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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02181725
Enrollment
60
Registered
2014-07-04
Start date
2014-07-31
Completion date
2018-01-31
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic Pain, Adolescent, Graded Exposure

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.

Interventions

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).

BEHAVIORALCare 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.

Sponsors

Fonds NutsOhra
CollaboratorOTHER
Stichting Vooruit
CollaboratorUNKNOWN
Adelante, Centre of Expertise in Rehabilitation and Audiology
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Functional DisabilityBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-reported functional disability

Secondary

MeasureTime frameDescription
Treatment expectationsBaselineAdolescent self-report
Treatment satisfaction/ patient centeredness16 weeks
Treatment satisfaction/ family centeredness16 weeks
Change in General Health Related Quality of LifeBaseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Functional DisabilityBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsParent-perceived functional disability of their child
Change in Quality of lifeBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-reported pain-specific quality of life
Change in parental responses to childrens painBaseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain CatastrophizingBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-reported pain catastrophizing
Change in Depressive symptomsBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-reported depressive symptoms
Change in Perceived HarmfulnessBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-reported perceived harmfulness of daily activities
Change in Pain IntensityBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-reported pain intensity
Cost-diary per monthBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-report of total health care utilization and other costs
Change in Fear of PainBaseline, 8 weeks, 16 weeks, 10 months, 12 monthsAdolescent self-reported fear of pain

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026