Allen, 2016

USA

Mean duration of pain: 170 months

Cluster RCT

Fair

A. Patient focused multidisciplinary treatment + provider focused multidisciplinary treatment + usual care (n=151 patients, 15 providers): 12 months (time duration NR), individual, Community-based outpatient clinics

B. Usual care (n=149 patients, 15 providers)

Patient Participants

Mean age: 61 years

Male: 91%

Non-White race: 50%

Pain etiology/type: Arthritis

Joints with OA:

-

Knee only: 79%

-

Hip only: 11%

-

Knee and hip: 10%

Fair or poor health: 38%

Mean BMI: 33.8 kg/m2

Provider Participants

Mean study patients per provider: 10.0

<15% females in patient panel: 83%

Male: 40%

Provider Type:

-

Physician: 63%

-

Physician Assistant: 23%

-

Nurse Practitioner: 10%

-

Registered Nurse: 3%

A vs. B, mean (SD)

WOMAC Pain Subscale (0-10)

Baseline: 5.1 (NR) (not reported by group)

Postintervention: 4.7 (NR) vs. 4.95 (NR), difference −0.25 (95% CI −0.6 to 0.1)

Estimated percentage improving ≥18% on WOMAC score from baseline (8.7 point reduction)

Postintervention: 36.1% (NR) vs. 28.2% (NR); OR 1.3 (95% CI, 0.9 to 1.8)

WOMAC Total (0-96)

Baseline: 48.9 (17.6) vs. 47.8 (17.4)

Postintervention: 44.4 (NR) vs. 48.5 (NR), difference −4.1 (95% CI −7.2 to −1.1)

WOMAC Function Subscale (0-68)

Baseline: 33.8 (NR) (not report by group)

Postintervention: 31.0 (NR) vs. 34.3 (NR), difference −3.3 (95% CI −5.7 to −1.0)

SPPB (Physical Function) (0-12)

Baseline: 8.0 (2.6) vs. 8.1 (2.5)

Postintervention: 7.8 (NR) vs. 7.6 (NR), difference 0.3 (95% CI −0.3 to 0.9)

A vs. B, mean (SD)

PHQ-8 (0-24)

Baseline: 7.2 (5.6) vs. 6.4 (5.1)

Postintervention: 6.2 (NR) vs. 6.8 (NR), difference −0.6 (95% CI −1.5 to 0.3)

A vs. B, % (n/N)

Adverse Events

4 study-related adverse events occurred, but none were associated with the OA intervention.

Provider Referrals Orthopedic visit:

-

Referral: 5.3% (8/151) vs. 6.0% (9/149)

-

Receipt: 50.0% (4/8) vs. 66.7% (6/9)

Allen, 2017

USA

Mean duration of symptoms: 124.8 months

Cluster RCT

Fair

A. Patient focused multidisciplinary treatment + provider focused multidisciplinary treatment + usual care (n=140 patients, 5 providers): 12 months (time duration NR), individual, Community-based outpatient clinics

B. Provider focused multidisciplinary treatment + usual care (n=140 patients, 5 providers): 12 months

C. Patient focused multidisciplinary treatment + usual care (n=128 patients, 5 providers): 12 months

D. Usual care (n=129 patients, 5 providers)

Patient Participants

Mean age: 63.3 years

Male: 26%

Non-White race: 40%

Joints with OA:

-

Knee only: 85%

-

Hip only: 9%

-

Knee and hip: 6%

Fair or poor health: 20%

Mean BMI: 35.6 kg/m2

Clinic and Provider Characteristics

Mean providers: 7.3

Mean medical physicians and osteopaths: 6.2

Mean nurse practitioners and physician assistants: 1.1

Family medicine practice: 60%

Internal medicine practice: 40%

Providers:

-

Male: 38%

-

Mean years since graduation: 18.9 years

A vs. B vs. C vs. D, difference in change scores (95% CI) from baseline to follow-up

WOMAC Pain Subscale (0-10)

Baseline: 4.2 (NR) vs. 4.0 (NR) vs. 4.4 (NR) vs. 3.8 NR)

Postintervention: difference in change scores from baseline for

A vs. D: −0.15 (–0.65 to 0.3)

B vs. D: 0.15 (–0.35 to 0.6)

C vs. D: −0.2 (–0.7 to 0.25)

Estimated percentage (95% CI) improving ≥18% on WOMAC score from baseline (8.7 point reduction)

Postintervention: 44% (35% to 56%) vs. 35% (28% to 44%) vs. 49% (37% to 63%) vs. 49% (42% to 57%)

Only group B (provider) differed from group D (usual care): OR 0.7 (95% CI, 0.4 to 0.9), p = 0.016

WOMAC Total (0-96)

Baseline: 40.1 (15.8) vs. 37.7 (17.9) vs. 41.0 (15.9) vs. 35.6 (18.0)

Postintervention: difference in change scores from baseline for

A vs. D: −0.7 (–4.2 to 2.8)

B vs. D: 2.5 (–0.9 to 5.9)

C vs. D: −1.5 (–5.1 to 2.0)

WOMAC Function Subscale (0-68)

Baseline: 27.5 (NR) vs. 26.0 (NR) vs. 28.5 (NR) vs. 24.7

Postintervention: difference in change scores from baseline for

A vs. D: −0.2 (–2.7 to 2.3)

B vs. D: 2.3 (–0.1 to 4.7)

C vs. D: −1.0 (–3.5 to 1.6)

SPPB (Physical Function)

Baseline: 8.5 (NR) vs. 8.8 (NR) vs. 8.3 (NR) vs. 8.5 (NR)

Postintervention: difference in change scores from baseline for

A vs. D: −0.3 (–0.8 to 0.3)

B vs. D: −0.4 (–1.0 to 0.1)

C vs. D: −0.3 (–0.8 to 0.3)

A vs. B vs. C vs. D, difference in change scores (95% CI) from baseline to follow-up

PHQ-8 score (0-24)

Baseline (mean, SD): 4.9 (NR) vs. 4.5 (NR) vs. 4.8 (NR) vs. 4.0 (NR)

Postintervention: difference in change scores from baseline for

A vs. D: 0.1 (–0.8 to 1.0)

B vs. D: 0.6 (–0.2 to 1.5)

C vs. D: 0.3 (–0.6 to 1.2)

A vs. B vs. C vs. D, % (n/N)

Harms

No study-related adverse events occurred

Joint Injection:

-

16.7% (17/102) vs. 22.9% (27/118) vs. 23.7% (22/93) vs. 18.5% (19/103)

New pain medication (medication not specified):

-

38.8% (40/103) vs. 33.1% (41/124) vs. 27.8% (27/97) vs. 28.8% (32/111)

-

3.6% (5/139) vs. 2.1% (3/143) vs. 3.9% (5/128) vs. 3.1% (4/129)

Orthopedic Visit:

-

Recommended: 1.4% (2/140) vs. 3.6% (5/140)

-

Receipt: NR

-

Recommended: 72.1% (101/140) vs. 76.4% (107/140)

-

Receipt: 33.7% (34/101) vs. 30.8% (33/107)

Angeles, 2013

Canada

Mean duration of pain: NR

RCT

Poor

A. IPMP (n=29) 2 months (2 hour group sessions 1 time per week) (16 hours total), group, Outpatient clinics

B. Waitlist (n=34):

40 to 59 years of age: 51% (mean age NR)

Male: 27%

Race/ethnicity: NR

Pain etiology/type: chronic MSK or neuropathic pain

-

work-related accident: 31%

-

non work-related accident: 27%

-

disease process: 60%

-

Taken medications not prescribed by doctor (medication not specified): 37%

-

before onset of pain: 8%

-

after onset of pain: 24%

A vs. B, % (n/N)

Early opioid prescription refill:

Intermediate term: 7.7% (1/19) vs. 25% (6/22), p=0.08; RR 0.19 (95% CI 0.03 to 1.46)

Increase in opioid medication dose:

Intermediate term: 11.5% (2/19) vs. 9.4% (2/22), p=0.56; RR 1.16 (95% CI 0.18 to 7.45)

A vs. B, Mean change (SD NR)

SF-36 PCS

Baseline: NR

Postintervention: change from baseline −2.9 vs. −3.0, p=0.98

SF-36 MCS

Baseline: NR

Postintervention: change from baseline 3.6 vs. 3.6, p=1.00

Harms

No study-related adverse events occurred.

Dobscha, 2008/2009 & Dickinson, 2010

USA

Mean duration of pain: 178 months

Cluster RCT

Fair

A. IPMP – provider assistance with pain treatment and use of stepped care (n=214): 12 months (time duration NR), mode of delivery NR, 3 urban and 2 rural outpatient clinics

B. Usual care (n=187)

Mean age: 62 years

Male: 92%

Race/Ethnicity

-

White: 89%

-

Black: 2%

-

American Indian/Alaska Native: 3%

-

Not reported: 6%

-

Back pain: 67%

-

Neck or joint pain: 65% - Rheumatism, OA, or arthritis: 49%

-

Proportion of patients with >1 musculoskeletal condition: 66%

-

All patients scored ≥6 on RMDQ

-

Currently receiving disability payment: 65%

-

Mean RxRisk-V (0-45): 4.9

-

Major depression diagnosis: 18%

-

Mean depression severity (0-27): 8.3

-

PTSD diagnosis: 16%

-

Anxiety syndrome: 13%

-

Panic attack within past 4 weeks: 17%

-

Positive AUDIT-C alcohol misuse screening: 16%

-

Endorses drug misuse in past 6 months: 3%

-

Reports prior substance use treatment: 16%

-

Taking antidepressant at study entry: 36%

-

Taking opioids 6 months prior to study entry: 43%

A vs. B, Mean (95% CI)

Chronic Pain Grade Severity/Intensity subscale (0–100) ^a

Baseline: 67.4 (65.4 to 69.3) vs. 66.0 (64.3 to 67.8)

Postintervention: : 63.2 (60.7 to 65.7) vs. 65.6 (63.3 to 67.9), difference −2.4 (95% CI −7.03 to 2.23)

Proportion of patients demonstrating a ≥30% reduction in RMDQ score

Postintervention: 21.9% (41/187) vs. 14.0% (30/214); RR 1.56 (95% CI 1.02 to 2.40)

RMDQ (0–24) ^a

Baseline: 14.6 (14.3 to 14.9) vs. 14.5 (14.0 to 15.0)

Postintervention: 13.3 (12.9 to 13.7) vs. 14.3 (13.6 to 15.0), difference −1.0 (95% CI −1.69 to −0.31)

Chronic Pain Grade Disability/Interference subscale (0–100) ^a

Baseline: 49.3 (45.9 to 52.8) vs. 48.7 (45.5 to 51.9)

Postintervention: 44.6 (40.7 to 48.4) vs. 51.1 (47.6 to 54.6), difference −6.5 (95% CI −11.74 to −1.26)

Pain disability-free days, Mean (SD)

Baseline to postintervention: 141.8 (108.3) vs. 124.1 (107.5), difference 17.7 (95% CI −3.54 to 38.94)

Medication prescriptions for a 52-week period, % (n/N) ^c

Any opioid prescribed: 65% (120/185) vs. 61% (129/212)

-

If opioid prescribed, any that is long acting: 31% (37/120) vs. 18% (23/129)

A vs. B, Mean (95% CI)

EQ-5D (0-1) ^a

Baseline: 0.65 (0.63 to 0.68) vs. 0.64 (0.62 to 0.67)

Postintervention: 0.64 (0.61 to 0.67) vs. 0.60 (0.57 to 0.63), difference 0.04 (95% CI – 0.002 to 0.08)

PHQ-9 (0-27) ^b

Baseline: 14.4 (13.4 to 15.5) vs. 14.4 (13.5 to 15.3)

Postintervention: 10.6 (9.1 to 12.1) vs. 13.2 (11.9 to 14.5), difference −2.6 (95% CI −4.61 to 0.59)

Global treatment satisfaction (scale NR) ^a

Baseline: 2.9 (2.8 to 3.0) vs. 2.9 (2.8 to 3.1)

Postintervention: 2.7 (2.5 to 2.8) vs. 2.6 (2.4 to 2.7), difference 0.1 (95% CI −0.11 to 0.31)

Global impression of change in past 6 months (0-7)

Postintervention: 3.7 (3.5 to 3.8) vs. 4.4 (4.3 to 4.6), difference −0.7 (95% CI −0.93 to −0.47)

A vs. B, Mean (SD) or % (n/N)

Harms

No study-related adverse events occurred.

Healthcare Utilization

-

Any mental health appointment: 45% (83/185) vs. 28% (59/212)

-

Any substance use disorder appointment: 0.5% (1/185) vs. 0.5% (1/212)

-

Any pain specialty consultation service appointment: 7% (13/185) vs. 3% (6/212)

-

Any orthopedic or neurosurgery appointment: 16% (30/185) vs. 13% (28/212)

-

Any emergency department visit: 30% (56/185) vs. 30% (64/212)

-

Any inpatient admission: 12% (22/185) vs. 13% (28/212)

Mas, 2019

Spain

Mean duration of pain: 0.5 to 3 months

Cluster RCT

Fair

A. IPMP (n=262; 26 primary healthcare centers): one 10 hour session (4 hours physical therapy, 4 hours psychology, 2 hours for questions with general practitioner (10 hours total), combined group and individual, outpatient clinic

B. Usual Care (n=239; 13 primary healthcare centers)

Mean age: 47 years

Male: 35%

Race/Ethnicity: NR

Pain etiology/type:

Subacute low back pain

Disability: NR

Comorbidities:

-

Obese: 17%

-

Overweight: 39%

A vs. B, Mean (SD or 95% CI)

MPQ VAS pain (0–10)

Baseline: 5.8 (2.3) vs. 5.9 (2.3)

Short term: 3.2 (3.2) vs. 4.1 (3.3), adjusted difference −0.77 (95% CI −1.53 to −0.01)

Long term (12 months): 3.6 (3.0) vs. 3.9 (3.2), adjusted difference −0.27 (95% CI – 0.88 to 0.34)

MPQ Total Intensity Score (0–14) ^d

Baseline: 6.7 (3.1) vs. 6.5 (3.1)

Short term: 4.0 (3.6) vs. 4.6 (3.6), adjusted difference −0.49 (–1.39 to 0.42)

Long term (12 months): 3.1 (3.2) vs. 3.6 (3.6), adjusted difference 0.69 (–1.41 to 0.02)

MPQ Current Intensity Score (0-5)

Baseline: 2.6 (1.1) vs. 2.5 (1.2)

Short term: 1.7 (1.5) vs. 1.3 (1.4), adjusted difference −0.32 (95% CI −0.63 to −0.02)

Long term (12 months): 1.6 (1.4) vs. 1.4 (1.3), adjusted difference −0.18 (95% CI – 0.43 to 0.08)

RMDQ (0-24)

Baseline: 10.0 (5.2) vs. 9.9 (5.3)

Short term: 6.2 (4.9) vs. 7.4 (5.5), adjusted difference −1.33 (95% CI −2.22 to −0.45)

Long term (12 months): 5.1 (4.9) vs. 6.0 (5.7), adjusted difference −1.11 (95% CI – 2.08 to −0.13)

A vs. B, Mean (SD)

SF-12 Physical health (0-100)

Baseline: 41.9 (9.0) vs. 40.7 (9.3)

Short term: 46.5 (8.7) vs. 45.3 (9.8), adjusted difference 0.55 (95% CI −1.19 to 2.29)

Long term (12 months): 47.0 (8.9) vs. 46.2 (9.5), adjusted difference 0.53 (95% CI −1.20 to 2.27)

SF-12 Mental health (0-100)

Baseline: 43.4 (12.8) vs. 42.3 (12.4)

Short term: 48.8 (12.0) vs. 45.0 (13.2), adjusted difference 2.56 (95% CI −0.33 to 5.45)

Long term (12 months): 48.9 (11.2) vs. 47.0 (11.9), adjusted difference 1.48 (95% CI −0.86 to 3.83)

McBeth 2012 & Beasley, 2015

England

Mean duration of pain: NR

RCT

Fair

A. IPMP with telephone delivered CBT and exercise (n=112): 6 months, initial assessment (0.75 to 1 hour) seven weekly sessions for 6 weeks (0.5 to 0.75 hours per session, 3.5 to 5.25 hours each week, 21 to 31.5 hours over 6 weeks), and a single 0.5- to 0.75-hour session at 3 and 6 months (0.5 to 1.5 hours) (21.25 to 34.75 hours total), individual, patient home and local gym

B. Usual Care (n=109)

C. Telephone-delivered CBT alone (n=112)

D. Exercise alone (n=109)

Mean age: 56 years

Male: 31%

Race/Ethnicity: NR

Pain etiology/type: Chronic widespread pain

Disability: NR

Comorbidities:

-

Patients with severe psychiatric disorders were excluded

% (n/N)

Chronic Pain Grade questionnaire

A vs. B

Baseline:

-

0: 0% (0/112) vs. 0% (0/109)

-

I: 25.9% (29/112) vs. 17.4% (19/109)

-

II: 43.8% (49/112) vs. 51.4% (56/109)

-

III: 22.3% (25/112) vs. 16.5% (18/109)

-

IV: 8.0% (9/112) vs. 14.7% (16/109)

-

0: 0% (0/76) vs. 0% (0/88)

-

I: 60.5% (46/76) vs. 41.2% (28/68)

-

II: 31.6% (24/76) vs. 47.1% (32/68)

-

III: 5.3% (4/76) vs. 7.4% (5/88)

-

IV: 2.6% (2/76) vs. 4.4% (3/68)

Short term:

-

0: 0% (0/71) vs. 0% (0/76)

-

I: 54.9% (39/71) vs. 35.5% (27/76)

-

II: 31.0% (22/71) vs. 52.6% (40/76)

-

III: 11.3% (8/71) vs. 4.0% (3/76)

-

IV: 2.8% (2/71) vs. 7.9% (6/76)

Long term (24 months):

-

0: 13.5% (10/74) vs. 19.4% (14/72)

-

I: 39.2% (29/74) vs. 25.0% (18/72)

-

II: 28.4% (21/74) vs. 30.6% (22/72)

-

III: 10.8% (8/74) vs. 15.3% (11/72)

-

IV: 8.1% (6/74) vs. 9.7% (7/72)

A vs. C

Baseline:

-

0: 0% (0/112) vs. 0% (0/112)

-

I: 25.9% (29/112) vs. 21.4% (24/112)

-

II: 43.8% (49/112) vs. 47.3% (53/112)

-

III: 22.3% (25/112) vs. 20.5% (23/112)

-

IV: 8.0% (9/112) vs. 10.7% (12/112)

-

0: 0% (0/76) vs. 0% (0/58)

-

I: 60.5% (46/76) vs. 44.8% (26/58)

-

II: 31.6% (24/76) vs. 36% (21/58)

-

III: 5.3% (4/76) vs. 17.2% (10/58)

-

IV: 2.6% (2/76) vs. 1.7% (1/58)

Short term:

-

0: 0% (0/71) vs. 1.7% (1/58)

