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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.)
Background
Nature and Burden of Low Back Pain
Low back pain is one of the most frequently encountered conditions in clinical practice. Up to 84 percent of adults have low back pain at some time in their lives, and over one quarter of U.S. adults report recent (in the last 3 months) low back pain.1, 2 Low back pain can have major adverse impacts on quality of life and function. Low back pain is also costly—in 1998, total US health care expenditures for low back pain were estimated at $90 billion.3 Since that time, costs of low back pain care have risen at a rate higher than observed for overall health expenditures.4 In addition to high direct costs, low back pain is one of the most common reasons for missed work or reduced productivity while at work, resulting in high indirect costs.5
The prognosis for acute low back pain (generally defined as an episode lasting less than 4 weeks) is generally favorable. Most patients experience a rapid improvement in (and often a complete resolution of) pain and disability and are able to return to work.6 In those with persistent symptoms, continued improvement is often seen in the subacute phase between 4 to 12 weeks, though at a slower rate than observed at first. In a minority of patients, low back pain lasts longer than 12 weeks, at which point it is considered chronic; levels of pain and disability often remain relatively constant thereafter.7 Recently, a National Institutes of Health Research Task Force defined chronic low back pain as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.8 Patients with chronic back pain account for the bulk of the burdens and costs of low back pain.9, 10 Predictors of chronicity are primarily related to psychosocial factors, such as presence of psychological comorbidities, maladaptive coping strategies (such as fear avoidance [avoiding activities because of fears that they will further damage the back] or catastrophizing [anticipating the worst possible outcomes from low back pain]), presence of nonorganic signs (symptoms without a distinct anatomical or physiological basis),11 high baseline functional impairment, low general health status, and others.7 Back pain is frequently associated with presence of depression and anxiety.
Attributing symptoms of low back pain to a specific disease or spinal pathology is a challenge.12 Spinal imaging abnormalities such as degenerative disc disease, facet joint arthropathy, and bulging or herniated intervertebral discs are extremely common in patients with or without low back pain, particularly in older adults, and such findings are poor predictors for the presence or severity of low back pain.13 Radiculopathy from nerve root impingement (often due to a herniated intervertebral disc) or spinal stenosis (narrowing of the spinal canal) are each present in about 4 to 5 percent of patients with low back pain and can cause neurological symptoms such as lower extremity pain, paresthesias, and weakness; the natural history and response to treatment for these conditions may differ from back pain without neurologic involvement.14
Interventions for Low Back Pain
Multiple treatment options for acute and chronic low back pain are available. Broadly, these can be classified as pharmacological treatments,15 noninvasive nonpharmacological treatments,16 injection therapies,17 and surgical treatments.18 This report focuses on the comparative benefits and harms of pharmacological and noninvasive nonpharmacological treatments; each of these categories encompasses a number of different therapies. Pharmacological treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, and corticosteroids; nonpharmacological treatments include exercise and related interventions (e.g., yoga), complementary and alternative therapies (e.g., spinal manipulation, acupuncture, and massage), psychological therapies (e.g., cognitive-behavioral therapy, relaxation techniques, and operant therapy), physical modalities (e.g., traction, ultrasound, transcutaneous electrical nerve stimulation [TENS], low level laser therapy, interferential therapy, superficial heat or cold, back supports, and magnets), and multidisciplinary rehabilitation.
Rationale for Evidence Review
The burden of low back pain, the numerous noninvasive treatment options to be considered by clinicians and patients, and the availability of new evidence and interventions (e.g., duloxetine) warrant a comprehensive comparative effectiveness review of this topic. An existing guideline14 and associated systematic reviews15, 16 from the American College of Physicians and the American Pain Society were published in 2007, emphasizing the role of pharmacological therapies and noninvasive nonpharmacological therapies for low back pain in most situations. A systematic evidence review that includes recently published research, explores potential variability in response to treatment depending on patient characteristics, considers multiple outcomes related to pain and function, and separately considers benefits and harms of interventions for acute or chronic nonradicular low back pain, as well as conditions such as radiculopathy and spinal stenosis, may provide a better understanding of the comparative effectiveness of treatment options for acute and chronic low back pain and could be used to update existing clinical recommendations. To aid in the efficiency of the review process, this review will be conducted as an update of prior systematic reviews on pharmacological and nonpharmacological noninvasive treatments used to develop the 2007 APS/ACP clinical practice guideline and conducted by the same review team.15, 16
Scope of Review and Key Questions
The Key Questions; populations, interventions, comparators, outcomes, timing, settings, and study designs (PICOTS); and analytic framework used to guide this review are shown below.
