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Completed

NCT Number: NCT02181725

2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal Rehabilitation Program

Behavioral

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

Care as usual

Behavioral

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

Primary outcomes

  1. Change in Functional Disability

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-reported functional disability

Secondary outcomes

  1. Change in Quality of life

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-reported pain-specific quality of life

  2. Change in Fear of Pain

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-reported fear of pain

  3. Change in Fear of Pain

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Parent proxy report measure

  4. Change in Pain Catastrophizing

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-reported pain catastrophizing

  5. Change in Pain Catastrophizing

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Parental catastrophizing about their child's pain

  6. Change in Depressive symptoms

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-reported depressive symptoms

  7. Change in Perceived Harmfulness

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-reported perceived harmfulness of daily activities

  8. Change in Pain Intensity

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-reported pain intensity

  9. Change in Functional Disability

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Parent-perceived functional disability of their child

  10. Change in parental responses to childrens pain

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

  11. Treatment expectations

    Time frame: Baseline

    Adolescent self-report

  12. Treatment expectations

    Time frame: Baseline

    Parent self-report

  13. Treatment satisfaction/ patient centeredness

    Time frame: 16 weeks

  14. Treatment satisfaction/ family centeredness

    Time frame: 16 weeks

  15. Change in General Health Related Quality of Life

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

  16. Cost-diary per month

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Adolescent self-report of total health care utilization and other costs

  17. Cost-diary per month

    Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months

    Parent self-reported adolescent related costs

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Adelante, Centre of Expertise in Rehabilitation and Audiology
  • Fonds NutsOhra
  • Stichting Vooruit

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 4, 2014
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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