-

I: 54.9% (39/71) vs. 46.6% (27/58)

-

II: 31.0% (22/71) vs. 31.0% (18/58)

-

III: 11.3% (8/71) vs. 10% (6/58)

-

IV: 2.8% (2/71) vs. 3.5% (2/58)

Long term (24 months):

-

0: 13.5% (10/74) vs. 18.2% (12/66)

-

I: 39.2% (29/74) vs. 33.3% (22/66)

-

II: 28.4% (21/74) vs. 30.3% (20/66)

-

III: 10.8% (8/74) vs. 12.1% (8/66)

-

IV: 8.1% (6/74) vs. 6.1% (4/66)

A vs. D

Baseline:

-

0: 0% (0/112) vs. 0% (0/109)

-

I: 25.9% (29/112) vs. 23.9% (26/109)

-

II: 43.8% (49/112) vs. 45.9% (50/109)

-

III: 22.3% (25/112) vs. 18.4% (20/109)

-

IV: 8.0% (9/112) vs. 11.9% (13/109)

-

0: 0% (0/76) vs. 0% (0/76)

-

I: 60.5% (46/76) vs. 43.4% (33/76)

-

II: 31.6% (24/76) vs. 44.7% (34/76)

-

III: 5.3% (4/76) vs. 10.5% (8/76)

-

IV: 2.6% (2/76) vs. 1.3% (1/76)

Short term:

-

0: 0% (0/71) vs. 47.3% (35/74)

-

I: 54.9% (39/71) vs. 44.6% (33/74)

-

II: 31.0% (22/71) vs. 8.1% (6/74)

-

III: 11.3% (8/71) vs. 0% (0/74)

-

IV: 2.8% (2/71) vs. 3.0% (2/74)

Long term (24 months):

-

0: 13.5% (10/74) vs. 14.1% (10/71)

-

I: 39.2% (29/74) vs. 32.4% (23/71)

-

II: 28.4% (21/74) vs. 22.5% (16/71)

-

III: 10.8% (8/74) vs. 21.1% (15/71)

-

IV: 8.1% (6/74) vs. 9.9% (7/71)

Mean (SD)

SF-36 PCS (0-100)

A vs. B

Baseline: 38.1 (8.0) vs. 37.4 (8.2)

Postintervention: 43.0 (9.2) vs. 39.9 (10.1), difference 3.1 (95% CI 0.54 to 5.66)

Short term: 42.8 (9.9) vs. 39.6 (10.5), difference 3.2 (95% CI 0.49 to 5.91)

Long term (24 months): NR

A vs. C

Baseline: 38.1 (8.0) vs. 38.9 (8.4)

Postintervention: 43.0 (9.2) vs. 41.5 (11.0), difference 1.5 (95% CI −1.17 to 4.17)

Short term: 42.8 (9.9) vs. 40.8 (11.2), difference 2.0 (95% CI −0.78 to 4.78)

Long term (24 months): NR

A vs. D

Baseline: 38.1 (8.0) vs. 37.8 (7.5)

Postintervention: 43.0 (9.2) vs. 40.2 (10.1), difference 2.8 (95% CI 0.24 to 5.36)

Short term: 42.8 (9.9) vs. 41.9 (9.1), difference 0.9 (95% CI −1.62 to 3.42)

Long term (24 months): NR

SF-36 MCS (0-100)

A vs. B

Baseline: 43.9 (10.0) vs. 42.5 (10.6)Postintervention: 46.0 (10.9) vs. 43.4 (10.2), difference: 2.6 (95% CI −0.20 to 5.4)

Short term: 45.5 (10.6) vs. 43.4 (11.0), difference 2.1 (95% CI −0.76 to 4.96)

Long term (24 months): NR

A vs. C

Baseline: 43.9 (10.0) vs. 43.6 (10.9)

Postintervention: 46.0 (10.9)vs. 46.3 (9.9), difference −0.3 (95% CI −3.04 to 2.44)

Short term: 45.5 (10.6) vs. 47.0 (10.2), difference −1.5 (95% CI −4.24 to 1.24)

Long term (24 months): NR

A vs. D

Baseline: 43.9 (10.0) vs. 43.5 (10.1)

Postintervention: 46.0 (10.9) vs. 46.7 (10.8), difference −0.7 (95% CI −3.58 to 2.18)

Short term: 45.5 (10.6) vs. 45.8 (9.7), difference −0.3 (95% CI −2.99 to 2.40)

Long term (24 months): NR

GHQ (0-12)

A vs. B

Baseline: 3.1 (3.5) vs. 3.4 (3.5)

Postintervention: 1.7 (2.8) vs. 2.8 (3.5), difference −1.1 (95% CI −1.94 to −0.26)

Short term: 2.0 (3.4) vs. 3.0 (3.8), difference −1.0 (95% CI −1.96 to −0.05)

Long term (24 months): 3.0 (3.7) vs. 3.0 (3.3), difference 0.0 (95% CI −0.93 to 0.93)

A vs. C

Baseline: 3.1 (3.5) vs. 3.3 (3.6) Postintervention: 1.7 (2.8) vs. 1.7 (2.9), difference: 0.0 (95% CI −0.75 to 0.75)

Short term: 2.0 (3.4) vs. 2.0 (3.6), difference 0.0 (95% CI −0.92 to 0.92)

Long term (24 months): 3.0 (3.7) vs. 2.2 (3.4), difference 0.8 (–0.14 to 1.74)

A vs. D

Baseline: 3.1 (3.5) vs. 3.2 (3.6)

Postintervention: 1.7 (2.8) vs. 1.8 (2.8), difference −0.1 (95% CI −0.84 to 0.64)

Short term: 2.0 (3.4) vs. 2.0 (3.0), difference 0.0 (95% CI −0.85 to 0.85)

Long term (24 months): 3.0 (3.7) vs. 2.6 (3.7), difference 0.4 (95% CI −0.581 to 1.38)

EQ-5D (0-1)

Long term (24 months):

A vs. B

0.68 (0.24) vs. 0.63 (0.32), difference 0.05 (95% CI −0.02 to 0.13)

A vs. C

0.68 (0.24) vs. 0.73 (0.24), difference −0.05 (95% CI – 0.11 to 0.01)

A vs. D

0/68 (0.24) vs. 0.71 (0.24), difference −0.03 (95% CI −0.09 to 0.03)

Clinical global impression change score (0-7, higher=greater feeling of change in health status; Much better or very much better = scores of 6 and 7; Less than much better = scores <6

A vs. B

Postintervention:

-

Much better or very much better: 37.2% (35/94) vs. 8.1% (7/87)

-

Less than much better: 62.8% (59/94) vs. 91.9% (80/88); RR 4.63 (95% CI 2.17 to 9.87)

-

Much better or very much better: 37.1% (36/101) vs. 8.3% (8/98)

-

Less than much better: 64.4% (65/101) vs. 91.8% (90/101); RR 4.37 (95% CI 2.14 to 8.92)

-

Much better or very much better: 31.2% (29/93) vs. 12.8% (12/94), adjusted OR 2.9 (95% CI 1.4 to 6.0)

-

Less than much better: 68.8% (64/93) vs. 87.2% (82/94); RR 2.44 (95% CI 1.33 to 4.50)

Postintervention:

-

Much better or very much better: 37.2% (35/94) vs. 29.9% (26/87)

-

Less than much better: 62.8% (59/94) vs. 70.1% (61/87); RR 1.25 (95% CI 0.82 to 1.89)

-

Much better or very much better: 37.1% (36/101) vs. 32.6% (29/91)

-

Less than much better: 64.4% (65/101) vs. 67.4% (60/91); RR 1.12 (95% CI 0.75 to 1.67)

-

Much better or very much better: 31.2% (29/93) vs. 35.4% (29/82)

-

Less than much better: 68.8% (64/93) vs. 64.6% (53/82); RR 0.88 (95% CI 0.58 to 1.34)

Postintervention:

-

Much better or very much better: 37.2% (35/94) vs. 34.8% (32/92)

-

Less than much better: 62.8% (59/94) vs. 65.2% (60/92); RR 1.07 (95% CI 0.73 to 1.57)

-

Much better or very much better: 37.1% (36/101) vs. 24.2% (24/99)

-

Less than much better: 64.4% (65/101) vs. 75.8% (75/99); RR 1.47 (95% CI 0.95 to 2.27)

-

Much better or very much better: 31.2% (29/93) vs. 29.3% (27/92)

-

Less than much better: 68.8% (64/93) vs. 70.7% (65/92); RR 1.06 (95% CI 0.69 to 1.65)

Harms

Two deaths due to cancer were recorded: (1 in the exercise group and 1 in the TCBT group). None of the adverse events were due to the interventions.

Von Korff, 2005

USA

Mean duration of pain: NR

USA

Fair

A. IPMP (n=119 randomized): 4 sessions over ~1 month, one 1.5 hour psychology session during first visit, then one 1 hour physical therapy session 1 to 1.5 weeks later, followed by a 0.5 hour psychology session 2 weeks later, and then a 0.5 hour physical therapy session 1.5 weeks later (3.5 hours total), individual, outpatient

B. Usual Care (n=121 randomized): NR

Mean age: 50 years

Male: 38%

Race/Ethnicity:

-

White race (not Hispanic): 83%

Disability:

-

Receiving worker’s compensation or disability payments for back pain: 4%

-

Kept from usual activities for ≥30 days in prior 3 months: 29%

-

Grade I (low pain intensity): 20%

-

Grade II (high pain intensity with low activity limitations): 20%

-

Grade III (moderate activity limitations): 24%

-

Grade IV (severe activity limitations): 36%

-

Prior back surgery for pain: 13%

A vs. B, Mean (SD)

Pain NRS (0-10)

Baseline: 5.7 (1.8) vs. 5.8 (1.8)

Postintervention: 4.9 (2.0) vs. 5.3 (1.9), difference: −0.4 (95% CI −0.90 to 0.10)

Short term: 4.2 (2.0) vs. 4.7 (2.2), difference: −0.5 (95% CI −1.04 to 0.04)

Intermediate term: 4.0 (2.3) vs. 4.7 (2.1), difference: −0.7 (95% CI −1.26 to −0.14)

Long term (24 months): 4.3 (2.1) vs. 4.6 (2.5), difference: −0.3 (95% CI −0.89 to 0.29)

RMDQ (0-23)

Baseline: 12.3 (5.5) vs. 11.4 (5.7)

Postintervention: 10.2 (6.3) vs. 11.5 (5.8), difference: −1.3 (95% CI −2.84 to 0.24)

Short term: 9.2 (6.6) vs. 10.1 (6.4), difference: −0.9 (95% CI −2.55 to 0.75)

Intermediate term: 8.4 (7.0) vs. 9.1 (6.3), difference: −0.7 (95% CI −2.39 to 0.99)

Long term (24 months): 8.1 (6.5) vs. 9.1 (7.2), difference: −1.0 (95% CI −2.75 to 0.75)

A vs. B, % (n/N)

Proportion of patients with greater than a one-third reduction in RMDQ score

Postintervention: 27.7% (28/101) vs. 13.2% (14/106), adjusted OR 3.9, p=0.0007

Short term: 42.2% (43/101) vs. 23.7% (25/106), adjusted OR 3.5, p=0.0005

Intermediate term: 44.6% (45/101) vs. 22.7% (24/106), adjusted OR 2.1, p=0.03

Long term (24 months): 49.4% (50/101) vs. 37.0% (39/106), adjusted OR 1.8, p=0.08

A vs. B, Mean (SD)

SF-36 Social functioning subscale (0-100)

Baseline 66.7 (26.7) vs. 70.4 (27.0)

Postintervention: NR

Short term: 74.4 (27.1) vs. 73.6 (27.8), difference: 0.8 (95% CI −6.18 to 7.78)

Intermediate term: 75.8 (28.3) vs. 74.4 (24.0), difference: 1.4 (95% CI −5.27 to 8.07)

Long term (24 months): 76.7 (25.2) vs. 76.3 (25.8), difference: 0.4 (95% CI −6.09 to 6.89)

SF-36 MCS (0-100)

Baseline 67.0 (18.3) vs. 68.9 (16.9)

Postintervention: NR

Short term: 70.3 (19.9) vs. 69.5 (19.1), difference: 0.8 (95% CI −4.16 to 5.76)

Intermediate term: 70.9 (19.9) vs. 71.1 (18.4), difference: −0.2 (95% CI −5.09 to 4.67)

Long term (24 months): 71.0 (18.2) vs. 72.4 (18.3), difference: −1.4 (95% CI −6.04 to 3.24)

A vs. B, % (n/N)

Proportion receiving workers compensation or disability payments for back pain

Baseline: 4.4% vs. 3.3%, p=NR

Postintervention: 1.8% vs. 4.2%, p=0.04

Short term: 4.6% vs. 4.6%, p=0.45

Intermediate term): 7.1% vs. 3.1%, p=0.53

Long term (24 months): 6.4% vs. 5.4%, p=0.67

Adverse Events

No study-related adverse events occurred.

Abbasi, 2012

Iran

Duration of pain: 74 months

RCT

Poor

A. Comprehensive, pain management program, spouse assisted group (n=9): 1 day a week for 7 weeks, (2-hour sessions, 14 hours total) group sessions; outpatient

B. Comprehensive pain management program, conventional group (n=10): 1 day a week for 7 weeks, (2-hour sessions, 14 hours total) group sessions; outpatient

C. Usual care (n=10)

Mean age: 45 years

Male: 12%

Race/Ethnicity: NR

Median duration of pain: 74 months

Pain etiology/type: Chronic LBP

Disability: NR

Comorbidities:

-

Patients with major cognitive dysfunction or coexisting psychiatric morbidity were excluded

A vs. B vs. C, Mean (SD)

VAS pain in last week (0-10)

A vs. C

Baseline: 5 (2.7) vs. 3.6 (1.7)

Postintervention: 3 (1.8) vs. 3.2 (1.6), difference −0.20 (95% CI −1.80 to 1.40)

Long term: 2.8 (2.7) vs. 4.3 (1.4); difference −1.50 (95% CI −3.55 to 0.55)

B vs. C

Baseline: 4.6 (2) vs. 3.6 (1.7)

Postintervention: 2.6 (2) vs. 3.2 (1.6); difference −0.60 (95% CI −2.18 to 0.98)

Long term: 3.7 (2.5) vs. 4.3 (1.4); difference −0.60 (95% CI −2.50 to 1.30)

RMDQ (0-24)

A vs. C

Baseline: 11.2 (4.3) vs. 8.4 (3.3)

Postintervention: 5.8 (3) vs. 3.2 (3.2); difference 2.60 (95% CI −0.34 to 5.54)

Long term: 8.2 (5.4) vs. 10.4 (6.2); difference −2.20 (95% CI −7.86 to 3.46)

B vs. C

Baseline: 12.1 (5.7) vs. 8.4 (3.3)

Postintervention: 6.2 (4.4) vs. 3.2 (3.2); difference 3.00 (95% CI −0.36 to 6.36)

Long term: 8.8 (5.9) vs. 10.4 (6.2); difference −1.60 (95% CI −7.29 to 4.09)

Ahlmen 1988

Sweden

Duration of pain: 11 years (≥10 years: 38%)

RCT

Fair

A. Comprehensive pain management program, Long-term (n=31): Duration of treatment: 12 months, 2 hours a week (14 hours total), individual + group sessions, outpatient

B. Usual care (n=28)

Mean age: 59 years

Female: 100%

Race/Ethnicity: NR

Pain etiology/type: Rheumatoid arthritis

Disability: NR

Comorbidities: NR

A vs. B, Mean (SD)

SIP Overall Score (0-100)

Baseline: 22.1 (11.8) vs. 19.8 (11.0)

Postintervention change score −3.6 (6.2) vs. −0.1 (5.3), p<0.05

SIP, Physical Index (scale NR)

Baseline: 22.7 (15.8) vs. 19.8 (13.1)

Postintervention change score: −4.6 (7.7) vs. 0.3 (5.5), p<0.01

SIP, Psychosocial Index (scale NR)

Baseline: 11.1 (7.8) vs. 11.2 (11.6)

Postintervention change score: −3.3 (7.1) vs. −0.7 (6.7), p=NS

A vs. B, Mean (SD)

MACL (scale NR)

Baseline: 3.28 (0.33) vs. 3.16 (0.46)

Postintervention: 3.29 (0.31) vs. 3.15 (0.44), p=NS

A vs. B, Mean (SD)

Utilization:

No between group differences in the following (data NR):

-

Drug treatment

-

Intraarticular corticosteroid injections

-

Orthopedic specialist consultations

-

Referral for inpatient rheumatologic care

Amris 2014 (IMPROvE trial)

Denmark

Duration of pain: median 126 months

RCT

Fair

A. Comprehensive pain management program (n=96): 2 weeks, (3 to 5 hours sessions, 35 hours total) group sessions; outpatient

B. Waitlist control (n=95)

Mean age: 44

Female: 100%

Race/Ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability:

-

Receiving disability pension at baseline: 12%

-

On sick leave: 16%

-

Patients with psychiatric disorders were excluded

A vs. B

Mean (95% CI) change scores from baseline

FIQ Pain VAS (0-10)

Baseline (mean, SD): mean 7.1 (2.0) vs 7.4 (1.7)

Short term: 0.07 (–0.31 to 0.44) vs. −0.14 (–0.52, 0.27), difference in change scores 0.21 (95% CI −0.32 to 0.74)

FIQ Total (0-100)

Baseline (mean, SD): 64.0 (15.8) vs 65.7 (13.0)

Short term: −1.28 (–3.90 to 1.33) vs. −1.37 (–4.01 to 1.28), difference in change scores 0.08 (95% CI −3.64 to 3.80)

A vs. B

% (n/N) or Mean (95% CI) change scores from baseline

Proportion of patients considered to be responders on the SF-36 PCS, % (n/N)

27% (26/96) vs. 23% (22/95), RR 1.16 (95% CI 0.72 to 1.91)

SF-36 PCS (0-100):

Baseline (mean, SD): 27.1 (6.9) vs 27.2 (7.0)

Short term: 1.35 (0.27 to 2.43) vs. 0.78 (−0.30 to 1.86), difference in change scores 0.57 (95% CI −0.95 to 2.1)

Proportion of patients considered to be responders on the SF-36 MCS, % (n/N)

27% (26/96) vs. 27% (26/95), RR 0.99 (95% CI 0.62 to 1.6)

A vs. B, Median (IQR) or Mean (95% CI)

SF-36 MCS (0-100)

Baseline (mean, SD): 39.4 (12.2) vs 37.8 (9.8)

Short term: 2.29 (0.41 to 4.18) vs. 1.15 (−0.73 to 3.03), difference in change scores 1.14 (95% CI −1.52 to 3.81)

Generalized Anxiety Disorder-10 (scale NR)

Baseline (median): 17.5 (IQR 13 to 26) vs 17.0 (IQR 13 to 23)

Short term: −0.78 (–2.01 to 0.46) vs. – 0.54 (–1.80 to 0.72), difference in change scores −0.24 (95% CI −2.00 to 1.53)