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.
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.
PICOTS
Population(s)
- Adults with acute (<4 weeks), subacute (4 to 12 weeks), or chronic (>12 weeks) nonradicular low back pain, radicular low back pain, or symptomatic spinal stenosis.
- Exclude: Children, pregnant women
- Exclude: Patients with low back pain related to cancer, infection, inflammatory arthropathy, high velocity trauma, fracture; or low back pain associated with severe or progressive neurological deficits
Interventions
KQ1. Oral or Topical Pharmacologic Therapies (Or Combinations Thereof)
- Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, celecoxib, acetylsalicylic acid (aspirin)
- Nonopioid analgesics, such as acetaminophen
- Opioid analgesics, such as oxycodone, hydrocodone, hydromorphone, morphine, fentanyl
- Tramadol and tapentadol (medications with dual mechanisms of action on the opioid receptor and as a norepinephrine reuptake inhibitor)
- Antidepressants, such as tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), and selective serotonin-reuptake inhibitors (SSRIs), or serotonin antagonist and reuptake inhibitors (SARIs)
- Skeletal muscle relaxants
- Benzodiazepines
- Corticosteroids, such as prednisone or prednisolone
- Antiepileptic drugs, such as gabapentin or pregabalin
- Capsaicin or topical lidocaine
- Exclude: Intravenously administered medications
KQ2. Noninvasive, Nonpharmacological Therapies (Or Combinations Thereof)
- Interdisciplinary or multicomponent rehabilitation
- Psychological therapies, such as cognitive behavioral therapy
- Exercise and related interventions, such as yoga or tai chi
- Complementary and alternative medicine therapies: spinal manipulation, acupuncture, massage
- Passive physical modalities: heat, cold, ultrasound, transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), interferential therapy (IFT), short-wave diathermy, traction, low level laser therapy, lumbar supports/braces
- Other noninvasive treatments, such as taping
- Exclude: Invasive, nonsurgical therapies (e.g., injections) and surgical therapies
Comparisons
- Any included pharmacological or nonpharmacological intervention or combination of interventions (combinations may include both pharmacological and nonpharmacological components) versus any other included intervention or combination of interventions, placebo (drug trials), sham (functionally-inert) treatments, or no treatment.
Outcomes
- Final health outcomes
- Reduction or elimination of low back pain, including related leg symptoms
- Improvement in back-specific and overall function
- Improvement in health-related quality of life (HRQOL)
- Reduction in work disability/return to work
- Global improvement
- Number of back pain episodes or time between episodes
- Patient satisfaction
- Adverse effects of intervention(s)
- Pharmaceutical: serious (anaphylaxis, death) and nonserious (mild allergic or untoward) drug reactions or effects; opioid addiction or overdose
- Nonpharmaceutical: serious (death, neurological including cauda equine syndrome, fracture, local skin burns, etc.) and nonserious (mild transient local or general soreness, stiffness, aching; local skin irritation, etc.)
Timing
- Duration of followup: Short term (up to 6 months) and long term (at least 1 year)
Setting
- Any nonhospital setting or in self-directed care
Analytic Framework
The analytic framework (Figure 1) illustrates the population, interventions, outcomes, and adverse effects that will guide the literature search and synthesis.
![Figure 1 is an analytic framework that depicts the populations, interventions, outcomes, and adverse effects/harms of interest for noninvasive treatments for low back pain. The far left of the framework describes the target population as patients with low back pain; patient characteristics include clinical, demographic, and psychosocial risk factors associated with low back pain outcomes. To the right of the populations is an arrow to represent the treatments for low back pain, including noninvasive, nonsurgical (pharmaceutical or nonpharmaceutical) single or multimodal treatments. Below the treatments is an oval for the adverse effects/harms of interventions. To the far right of the framework the final health outcomes of interest are listed, including pain, function, health-related quality of life, work disability/return to work, global improvement, time between episodes, and patient satisfaction.](/books/NBK350262/bin/introductionf1.gif)
Figure 1
Analytic framework. * Patient characteristics include clinical, demographic, and psychosocial risk factors associated with low back pain outcomes. † Intermediate outcomes are typically not measured (e.g., inflammation).
- Introduction - Noninvasive Treatments for Low Back PainIntroduction - Noninvasive Treatments for Low Back Pain
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