Chronic PainNCT02181725
2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain
A study testing Multimodal Rehabilitation Program and Care as Usual in people with Chronic Pain, run by Maastricht University Medical Center at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Multimodal Rehabilitation Program and Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jul 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Revant Revalidatiecentrum Breda
Breda, North Brabant, 4817 JW
Maastricht University Medical Center
Maastricht, Limburg, 6200 MD
Laurentius Ziekenhuis Roermond
Roermond, Limburg, 6040 AX
Rijndam Revalidatiecentrum
Rotterdam, South Holland, 3015 LJ
About this study
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)
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.
- Conditions
- Chronic Pain
- Being tested
- Multimodal Rehabilitation Program, Care as Usual
- Keywords
- Chronic Pain, Adolescent, Graded Exposure
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Rehabilitation ProgramBehavioural
Also called MRP
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 UsualBehavioural
Also called CAU
Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Rehabilitation Program | Experimental | Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM) Receives: 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. Receives: Behavioral: Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Disability
Adolescent self-reported functional disability
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Secondary outcomes (17)
Change in Quality of life
Adolescent self-reported pain-specific quality of life
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Fear of Pain
Adolescent self-reported fear of pain
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Fear of Pain
Parent proxy report measure
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Catastrophizing
Adolescent self-reported pain catastrophizing
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Catastrophizing
Parental catastrophizing about their child's pain
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Depressive symptoms
Adolescent self-reported depressive symptoms
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Perceived Harmfulness
Adolescent self-reported perceived harmfulness of daily activities
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Intensity
Adolescent self-reported pain intensity
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Functional Disability
Parent-perceived functional disability of their child
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in parental responses to childrens pain
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Treatment expectations
Adolescent self-report
Measured: Baseline
Treatment expectations
Parent self-report
Measured: Baseline
Treatment satisfaction/ patient centeredness
Measured: 16 weeks
Treatment satisfaction/ family centeredness
Measured: 16 weeks
Change in General Health Related Quality of Life
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Cost-diary per month
Adolescent self-report of total health care utilization and other costs
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Cost-diary per month
Parent self-reported adolescent related costs
Measured: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds NutsOhra, Stichting Vooruit, Adelante, Centre of Expertise in Rehabilitation and Audiology
- Responsible party
- Sponsor
- Investigators
- Marielle Goossens, PhD, Principal investigator, Maastricht University, FHML, Department of Rehabilitation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181725
- Sponsor's protocol ID
- NL47323.068.13/METC13-3-062
- Other IDs
- 1202-068
- Status last verified
- Jun 2018
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32171308Dekker 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.
PubMed 27464953
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02181725
- Acronym / sponsor ID
- NL47323.068.13/METC13-3-062
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Adolescent, Graded Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Fonds NutsOhra, Stichting Vooruit, Adelante, Centre of Expertise in Rehabilitation and Audiology
- Study start
- Jul 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Rehabilitation Program | Experimental | Behavioral: Multimodal Rehabilitation ProgramMultimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM) |
| Care as Usual | Active comparator | Behavioral: Care as UsualCare as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Rehabilitation ProgramAlso: MRPThe 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). | Behavioural | Multimodal Rehabilitation Program |
| Care as UsualAlso: CAUCare as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity. | Behavioural | Care as Usual |
Primary outcome
Change in Functional Disability
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported functional disability
17 secondary outcomes
Change in Quality of life
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Fear of Pain
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Fear of Pain
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Catastrophizing
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Catastrophizing
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Depressive symptoms
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Perceived Harmfulness
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Intensity
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Functional Disability
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in parental responses to childrens pain
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Treatment expectations
Time frame: Baseline
Treatment expectations
Time frame: Baseline
Treatment satisfaction/ patient centeredness
Time frame: 16 weeks
Treatment satisfaction/ family centeredness
Time frame: 16 weeks
Change in General Health Related Quality of Life
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Cost-diary per month
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Cost-diary per month
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Derived from this study: PubMed 32171308Dekker 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.
- Derived from this study: PubMed 27464953Dekker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Goossens, PhD principal investigator
Maastricht University, FHML, Department of Rehabilitation Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Rehabilitation Program and Care as Usual in people with Chronic Pain, run by Maastricht University Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Disability (time frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02181725, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.