Major Depression Inventory (scale NR)

Baseline (median): 18.0 (IQR 13 to 27) vs 21.0 (IQR 15 to 27)

Short term: −1.73 (–3.19 to −0.27) vs. – 0.47 (–1.96 to 1.01), difference in change scores −1.26 (95% CI −3.34 to 0.82)

Basler, 1997

Germany

Duration of pain: 129.6 months

RCT

Fair

A. Comprehensive pain management (n=36) 12 weeks (one 2.5-hour sessions per week) patients attended an outpatient review appointment (2-4 hours) at 1 and 3 months postdischarge group sessions, outpatient

B. Usual Care (n=40)

Mean age: 49 years

% Male: 24%

Race/ethnicity: NR

Pain etiology/type: Chronic LBP

Quebec Task Force on Spinal Disorders:

-

73% chronic pain syndrome

-

26% post-surgical spinal or radicular pain

-

70% unemployed

-

90.4% considered significantly disabled

-

69% unemployed

-

Spinal surgery: 1.3%

-

Days using an opioid pain medication per week, mean (SD): 3.02 (2.85) vs. 3.41 (2.76)

A vs. B, Mean (SD)

VAS (0-10)

Baseline: 4.58 (1.77) vs. 3.99 (1.02)

Postintervention 4.08 (2.11) vs. 4.18 (1.37), difference −0.10 (95% CI −0.91 to 0.71)

Short term: 3.71 (2.01) vs. NR

Days without pain per week

Baseline: 0.30 (1.11) vs. 0.26 (0.92)

Postintervention: 0.58 (1.54) vs. 0.28 (0.85); difference 0.30 (95% CI −0.26 to 0.86)

Short term: 0.93 (2.04) vs. NR

Dusseldorf Disability Scale - physical function (0-5)

Baseline: 1.98 (0.92) vs. 1.84 (0.64)

Postintervention: 1.63 (0.87) vs. 1.84 (0.62); difference −0.21 (95% CI −0.55 to 0.13)

Short term: 1.44 (0.82) vs. NR

Days with pain medication per week

Baseline: 3.02 (2.85) vs. 3.41 (2.76)

Postintervention: 2.59 (2.91) vs. 3.23 (2.90); difference −0.64 (95% CI −1.97 to 0.69)

Short term: 2.34 (2.86) vs. NR

Bendix, 1996, 1998a, 1998b (PROJECT A)

Denmark

Mean duration of pain: NR (≥6 months)

RCT

Fair

A. Comprehensive pain management program (n=55):

3 weeks full time (39 hours/week), then 1 day weekly for 3 additional weeks patients participated in a 6-hour followup program) group sessions, outpatient

B. Usual care (n=51)

Median age:

-

Group A: 41 years

-

Group B: 40 years

Race/ethnicity: NR

Pain etiology/type: Chronic LBP

Disability: NR

Comorbidities:

-

Smoker: 56%

-

Prior back surgery: 17%

A vs. B, median (IQR)

Back pain VAS (0-10)

Baseline (median): 6.1 vs. 6.1

Short term (mean, SD): 5.7 (4.1) vs. 6.9 (2.2), difference −1.20 (95% CI −2.54 to 0.14)

Long term (24 months) (mean, SD): 6.0 (3.7) vs. 6.5 (2.2), difference −0.50 (95% CI −1.70 to 0.70)

Long term (60 months) (mean SD): 5.0 (2.2) vs. 5.0 (1.8), difference 0 (95% CI −0.84 to 0.84)

Patient subjective disability due to back pain (0-30)

Baseline (median): 16.9 vs. 15.9

Short term: 12.1 (7.2 to 16.8) vs. 16.8 (13.1 to 20.1), p<0.001

Long term (24 months): 16.0 (8 to 19) vs. 15.0 (11 to 18), p=0.9

Long term (60 months): 12.0 (NR) vs. 16.0 (NR), p=0.2

A vs. B, Median (IQR)

Leg pain VAS (0-10)

Baseline (median): 4.1 vs. 4.6

Short term: 3.5 (0.3 to 7.0) vs. 5.4 (3.0 to 7.3), p=0.17

Long term (24 months): 4.5 (1.0 to 7.0) vs. 4.0 (1.0 to 7.0), p=0.90

Long term (60 months): 4.0 (NR) vs. 5.0 (NR), p=0.60

A vs. B, % (n/N)

Proportion of patients taking prescription pain medications (opioids not specified)

Baseline: 80% (36/45) vs. 73% (36/49), p=0.39

Short term: NR

Long term (24 months): 72% (36/50) vs. 56% (27/49), p=0.20

Long term (60 months): NR

Proportion of patients hospitalized due to low back pain, % (n/N)

Short term: NR

Long term (24 months): NR

Long term (60 months): 22% (10/46) vs. 38% (16/42), p=0.09

Proportion of patients who underwent back surgery during the study period, % (n/N)

4 months: NR

24 months: NR

60 months: 7% (3/46) vs. 12% (5/42), p=0.40

Browne, 2013

Australia

Duration of pain: 1 month

RCT

Poor

A. Comprehensive pain management program (n=69):

Duration of treatment unclear (2.5 hours/week; 20 hours total) individual sessions; outpatient

B. Usual care (n=73)

Mean age: 37 years

% Male: 75%

Race/Ethnicity:

-

Caucasian: 92%

-

Asian: 4%

-

Indigenous: 4%

Pain etiology/type: Traumatic injury

Mechanism of injury

-

MVA/MBA: 73%

-

Fall: 8%

-

Assault: 7%

-

Sports related: 6%

-

Work related: 4%

-

Other 1%

Injury Severity Score: 9.6

Disability: NR

Comorbidities: NR

Mental Health History: 19%

Pain Medications at discharge:

-

slow release opioids (i.e., MS Contin, Kapanol, Oxycontin, Methadone, Fentanyl): 27%

-

antineuropathic (Gabapentin, Pregabalin, Clonazepam, Amitryptaline): 1%

-

combination of above: 10%

A vs. B, Mean (SD)

BPI (0-10)

Baseline: 5.12 (2.26) vs. 5.48 (2.11)

Postintervention: 3.13 (2.03) vs. 3.03 (2.74), difference 0.10 (95% CI −1.06 to 1.26)

FIM (scale 18-126)

Baseline: NR

Postintervention: 122.73 (4.74) vs. 123.00 (3.91), difference −0.27 (95% CI −2.40 to 1.86)

A vs. B, Mean (SD)

CES-D (0-60)

Baseline: 16.56 (9.55) vs. 14.88 (11.23)

Postintervention: 17.40 (12.39) vs. 14.97 (11.48); difference 2.43 (95% CI −3.44 to 8.30)

A vs. B, % (n/N) *

Clinical Pain Diagnosis at 6 months (made by attending Pain Specialist, includes both nociceptive and neuropathic pain)

-

pain with no impairment: 34.6% (11/31) vs. 29% (10/35); RR 1.24 (95% CI 0.61 to 2.52)

-

pain with impairment: 46.2% (14/31) vs. 38.7% (14/35); RR 1.13 (95% CI 0.64 to 1.98)

Postintervention: 50.0% (16/31) vs. 45.2% (16/35); RR 1.13 (95% CI 0.69 to 1.86)

Walking Impairment (yes)

Postintervention: 56.0% (17/31) vs. 37.9% (13/35); RR 1.48 (95% CI 0.86 to 2.52)

*numerators back-calculated using % and denominator provided

de Buck, 2005

The Netherlands

Duration of pain:

Group A.11.0 months

Group B. 19.5 months

RCT

Fair

A. Comprehensive pain management program (n=74):

Duration NR (average between 4 and 12 weeks) Individual or group sessions NR; outpatient

B. Usual care (n=66)

Median age:

-

Group A: 43 years

-

Group B: 44 years

Race/Ethnicity: NR

Median duration of disease:

-

Group A: 11.0 months

-

Group B: 19.5 months

-

Rheumatoid arthritis: 50%

-

Ankylosing spondylitis, psoriatic arthritis, or reactive arthritis: 21%

-

Systemic lupus erythematosus, scleroderma: 29%

-

Partial work disability benefit: 16.4%

-

Sick leave: 55%

-

Complete sick leave: 29%

-

Charlson index ≥0: 43%

A vs. B, Mean (95% CI) change scores from baseline

VAS (0-10)

Baseline (mean, SD): 4.37 (2.31) vs. 4.71 (2.27)

Intermediate term change: −0.70 (95% CI −1.40 to 0.01) vs. −0.20 (95% CI −0.81 to −0.41)

Long term (12 months) change: −0.31 (95% CI −1.08 to 0.47) vs. −0.58 (95% CI −1.28 to 0.13)

Long term (18 month) change: −0.43 (95% CI −1.19 to 0.32) vs. −0.33 (95% CI −1.00 to 0.34)

Long term (24 month) change: −0.59 (95% CI −1.28 to 0.09) vs. −0.42 (95% CI −1.16 to 0.32)

HAQ (0-3)

Baseline (mean, SD): 0.76 (0.50) vs. 0.83 (0.55)

Intermediate term change: 0.03 (95% CI −0.08 to 0.13) vs. −0.04 (95% CI −0.16 to 0.08)

Long term (12 months) change: −0.04 (95% CI −0.15 to 0.06) vs. −0.07 (95% CI −0.19 to 0.05)

Long term (18 month) change: 0.00 (95% CI −0.11 to 0.11) vs. 0.08 (95% CI −0.04 to 0.21)

Long term (24 month) change: −0.01 (95% CI −0.14 to 0.12) vs. −0.10 (95% CI −0.23 to 0.03)

A vs. B, Mean (95% CI) change scores from baseline

RAND 36-item Health Survey PCS (0-100)

Baseline (mean, SD): 40.64 (17.66) vs. 43.32 (19.03)

Intermediate term change: 5.75 (95% CI −0.45 to 11.95) vs. 5.96 (95% CI 0.38 to 11.53)

Long term (12 months) change: 13.6 (95% CI 7.04 to 20.18) vs. 11.7 (95% CI 5.04 to 18.39)

Long term (18 month) change: 13.78 (95% CI 6.32 to 21.25) vs. 9.32 (95% CI 2.75 to 15.9)

Long term (24 month) change: 13.72 (95% CI 6.73 to 20.71) vs. 11.69 (95% CI 5.36 to 18.02)

RAND 36-item Health Survey MCS (0-100)

Baseline (mean, SD): 59.59 (24.08) vs. 64.10 (23.31)

Intermediate term change: −1.4 (95% CI −8.40 to 5.54) vs. 1.72 (95% CI −5.05 to 8.50)

Long term (12 months) change: 5.31 (95% CI −1.99 to 12.61) vs. 3.33 (95% CI −4.42 to 11.08)

Long term (18 month) change: 11.20 (95% CI 2.40 to 20.06) vs. 3.60 (95% CI −4.78 to 12.00)

Long term (24 month) change: 13.61 (95% CI 6.61 to 20.60) vs. 2.16 (95% CI −5.30 to 9.62)

HADS anxiety (0-21)

Baseline (mean, SD): 7.20 (4.00) vs. 6.80 (4.10)

Intermediate term change: −0.30 (95% CI −1.78 to 0.11) vs. −0.43 (95% CI −1.39 to 0.54)

Long term (12 months) change: −0.83 (95% CI −1.78 to 0.11) vs. −0.25 (95% CI −1.37 to 0.89)

Long term (18 month) change: −0.94 (95% CI −1.87 to −0.02) vs. −0.34 (95% CI −1.53 to 0.89)

Long term (24 month) change: −1.83 (95% CI −2.86 to −0.80) vs. −0.03 (95% CI −1.26 to 1.34)

HADS depression (0-21)

Baseline (mean, SD): 6.10 (3.30) vs. 5.70 (3.50)

Intermediate term change: −0.02 (95% CI −1.05 to 1.01) vs. 0.28 (95% CI −0.54 to 1.10)

Long term (12 months) change: −0.46 (95% CI −1.50 to 0.57) vs. 0.02 (–0.89 to 0.92)

Long term (18 month) change: −0.64 (95% CI −1.71 to 0.44) vs. −0.21 (95% CI −0.36 to 0.93)

Long term (24 month) change: −1.66 (95% CI −2.72 to −0.60) vs. 0.15 (95% CI −1.12 to 1.42)

Härkäpää, 1989, 1990

Finland

Duration of pain:168 months

RCT

Poor

A. Comprehensive pain management program Inpatient group (n=156) 2 times a week for 2 months (15 sessions) (+ 2-week refresher sessions after 1.5 years) group sessions; inpatient

B. Comprehensive pain management program Outpatient group (n=150) 2 times a week for 2 months (15 sessions) (+ 8 refresher sessions after 1.5 years) group sessions; outpatient

C. Usual Care (n=153)

Mean age: 45 years

% Male: 63%

Race/Ethnicity: NR

Pain etiology/type: Chronic LBP

-

Continuous LBP during past year: 41%

-

Severe LPB during past year: 81%

-

% Disability compensation, pensions: 10%

-

Use of opioid medication: NR

-

Use of analgesics: 65%

-

Work absenteeism due to LBP in past two years: 34%”

A vs. B vs. C, Mean (SD)

Pain Index (0-400)

Baseline: 184.9 (76.9) vs. 178.6 (81.8) vs. 175.8 (87.3)

Short term: 128 (NR) vs. 146 (NR) vs. 162 (NR)

Intermediate term: 158 (NR) vs. 160 (NR) vs. 154.5 (NR)

Long term (18 months): 156.5 (NR) vs. 174 (NR) vs. 161(NR)

Long term (22 months): 149 (NR) vs. 164 (NR) vs. 161.5 (NR)

Long term (30 months): 161.5 (NR) vs. 168 (NR) vs. 158.5 (NR)

LBP Disability Index (0-45)

Baseline: 16.7 (7.9) vs. 17.6 (7.4) vs. 16.7 (8.4)

Short term: 15.7 (NR) vs. 16 (NR) vs. 15.9 (NR)

Intermediate term: 15.7 (NR) vs. 16 (NR) vs. 15.9 (NR)

Long term (18 months): 15.55 (NR) vs. 17.05 (NR) vs.16.0 (NR)

Long term (22 months): 14.5 (NR) vs. 15.65 (NR) 15.65 vs. (NR)

Long term (30 months): 15.4 (NR) vs. 16.55 (NR) vs. 15.8 (NR)

A vs. B %, p-value

Benefits of treatment

Short term:

-

Increased knowledge concerning low back pains 88 vs. 84, p=NS

-

Increased knowledge of factors affecting low back pain: 81 vs. 77, p=NS

-

Increased motivation for self-care: 60 vs. 40, p=0.001

-

Decrease in low back pain: 57 vs. 38, p=0.05

-

Mental recreation: 56 vs. 25, p=0.001

-

Improved physical condition: 55 vs. 23, p=0.001

-

Improved working capacity: 45 vs. 22, p=0.01

-

Decrease in other illness symptoms: 24 vs. 10, p=0.02

Jensen, 2001

Sweden

Duration of pain: 31 months

RCT

Fair

A. Comprehensive pain management program (n=63):

4 weeks*, (20 hours a week, 80 hours total) group sessions; outpatient

* (plus six 90-minute booster sessions over a period of 1 year after treatment)

B. Usual care (n=48)

Mean age: 43 years

% Male: 45%

Race/ethnicity:

-

Swedish origin: 67%

-

Cervical/thoracic pain: 42%

-

Lumbar pain: 46%

-

Mixed pain areas: 12%

-

Mean total sick leave in 6 months prior to inclusion in study: 292 (63)

A vs. B, Mean (SD)

SF-36 Global health (scale 0-100)

Females only

A vs. B (n=30 vs. 28)

Baseline: 38.1 (14.5) vs. 45.6 (16.5)

Postintervention: 47.6 (18.0) vs. 47.0 (15.2); difference 0.60 (95% CI −8.12 to 9.40)

Intermediate term: 52.4 (21.6) vs. 46.3 (19.3); difference 6.10 (95% CI −4.70 to 16.90)

Long term (18 months): 53.1 (24.5) vs. 43.4 (20.1); difference 9.70 (95% CI – 2.14 to 21.5)

Males only

A vs. B (n=33 vs. 20)

Baseline: 41.6 (14.6) vs. 45.0 (14.7)

Postintervention: 48.5 (17.2) vs. 45.1 (13.2); difference 3.40 (95% CI −5.61 to 12.41)

Intermediate term: 54.3 (18.3) vs. 51.5 (24.2); difference 2.80 (95% CI −8.97 to 14.57)

Long term (18 months): 57.2 (21.8) 45.9 (21.2); difference 11.30 (95% CI −0.98 to 23.58)

A vs. B, Mean (SD)

Harms: NR

Perceived appropriateness of the treatment program to treating patient’s pain

Females only Postintervention: 6.4 (3.1) vs. NR

Males only Postintervention: 6.0 (3.6) vs. NR

Johansson, 1998

Norway

Duration of pain: 132 months

RCT

Fair

A. Comprehensive pain management program (n=21):

5 days a week for 5 weeks, (hours total NR) * group sessions; inpatient and outpatient

*(+ booster sessions after 2 months)

B. Waitlist control (n=21):

Mean age: 44 years

% Male: 22%

Race/ethnicity: NR

Pain etiology/type: Chronic musculoskeletal pain

Disability: NR

-

On sick leave: 75%

-

Unemployed: 32%

-

Patients with psychotic illness were excluded

A vs. B, Mean (SD)

VAS pain intensity (0-10)

Baseline: 5.28 (1.72) vs. 5.33 (1.84)

Postintervention: 4.93 (2.19) vs. 5.22 (2.19), difference −0.29 (95% CI −1.72 to 1.14)

Short term: 5.42 (2.42) vs. 5.32 (1.77), difference 0.10 (95% CI – 1.30 to 1.50)

VAS pain interference (0-10)

Baseline: 5.08 (1.85) vs. 4.69 (1.50)

Postintervention: 4.23 (2.23) vs. 4.82 (2.31), difference −0.59 (95% CI −2.13 to 0.95)

Short term: 4.76 (2.36) vs. 4.82 (1.72), difference −0.06 (95% CI – 1.45 to 1.33)

MPI general activity level (0-6)

Baseline: 2.8 (0.7) vs. 2.8 (0.7)

Postintervention: 3.0 (0.7) vs. 2.6 (0.7), difference 0.40 (95% CI −0.08 to 0.88)

Short term: 2.9 (0.7) vs. 2.4 (0.7), difference 0.50 (95% CI 0.03 to 0.98)

Lemstra, 2005

Canada

Duration of pain: 121 months

RCT

Fair

A. Comprehensive pain management program (n=43):

6 weeks, (18 one-hour sessions 18 hours total) group sessions; outpatient setting

B. Usual care (n=36):

Mean age: 50

% Male: 15%

Race/ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability: NR

Comorbidities (all self-reported):

-

Fatigue: 94%

-

Sleep deprivation: 96%

-

Emotional problems: 64%

-

Headaches: 77%

-

Morning stiffness: 94%

-

Depression: 89%

-

Anxiety: 67%

-

Frustration: 82%

A vs. B, Mean (SD) changes scores from baseline

VAS average pain in last month (0-10)

Baseline (mean, SD): 7.14 (1.37) vs. 7.56 (1.38)

Postintervention change: −1.02 (1.48) vs. −0.22 (1.2), difference in change scores −0.80 (95% CI −1.46 to −0.14)

Number of days in last month with pain

Baseline (mean, SD): 28.86 (3.19) vs. 28.82 (4.45)

Postintervention change: −7.49 (9.35) vs. −1.17 (6.36), difference in change scores −6.32 (95% CI – 10.28 to −2.36)

PDI (0-70)

Baseline (mean, SD): 33.63 (10.78) vs. 33.47 (7.89)

Postintervention change: −8.70 (8.93) vs. −1.97 (9.36), difference in change scores −6.73 (95% CI – 11.07 to −2.38)

A vs. B, Mean (SD) changes scores from baseline

BDI (0-63)

Baseline (mean, SD): 18.23 (10.72) vs. 17.89 (10.03)

Postintervention change: −7.74 (6.92) vs. −0.97 (4.5), difference in change scores −6.77 (95% CI −9.67 to −3.87)

Self-reported health status (0-5)

Baseline (mean, SD): 3.60 (1.03) vs. 3.67 (0.89)

Postintervention change: −0.60 (0.12) vs. 0.03 (0.11), difference in change scores −0.63 (95% CI −0.95 to −0.31)

Linton, 2005

Sweden

Duration of pain: NR (>12 weeks: 84%)

RCT

Fair

A. Comprehensive pain management program (n=69):

6 weeks (1x/week, 2 hours, at least 12 total) group sessions; outpatient setting

B. Usual care (n=47)

Mean age: 48 years

% Male: 16%

Race/ethnicity: NR

Pain etiology/type:

-

Back pain: 90%

-

Neck pain: 10%

Comorbidities: NR

Mean (SD)

Average pain last week (0-10)

Baseline: 4.4 (2.1) vs. 5.0 (2.3)

Long term (12 months): 2.9 (2.1) vs. 4.1 (2.8), difference −1.20 (95% CI – 2.19 to −0.21)

Average pain last 3 months

Baseline: 4.5 (1.9) vs. 4.7 (1.6)

Long term (12 months): 3.0 (1.8) vs. 4.1 (2.5), difference −1.10 (95% CI −1.94to −0.26)

Worst pain last 3 months

Baseline: 6.0 (2.3) vs. 6.2 (2.1) 12 months: 4.3 (2.8) vs. 5.4 (2.8), difference −1.10 (95% CI −2.21 to 0.01)

Pain-free days in last week (0-7)

Baseline: 2.3 (2.5) vs. 2.2 (2.5)

Long term (12 months): 3.5 (3.0) vs. 2.8 (2.7), difference 0.70 (95% CI – 0.44 to 1.84)

Modified RMDQ (0-18)

Baseline: 3.7 (4.5) vs. 3.3 (3.7)

Long term (12 months): 3.4 (4.2) vs. 4.0 (4.7), difference −0.60 (95% CI – 2.34 to 1.14)

Activities of Daily Living (0-50)

Baseline: 38.9 (10.6) vs. 40.0 (8.2)

Long term (12 months): 41.5 (10.4) vs. 41.1 (8.9), difference 0.40 (95% CI −3.48 to 4.28)

Mean (SD)

HADS Anxiety (0-21)

Baseline: 4.9 (3.8) vs. 6.1 (4.2)

Long term (12 months): 5.2 (3.6) vs. 7.1 (4.9), difference −1.9 (95% CI −3.55 to – 0.25)

HADS Depression (0-21)

Baseline: 3.8 (3.4) vs. 4.3 (3.7)

Long term (12 months): 3.8 (3.6) vs. 4.5 (4.4), difference −0.70 (95% CI −2.26 to 0.86)

Peters 1990, 1992

New Zealand

Duration of pain: 6 to 48 months,49%; 48 months to 240+ months, 51%

RCT

Poor

A. Comprehensive pain management program, Inpatient group (n=23): 5 days a week for 4 weeks, (hours total unclear)

group sessions; inpatient (Monday – Friday)

B. Comprehensive pain management program, Outpatient group (n=29) 9 weeks, (one 2-hour session per week, 18 hours total)

group sessions; outpatient

C. Usual care (n=16)

Mean age: 44 years

% Male: 38%

Race/Ethnicity:

-

European: 93%

-

Maori: 4%

-

Polynesian: 3%

-

Back pain: 43%

-

Head pain: 35%

-

Arm pain: 26%

-

Leg pain: 18%

-

Chest pain: 10%

-

Abdomen pain: 6%

Comorbidities: NR

A vs. B vs. C, Mean (SD)

VAS pain (0-10)

A vs. C

Baseline: 5.12 (2.56) vs. 4.21 (2.55)

Postintervention: 3.92 (2.33) vs. 5.29 (2.70)

B vs. C

Baseline: 5.25 (2.46) vs. 4.21 (2.55)

Postintervention: 4.25 (2.18) vs. 5.29 (2.70)

SIP (0-100)

A vs. C

Baseline: 204.31 (75.43) vs. 165.00 (125.26)

Postintervention: 122.89 (80.84) vs. 180.67 (152.40)

Long-term followup: NR

B vs. C

Baseline: 137.78 (105.49) vs. 165.00 (125.26)

Postintervention: 96.00 (78.84) vs. 180.67 (152.40)

A vs. B vs. C, % (n/N)

Proportion of patients taking an opioid

Baseline:

Any opioid: 31.8% (7/22) vs. 33% (6/18) vs. 50% (6/12)

-

strong opioid: 9.1% (2/22) vs. 17% (3/18) vs. 0% (0/12)

-

mild opioid: 22.7% (5/22) vs. 17% (3/18) vs. 50% (6/12)

Long-term followup:

Any opioid: 13.6% (3/22) vs. 22% (4/18) vs. 66.7% (8/12)

-

strong opioid: 0% (0/22) vs. 6% (1/18) vs. 8.3% (1/12)

-

mild opioid: 13.6% (3/22) vs. 17% (3/18) vs. 58.3% (7/12)

A vs. B vs. C, Mean (SD)

BDI (0-63)

A vs. C

Baseline: 19.18 (9.34) vs. 12.33 (7.29)

Postintervention: 12.25 (15.64) vs. 11.07 (5.82)

B vs. C

Baseline: 13.55 (6.03) vs. 12.33 (7.29)

Postintervention: 10.73 (6.16) vs. 11.07 (5.82)

GHQ (0-36)

A vs. C

Baseline: 15.52 (8.58) vs. 11.50 (10.08)

Postintervention: 5.96 (7.11) vs. 10.36 (9.46)

B vs. C

Baseline: 8.67 (7.23) vs. 11.50 (10.08)

Postintervention: 5.91 (6.42) vs. 10.36 (9.46)

A vs. B vs. C, % (n/N)

Proportion of patients reported to be “nonactive” (i.e., those receiving accident compensation, unemployment benefit, sickness benefit, invalids benefit, health insurance, or unable to manage a home) % (n/N)

Baseline: 82% (18/22) vs. 67% (13/18) vs. 33% (4/12)

Postintervention: NR

Long-term followup: 18% (4/22) vs. 33% (6/18) vs. 58% (7/12)

Proportion of patients demonstrating treatment “success” (using medication appropriately + active + no pain increase), % (n/N)

Postintervention: NR

Long-term followup: 68% (15/22) vs. 61% (11/18) vs. 25% (3/12)

Saral, 2016

Turkey

Duration of pain: 90 months

RCT

Fair

A. Comprehensive pain management program, long-term group (n=22): 10 weeks (~7.5 hours/week; ~75 hours total); group + individual sessions; outpatient

B. Comprehensive pain management program, short-term group (n=22): 2 days (~10 hours total); group + individual sessions; outpatient

C. Usual care (n=22)

Mean age: 42 years

% Male: 0% (female only for inclusion)

Race/ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability: NR

Comorbidities: NR Other characteristics:

-

Excluded: history of severe trauma, advanced psychiatric diseases, serious physical comorbidities

A vs. B vs. C, Mean (SD)

VAS pain (0-10)

Baseline: 8.2 (0.9) vs. 7.6 (0.8) vs. 7.5 (0.9)

Intermediate term: 5.1 (2.4) vs. 5.8 (1.0) vs. 7.6 (1.4)

FIQ (0-100)

Baseline: 71.6 (14.2) vs. 67.7 (12.0) vs. 65.5 (13.2)

Intermediate term: 53.9 (19.3) vs. 54.5 (14.2) vs. 65.5 (11.5)

A vs. B vs. C, Mean (SD)

BDI (0-63)

Baseline: 23.4 (11.0) vs. 20.7 (6.6) vs. 21.4 (10.4)

Intermediate term:16.6 (9.6) vs. 15.0 (10.2) vs. 18.7 (9.5)

SF-36 PCS (0-100)

Baseline: 32.8 (7.9) vs. 36.5 (8.7) vs. 36.0 (7.2)

Intermediate term: 39.9 (7.5) vs. 39.6 (8.1) vs. 34.3 (8.1)

SF-36 MCS (0-100)

Baseline: 30.4 (11.7) vs. 33.2 (8.9) vs. 36.1 (9.8)

Intermediate term: 40.7 (12.3) vs. 40.2 (10.0) vs. 37.6 (10.0)

Scholten, 1999

Austria

Duration of pain: 106.8 months

RCT

Poor

A. Comprehensive pain management program (n=38):

9 days over 2 weeks, (unclear hours total)

group; outpatient setting

B. Waitlist control (n=30):

Mean age: 48 years

% Male: 21%

Race/ethnicity: NR

Pain etiology/type: Rheumatoid arthritis Joint status (Steinbrocker’s criteria):

-

functional class I: 21%

-

functional class II: 54%

-

functional class III: 25%

Comorbidities: NR

A vs. B, mean (SD)

Stanford Health Assessment Questionnaire (1-5)

Baseline: 2.6 (0.78) vs. 2.9 (0.62)

Postintervention: 1.6 (0.41) vs. 2.9 (0.68)

Short term: 1.8 (0.54) vs. 2.7 (0.71)

Intermediate term: 2.2 (0.32) vs. 2.6 (0.69)

A vs. B, mean (SD)

BDI (0-63)

Baseline: 12.1 (6.2) vs. 12.0 (6.4)

Postintervention: 6.9 (3.6) vs. 12.2 (6.5)

Short term: 8.2 (3.0) vs. 11.9 (7.0)

Intermediate term: 9.6 (2.3) vs. 12.1 (6.5)

FQCI, Depression (5-25)

Baseline: 12.7 (6.6) vs. 11.9 (5.3)

Postintervention: 10.7 (4.2) vs. 12.4 (5.9)

Short term; 10.0 (3.7) vs. 12.3 (5.9)

Intermediate term: 10.8 (2.0) vs. 12.7 (6.2)

Smeets, 2006a, 2008

Netherlands

Duration of pain: 56.7 months

Cluster RCT

Fair

A. Comprehensive pain management program (n=61):

3 days a week for 10 weeks, (1.75 hours/day, 3 times a week 52.5 hours total)

Group and individual sessions; outpatient setting

B. Waitlist control (n=51):

Mean age: 42 years

% Male: 53%

Race/ethnicity: NR

Mean duration of functional limitations: 35.1 months

Pain etiology/type: Chronic LBP

-

radiation of pain below knee: 49%

-

radiation of pain above knee: 37%

-

without radiation of pain: 14%

-

Full sick leave/disability pension: 38%

-

Partial sick leave/disability pension: 24%

Other characteristics:

-

Previous back surgery: 15%

-

Trauma preceding LBP:18%

A vs. B, adjusted mean (SD)^a

VAS, current pain (0-10)

Baseline: 4.598 (2.395) vs. 5.102 (2.540)

Postintervention: 4.231 (2.556) vs. 5.335 (2.26); adjusted difference −0.823 (95% CI −1.637 to −0.010)^a

VAS, main complaints (0-10)

Baseline: 7.244 (1.703) vs. 7.742 (1.135)

Postintervention: 5.468 (2.179) vs. 7.425 (1.47); adjusted difference −1.784 (95% CI −2.654 to −0.914)^a

PRI-T (scale NR)

Baseline: 18.08 (9.04) vs. 17.37 (8.52)

Postintervention: 17.53 (10.53) vs. 17.28 (10.48); adjusted difference −0.33 (95% CI −4.14 to 3.48)^a

RMDQ (0-24)

Baseline: 13.51 (3.92) vs. 13.96 (3.88)

Postintervention: 11.40 (5.25) vs. 13.88 (4.78); adjusted MD −2.56 (95% CI −4.27 to −0.85)^a

A vs. B, adjusted mean (SD)^a

BDI (0-63)

Baseline: 9.75 (6.68) vs. 9.78 (7.67)

Postintervention: 9.07 (6.53) vs. 9.42 (7.81); adjusted difference 0.04 (95% CI −1.71 to 1.79)^a

Global Improvement (1-7)

Postintervention: 4.53 (1.33) vs. 3.78 (0.91); adjusted difference 0.70 (95% CI 0.17 to 1.24)^a

Harms:

Increased pain in the lower back or radiating leg pain: 5.5% (3/55)

Satisfaction (0-100 VAS): 10th percentile of baseline RMDQ (=9):

Postintervention: 64.98 (25.30) vs. 45.65 (25.30); adjusted MD 19.33 (95% CI 2.01 to 36.65)^a

50th percentile of baseline RMDQ (=14)

Postintervention: 70.24 (25.30) vs. 46.67 (25.30); adjusted MD 23.57 (95% CI 11.28 to 35.86)^a

90th percentile of baseline RMDQ (=19)

Postintervention: 75.50 (25.30) vs. 47.69 (25.30); adjusted MD 27.81 (95% CI 9.54 to 46.08)^a

Smith, 2019

Australia

Duration of pain: >60 months, 59% <5 60 months, 41%

RCT

Fair

A. Comprehensive pain management program (n=41):

8 (online lessons with a 2-week gap between each lesson) 16 weeks, (hours total NR)

Individual sessions; outpatient (online)

B. Usual care (n=39):

Mean age: 45 years

% Male: 12.5%

Race: NR

Pain etiology/type: Chronic pain

-

injury-related pain: 51%

-

noninjury related pain: 9%

Comorbidities: NR

Prescribed medication:

-

opioid: 54%

-

gabanoid: 31%

-

simple analgesia: 69%

-

any: 90%

-

for anxiety/major depressive disorder: 40%

-

major depressive disorder: 24%

A vs. B, estimated marginal mean (SD)

BPI Severity (0-10)

Baseline: 5.40 (1.66) vs. 5.05 (1.66)

Postintervention: 4.44 (1.56) vs. 4.73 (1.63), difference −0.29 (95% CI −1.07 to 0.49)

Short term: 4.38 (1.58) vs. 4.77 (1.64), difference −0.39 (95% CI – 1.18 to 0.40)

BPI Interference (0-10)

Baseline: 6.70 (2.10) vs. 5.88 (2.10)

Postintervention: 4.90 (1.98) vs. 4.82 (2.04)

Short term: 5.19 (1.98) vs. 4.64 (2.05)

PDI (scale 0-70)

Baseline: 38.33 (10.07) vs. 37.06 (10.04)

Postintervention: 26.59 (9.88) vs. 33.64 (9.97)

Short term: 30.47 (9.89) vs. 32.44 (9.94)

A vs. B, % (n/N)

Opioid use

Baseline: 56.1% (23/41) vs. 51.3% (20/39)

Postintervention: 63.3% (19/30) vs. 50.0% (17/34)

Short term: 60.0% (18/30) vs. 51.5% (17/33)

A vs. B, estimated marginal mean (SD)

PHQ-9 (0-27)

Baseline: 11.42 (5.78) vs. 10.55 (5.88)

Postintervention: 9.58 (5.36) vs. 9.51 (5.70)

Short term: 9.81 (5.45) vs. 9.26 (5.65)

Major Depressive Disorder Diagnosis:

Baseline: 34% (12/35) vs. 18% (6/33)

Short term: 17% (6/35) vs. 33% (11/33)

Turner, 1990

USA

Duration of pain:

155 months

RCT

Poor

A. Comprehensive pain management program (n=18): 8 weeks (4 hours/week, 32 hours total); group + individual sessions; outpatient

B. Waitlist control (n=39)

Mean age: 44 years

% Male: 52.1%

Race/ethnicity: White: 100%

Pain etiology/type: Chronic LBP

Disability: NR

Comorbidities: NR

A vs B, Mean (SD)

MPQ (0-78)

Baseline: 25.54 (12.41) vs. 21.17 (8.84)

Postintervention: 14.78 (11.44) vs. 20.95 (10.62) [on a 0-10 scale, 1.9 (1.5) vs. 2.7 (1.4), difference −0.79 (95% CI −1.70 to 0.12)]

SIP (scale NR)

Baseline: 8.50 (4.59) vs. 6.24 (4.99)

Postintervention: 3.63 (2.98) vs. 5.37 (5.93)

A vs. B, Mean (SD)

CES-D (0-60)

Baseline: 12.38 (7.31) vs.10.48 (4.19)

Postintervention: 7.36 (5.89) vs. 7.03 (5.02)

A vs. B, Mean (SD)

Patient satisfaction (1-7)

5.50 (NR) vs. NR

van Eijk-Hustings, 2013, 2016

Netherlands

Duration of pain: 81.6 months

RCT

Fair

A. Comprehensive pain management program (n=108):

12 weeks*, (2x/week, 1.5 hours/day 36 hours total) group sessions outpatient setting

*(+ 9-month aftercare program)

B. Usual care (n=48):

Mean age: 42 years

% Male: 4%

Race/ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability: NR

Comorbidities: NR

A vs. B, Estimated marginal means (SD)

FIQ Total (0-100)

Baseline: 64.5 (14.55) vs. 55.4 (15.93)

Postintervention: 55.1 (15.59) vs. 58.1 (15.93)

Long term (18 months): 50.9 (20.78) vs. 56.2 (20.09); effect size 0.25 (95% CI −0.09 to 0.59)

A vs. B, Estimated marginal means (SD)

EQ-5D scale?

Baseline: 0.36 (0.31) vs. 0.51 (0.28)

Postintervention: 0.49 (0.31) vs. 0.50 (0.28)

Long term (18 months): 0.55 (0.31) vs. 0.51 (0.35); effect size 0.12 (95% CI −0.22 to 0.46)

EQ5D VAS, overall impression of health (0-100)

Baseline: 48.1 (17.67) vs. 54.0 (18.01)

Postintervention: 54.0 (19.75) vs. 48.3 (20.09)

Long term (18 months): 57.3 (23.90) vs. 51.9 (22.89); effect size 0.22 (95% CI – 0.12 to 0.56)

FIQ, Depression (0-10)

Baseline: 5.2 (3.12) vs. 4.2 (2.77)

Postintervention: 4.1 (3.12) vs. 4.5 (2.77)

Long term (18 months): 3.9 (3.12) vs 4.2 (2.77); A vs. B, effect size 0.10 (95% CI – 0.24 to 0.44)

FIQ, Anxiety (0-10)

Baseline: 5.9 (3.12) vs. 4.8 (2.77)

Postintervention: 5.0 (2.08) vs. 5.2 (2.77)

Long term (18 months): 4.7 (3.12) vs. 4.8 (2.77); A vs. B, effect size 0.03 (95% CI – 0.31 to 0.37)

A vs. B, Estimated marginal means (SD)

Average resource use per patient per 2 months, mean (IQR) or % (n/N):

Formal home help:

Baseline: 0.2 (0 to 0) vs. 0.1 (0 to 0)

During intervention: 0.4 (0 to 0) vs. 0.6 (0 to 0)

Postintervention: 0.4 (0 to 0) vs. 0.5 (0 to 0)

Paid home help:

Baseline: 0.1 (0 to 0) vs. 0.2 (0 to 0)

During intervention: 0 (0 to 0) vs. 0.1 (0 to 0)

Postintervention: 0.3 (0 to 0.5) vs. 0.1 (0 to 0.2)

Informal care:

Baseline: 0.6 (0 to 0) vs. 0.3 (0 to 0)

During intervention: 1.6 (0 to 1.5) vs. 0.6 (0 to 0.4)

Postintervention: 0.9 (0 to 1.1) vs. 0.6 (0 to 0.8)

van Koulil, 2010, 2011

Netherlands

Duration of pain: NR

Cluster RCT

Fair

A. Comprehensive pain management program, pain avoidance treatment tailoring group (n = 29): 8 weeks (32 hours) + booster session (4 hours) 3 months after treatment conclusion (36 hours total); individual sessions; outpatient

B. Comprehensive pain management program, pain persistence treatment tailoring group (n = 39): 8 weeks (32 hours) + booster session (4 hours) 3 months after treatment conclusion (36 hours total); individual sessions; outpatient

C. Waitlist control, pain avoidance treatment (n = 45)

D. Waitlist control, pain persistence treatment (n = 45)

Mean age: 42 years

Male: 6%

Race/ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability: NR

Comorbidities:

-

self-reported heightened psychological distress (part of inclusion criteria)

A vs. B vs. C vs. D, Mean (SD)

IRGL pain (6-25)

Baseline: 20.3 (2.4) vs. 19.1 (3.7) vs. 19.8 (3.1) vs. 17.6 (3.4)

Postintervention: 16.0 (3.2) vs. 15.9 (3.8) vs. 20.0 (4.3) vs. 17.4 (3.5)

Short term: 17.2 (3.3) vs. 16.4 (5.1) vs. 20.4 (3.4) vs. 16.4 (3.6)

FIQ (0 to 100)

Baseline: 66.3 (11.6) vs. 57.2 (11.0) vs. 67.0 (11.8) vs. 54.1 (14.7)

Postintervention: 47.6 (14.7) vs. 46.8 (15.3) vs. 63.6 (14.9) vs. 53.9 (12.8)

Short term: 50.0 (15.6) vs. 43.2 (18.5) vs. 66.0 (13.9) vs. 50.8 (15.2)

IRGL mobility (7-28)

Baseline: 13.6 (3.0) vs. 18.6 (4.5) vs. 13.6 (3.0) vs. 18.7 (4.3)

Postintervention: 18.4 (3.5) vs. 21.4 (4.0) vs. 14.5 (4.3) vs. 19.4 (4.1)

Short term: 19.3 (3.8) vs. 22.2 (4.8) vs. 14.5 (4.2) vs. 19.8 (4.4)

A vs. B vs. C vs. D, Mean (SD)

IRGL negative mood scale (0-24)

Baseline: 8.9 (3.8) vs. 5.9 (3.3) vs. 10.5 (5.7) vs. 5.6 (3.6)

Postintervention: 4.7 (3.7) vs. 4.0 (3.5) vs. 8.8 (6.2) vs. 6.3 (3.7)

Short term: 5.0 (3.5) vs. 3.5 (2.6) vs. 8.4 (5.2) vs. 6.1 (4.5)

IRGL anxiety scale (10-40)

Baseline: 26.3 (5.9) vs. 23.2 (4.3) vs. 27.0 (6.4) vs. 23.9 (5.1)

Postintervention: 21.6 (5.9) vs. 20.6 (4.3) vs. 25.6 (6.7) vs. 23.6 (5.2)

Short term: 20.3 (5.6) vs. 19.0 (4.4) vs. 26.0 (5.4) vs. 22.7 (5.4)

Weiner 2020

USA

Duration of pain: 3 months

RCT

Fair

A. Comprehensive pain management program (n=25):

duration NR, (6 months total)

Individual or group sessions NR; outpatient setting

B. Usual care (n=30): Standard clinical care

Mean age: 69 years

% Male: 96%

Race:

-

Black: 31%

-

White: 67%

-

Unknown: 2%

-

Not Hispanic: 93%

Disability:

-

due to LBP: 15%

-

due to Other: 5%

-

General: 69%

-

Diabetes: 29%

-

Lung: 29%

-

Cardiovascular: 27%

-

Cancer: 18%

-

Neurological: 11%

Current Medications:

-

NSAID: 40%

-

Opioid: 27%

-

Gabapentin: 20%

-

Skeletal muscle relaxant: 13%

-

Acetaminophen: 13%

-

Topical: 5%

-

Antidepressant: 4%

-

Other: 4%

-

Salicylate: 2%

-

Corticosteroid, pregabalin: 0%

A vs. B, Mean (SD) change scores from baseline to followup

VAS pain, Current (0-10)

Baseline: mean 4.5 (2.8) vs. mean 5.3 (2.4)

Postintervention: 0.46 (2.99) vs.0.96 (2.18); unadjusted difference in change scores −0.46 (SE 0.72), p=0.53; adjusted^b difference in change scores −1.07 (SE 0.59), p=0.07

VAS pain, Average over prior week (0-100)

Baseline: mean 6.6 (1.7) vs. mean 6.5 (1.4)

Postintervention: −1.38 (2.46) vs. – 0.08 (2.02); unadjusted difference in change scores −1.24 (SE 0.62), p=0.046; adjusted^b MD in change scores −1.22 (SE 0.54), p=0.02

VAS pain, Worst pain over prior week (0-10)

Baseline: mean 8.8 (1.5) vs. mean 8.5 (1.9)

Postintervention: −2.25 (2.44) vs. – 0.42 (1.42); unadjusted difference in change scores −1.74 (SE 0.60), p=0.004; adjusted^b difference in change scores −1.70 (SE 0.57), p=0.003

RMDQ (0-24)

Baseline: mean 14.8 (5.1) vs. 15.1 (5.3)

Postintervention −1.29 (6.05) vs. 0.08 (4.12); unadjusted difference in change scores −1.24 (SE 1.28), p=0.33; adjusted^b difference in change scores −1.42 (SE 1.25), p=0.26

A vs. B, Mean (SD) change scores from baseline to followup

SF-12 PCS (0-100)

Baseline: mean 31.2 (8.1) vs. mean 32.5 (9.4)

Postintervention: 1.46 (8.38) vs. −1.08 (8.84); unadjusted difference in change scores 2.36 (SE 2.23), p=0.29; adjusted^b difference in change scores 2.17 (SE 2.12), p=0.31

SF-12 MCS (0-100)

Baseline: mean 51.7 (11.4) vs. mean 51.3 (10.8)

Postintervention: −1.14 (9.55) vs. −3.12 (10.59); unadjusted MD in change scores 2.12 (SE 2.60), p=0.42; adjusted^b difference in change scores 2.47 (SE 2.46), p=0.32

Whitfill, 2010

USA

Duration of pain:

NR

RCT

Poor

A. Comprehensive pain management program (n=90): 4 to 10 weeks; intensity unclear; individual sessions; outpatient

B. Usual care (n=52)

Mean age: 40 years

% Male: 50%

Race/ethnicity:

-

Caucasian: 51.7% vs. 40.3%

-

Latino: 19.0% vs. 20.7%

-

African American: 27.6% vs. 32.0%

-

Asian: 1.7% vs. 7.0%

-

Other: 0.0% vs. 0.0%

Disability: NR

Other characteristics: NR

A vs. B, Mean (SD)

VAS pain (0-10)

Baseline: 6.00 (2.07) vs. 5.95 (1.95)

Intermediate term: 3.91 (2.86) vs. 5.07 (2.78), difference −1.16 (95% CI −2.26 to −0.06)

CPI (0-10)

Baseline: 5.23 (2.51) vs. 2.50 (2.45)

Intermediate term: 2.96 (2.82) vs. 4.27 (3.01)

A vs. B, Mean (SD)

SF-36 (0 to 100)

Baseline: 33.00 (8.09) vs. 35.99 (10.13)

Intermediate term: 40.47 (11.47) vs. 39.45 (10.59)

BDI (0 to 63)

Baseline: 11.63 (9.30) vs. 9.43 (9.58)

Intermediate term: 8.81 (9.49) vs. 10.11 (10.23)

Williams, 1996 UK

Duration of pain: 93.7 months

RCT

Poor

A. Comprehensive pain management program, inpatient group (n=43): 4.5 days a week for 4 weeks, (28 hours total) group sessions; inpatient

B. Comprehensive pain management program, outpatient group (n=45): 8 weeks, (3.5 hours a week, 28 hours total) group sessions outpatient

C. Waitlist control (n=33)

Mean age: 50 years

% Male: 47%

Race/ethnicity:

Afro-Caribbean or Asian: 12%-16%

White: 84%-88%

Pain etiology/type: Mixed chronic pain

-

back/neck/legs: 74%

-

≥1 surgery: 39%

-

central/peripheral nerve system damage: 26%

-

other tissue damage: 16%

-

unknown mechanism: 58%

Receiving disability income: 62%

Litigation related to pain: 21%

Opioid use: 61%

Excess drug use: 59%

A vs. B vs. C, mean (SD)

VAS pain intensity (0-10)

Baseline: 7.11 (1.90) vs. 6.86 (1.49) vs. 6.79 (2.23)

Short term: 6.10 (2.17) vs. 6.34 (1.96) vs. 6.81 (2.07); p=NS

VAS pain distress (0-10)

Baseline: 6.64 (2.24) vs. 7.03 (2.10) vs. 6.05 (2.31)

Short term: 4.16 (2.90) vs. 5.42 (2.75) vs. 6.30 (2.53); p=NS

SIP (0-100)

Baseline: 29.53 (12.55) vs. 28.48 (9.49) vs. 28.44 (9.83)

Short term: 15.81 (11.20) vs. 20.95 (10.29) vs. 29.65 (10.82); p<0.0005

A vs. B vs. C

Opioid use: no use of opioids

Baseline: 47% (18/38) vs. 33% (11/33) vs. NR

Short term: 82% (31/38) vs. 57% (19/33) vs. NR

Long term (12 months): 80% (24/38) vs. 55% (17/33) vs. NR

Opioid dose equivalent to >10 mg morphine per day:

Baseline: 34.2% (13/38) (mean 30 mg, maximum of 120 mg/day) vs. 48.5% (16/33) (mean 22 mg, maximum of 60 mg/day) vs. NR

Short term: 10.5% (4/38) (maximum of 30 mg/day) vs. 33.3% (11/33) (maximum of 45 mg/day) vs. 32.3% (10/31), p=NS

Long term (12 months): 10.5% (4/38) (mean 22 mg, maximum of 45 mg/day) vs. 18.2% (6/33) (mean 15 mg, maximum of 70 mg/day) vs. NR, p=NS

A vs. B vs. C, mean (SD)

BDI (0-63)

Baseline: 17.8 (8.0) vs. 16.8 (5.6) vs. 16.6 (6.5)

Short term: 9.5 (7.8) vs. 12.2 (6.3) vs. 17.3 (7.0); p<0.0005

STAI (20-80)

Baseline: 45.1 (10.7) vs. 45.7 (8.2) vs. 44.8 (11.6)

Short term: 36.8 (13.6) vs. 42.3 (10.6) vs. 45.0 (11.7), p<0.05 for all

A vs. B vs. C

Utilization:

Subsequent treatments:

-

Surgery: 0% for all groups

-

Any, to include the above as well as prescribed and nonprescribed analgesics: 44.8% (13/29) vs. 85.7% vs. NR (24/28); RR 0.52 (95% CI 0.34 to 0.80)

Alaranta, 1994

Finland

Mean duration of pain: NR (≥6 months)

RCT

Fair

A. CPMP (n=152)

6 weeks, 52 hours total; group + individual; 3 weeks at home + 3 weeks inpatient

B. PA (n=141)

3 weeks 45-60 hours total, session format NR, inpatient

Mean age: 40 years

Male: 45%

Race/Ethnicity: NR

Pain etiology/type: Chronic LBP

Disability:

-

Million index (0-100): 58.1

-

NR

A vs. B, Mean (SD)

MVAS disability (0-100)

(f/u data estimated by EPC from Fig 4 of study publication)

Baseline: 45.5 (18.8) vs. 45.1 (20.8)

Short term: 28.5 (20.9) vs. 35.8 (20.3), difference −7.3 (95% CI −12.1 to 2.5)

Intermediate term: 29.6 (23.2) vs. 36.1 (23.9), difference −6.5 (95% CI −12.0 to – 1.0)

Symptom Check List Pain and Anxiety Subscales: Data not reported (p>0.05)

BDI: Data not reported.

A vs. B

Harms: NR

Decrease (%) in the number of yearly visits

Physician: 74% vs. 67%

Outpatient PT: 69% vs. 77%

Bendix, 1995, 1997, 1998a, 1998b (PROJECT B)

Denmark

Mean duration of pain: NR (≥6 months)

RCT

Fair

A. CPMP, high intensity (n=46)

3 weeks (39 hours/week + one 6hour session /week for 3 weeks, group, outpatient

B. CPMP, lower intensity (n=43)

Twice weekly for 6 weeks (total 24 hours), group, outpatient

C. PA (n=43)

Twice weekly for 6 weeks (total 24 hours), group, outpatient

Mean age: 42 years

Male: 25%

Race/Ethnicity: NR

Pain etiology/type: Chronic LBP

Disability:

Patient’s perception of disability due to back pain (0-30): 15

Comorbidities:

Smoker: 66%

Prior back surgery: 21%

Disability Index (from LBP Rating Scale, 0-30)

Baseline: 15.5 (NR) vs. 15.3 (NR) vs. 14.4 (NR)

Short term: 8.5 (5 to 15) vs. 16.1 (11 to 19) vs. 13.5 (10 to 17), p=0.002 for A vs. B and A vs. C

Long term (12 months): 8.9 (5 to 13) vs. 16.4 (14 to 19) vs. 13.7 (9 to 17), p<0.001 for A vs. B and A vs. C

Long term (24 months): 10 (6 to 14) vs. 17 (9 to 21) vs. 14 (9 to 17), p=0.002 for A vs. B, p=0.02 for A vs. C

Long term (60 months): 8 (NR) vs. 16 (NR) vs. 14 (NR), p=0.03 for A vs. B, p=0.01 for A vs. C

A vs. B vs. C, Median (IQR)

Back pain VAS (0-10)

Baseline: 5.3 (NR) vs. 5.9 (NR) vs. 5.4 (NR)

Short term: 2.7 (1.4 to 4.3) vs. 5.6 (3.8 to 7.6) vs. 4.4 (2.4 to 6.2), p<0.001 for A vs. B and A vs. C

Long term (12 months): 3.3 (2.1 to 5.6) vs. 6.5 (4.8 to 7.7) vs. 5.3 (3.3 to 7.6), p=0.005 for A vs. B and A vs. C

Long term (24 months): 3 (2 to 6) vs. 6 (4 to 8) vs. 5 (3 to 7), p=0.003 for A vs. B, p=0.07 for A vs. C

Long term (60 months): 4 (NR) vs. 6 (NR) vs. 5 (NR), p=0.3

Leg pain VAS (0-10)

Baseline: 2.9 (NR) vs. 3.7 (NR) vs. 3.7 (NR)

Short term: 0.4 (0 to 2.3) vs. 3.1 (0.5 to 5.9) vs. 2.6 (0.1 to 4.6), p=0.01 for A vs. B and A vs. C

Long term (12 months): 2.1 (0.2 to 4.13) vs. 4.8 (2.3 to 7.3) vs. 2.8 (1.4 to 7.0), p=0.001 for A vs. B, p=0.04 for A vs. C

Long term (24 months): 2 (0 to 5) vs. 5 (1 to 6) vs. 4 (2 to 6), p=0.08

Long term (60 months): 3 (NR) vs. 4 (NR) vs. 4 (NR), p=0.07

A vs. B vs. C, Median (IQR)

Harms: NR

Number contacts to any health-care professional

Short term: 0.5 (0 to 2.4) vs. 2.8 (0.4 to 4.6) vs. 1.3 (0.1 to 3.1), p=NS for A vs. B, p<0.05 for A vs. C

Long term (12 months): 4.5 (0.3 to 12.3) vs. 12.0 (0.8 to 23.3) vs. 11.8 (4.0 to 25.0), p=0.002 for A vs. B and A vs. C

Long term (24 months): 5 (0 to 19) vs. 21 (3 to 34) vs. 14 (7 to 27), p=0.03

Long term (60 months): 15 (NR) vs. 10 (NR) vs. 24 (NR), p=0.20

Proportion of patients hospitalized due to LBP, % (n/N)

Long term (60 months): 22% (8/37) vs. 23% (7/31) vs. 24% (7/29), p=1.0

Proportion who underwent back surgery during study period, % (n/N)

Long term (60 months): 5% (2/37) vs. 10% (3/31) vs. 10% (3/29), p=0.70

Bendix, 2000

Denmark

Mean duration of pain: NR (≥6 months)

RCT

Fair

A. CPMP (n=59)

3 weeks (40 hours/week), then 1 day weekly for 3 weeks + a 6-hour follow-up, group, outpatient

B. PA (n=68)

8 weeks (1.5 hour per day, 3x/week, 36 hours total), group, outpatient

Median age: 41 years

Male: 35%

Race/Ethnicity: NR

Pain etiology/type: Chronic LBP

Disability:

-

Working capable: 46%

Comorbidities: NR

A vs. B, Median (IQR)

Back pain VAS (0-10)

Baseline: 5.1 (4 to 7) vs. 6.0 (5 to 7)

Long term: 5.1 (2 to 7) vs. 5.7 (3 to 7.3)

Leg pain VAS (0-10)

Baseline: 2.2 (0 to 5) vs. 3.2 (0 to 6)

Long term: 2.8 (0 to 7) vs. 3.5 (1 to 6.3) (ns)

Disability Index (from LBP Rating Scale, 0-30)

Baseline: 16 (12 to 20) vs. 16 (12 to 21)

Long term: 12 (6 to 21) vs. 13 (9 to 19)

A vs. B, Median (IQR)

Overall assessment of how much the treatment influenced the QoL (0-5)

Long term: 1.7 (1 to 3) vs. 2.7 (2 to 3.3) (P=0.03)

