NCT02181725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

3.5 years

First QC Date

July 2, 2014

Last Update Submit

June 15, 2018

Conditions

Chronic Pain

Keywords

Chronic PainAdolescentGraded Exposure

Outcome Measures

Primary Outcomes (1)

  • Change in Functional Disability

    Adolescent self-reported functional disability

    Baseline, 8 weeks, 16 weeks, 10 months, 12 months

Secondary Outcomes (17)

  • Change in Quality of life

    Baseline, 8 weeks, 16 weeks, 10 months, 12 months

  • Change in Fear of Pain

    Baseline, 8 weeks, 16 weeks, 10 months, 12 months

  • Change in Fear of Pain

    Baseline, 8 weeks, 16 weeks, 10 months, 12 months

  • Change in Pain Catastrophizing

    Baseline, 8 weeks, 16 weeks, 10 months, 12 months

  • Change in Pain Catastrophizing

    Baseline, 8 weeks, 16 weeks, 10 months, 12 months

  • +12 more secondary outcomes

Study Arms (2)

Multimodal Rehabilitation Program

EXPERIMENTAL

Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM)

Behavioral: Multimodal Rehabilitation Program

Care as Usual

ACTIVE COMPARATOR

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

Interventions

Multimodal Rehabilitation ProgramBEHAVIORAL

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).

Also known as: MRP
Multimodal Rehabilitation Program
Care as UsualBEHAVIORAL

Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.

Also known as: CAU
Care as Usual

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Location

Laurentius Ziekenhuis Roermond

Roermond, Limburg, 6040 AX, Netherlands

Location

Revant Revalidatiecentrum Breda

Breda, North Brabant, 4817 JW, Netherlands

Location

Rijndam Revalidatiecentrum

Rotterdam, South Holland, 3015 LJ, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 32171308DERIVED

  • 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.

    PMID: 27464953DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marielle Goossens, PhD

    Maastricht University, FHML, Department of Rehabilitation Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 4, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

June 18, 2018

Record last verified: 2018-06

Locations

NL(4)