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Skelly AC, Chou R, Dettori JR, et al. Integrated and Comprehensive Pain Management Programs: Effectiveness and Harms [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 Oct. (Comparative Effectiveness Review, No. 251.)

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Integrated and Comprehensive Pain Management Programs: Effectiveness and Harms [Internet].

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Table B-6Summary results for trials addressing KQ1: CPMPs versus physical activity

Author, Year

Country

Pain Duration

Study Design

Study Quality

Intervention (n)

Comparator (n)

Duration/Intensity

Session Format

Setting (IP/OP)

Population

Primary Outcomes:

Pain, Function, and Opioid Use

Secondary Outcomes: HRQOL, Psychological Measures, Global ImprovementHarms, Utilization, Patient Satisfaction

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

Comorbidities:
-

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

NR

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)

NRNR

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%

Pain etiology/type: Chronic nonspecific spinal pain
-

Cervical/thoracic pain: 42%

-

Lumbar pain: 46%

-

Mixed pain areas: 12%

Disability: NR
-

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

Comorbidities: NR

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

Comorbidities:
-

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.

Other characteristics:
-

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)

Harms: one right tibial fracture in Group A which occurred at home; no other details provided

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

Harms: No adverse effect related to the interventions was reported

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%

Comorbidities: NR

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)

NR

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%

no leg pain: 14%

Disability pension:

-

Full 38%

-

Partial 24%

Previous back surgery: 15%

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)

VAS satisfaction (0-100)

(effect modification by RMDQ)

p=NS between groups except for in the 90th 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)

BDI = Beck Depression Inventory; CES-D = Center for Epidemiological Studies Depression; CI = confidence interval; CPMP = comprehensive pain management program; EQ-5D = EuroQol 5Dimensions; FIQ = Fibromyalgia Impact Questionnaire; FM = fibromyalgia; HADS = Hospital Anxiety and Depression Scale; HRQOL = health-related quality of life; IP = Inpatient; LBP = low back pain; MCS = Mental component summary score (of the SF-12 or SF-36); MVAS = Million visual analog scale; NR = not reported; NS = not statistically significant; ODI = Oswestry Disability Index; OP = outpatient; PA = physical activity; PACT = Performance Assessment of Capacity Testing; PCS = Physical component summary score (of the SF-12 or SF-36); PDI = Pain Disability Index; PPS = Pain Perception Scale; RCT = randomized controlled trial; SIP = Sickness Impact Profile; SD = standard deviation; SF-36 = Short-Form 36 questionnaire; STAI = State-Trait Anxiety Inventory; VAS = visual analog scale

a

Total number of consultations over a period of 2 months prior to measurement

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