A vs. B, Median (IQR)

Harms: NR

Number contacts to any health-care professional

Long term: 2.5 (0 to 10) vs. 4 (0 to 12.3) (ns)

Henchoz, 2010

Switzerland

Mean duration of pain: NR (>6 weeks)

RCT

Fair

A. CPMP (n=40)

3 weeks (~31 hours/week, 93 hours total), group + individual, outpatient

B. PA (n=27)

9 weeks (1.5 hours/week, 13.5 hours total), individual, outpatient

Mean age: 40 years

Male: 67%

Race/Ethnicity: NR

Pain etiology/type: LBP

Disability: NR

Comorbidities: NR

A vs. B, Mean (SD)

ODI (0-100)

Baseline: 37.6 (15.8) vs. 39.1 (14.7)

Postintervention: 30.1 (16.5) vs. 37.2 (13.5), difference −7.1 (95% CI −14.75 to 0.55)

Short term: 25.7 (15.8) vs. 35.0 (12.3), difference −9.3 (95% CI −16.51 to −2.09)

Intermediate term (6 months): 28.6 (18.4) vs. 35.4 (15.0), difference −6.8, (95% CI – 15.32 to 1.72)

Intermediate term (9 months): 29.6 (17.9) vs. 39.8 (17.3), difference −10.2, (95% CI −18.99 to −1.41)

Long term (12 months): 26.2 (18.0) vs. 38.0 (18.4), difference −11.8 (95% CI – 20.83 to −2.77)

Jensen, 2001

Sweden

Mean duration of pain: 31 months

RCT

Fair

A. CPMP (n=63)

4 weeks (20 hours/week, 80 hours total, plus six 90-minute booster sessions over 1 year after treatment), group, outpatient

B. PA (n=54)

Duration: 4 weeks (20 hours/week, 80 hours total, plus six 90-minute booster sessions over 1 year after treatment), group + individual, outpatient

Mean age: 43 years

% Male: 45%

Race/Ethnicity:

-

Swedish origin: 67%

-

Cervical/thoracic pain: 42%

-

Lumbar pain: 46%

-

Mixed pain areas: 12%

-

Mean total sick leave in 6 months prior to inclusion in study: 292 (63)

Comorbidities: NR

A vs. B, Mean (SD)

SF-36 Global health (0-100)

Females only

A vs. B (n=30 vs. 37)

Baseline: 38.1 (14.5) vs. 35.1 (11.4)

Postintervention: 47.6 (18.0) vs. 41.0 (15.1), difference 6.6 (95% CI −1.48 to 14.68)

Intermediate term: 52.4 (21.6) vs. 43.6 (22.7), difference 8.8 (95% CI −2.10 to 19.70)

Long term: 53.1 (24.5) vs. 47.2 (24.7), difference 5.9 (95% CI −6.18 to 17.98)

Males only

A vs. B (n=33 vs. 17)

Baseline: 41.6 (14.6) vs. 42.6 (13.3)

p=ns

Postintervention: 48.5 (17.2) vs. 46.3 (14.4), difference 2.2 (95% CI −7.60 to 12.00)

Intermediate term: 54.3 (18.3) vs. 50.3 (16.5), difference 4.0 (95% CI −6.64 to 14.64)

Long term: 57.2 (21.8) vs. 52.4 (17.9), difference 4.8 (95% CI −7.56 to 17.16)

A vs. B, Mean (SD)

Harms: NR

Perceived treatment appropriateness (0-10)

Females only

A vs. B (n=30 vs. 37)

Postintervention: 6.4 (3.1) vs. 7.1 (3.4), difference −0.70 (95% CI −2.30 to 0.90)

Males only

A vs. B (n=33 vs. 17)

Postintervention: 6.0 (3.6) vs. 6.3 (3.2), difference −0.30 (95% CI −2.38 to 1.78)

Recommend treatment to relative with a similar pain (0-10)

Females only

A vs. B (n=30 vs. 37)

Postintervention: 7.0 (3.7) vs. 7.9 (3.2), difference −0.90 (95% CI −2.58 to 0.78)

Males only

A vs. B (n=33 vs. 17)

Postintervention: 6.1 (4.3) vs. 7.6 (3.8), difference −1.50 (95% CI −3.99 to 0.99)

Jousett, 2004

France

Mean duration of pain: NR

RCT

Fair

A. CPMP (n=43)

5 weeks (6 hours per day, 30 hours total), group + individual, outpatient

B. PA (n=41)

5 weeks (3 hours per week in clinic, 2 hours per week at home, 25 hours total), individual, outpatient

Mean age: 41 years

% Male: 67%

Race/Ethnicity: NR

Pain etiology/type: Chronic LBP

Disability:

-

On sick leave

-

Mean sick leave days in the 2 prior years: 198 days

-

Prior surgery: 25%

-

Prior depression: 30%

-

Smoking: 39%

A vs. B, Mean (SD)

VAS pain (0-10)

Baseline: 5.0 (2.2) vs. 4.6 (2.2)

Intermediate term: 3.1 (2.5) vs. 4.0 (2.8), difference −0.90 (95% CI −2.04 to 0.24)

Dallas Pain questionnaire ADLs subscale (0-100)

Baseline: 53.7 (16.7) vs. 50.3 (16.7)

Intermediate term: 36.7 (23.0) vs. 41.5 (24.4), difference −4.80 (95% CI −15.15 to 5.55)

Quebec Back Pain Disability scale (0-100)

Baseline: 34.6 (15.4) vs. 31.6 (15.9)

Intermediate term: 22.0 (16.0) vs. 22.9 (17.7), difference −0.90 (95% CI −8.27 to 6.47)

A vs. B, Mean (SD)

HADS (0-21):

Baseline: 17.0 (6.5) vs. 14.3 (6.2)

Intermediate term: 12.7 (7.2) vs. 13.4 (6.4), difference −0.70 (95% CI −3.68 to 2.28)

Dallas Pain Questionnaire anxiety/depression subscale (0-100):

Baseline: 40.6 (25.3) vs. 31.8 (23.1)

Intermediate term: 21.6 (22.9) vs. 27.8 (22.2), difference −6.20 (95% CI −16.05 to 3.65)

A vs. B, % (n/N) or Mean (SD)

Harms: NR

Proportion seeking pain treatments

Baseline: 85.7% (63/42) vs. 78.0% (32/41)

Intermediate term: 64.3% (27/42) vs. 61.0% (25/41), RR 1.05 (95% CI 0.76 to 1.47)

Treatment appreciation (1-5)

Intermediate term: 1.9 (0.8) vs. 2.3 (0.9), difference −0.40 (95% CI −0.77 to −0.03)

Kaapa, 2006

Finland

Mean duration of pain: 26 months

RCT

Fair

A. CPMP (n=59)

8 weeks (70 hours total), group + individual, outpatient

B. PA (n=61)

6-8 weeks (10 hours total), individual, outpatient

Mean age: 46

% Male: 0%

Race/Ethnicity: NR

Pain etiology/type: Chronic LBP

Disability: NR

Comorbidities:

-

Smoker: 31%

A vs. B, Mean (SD)

Low back pain NRS (0-10)

Baseline: 4.6 (1.9) vs. 5.0 (2.6)

Postintervention: 3.3 (2.5) vs. 3.4 (2.4), difference −0.10 (95% CI −0.98 to 0.78)

Intermediate term: 3.3 (2.5) vs. 3.4 (2.5), difference −0.10 (95% CI −1.01 to 0.81)

Long term (12 months): 3.6 (2.7) vs. 3.4 (2.5), difference −0.20 (95% CI −0.80 to 1.20)

Long term (24 months): 3.5 (2.6) vs. 4.0 (2.9), difference −0.50 (95% CI −1.61 to 0.61)

Sciatic pain NRS (0-10)

Baseline: 2.7 (2.7) vs. 3.1 (3.1)

Postintervention: 2.2 (2.7) vs. 2.0 (2.6), difference 0.20 (95% CI −0.76 to 1.16)

Intermediate term: 2.3 (2.8) vs. 1.8 (2.3), difference 0.50 (95% CI −0.45 to 1.45)

Long term (12 months): 2.5 (3.0) vs. 2.0 (2.5), difference 0.50 (95% CI −0.56 to 1.56)

Long term (24 months): 2.1 (2.8) vs. 2.7 (2.9)

ODI (0-100)

Baseline: 25.4 (10.6) vs. 23.8 (11.7)

Postintervention: 20.9 (10.1) vs. 21.6 (11.4), difference −0.70 (95% CI −4.60 to 3.20)

Intermediate term: 20.4 (11.6) vs. 18.0 (11.5), difference 2.4 (95% CI −1.87 to 6.67)

Long term (12 months): 18.9 (12.8) vs. 18.5 (12.4), difference 0.40 (95% CI −4.43 to 5.23)

Long term (24 months): 19.7 (14.3) vs. 19.3 (13.1), difference 0.40 (95% CI −5.20 to 6.00)

A vs. B, Mean (SD)

Symptoms of depression (DEPS) (0–30)

Baseline: 7.5 (5.2) vs. 6.7 (5.5)

Postintervention: 5.5 (5.5) vs. 5.7 (5.2), difference −0.20 (95% CI −2.13 to 1.73)

Intermediate term: 5.7 (4.6) vs. 5.8 (5.7), difference −0.10 (95% CI −2.01 to 1.81)

Long term (12 months): 6.6 (5.8) vs. 5.0 (4.0), difference 1.60 (95% CI −0.31 to 3.51)

Long term (24 months): 6.7 (5.3) vs. 5.7 (4.7), difference 1.00 (95% CI – 1.05 to 3.05)

A vs. B, Mean (SD)

Harms: NR

Number contacts to any health-care professional

Long term (12 months): 5.8 (9.9) vs. 5.4 (8.2), difference 0.40 (95% CI −3.08 to 3.88)

Long term (24 months): 3.4 (7.0) vs. 5.3 (8.6), difference −1.90 (95% CI −5.09 to 1.29)

Mangels, 2009

Germany

Mean duration of pain: NR

RCT

Fair

A. CPMP + booster sessions (n=119) ~4 weeks + 7, 20-minute booster sessions over 12 months, group + individual, inpatient

B. CPMP (n=113) ~4 weeks, group + individual, inpatient

C. PA (n=131) ~3.5 weeks, group + individual, inpatient

Mean age: 49 years

% Male: 22%

Race/Ethnicity: NR

Pain etiology/type

Dorsalgia: 84%

Other dorsopathies, 71%

Arthrosis: 34%

Disability: NR

Comorbidities: NR

A vs. B vs. C, Mean (SD)

PPS - Affective pain perception (14-56)

Baseline: 30.9 (9.4) vs. 30.9 (10.4) vs. 29.6 (9.0)

Postintervention: 23.4 (9.4) vs. 23.7 (9.2) vs. 22.9 (8.2)

A vs. C: difference 0.50 (95% CI −1.69 to 2.69)

B vs. C: difference 0.80 (95% CI −1.39 to 2.99)

12 months: 24.1 (9.8) vs. 25.5 (9.9) vs. 25.1 (9.6)

A vs. C: difference −0.10 (95% CI −3.50 to 1.50)

B vs. C: difference 0.40 (95% CI −2.14 to 2.94)

PPS - Sensory pain perception (10-40)

Baseline: 18.9 (5.9) vs. 18.5 (5.6) vs. 18.8 (5.9)

Postintervention: 15.9 (5.3) vs. 15.9 (5.2) vs. 16.4 (5.8)

A vs. C: difference −0.50 (95% CI −1.89 to 0.89)

B vs. C: difference −0.50 (95% CI −1.90 to 0.90)

Long term: 16.3 (5.7) vs. 17.0 (6.1) vs. 17.3 (6.1)

A vs. C: difference −1.0 (95% CI −2.53 to 0.53)

B vs. C: difference −0.30 (95% CI −1.89 to 1.29)

PDI (0-70)

Baseline: 26.9 (13.9) vs. 26.1 (11.8) vs. 24.8 (12.5)

Postintervention: 21.7 (13.3) vs. 20.3 (13.9) vs. 21.0 (13.1)

A vs. C: difference 0.70 (95% CI −2.59 to 3.99)

B vs. C: difference −0.70 (95% CI −4.12 to 2.71)

Long term: 22.6 (16.0) vs. 22.0 (14.0) vs. 20.6 (13.5)

A vs. C: difference 2.0 (95% CI −1.80 to 5.80)

B vs. C: difference 1.4 (95% CI −2.19 to 4.99)

A vs. B vs. C, Mean (SD)

SF-12 PCS (0-100)

Baseline: 33.5 (9.1) vs. 33.6 (7.4) vs. 33.9 (8.7)

Postintervention: 38.9 (9.4) vs. 39.3 (9.9) vs. 38.6 (8.6)

A vs. C: difference 0.30 (95% CI −1.94 to 2.54)

B vs. C: difference 0.70 (95% CI −1.63 to 3.03)

Long term: 38.4 (10.4) vs. 38.4 (9.7) vs. 38.4 (10.1)

A vs. C: difference 0 (95% CI −2.64 to 2.64)

B vs. C: difference 0 (95% CI −2.59 to 2.59)

SF-12 MCS (0-100)

Baseline: 43.9 (12.1) vs. 44.0 (11.1) vs. 44.5 (11.5)

Postintervention: 48.9 (12.1) vs. 50.8 (10.5) vs. 50.9 (10.5)

A vs. C: difference −2.0 (95% CI −4.82 to 0.82)

B vs. C: difference −0.10 (95% CI −2.76 to 2.56)

Long term: 45.6 (11.7) vs. 46.0 (11.2) vs. 45.0 (11.7)

A vs. C: difference 0.60 (95% CI −2.42 to 3.62)

B vs. C: difference 1.0 (95% CI – 2.00 to 4.00)

BDI (0-63)

Baseline: 11.4 (9.8) vs. 11.1 (10.1) vs. 10.1 (8.1)

Postintervention: 7.2 (7.8) vs. 6.7 (6.0) vs. 7.8 (7.8)

A vs. C: difference −0.60 (95% CI −4.08 to 2.88)

B vs. C: difference −1.10 (95% CI −4.56 to 2.36)

Long term: 10.7 (8.8) vs. 10.4 (7.8) vs.11.4 (8.2)

A vs. C: difference −0.70 (95% CI −2.89 to 1.49)

B vs. C: difference −1.0 (95% CI – 3.09 to 1.09)

A vs. B vs. C, Mean (SD)

Harms: One death during inpatient treatment (group A); no other details provided

German Life Satisfaction (with health)

Questionnaire (scale NR)

Baseline: 28.4 (9.5) vs. 28.1 (9.0) vs. 28.9 (8.5)

Postintervention: 33.1 (8.8) vs. 33.1 (9.2) vs. 32.5 (8.8)

A vs. C: 0.60 (95% CI −1.60 to 2.80)

B vs. C: 0.60 (95% CI −1.67 to 2.87)

Long term: 33.3 (9.5) vs. 31.7 (9.8) vs. 31.2 (8.4)

A vs. C: difference 2.1 (95% CI −0.21 to 4.41)

B vs. C: difference 0.50 (95% CI −1.87 to 2.87)

Meyer, 2005

Switzerland

RCT

Mean duration of pain: 36 months

Fair

A. CPMP (n=17)

8 weeks (17.5 hours/week, 140 hours total), session format NR for physical component, individual + group for psychological component, setting NR

B. PA (n=16) 8 weeks 1.5 hours/week (12 hours total), session format NR, outpatient

Median age: 43 years

Male: 79%

Race/Ethnicity: NR

Pain etiology/type:

Cervical, arm, and or head: 15%

Knee: 3%

Back and or leg: 69%

Widespread areas: 9%

Comorbidities: 1 or more, 39%

Other characteristics: To be included, patients needed to have Sick-leave for at least 2 months or 50% work incapacity from a full-time job over 3 months

A vs. B, Median (IQR)

Pain, NRS (0-10)

Baseline: 6.0 (3.5 to 7.0) vs. 5.5 (5.0 to 6.0)

Postintervention change score: 1.0 (−1.0 to 2.0) vs. 1.0 (0.0 to 2.0), p=0.34

PACT (scale NR)

Baseline: 82.0 (58.5 to 124.5) vs. 136.5 (74.8 to 160.8)

Postintervention change score: 10.0 (−9.0 to 37.0) vs. 3.0 (−10.0 to 36.0), p=0.60

A vs. B, Median (IQR)

SF-36 MCS (0-100)

Baseline: 32.0 (26.7 to 44.0) vs. 29.6 (25.2 to 37.4)

Postintervention change score: 6.0 (−5.4 to 12.9) vs. 2.5 (−3.6 to 11.9), p=0.90

SF-36 PCS (0-100)

Baseline: 30.0 (25.5 to 34.5) vs. 32.8 (28.4 to 37.4)

Postintervention change score: −0.4 (−3.8 to 2.6) vs. −4.4 (−9.0 to 0.4), p=0.17

A vs. B, % (n/N)

Harms

-

Pain in new localizations: 11.8% (2/17) vs. 31.2% (5/16), RR 0.38 (95% CI 0.08 to 1.7)

-

Other adverse reactions were not reported.

Roche, 2007, Roche-LeBoucher 2011

France

RCT

Mean duration of pain: NR (≥3 months)

Fair

A. CPMP (n=68)

5 weeks (6 hours/day, 150 hours total), group, outpatient

B. PA (n=64)

5 weeks (5 hours/week, ~25 hours total), individual, outpatient + home setting

Mean age: 40 years

% Male: 65%

Race/ethnicity: NR

Pain etiology/type: Chronic LBP

Disability:

-

Excluded if receiving disability pension.

