2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

Chronic Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181725
• Other study ID #: NL47323.068.13/METC13-3-062
• Secondary ID: 1202-068
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: January 2018

Study information

• Verified date: June 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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).
• 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.

Locations

Country	Name	City	State
Netherlands	Revant Revalidatiecentrum Breda	Breda	Noord Brabant
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Laurentius Ziekenhuis Roermond	Roermond	Limburg
Netherlands	Rijndam Revalidatiecentrum	Rotterdam	Zuid Holland

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Adelante, Centre of Expertise in Rehabilitation and Audiology, Fonds NutsOhra, Stichting Vooruit

Country where clinical trial is conducted

Netherlands, 

Outcome

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