2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Multimodal Rehabilitation Program; Behavioral: Care as Usual

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Maastricht University Medical Center
    • Roermond, Limburg, Netherlands, 6040 AX
      • Laurentius Ziekenhuis Roermond
  • Noord Brabant
    • Breda, Noord Brabant, Netherlands, 4817 JW
      • Revant Revalidatiecentrum Breda
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015 LJ
      • Rijndam Revalidatiecentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Rehabilitation Program; Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM)	Behavioral: Multimodal Rehabilitation Program; 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).; Other Names: MRP
Active Comparator: 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.	Behavioral: 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.; Other Names: CAU

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Fonds NutsOhra; Adelante, Centre of Expertise in Rehabilitation and Audiology; Stichting Vooruit
• Investigators: Principal Investigator: Marielle Goossens, PhD, Maastricht University, FHML, Department of Rehabilitation Medicine

Publications and helpful links

General Publications

• Dekker C, van Haastregt JCM, Verbunt JAMCF, de Jong JR, van Meulenbroek T, Pernot HFM, van Velzen AD, Bastiaenen CHG, Goossens MEJB. Pain-related fear in adolescents with chronic musculoskeletal pain: process evaluation of an interdisciplinary graded exposure program. BMC Health Serv Res. 2020 Mar 14;20(1):213. doi: 10.1186/s12913-020-5053-6.
• Dekker C, Goossens ME, Bastiaenen CH, Verbunt JA. Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active). BMC Musculoskelet Disord. 2016 Jul 28;17:317. doi: 10.1186/s12891-016-1178-5.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Adolescent; Chronic Pain; Graded Exposure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: NL47323.068.13/METC13-3-062; 1202-068 (Other Grant/Funding Number: Fonds NutsOhra)