Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02181725
Recruitment Status : Completed
First Posted : July 4, 2014
Last Update Posted : June 18, 2018
Sponsor:
Collaborators:
Fonds NutsOhra
Stichting Vooruit
Adelante, Centre of Expertise in Rehabilitation and Audiology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Multimodal Rehabilitation Program Behavioral: Care as Usual Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : July 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: CAU




Primary Outcome Measures :
  1. Change in Functional Disability [ Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months ]
    Adolescent self-reported functional disability


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181725


Locations
Layout table for location information
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200 MD
Laurentius Ziekenhuis Roermond
Roermond, Limburg, Netherlands, 6040 AX
Revant Revalidatiecentrum Breda
Breda, Noord Brabant, Netherlands, 4817 JW
Rijndam Revalidatiecentrum
Rotterdam, Zuid Holland, Netherlands, 3015 LJ
Sponsors and Collaborators
Maastricht University Medical Center
Fonds NutsOhra
Stichting Vooruit
Adelante, Centre of Expertise in Rehabilitation and Audiology
Investigators
Layout table for investigator information
Principal Investigator: Marielle Goossens, PhD Maastricht University, FHML, Department of Rehabilitation Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02181725    
Other Study ID Numbers: NL47323.068.13/METC13-3-062
1202-068 ( Other Grant/Funding Number: Fonds NutsOhra )
First Posted: July 4, 2014    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Keywords provided by Maastricht University Medical Center:
Chronic Pain
Adolescent
Graded Exposure
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations