2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Care as Usual; Behavioral: Multimodal Rehabilitation Program

• 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

Arm && Interventions

Group	Intervention	Description
Care as Usual	Care as Usual	Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
Multimodal Rehabilitation Program	Multimodal Rehabilitation Program	Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM)

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)

Laurentius Ziekenhuis Roermond; 🇳🇱 Roermond, Limburg, Netherlands

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

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

Rijndam Revalidatiecentrum; 🇳🇱 Rotterdam, Zuid Holland, Netherlands