniques all involved some degree of tension, though the taping pattern, reapplication interval, and duration of treatment (7 days to 12 weeks) varied. Outcomes were assessed at the end of a 4-week course of therapy in two trials595, 596 and at 5 to 12 weeks (4 to 10 weeks after the end of therapy in three trials and at the end of therapy in one trial592). Two trials were rated good quality,593, 597 three fair quality,592, 594, 596 and one poor quality.595 Methodological shortcomings in the fair- and poor-quality trials included unclear randomization and allocation concealment methods, unblinded design, failure to report attrition, and unclear use of intention-to-treat analysis.
Table 29
Characteristics and conclusions of included taping trials.
Taping Versus Sham Taping
Chronic Low Back Pain
Two good-quality trials (n=60 and 148) and one fair-quality trial (n=20) found no differences between a Kinesio Taping® versus sham taping in back-specific function (RDQ or ODI) after 5 weeks (following 1 week of therapy)593 or 12 weeks (following 4 or 12 weeks of therapy).592, 597 Effects on pain were somewhat mixed, with one trial finding a 1-week course of taping associated with greater improvement in pain (mean difference, 0-10 VAS −1.0, 95% CI −1.7 to 0.2) after 5 weeks,593 but two trials finding no effect of a 4-week course of taping (mean difference, 0-10 VAS −0.5, 95% CI −1.4 to 0.4)597 or a 12-week course of taping (mean, 0-10 VAS 5.07 vs. 5.14).592
Taping Plus Exercise Versus Exercise Alone
Chronic Low Back Pain
A fair-quality trial (n=43) found no difference between 2 weeks of Functional Fascial Taping plus exercise versus sham taping plus exercise in pain or ODI scores when outcomes were assessed at 6 or 10 weeks.594
Taping Versus Exercise
Chronic Low Back Pain
One fair-quality (n=39)596 and one poor-quality (n=40) trial595 found no differences between a 4-week course of Kinesio Taping® versus exercise therapy in pain or the RDQ when outcomes were assessed at the end of therapy. Differences in pain scores favored taping by less than 1 point on a 0-10 scale, though effects on the RDQ were in opposite directions (favored taping in one trial and exercise in the other). One of the trials also found no differences between taping and taping plus exercise.
Harms
No trial of taping reported harms.
- Results of Literature Searches
- What are the comparative benefits and harms of different pharmacological therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids, and topical/patch-delivered medications
- What are the comparative benefits and harms of different nonpharmacological noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes but is not limited to multidisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, transcutaneous electrical nerve stimulation, electrical muscle stimulation, interferential therapy, heat [various forms], and ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets, and low-level lasers
- Results - Noninvasive Treatments for Low Back PainResults - Noninvasive Treatments for Low Back Pain
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