Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

Study Overview
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Brief Summary
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Purpose: The overall aim is to investigate the effect of interdisciplinary rehabilitation in primary health care (PHC) for patients with chronic pain. Specific questions: What is the effect of extended access to the interdisciplinary PHC pain team + a booster session after finishing the rehabilitation program? Does participation in PHC interdisciplinary rehabilitation contribute to health improvements and are there predictors of this? Method: A randomized controlled trial (RCT). 200 patients with chronic pain that participate in interdisciplinary rehabilitation in primary healthcare in Region Västra Götaland (VGR) in Sweden will be included in the RCT and randomized to Intervention; standard care by the interdisciplinary teams in PHC + extended access to the team and a booster session 3 months after the end of the rehabilitation, or Control; only standard care by the interdisciplinary teams. Outcomes are health related quality of life, pain intensity and other health aspects.

Detailed Description
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The participants will be randomly allocated to intervention or active control. All participants in both arms receive the standard care for interdisciplinary rehabilitation at any of the six PHC pain teams in VGR. The teams consist of a physician, physiotherapist, occupational therapist and psychologist. All teams provide person-centred rehabilitation, aiming to increase physical activity and support behavioural changes, and to decrease symptoms and the impact of pain on the patients´ daily lives. The standard care interdisciplinary rehabilitation period contains both theoretical and practical components such as patient education, physical exercise and behavioural interventions. The sessions are mainly group-based. The duration of the rehabilitation period varies between 5 to 7 weeks + a follow-up visit after 3 months. The participants in the intervention arm also receive an extra booster-session 3 months after the standard follow-up. At the booster-session, the participant´s individual rehabilitation plan is followed-up and adjusted. This extra period also includes extended access to the team, meaning that the participants have the possibility to contact the team and, if needed, have digital or telephone contact. The participants complete a battery of questionaires included in the Swedish Quality Registry for Pain Rehabilitation an also extra questionnaires provided to the participants through an electronic research form. Data collection is made at baseline before starting the rehabilitation, directly after the 5 to 7 weeks rehabilitation period and 6, 12 and 24 months after baseline.

Official Title
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Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare

Conditions
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Chronic Pain, Pain Management

Intervention / Treatment
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* Other: Interdisciplinary care + booster session (intervention)
* Other: Interdisciplinary care (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons participating in interdisciplinary team rehabilitation in primary healthcare in Region Västra Götaland, Sweden. Exclusion Criteria: Severe psychiatric disease, language difficulties that makes it impossible to complete the questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interdisciplinary rehabilitation + booster-session (intervention)<br>Standard care by the interdisciplinary rehabilitation teams in primary healthcare + extended access to the team and a booster visit after 3 months. | Other: Interdisciplinary care + booster session (intervention)<br>* Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden + one extra booster-session 3 months after the standard care rehabilitation. At the booster-session, the participant´s individual rehabilitation plan is followed-up and adjusted. This extra period also includes extended access to the team, meaning that the participants have the possibility to contact the team and, if needed, have digital or telephone contact.<br>|
| Active Comparator: Interdisciplinary rehabilitation (control)<br>Standard care by the interdisciplinary rehabilitation teams in primary healthcare. | Other: Interdisciplinary care (control)<br>* Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Assessed with visual analog scale and numeric rating scale | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Health related quality of life | Assessed with RAND-36, EQ5D-3L, EQ-VAS | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain spread | The participants mark in boxes painful areas. | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Pain acceptance | The Chronic pain acceptance questionnaire | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Self-efficacy | The Pain self-efficacy questionnaire short-form | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Symptoms of stress | The stress and crisis inventory (SCI-93) | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Physical activity | The Godin questionnaire | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Anxiety and depression | The hospital anxiety and depression scale | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Self-rated function | The Functional rating index | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Work ability | One question from the Work ability index | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Life satisfaction | The LiSat questionnaire | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Fatigue | The multidimensional fatigue inventory | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Pain catastrophizing | The pain catastrophizing scale | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Patients´ own impression of change | Patient global impression of change | Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline. | 
| Health care use | Health care visit statistics | From 12 months before to 24 months after the rehabilitation period | 
| Sickness abscence | Sickness absence data | From 12 months before to 24 months after the rehabilitation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised controlled trial, primary care