2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT02181725
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-15
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Functional Disability	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Adolescent self-reported functional disability

Secondary Outcome Measures

Name	Time	Method
Change in Pain Catastrophizing	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Parental catastrophizing about their child's pain
Change in Functional Disability	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Parent-perceived functional disability of their child
Change in Depressive symptoms	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Adolescent self-reported depressive symptoms
Change in Pain Intensity	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Adolescent self-reported pain intensity
Change in General Health Related Quality of Life	Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Treatment expectations	Baseline	Parent self-report
Treatment satisfaction/ patient centeredness	16 weeks
Change in Quality of life	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Adolescent self-reported pain-specific quality of life
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	Parent self-reported adolescent related costs
Change in Perceived Harmfulness	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Adolescent self-reported perceived harmfulness of daily activities
Change in Fear of Pain	Baseline, 8 weeks, 16 weeks, 10 months, 12 months	Parent proxy report measure

Trial Locations

Locations (4)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands

Laurentius Ziekenhuis Roermond; 🇳🇱 Roermond, Limburg, Netherlands

Revant Revalidatiecentrum Breda; 🇳🇱 Breda, Noord Brabant, Netherlands

Rijndam Revalidatiecentrum; 🇳🇱 Rotterdam, Zuid Holland, Netherlands