-

Excluded if acute LBP or sciatica, spondylolisthesis, or cardiac or respiratory insufficiency, or psychiatric disorders preventing participation

A vs. B, Mean (SD)

VAS pain (0-10)

Baseline: 4.7 (2.1) vs. 4.5 (2.1)

Postintervention change score: −1.9 (NR) vs. −1.5 (NR)

Long term change score: −1.7 (2.6) vs. −1.0 (2.3), difference in change scores −0.70 (95% CI −1.64 to 0.24)

DPQ, daily activities (0%-100%)

Baseline: 51.8% (NR) vs. 51.0% (NR)

Postintervention change score: −21.5% (NR) vs. −17.2% (NR)

Long term change score: −20.3% (18.1%) vs. −10.4% (23.3%), difference in change scores −9.9 (95% CI −17.62 to −2.19)

A vs. B

DPQ, anxiety and depression (0%-100%)

Baseline: 36.9% (NR) vs. 30.9% (NR)

Postintervention change score: −17.6% (NR) vs. −7.4% (NR)

Long term change score: −15.6% (21.4%) vs. −4.8% (23.5%), difference in change scores −10.8 (95% CI −19.20 to −2.40)

Ronzi, 2017

France

Mean duration of pain: NR (≥3 months)

RCT

Poor

A. CPMP (n=49)

5 weeks (30 hours/week; 150 hours total), group + individual, inpatient

B. CPMP (n=56)

5 weeks (11 hours/week; 55 hours total), group + individual, outpatient

C. PA (n=54)

Duration: 5 weeks (~5 hours/week, ~25 hours total), individual, outpatient + home setting

Mean age: 42 years

% Male: 59%

Race/ethnicity: NR

Pain etiology/type: Chronic LBP

Disability: NR

Other characteristics: NR

A vs. B vs. C, Median (IQR)

VAS pain (0-100)

Baseline: 54 (45 to 65) vs. 55 (36 to 68) vs. 45 (24 to 65)

Long term: 45 (25 to 59) vs. 37 (15 to 61) vs. 33 (19 to 48)

DPQ, daily activities (0%-100%)

Baseline: 63.0% (51.0% to 72.0%) vs. 57.0% (48.0% to 66.0%) vs. 54.0% (48.0% to 69.0%)

Long term: 51.0% (12.0% to 64.5%) vs. 39.0% (24.0% to 57.0%) vs. 54.0% (36.0% to 63.0%)

A vs. B vs. C, Median (IQR)

HADS (0-100)

Baseline: 17.0 (12.0 to 21.0) vs. 14.0 (11.0 to 18.0) vs. 16.0 (12.0 to 21.0)

Long term 11.5 (7.5 to 18.0) vs. 12.0 (7.0 to 15.0) vs. 13.0 (8.0 to 19.0)

A vs. C and B vs. C, p=ns

DPQ, anxiety and depression (0%-100%)

Baseline: 45.0% (20.0% to 60.0%) vs. 35.0% (25.0% to 45.0%) vs. 40.0% (15.0% to 55.0%)

Long term: 30.0% (5.0% to 45.0%) vs. 25.0% (5.0% to 45.0%) vs. 30.0% (5.0% to 45.0%)

SF-36 PCS (0-100)

Baseline: 35.7 (29.4 to 39.5) vs. 34.5 (30.7 to 39.2) vs. 35.6 (31.9 to 37.2)

Long term: 39.1 (33.8 to 50.4) vs. 41.6 (34.2 to 49.9) vs. 37.5 (33.0 46.8)

A vs. C and B vs. C, p=ns

SF-36 MCS (0-100)

Baseline: 43.3 (32.1 to 49.8) vs. 43.4 (35.9 to 51.1) vs. 41.2 (36.1 to 50.8)

Long term: 48.3 (42.1 to 53.4) vs. 46.6 (38.7 to 56.6) vs. 48.9 (41.4 to 54.8)

A vs. C and B vs. C, p=ns

Schweikert, 2006

Germany

RCT

Mean duration of pain: NR (≥6 months)

Fair

A. CPMP (n=200)

3 weeks hours total NR), group, inpatient

B. PA (n=209)

3 weeks hours total NR), group + individual, inpatient

Mean age: 47 years

Male: 83%

Race/Ethnicity: NR

Pain etiology/type: Chronic LBP

Disability:

-

Sick listed <6 months in last year: 69%

-

Sick listed >6 months in last year: 6%

A vs. B, Mean (SD)

Back pain (scale 1-6)

Baseline: 4.3 (1.3) vs. 4.5 (1.2)

Postintervention change score: −1.2 (1.2) vs. −1.2 (1.2), difference in change scores 0 (95% CI −0.25 to 0.25)

Hannover functional questionnaire (FFbH) (0-100)

Baseline: 76.0 (19.2) vs. 72.2 (18.3)

Postintervention change score: 2.8 (12.3) vs. 3.5 (13.4), difference in change scores −0.70 (95% CI −3.37 to 1.97)

A vs. B, Mean (SD)

Depression (0-48)

Baseline: 8.3 (7.3) vs. 7.4 (6.3)

Postintervention change score: −2.3 (4.7) vs. −1.6 (4.2), difference in change scores −0.70 (95% CI −1.62 to 0.22)

STAI (20-80)

Baseline: 39.2 (10.4) vs. 38.8 (9.9)

Postintervention change score: −2.7 (6.9) vs. −2.3 (6.3), difference in change scores −0.40 (95% CI −1.78 to 0.98)

EQ-5D HRQOL (0-100)

Baseline: 60.8 (17.6) vs. 59.3 (16.6)

Postintervention: 70.3 (19.3) vs. 68.6 (19.5), difference 1.7 (95% CI −2.21 to 5.61)

Intermediate term: 70.0 (17.7) vs. 63.8 (19.9), difference 6.2 (95% CI 2.39 to 10.01)

Smeets, 2006a, 2008

Netherlands

Mean duration of pain: 56.7 months

Cluster RCT

Fair

A. CPMP (n=61)

10 weeks (~75 hours total), group + individual, outpatient

B. PA (n=53)

10 weeks (~75 hours total), group + individual, outpatient

Mean age

42 years

Male: 53%

Race/ethnicity: NR

Mean duration of functional limitations: 35.1 months

Pain etiology/type: Chronic LBP

-

pain below knee: 49%

-

pain above knee: 37%

Disability pension:

-

Full 38%

-

Partial 24%

Trauma preceding LBP: 18%

A vs. B adjusted mean change score (SD) from baseline

VAS, current pain (0-10)

Baseline: 4.60 (2.40) vs. 5.12 (2.66)

Postintervention: adjusted difference in change scores: −0.018 (95% CI −0.934 to 0.899)

Intermediate term: adjusted difference in change scores: 0.498 (95% CI −0.429 to 1.425)

Long term: adjusted difference in change scores: 0.804 (95% CI −0.123 to 1.731)

Pain Rating Index Total (MPQ) (scale NR)

Baseline: 18.08 (9.04) vs. 18.34 (11.32)

Postintervention: adjusted difference in change scores: −0.95 (95% CI −4.59 to 2.98)

Intermediate term: adjusted difference in change scores: 1.97 (95% CI −1.71 to 5.65)

Long term: adjusted difference in change scores: 2.64 (95% CI −1.04 to 6.32)

RMDQ (0-23)

Baseline (mean, SD): 13.51 (3.92) vs. 14.15 (3.70))

Postintervention: adjusted difference in change scores: −0.05 (95% CI −1.71 to 1.62)

Intermediate term: adjusted difference in change scores: 0.62 (95% CI −1.06 to 2.30)

Long term: adjusted difference in change scores: 1.16 (–0.52 to 2.84)

VAS, main (activity) complaints (0-10)

Baseline: 7.24 (1.70) vs. 7.45

Postintervention: adjusted difference in change scores: −0.64 (95% CI −1.60 to 0.33)

Intermediate term: adjusted difference in change scores: −0.23 (95% CI −1.19 to 0.74)

Long term: adjusted difference in change scores: 0.03 (95% CI −0.94 to 1.00)

A vs. B adjusted mean change score (SD) from baseline

BDI (0-63)

Baseline: 9.75 (6.68) vs. 10.38 (7.62)

Postintervention: adjusted difference in change scores: 2.17 (95% CI 0.18 to 4.17)

Intermediate term: adjusted difference in change scores for group: 0.49 (95% CI −1.54 to 2.51)

Long term: adjusted difference in change scores: 1.05 (95% CI −0.97 to 3.07)

Global Improvement (1-7)

Postintervention: adjusted difference in change scores: 0.20 (95% CI – 0.35 to 0.75)

Intermediate term: adjusted difference in change scores: −0.38 (95% CI −0.94 to 0.18)

Long term: adjusted difference in change scores: −0.61 (95% CI −1.16 to −0.05)

A vs. B, % (n/N) or mean (SD)

Harms:

-

Increased low back pain or radiating leg pain leading to study withdrawal: 5.5% (3/55) vs. 5.8% (3/52); RR 0.95 (95% CI 0.20 to 4.48)

-

Herniated disc with neurological deficits needing neurosurgical intervention: 0% (0/55) vs. 1.9% (1/52) [one of the patients above]

-

Knee complaints causing patient to stop aerobic exercise: 0% (0/55) vs. 1.9% (1/52)

-

Pain complaints in both legs during cycling (vascular problems resolved by vascular surgery): 0% (0/55) vs. 1.9% (1/52)

(effect modification by RMDQ)

p=NS between groups except for in the 90^th percentile strata of RMDQ.

Postintervention: adjusted difference: −21.58 (95% CI −39.56 to −3.59)

Turner, 1990

USA

Mean duration of pain: 12.9 years

RCT

Poor

A. CPMP (n=18)

8 weeks (4 hours/week, 32 hours total), group and individual, outpatient

B. PA (n=21)

8 weeks (2 hours/week, 16 hours total). group + individual, outpatient

Mean age: 44 years

Male: 52.1%

Race/ethnicity: White: 100%

Pain etiology/type: Chronic LBP

Disability: N/A

A vs. B, Mean (SD)

MPQ Pain Rating Index (0-78)

Baseline: 25.5 (12.41) vs. 19.4 (10.6)

Postintervention: 14.78 (11.44) vs. 17.51 (10.2), difference −2.73 (95% CI −9.75 to 4.29)

Intermediate term: 13.29 (9.15) vs.15.65 (9.15), difference −2.36 (95% CI −8.32 to 3.60)

Long term: 18.21 (13.31) vs. 14.94 (7.86), difference 3.27 (95% CI −3.70 to 10.24)

SIP (0-100)

Baseline: 8.50 (4.59) vs. 8.42 (8.21)

Postintervention: 3.63 (2.98) vs. 5.49 (6.79), difference −1.86 (95% CI −5.36 to 1.64)

Intermediate term: 4.51 (4.68) vs. 6.25 (10.08), difference −1.74 (95% CI −6.99 to 3.51)

Long term: 4.75 (3.40) vs. 4.73 (7.85) difference 0.02 (95% CI −4.02 to 4.06)

A vs. B, Mean (SD)

CES-D (0-60)

Baseline: 12.38 (7.31) vs. 11.95 (7.68)

Postintervention: 7.36 (5.89) vs. 7.38 (4.57), difference −0.02 (95% CI −3.42 to 3.38)

Intermediate term: 8.29 (7.94) vs. 9.29 (8.30), difference −1.0 (95% CI −6.30 to 4.30)

Long term: 10.00 (7.57) vs. 9.31 (7.73), difference 0.69 (95% CI – 4.29 to 5.67)

A vs. B, Mean (SD)

Harms: NR

Patient satisfaction (1-7): Postintervention: 5.50 (NR) vs. 4.48 (NR), p=NS

van Eijk-Hustings, 2013, 2016

Netherlands

Mean duration of pain: 6.8 years

RCT

Fair

A. CPMP (n=108)

12 weeks (36 days of sessions), group, outpatient

B. PA (n=47)

12 weeks (24 sessions), group, outpatient

Mean age 42 years

Male: 4%

Race/Ethnicity: NR

Pain etiology/type: FM

Disability: NR

Estimated marginal means (SD), A vs. B

FIQ, Pain

Baseline: 6.3 (2.1) vs. 6.2 (1.8)

Postintervention: 5.5 (2.1) vs. 5.3 (2.1), difference 0.20 (95% CI −0.53 to 0.93

Long term: 5.3 (2.1) vs. 5.2 (2.5) difference 0.10 (95% CI −0.67 to 0.87)

FIQ Total

Baseline: 64.5 (14.6) vs. 60.0 (14.4)

Postintervention: 55.1 (15.6) vs. 53.2 (16.5), difference 1.90 (95% CI −3.58 to 7.38

Long term: 50.9 (20.8) vs. 52.0 (21.9), difference −1.1 (95% CI −8.40 to 6.20)

Estimated marginal means (SD), A vs. B

EQ-5D (scale −0.59 to 1)

Baseline: 0.36 (0.3) vs. 0.41 (0.3)

Postintervention): 0.49 (0.3) vs. 0.47 (0.3), difference 0.02 (95% CI −0.08 to 0.12

Long term: 0.55 (0.3) vs. 0.54 (0.3), difference 0.01 (95% CI −0.09 to 0.11

FIQ, Depression

Baseline: 5.2 (3.1) vs. 4.8 (2.1)

Postintervention: 4.1 (3.1) vs. 4.6 (2.7), difference −0.50 (95% CI −1.53 to 0.53

Long term: 3.9 (3.1) vs. 5.0 (3.4), difference −1.1 (95% CI −2.20 to 0.002)

FIQ, Anxiety

Baseline: 5.9 (3.1) vs. 4.9 (2.1)

Postintervention: 5.0 (2.1) vs. 4.6 (2.7), difference 0.40 (95% CI −0.39 to 1.19

Long term: 4.7 (3.1) vs. 5.0 (3.4), difference −0.30 (95% CI −1.40 to 0.80

Estimated marginal means (SD), A vs. B

Harms: NR

A vs. B

Contact with GPs ^a

Baseline: 2.3 (3.1) vs. 3.3 (5.5)

Long term: 0.9 (2.1) vs. 0.7 (2.1), difference 0.20 (95% CI −0.53 to 0.93

Contact with medical specialists ^a

Baseline: 1.9 (1.0) vs. 1.9 (1.4)

Long term: 0.3 (1.0) vs. 0.4 (0.7), difference – 0.10 (95% CI −0.42 to 0.22

Contact with physiotherapists ^a

Baseline: 2.7 (5.2) vs. 1.9 (1.4)

Long term: 2.6 (5.2) vs. 0.4 (0.7) difference 2.20 (95% CI 0.69 to 3.71)

Contact with other paramedical professionals ^a

Baseline: 1.1 (3.1) vs. 1.1 (2.7)

Long term: 1.0 (3.1) vs. 2.1 (3.4), difference – 1.10 (95% CI −2.20 to 0.002)

Castel, 2013, 2015, Salvat, 2017

Spain

Mean pain duration: 140 months

RCT

Fair

A. Comprehensive pain management program (n=74)

12 weeks, 4 hours/week, 48 hours total, group, outpatient

B. Pharmacological therapy only (n=81)

12 weeks, Analgesics, antidepressants, benzodiazepine and nonbenzodiazepine hypnotics (dosages NR); adjusted as recommend by guidelines

Mean age: 49 years

% Female: 100%

Race/Ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability: NR

-

Receiving workers compensation: 6%

Comorbidities: NR

A vs. B, Mean (SD) (unless otherwise stated)

Proportion of patients meeting the MCID of 30% improvement on the NRS, % (n’s and N’s NR)

Posttreatment: 22.2% (18/81) vs. 6.7% (5/74), RR 3.3 (95% CI 1.3 to 8.4)

Short term: 13.6% (11/81) vs. 10.8% (8/74), RR 1.3 (95% CI 0.53 to 3.0)

Intermediate term: 16.0% (13/81) vs. 5.4% (4/74), RR 3.0 (95% CI 1.0 to 8.7)

Long term: 8.6% (7/81) vs. 0% (0/74), RR not calculable

Pain NRS (0 to 10)

Baseline: 6.8 (1.4) vs. 7.1 (1.6)

Posttreatment: 5.7 (1.9) vs. 6.9 (1.8), difference −1.2 (95% CI −7.8 to −0.61)

Short term: 6.4 (1.9) vs. 6.8 (1.8), difference −0.40 (95% CI −0.99 to 0.19)

Intermediate term: 6.4 (1.9) vs. 7.0 (1.9), difference −0.60 (95% CI −1.2 to 0.00)

Long term: 6.7 (1.6) vs. 7.1 (1.8), difference −0.40 (95% CI −0.94 to 0.14)

Proportion of patients meeting the MCID of 14% improvement on the FIQ, % (n/N)

Posttreatment: 64.2% (52/81) vs. 24.3% (18/74), RR 2.6 (95% CI 1.7 to 4.1)

Short term: 48.1% (39/81) vs. 23.0% (17/74), RR 2.1 (95% CI 1.3 to 3.4)

Intermediate term: 42.0% (34/81) vs. 18.9% (14/74), RR 2.2 (95% CI 1.3 to 3.8)

Long term: 27.2% (22/81) vs. 4.0% (3/74), RR 6.7 (95% CI 2.1 to 21.5)

FIQ (0 to 100)

Baseline: 64.6 (16.0) vs. 66.6 (17.4)

Posttreatment: 47.7 (20.2) vs. 65.9 (16.1), difference −18.2 (95% CI −24.0 to −12.4)

Short term: 55.5 (19.3) vs. 64.6 (17.6), difference −9.1 (95% CI −15.0 to −3.2)

Intermediate term: 55.8 (20.9) vs. 67.8 (18.4), difference −12.0 (95% CI −18.3 to −5.7)

Long term: 58.8 (20.5) vs. 69.6 (17.2), difference −10.8 (95% CI −16.8 to −4.8)

COOP/WANCA physical function subscale (0 to 5)

Baseline: 3.0 (0.84) vs. 3.3 (0.77)

Posttreatment: 2.4 (0.76) vs. 3.3 (0.72), difference −0.90 (95% CI −1.1 to −0.65)

Short term: 2.7 (1.2) vs. 3.2 (0.61), difference −0.50 (95% CI −0.84 to −0.16)

Intermediate term: 2.7 (0.74) vs. 3.4 (0.91), difference −0.70 (95% CI −0.99 to −0.41)

Long term: 2.7 (0.86) vs. 3.3 (0.57), difference −0.60 (95% CI −0.93 to – 0.27)

COOP/WANCA daily activities subscale (1 to 5)

Baseline: 3.3 (0.47) vs. 3.4 (0.43)

Posttreatment: 2.8 (0.43) vs. 3.1 (0.40), difference −0.30 (95% CI −0.44 to −0.16)

Short term: 2.9 (0.43) vs. 3.2 (0.61), difference −0.30 (95% CI −0.48 to −0.12)

Intermediate term: 3.0 (0.42) vs. 3.3 (0.58), difference −0.30 (95% CI −0.47 to −0.12)

Long term: 2.9 (0.55) vs. 3.3 (0.57), difference −0.40 (95% CI −0.64 to – 0.16)

Authors found no significant interactions in BMI × time, and in BMI × group treatment × time. There are not differences among normal weight, overweight, and obese patients with FM regarding their response to a CPMP for any of the outcomes listed above.

A vs. B, Mean (SD)

COOP/WANCA measure of HRQOL (9-45)

Baseline: 26.8 (32.9) vs. 28.0 (27.7)

Posttreatment: 22.1 (29.7) vs. 26.7 (28.0), difference −5.9 (95% CI −16.0 to 4.2)

Short term: 23.8 (29.7) vs. 26.5 (28.0), difference −2.7 (95% CI −12.8 to 7.3)

Intermediate term: 23.7 (28.9) vs. 27.3 (26.6), difference −3.6 (95% CI −13.5 to 6.2)

Long term: 23.4 (25.1) vs. 26.5 (21.9), difference −3.1 (95% CI −13.4 to 7.2)

HADS (scale NR)

Baseline: 21.9 (8.0) vs. 23.2 (8.1)

Posttreatment: 14.3 (9.0) vs. 21.7 (8.4), difference −7.4 (95% CI −10.2 to −4.6)

Short term: 15.2 (9.1) vs. 20.6 (8.5), difference −5.4 (95% CI −8.2 to −2.6)

Intermediate term: 16.2 (9.3) vs. 21.5 (8.5), difference −5.3 (95% CI −8.1 to −2.5)

Long term: 17.1 (9.9) vs. 22.8 (9.2), difference −5.7 (95% CI −8.7 to −2.7)

Authors found no significant interactions in BMI × time, and in BMI × group treatment × time. There are not differences among normal weight, overweight, and obese patients with FM regarding their response to a CPMP for any of the outcomes listed above.

