Extraction form for project: IPMP (Integrated Pain Management Programs)

Design Details

1. What type of program does the study assess (IPMP or CPMP)?
Integrated Pain Management Program (IPMP): Based in, integrated with, coordinated by primary care. Comprehensive Pain Management Program (CPMP): Referral based and separate from primary care.
2. In what country was the study conducted?
List all applicable countries.
3. What study design was used?
Please select the appropriate study design for the study. If the study design is not listed, you may add the appropriate study design.
4. Mean age
Report across all patients included in relevant study arms. Round to whole number. Include the word "years" after reporting the mean age.
5. % male
Report across all patients included in relevant study arms. Round to whole number. Include "%" symbol.
6. % Non-white
Report across all patients included in relevant study arms. Round to whole number. Include "%" symbol. If not reported, put NR.
7. Mean duration of pain or symptoms
Report across all patients included in relevant study arms. Round to whole number. Report duration in terms of months. If not reported, put NR.
8. Pain etiology/type
9. Disability
Disability can be measured in several ways. For example, authors may report the percent of patients receiving disability payments or they may report the mean score of a continuous disability scale such as the Pain Disability Index. Either are appropriate here, just be explicit about what is being reported.
10. Comorbidities
Extract the percent of patients with relevant comorbidities. Round percentages to whole numbers. If not reported, put NR.
% Depression diagnosis
% Anxiety diagnosis
% PTSD disagnosis
% Overweight or obese
% w/ Substance Use Disorder
% Smokers
% Suicidal
11. Randomized, Analyzed, and Attrition (at longest followup point)
For attrition report as: % (n/N)
Randomized
Analyzed
Attrition
12. How was the study funded?
13. Notes and comments

Arms

Arm NameArm Description
IPMP
Usual Care- Patient education, give reassuring and positive information about the benign nature of LBP, offer written information including specific advice. - Advise avoiding bed rest and encourage the person to be physically active and continue with normal activities as far as possible. - Consider offering a structured physical exercises program tailored to personal preferences. - Physical exercise should be introduced gently at first (walking, cycling and swimming) and progressively increased in intensity. - Recommend attendance to the “Back school” after six weeks to those patients who have resumed their daily tasks. - Prescribe pharmacological treatment according to established guidelines.

Arm Details

1. Is the program practice-based or system-based?
IPMP
Usual Care
2. How many patients were randomized to this treatment arm?
IPMP
Usual Care
3. Program duration (weeks)
Please report the duration of the program in weeks and include "weeks" in the text box.
IPMP
Usual Care
4. Number of sessions per week
Report as X sessions/week
IPMP
Usual Care
5. Was the program conducted in the inpatient or outpatient setting?
Select one.
IPMP
Usual Care
6. Physical Functioning/Reconditioning & Psychological and Mental Health Components of Intervention
For treatment providers, you may write-in any options that are needed that are not already presented. For duration of treatment report as "X sessions per week over X weeks", when possible. For anything not reported, put NR.
IPMP
Physical Functioning/Reconditioning Components of InterventionPsychological and Mental Health Components of Intervention
Treatment types
Treatment providers
Mode of delivery
Duration of treatment
Tailoring
Adherence
Usual Care
Physical Functioning/Reconditioning Components of InterventionPsychological and Mental Health Components of Intervention
Treatment types
Treatment providers
Mode of delivery
Duration of treatment
Tailoring
Adherence
7. Medication Review and/or Management Components of Intervention
IPMP
Usual Care
8. Additional components of the intervention
IPMP
Usual Care
9. Description of care coordination/collaboration
IPMP
Usual Care

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainMcGill Pain Questionnaire Total Intensity Score
  • All Participants
  • Baseline
  • 3 months
  • 12 months
  • 3 month ∆
  • 12 month ∆
ContinuousPainMcGill Pain Questionnaire Current Intensity Score
  • All Participants
  • Baseline
  • 3 months
  • 12 months
  • 3 month ∆
  • 12 month ∆
ContinuousPainMcGill Pain Questionnaire VAS Pain Score
  • All Participants
  • Baseline
  • 3 months
  • 12 months
  • 3 month ∆
  • 12 month ∆
ContinuousDisabilityRoland–Morris Disability Questionnaire
  • All Participants
  • Baseline
  • 3 months
  • 12 months
  • 3 month ∆
  • 12 month ∆
ContinuousQOLSF-12 Physical Health Subscale
  • All Participants
  • Baseline
  • 3 months
  • 12 months
  • 3 month ∆
  • 12 month ∆
ContinuousQOLSF-12 Mental Health Subscale
  • All Participants
  • Baseline
  • 3 months
  • 12 months
  • 3 month ∆
  • 12 month ∆

Outcome Details

N/A

Risk of Bias Assessment

1. Randomization adequate?
Rating
2. Allocation concealment adequate?
Rating
3. Groups similar at baseline?
Rating
4. Outcome assessors masked?
Rating
5. Care providers masked?
Rating
6. Patient masked?
Rating
7. Reporting of attrition, crossovers, adherence, and contamination?
Rating
8. Loss to followup acceptable?
Overall ≤20%?
Difference between groups <10%?
9. Intention-to-treat (ITT) analysis?
Overall ≤20%?
10. Outcomes prespecified?
Overall ≤20%?
11. Quality determination
Overall ≤20%?

Results

Continuous


Pain (McGill Pain Questionnaire Total Intensity Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)

Pain (McGill Pain Questionnaire Current Intensity Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)

Pain (McGill Pain Questionnaire VAS Pain Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)

Disability (Roland–Morris Disability Questionnaire )

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)

QOL (SF-12 Physical Health Subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)

QOL (SF-12 Mental Health Subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
3 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
12 month ∆
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI low
95% CI high (adjMD)
95% CI high
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care (- Patient...)