2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether a multimodal rehabilitation program effectively reduces functional disability in adolescents with chronic musculoskeletal pain, compared to care as usual.

Official Title
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Effectiveness and Cost-effectiveness of a Multimodal Rehabilitation Programme (MRP) for Adolescents With Chronic Musculoskeletal Pain (12-21 Years) Compared to Care as Usual (CAU); a Randomized Clinical Trial (2B Active)

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Multimodal Rehabilitation Program
* Behavioral: Care as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12-21 years at the start of the study Complaints of chronic non-specific musculoskeletal pain of a duration > 3 months Considerable activity limitations Fear of movement Indication for outpatient multidisciplinary rehabilitation treatment Adequate Dutch literacy to complete the assessments (which mainly comprise questionnaires) Exclusion Criteria: Any suspicion of a medical (orthopaedic, rheumatic or neurological) disease, that can explain the current pain complaints Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine. Pregnancy

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal Rehabilitation Program<br>Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM) | Behavioral: Multimodal Rehabilitation Program<br>* The Multimodal Rehabilitation Program is a Graded exposure based treatment. It consists of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM).<br>* Other names: MRP;|
| Active Comparator: Care as Usual<br>Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity. | Behavioral: Care as Usual<br>* Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.<br>* Other names: CAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Disability | Adolescent self-reported functional disability | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life | Adolescent self-reported pain-specific quality of life | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Fear of Pain | Adolescent self-reported fear of pain | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Fear of Pain | Parent proxy report measure | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Pain Catastrophizing | Adolescent self-reported pain catastrophizing | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Pain Catastrophizing | Parental catastrophizing about their child's pain | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Depressive symptoms | Adolescent self-reported depressive symptoms | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Perceived Harmfulness | Adolescent self-reported perceived harmfulness of daily activities | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Pain Intensity | Adolescent self-reported pain intensity | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in Functional Disability | Parent-perceived functional disability of their child | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Change in parental responses to childrens pain |  | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Treatment expectations | Adolescent self-report | Baseline | 
| Treatment expectations | Parent self-report | Baseline | 
| Treatment satisfaction/ patient centeredness |  | 16 weeks | 
| Treatment satisfaction/ family centeredness |  | 16 weeks | 
| Change in General Health Related Quality of Life |  | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Cost-diary per month | Adolescent self-report of total health care utilization and other costs | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 
| Cost-diary per month | Parent self-reported adolescent related costs | Baseline, 8 weeks, 16 weeks, 10 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Adolescent, Graded Exposure