Martin, 2014a, 2014b, 2014c

Spain

Mean duration of pain: 170 months

RCT

Poor

A. Comprehensive pain management program (n=54)

6 weeks, 2.75 hours/week, 16.5 hours total, session format NR, outpatient

B. Pharmacological therapy only (n=56)

6 weeks, Amitriptyline (maximum dose 75 mg/day), Paracetamol, (maximum dose 4 g/day), Tramadol, (maximum dose 400 mg/day)

Mean age: 50 years

% Male: 9%

Race/Ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability: 15%

Comorbidities:

-

Hypothyroidism: 12%

-

High blood pressure: 10%

-

COPD: 12%

-

Diabetes mellitus: 3%

-

Rheumatoid arthritis: 3%

-

Other: 42%

A vs. B, Mean (SD)

VAS current pain (0 to 10)

Baseline: 6.76 (1.98) vs. 7.06 (2.04)

Intermediate term: 5.99 (2.37) vs. 7.21 (1.56), difference −1.2 (95% CI −2.0 to – 0.46)

FIQ Total (0 to 100)

Baseline: 76.28 (13.17) vs. 76.23 (14.80)

Intermediate term: 70.33 (16.98) vs. 76.81 (14.18), difference −6.5 (95% CI −12.4 to −0.58)

A vs. B, Mean (SD)

FIQ depression subscale (0 to 10)

Baseline: 6.90 (3.06) vs. 7.20 (2.83)

Intermediate term: 6.44 (3.13) vs. 6.61 (3.14), difference −0.17 (95% CI −1.4 to 1.0)

HADS depression (0 to 21)

Baseline: 10.63 (4.57) vs. 10.57 (4.06)

Intermediate term: 9.77 (4.09) vs. 10.25 (4.22), difference −0.48 (95% CI −2.1 to 1.1)

HADS anxiety (0 to 21)

Baseline: 13.13 (3.39) vs. 13.39 (3.45)

Intermediate term: 13.49 (4.31) vs. 12.75 (4.55), difference 0.74 (95% CI −0.94 to 2.4)

Onac, 2012, 2017

Romania

Mean duration of pain: NR

RCT

Poor

A. Comprehensive pain management program (n=29)

2 weeks, 5 days/week (total hours NR), individual, inpatient

B. Pharmacological therapy (n=20)

2 weeks, Diclofenac (50mg, 3 times/day), Omeprazole (20 mg, 1 time/day), and Acetaminophen (1000 mg, 4 times/day)

Population data include patients from the third arm of this trial

Mean age: 47 years

% Male: 57%

Race/ethnicity: NR

Pain etiology/type: Lumbar disk hernia

Disability: NR

Other characteristics:

-

Excluded: history of psychotic disorders, substance abuse disorders, certain personality disorders.

A vs. B Mean (SD)

VAS pain (0 to 10)

All patients

Baseline: 3.83 (1.89) vs. 5.77 (2.55)

Postintervention (2 weeks): 3.02 (1.94) vs. 4.73 (2.67), difference −1.71 (95% CI −3.0 to −0.39)

Nonclinical catastrophizers

Baseline: 3.12 (1.70) vs. 4.67 (2.56)

Postintervention (2 weeks): 1.78 (1.14) vs. 3.65 (2.44), difference −1.87 (95% CI −3.3 to −0.45)

Clinical catastrophizers

Baseline: 4.32 (2.00) vs. 7.80 (1.39)

Postintervention (2 weeks): 3.77 (1.91) vs. 6.60 (2.45), difference −2.83 (95% CI −4.8 to −0.83)

RMDQ (0 to 24)

All patients

Baseline: 10.66 (6.73) vs. 9.95 (5.75)

Postintervention (2 weeks): 8.66 (7.11) vs. 8.90 (6.406), difference −0.24 (95% CI −4.2 to 3.8)

A vs. B Mean (SD)

POMS-SV Emotional Distress (scale NR)

All patients

Baseline: 46.03 (26.52) vs. 39.85 (21.52)

Postintervention (2 weeks): 43.15 (31.16) vs. 37.94 (21.01), difference 5.2 (95% CI −10.9 to 21.3)

Tavafian, 2011, 2014, 2017a, 2017b

Iran

Mean duration of pain: 82.2 months

RCT

Fair

A. Comprehensive pain management program (n=97)

1 week + monthly booster sessions, 69 hours total, session format NR, outpatient

B. Pharmacologic therapy alone (n=100)

Analgesics, NSAIDS, muscle relaxants, and antidepressant drugs

Mean age: 45 years

% Male: 26.08%

Race/ethnicity: NR

Pain etiology/type: Chronic LBP

Disability: NR

Comorbidities:

-

% Smokers: 5.6%

-

% with sciatica: 85.8%

-

Excluded: back surgery within last 2 years

A vs. B, Mean (SD)

QDS (0 to 100)

Baseline: 35.45 (20.19) vs. 33.08 (19.69)

Short term: 23.48 (18.54) vs. 32.70 (18.19), difference −9.2 (95% CI −14.5 to −3.9)

Intermediate term: 18.65 (16.14) vs. 27.19 (17.85), difference −8.5 (95% CI −13.4 to −3.6)

Long term (12 months): 17.4 (16.4) vs. 24.4 (18.3), difference −7.0 (95% CI – 12.1 to −1.9)

Long term (18 months): 17.56 (15.62) vs. 23.80 (18.53), difference −6.2 (95% CI −11.9 to −0.60)

Long term (24 months): 15.36 (16.22) vs. 23.32 (17.74), difference −8.0 (95% CI −13.5 to −2.4)

Long term (30 months): 15.85 (16.39) vs. 21.41 (17.21), difference −5.6 (95% CI −11.1 to −0.05)

RMDQ (0 to 24)

Baseline: 9.80 (5.07) vs. 10.04 (5.28)

Short term: 9.01 (5.71) vs. 10.56 (5.78), difference −1.6 (95% CI −3.2 to 0.10)

Intermediate term: 7.03 (5.49) vs. 8.80 (5.68), difference −1.8 (95% CI −3.4 to −0.17)

Long term (12 months): 6.01 (5.8) vs. 8.9 (6.6), difference −2.89 (95% CI −4.5 to −1.2)

Long term (18 months): 5.86 (5.62) vs. 8.97 (6.54), difference −3.1 (95% CI −5.1 to −1.1)

Long term (24 months): 5.62 (5.89) vs. 7.88 (5.90), difference −2.3 (95% CI −4.2 to −0.33)

Long term (30 months): 5.52 (5.89) vs. 7.71 (6.35), difference −2.2 (95% CI – 4.2 to −0.18)

A vs. B, Mean (SD)

SF-36, Physical function (0 to 100) ^a

Baseline: 54.61 (23.27) vs. 54.53 (23.30)

Short term: 68.64 (23.39) vs. 60.93 (22.04), difference 7.7 (95% CI 1.2 to 14.3)

Intermediate term: 77.77 (18.71) vs. 63.698 (21.88), difference 14.1 (95% CI 8.2 to 19.9)

Long term (12 months): 80.3 (18.6) vs. 64.4 (22.8), difference 15.9 (95% CI 9.7 to 22.1)

SF-36, Role physical (0 to 100) ^a

Baseline: 30.70 (33.98) vs. 32.81 (36.86)

Short term: 57.88 (68.33) vs. 39.58 (36.93), difference 18.3 (95% CI 2.6 to 34.0)

Intermediate term: 66.03 (36.79) vs. 47.13 (39.04), difference 18.9 (95% CI 8.0 to 29.8)

Long term (12 months): 72.4 (37.3) vs. 56.04 (38.3), difference 16.3 (95% CI 5.2 to 27.6)

SF-36, Bodily pain (0 to 100) ^a

Baseline: 43.27 (22.59) vs. 47.45 (23.59)

Short term: 65.82 (22.56) vs. 56.35 (23.62), difference 9.5 (95% CI 2.8 to 16.1)

Intermediate term: 72.34 (22.77) vs. 60.27 (25.82), difference 12.1 (95% CI 5.1 to 19.1)

Long term (12 months): 69.5 (18.3) vs. 56.2 (21.3), difference 13.3 (95% CI 7.4 to 19.2)

SF-36, General health (0 to 100) ^a

Baseline: 50.41 (20.16) vs. 49.92 (19.80)

Short term: 59.67 (21.59) vs. 52.65 (23.34), difference 7.0 (95% CI 0.69 to 13.3)

Intermediate term: 61.01 (21.96) vs. 53.29 (22.83), difference 7.7 (95% CI 1.3 to 14.2)

Long term (12 months): 69.6 (21.7) vs. 59.9 (24.3), difference 9.7 (95% CI 2.9 to 16.5)

SF-36,Vitality (0 to 100) ^a

Baseline: 53.58 (19.22) vs. 53.95 (20.02)

Short term: 60.10 (23.25) vs. 55.05 (20.74), difference 5.1 (95% CI −1.3 to 11.4)

Intermediate term: 65.70 (22.25) vs. 59.84 (22.35), difference 5.9 (95% CI −0.56 to 12.3)

Long term (12 months): 70.3 (22.5) vs. 63.1 (22.5), difference 7.2 (95% CI 0.54 to 13.9)

SF-36, Mental health (0 to 100) ^a

Baseline: 47.43 (13.96) vs. 44.00 (13.10)

Short term: 65.13 (21.59) vs. 57.70 (23.22), difference 7.4 (95% CI 0.97 to 13.9)

Intermediate term: 66.04 (23.67) vs. 61.41 (23.25), difference 4.6 (95% CI −2.1 to 11.4)

Long term (12 months): 71.8 (20.2) vs. 58.9 (24.9), difference 12.9 (95% CI 6.2 to 19.6)

SF-36, Role emotional (0 to 100) ^a

Baseline: 38.04 (40.32) vs. 49.65 (44.580)

Short term: 50.72 (45.15) vs. 41.31 (44.25), difference 9.4 (95% CI −3.5 to 22.3)

Intermediate term: 58.33 (45.99) vs. 52.43 (47.07), difference 5.9 (95% CI −7.5 to 19.3)

Long term (12 months): 72.4 (42.3) vs. 53.1 (46.6), difference 19.3 (95% CI 6.1 to 32.5)

SF-36, Social Function (0 to 100) ^a

Baseline: 62.22 (24.65) vs. 63.02 (28.55)

Short term: 59.78 (21.12) vs. 51.77 (21.20), difference 8.0 (95% CI 1.9 to 14.1)

Intermediate term: 76.90 (23.50) vs. 69.37 (26.65), difference 7.5 (95% CI 0.30 to 14.8)

Long term (12 months): 81.6 (19.3) vs. 70.05 (27.4), difference 11.6 (95% CI 4.5 to 18.6)

Tavaflan, 2008

Iran

Mean duration of pain: 9.07 months

RCT

Fair

A. Comprehensive pain management program (n=50)

4 days, intensity NR, individual, outpatient

B. Pharmacological therapy alone (n=52)

Acetaminophen, NSAID and chlordiazepoxide

Mean age: 44 years

% Female: 100%

Race/ethnicity: NR

Pain etiology/type: Chronic LBP

Disability: NR

Comorbidities:

-

% Smokers: 3.9%

A vs. B, Mean (SD)

SF-36 PCS (0 to 100)

Baseline: 44.3 (16.8) vs. 42.6 (24.0)

Short term: 76.7 (17.3) vs. 51.2 (28.1), difference 25.5 (95% CI 14.9 to 36.3)

Intermediate term: 66.6 (27.5) vs. 51.2 (28.8), difference 15.4 (95% CI 2.4 to 28.5)

Long term: 64.7 (36.3) vs. 51.1 (28.3), difference 13.6 (95% CI −1.5 to 28.7)

SF-36 MCS (0 to 100)

Baseline: 47.7 (28) vs. 49.5 (23.1)

Short term: 80.4 (22.8) vs. 57.4 (29.5), difference 23.0 (95% CI 10.8 to 35.2)

Intermediate term: 66.9 (29.9) vs. 57.9 (25.5), difference 9.0 (95% CI −3.9 to 21.9)

Long term: 65.1 (27.2) vs. 60.2 (26.6), difference 4.9 (95% CI −7.6 to 17.4)

Thieme 2003

Germany

Mean duration of pain: 195.7 months

RCT

Fair

A. Comprehensive pain management program (n=42)

5 weeks, 75 hours total, combination of individual and group, inpatient

B. Physical Activity + Pharmacological therapy (n=21)

5 weeks, Antidepressants, physical component not well described, mostly passive

Mean age: 48 years

% Male: 0% (female only for inclusion)

Race/ethnicity: NR

Pain etiology/type: Fibromyalgia

Disability: NR

Other characteristics:

-

Patients were excluded if they had inflammatory cause of the pain, neurologic complications, duration of pain less than 4 months, pregnancy, another severe disease such as a tumor, liver, or renal disease, major psychiatric disorders.

A vs. B, Mean (SD)

MPI, Pain intensity (0 to 6)

Baseline: 4.43 (0.98) vs. 4.34 (1.11)

Postintervention: 3.82 (0.96) vs. 5.47 (1.06), difference −1.7 (95% CI −2.2 to −1.1)

Intermediate term: 3.66 (1.22) vs. 4.85 (0.86), difference −1.2 (95% CI −1.8 to −0.59)

Long term: 3.18 (1.27) vs. 5.28 (0.83), difference – 2.1 (95% CI −2.7 to −1.5)

MPI, Interference (0 to 6)

Baseline: 4.35 (1.01) vs. 4.43 (0.91)

Postintervention: 3.29 (1.02) vs. 5.28 (0.86), difference −2.0 (95% CI −2.5 to −1.5)

Intermediate term: 2.96 (1.18) vs. 4.83 (0.72), difference −1.9 (95% CI −2.4 to −1.3)

Long term: 2.79 (1.37) vs. 5.33 (0.81), difference – 2.5 (95% CI −3.2 to −1.9)

MPI, Total activity (0 to 6)

Baseline: 2.53 (0.78) vs. 2.89 (0.91)

Postintervention: 2.65 (0.65) vs. 2.90 (0.92), difference −0.25 (95% CI −0.66 to 0.16)

Intermediate term: 2.68 (0.81) vs. 2.90 (0.93), difference −0.22 (95% CI −0.68 to 0.24)

Long term: 2.63 (0.70) vs. 2.90 (0.93), difference – 0.27 (95% CI −0.69 to 0.15)

A vs. B, Mean (SD)

MPI, Affective distress (0 to 6)

Baseline: 3.69 (1.33) vs. 3.72 (1.57)

Postintervention: 2.54 (1.03) vs. 4.46 (1.48), difference −1.9 (95% CI −2.6 to −1.3)

Intermediate term: 2.38 (1.29) vs. 4.47 (1.65), difference −2.1 (95% CI −2.9 to −1.3)

Long term: 2.46 (1.28) vs. 4.78 (1.60), difference −2.3 (95% CI −3.1 to −1.6)

A vs. B, mean (SD)

Program-related outcomes:

Number of doctor visits:

Baseline: 31.61 (19.88) vs. 28.60 (18.40)

15 months: 14.70 (9.90) vs. 37.8 (22. 03), difference 3.0 (95% CI −7.4 to 13.5)

Number of days at the hospital:

Baseline: 13.24 (22.96) vs. 10.35 (14.76)

15 months: 2.61 (6.34) vs. 18.65 (17.82), difference −16.04 (95% CI – 22.3 to −9.8)

Onac, 2012 & 2017

Romania

Mean duration of pain: NR

RCT

Poor

A. Comprehensive pain management program (n=29)

2 weeks, 5 days/week (total hours NR), individual, inpatient

B. Physical Activity + Pharmacological therapy (n=26)

2 weeks (total hours NR), Diclofenac (50mg, 3 times/day), Omeprazole (20 mg, 1 time/day), and Acetaminophen (1000 mg, 4 times/day) physical component not well described, mostly passive

Population data include patients from the third arm of this trial

Mean age: 47 years

% Male: 57%

Race/ethnicity: NR

Pain etiology/type: Lumbar disk hernia

Disability: NR

Other characteristics: Patients were excluded if they had history of psychotic disorders, substance abuse disorders in past Short term, or certain personality disorders.

A vs. B, Mean (SD)

VAS pain (0 to 10)

All patients

Baseline: 3.83 (1.89) vs. 4.58 (2.59)

Postintervention (2 weeks): 3.02 (1.94) vs. 2.086 (2.17), difference 0.93 (95% CI −0.19 to 2.1)

Nonclinical catastrophizers

Baseline: 3.12 (1.70) vs. 3.53 (2.47)

Postintervention (2 weeks): 1.78 (1.14) vs. 1.52 (1.82), difference 0.26 (95% CI −0.83 to 1.3)

Clinical catastrophizers

Baseline: 4.32 (2.00) vs. 6.45 (1.60)

Postintervention (2 weeks): 3.77 (1.91) vs. 3.07 (2.49), difference 0.70 (95% CI −1.3 to 2.7)

RMDQ (0 to 24)

All patients

Baseline: 10.66 (6.73) vs. 11.16 (5.82)

Postintervention (2 weeks): 8.66 (7.11) vs. 7.16 (5.23), difference 1.5 (95% CI −2.0 to 5.0)

A vs. B, Mean (SD)

POMS-SV Emotional Distress (scale NR)

All patients

Baseline: 46.03 (26.52) vs. 45.16 (28.09)

Postintervention (2 weeks): 43.15 (31.16) vs. 41.90 (32.18), difference 1.25 (95% CI −16.1 to 18.6)

Jensen, 2001

Sweden

Duration of pain: 31 months

RCT

Fair

A. Comprehensive pain management program, (n=63): 4 weeks (33-34 hours/week, plus six 90-minute booster sessions over a period of 1 year after treatment); high intensity, group; Rehabilitation clinic

B. Psychological Therapy (n=49): 4 weeks, (13-14 hours/week, plus six 90-minute booster sessions over a period of 1 year after treatment); low intensity, group in person; Rehabilitation clinic

Mean age: 43 years

Male: 45%

Race/ethnicity: Swedish origin 67%

Pain etiology/type: Chronic nonspecific spinal pain

-

Cervical/thoracic pain: 42%

-

Lumbar pain: 46%

-

Mixed pain areas: 12%

-

Mean total sick leave in 6 months prior to inclusion in study: 292 (63)

-

NR

A vs. B, Mean (SD)

SF-36 Global health (0-100)

Females only (n=30 vs. 22)

Baseline: 38.1 (14.5) vs. 38.9 (13.7)

Postintervention: 47.6 (18.0) vs. 48.8 (16.8)

Intermediate term: 52.4 (21.6) vs. 54.2 (19.3)

Long term: 53.1 (24.5) vs. 58.2 (18.4)

-

improvement approached significance for group B at Long term(p=0.057)