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| ID | Type | Description | Link |
|---|---|---|---|
| 1202-068 | Other Grant/Funding Number | Fonds NutsOhra |
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| Name | Class |
|---|---|
| Fonds NutsOhra | OTHER |
| Stichting Vooruit | UNKNOWN |
| Adelante, Centre of Expertise in Rehabilitation and Audiology | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Rehabilitation Program | Experimental | Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Disability | Adolescent self-reported functional disability | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of life | Adolescent self-reported pain-specific quality of life | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Fear of Pain | Adolescent self-reported fear of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marielle Goossens, PhD | Maastricht University, FHML, Department of Rehabilitation Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6200 MD | Netherlands | ||
| Laurentius Ziekenhuis Roermond |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32171308 | Derived | 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. | |
| 27464953 |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
|
| Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Fear of Pain | Parent proxy report measure | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Pain Catastrophizing | Adolescent self-reported pain catastrophizing | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Pain Catastrophizing | Parental catastrophizing about their child's pain | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Depressive symptoms | Adolescent self-reported depressive symptoms | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Perceived Harmfulness | Adolescent self-reported perceived harmfulness of daily activities | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Pain Intensity | Adolescent self-reported pain intensity | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in Functional Disability | Parent-perceived functional disability of their child | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Change in parental responses to childrens pain | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Treatment expectations | Adolescent self-report | Baseline |
| Treatment expectations | Parent self-report | Baseline |
| Treatment satisfaction/ patient centeredness | 16 weeks |
| Treatment satisfaction/ family centeredness | 16 weeks |
| Change in General Health Related Quality of Life | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Cost-diary per month | Adolescent self-report of total health care utilization and other costs | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Cost-diary per month | Parent self-reported adolescent related costs | Baseline, 8 weeks, 16 weeks, 10 months, 12 months |
| Roermond |
| Limburg |
| 6040 AX |
| Netherlands |
| Revant Revalidatiecentrum Breda | Breda | North Brabant | 4817 JW | Netherlands |
| Rijndam Revalidatiecentrum | Rotterdam | South Holland | 3015 LJ | Netherlands |
| 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. |