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)

Maastricht University Medical Center4 sites in 1 country60 target enrollmentJuly 2014

ConditionsChronic Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Maastricht University Medical Center
Enrollment: 60
Locations: 4
Primary Endpoint: Change in Functional Disability
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

January 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Functional Disability

Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

Adolescent self-reported functional disability

Secondary Outcomes

Change in Pain Catastrophizing(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
Change in Functional Disability(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
Change in Depressive symptoms(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
Change in Pain Intensity(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
Change in General Health Related Quality of Life(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
Treatment expectations(Baseline)
Treatment satisfaction/ patient centeredness(16 weeks)
Change in Quality of life(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 satisfaction/ family centeredness(16 weeks)
Cost-diary per month(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
Change in Perceived Harmfulness(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
Change in Fear of Pain(Baseline, 8 weeks, 16 weeks, 10 months, 12 months)