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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)