Trial reportBMC musculoskeletal disorders2016
Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active).
Trial report in BMC musculoskeletal disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02181725 (Effectiveness and Cost-effectiveness of a Multimodal Rehabilitation Programme), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Physical activity and education about physical activity for chronic musculoskeletal pain in children and adolescents.The Cochrane database of systematic reviews · 2023Pooled it
- Pain-related fear in adolescents with chronic musculoskeletal pain: process evaluation of an interdisciplinary graded exposure program.BMC health services research · 2020Trial
- Trial
- Achievement Goals, Fear of Failure and Self-Handicapping in Young Elite Athletes with and without Chronic Pain.Children (Basel, Switzerland) · 2021Article
- Functional Disability in Adolescents with Chronic Pain: Comparing an Interdisciplinary Exposure Program to Usual Care.Children (Basel, Switzerland) · 2020Article
- mHealth for pediatric chronic pain: state of the art and future directions.Expert review of neurotherapeutics · 2020Review
- Article
- Multidisciplinary Treatment for Hypermobile Adolescents with Chronic Musculoskeletal Pain.Journal of rehabilitation medicine. Clinical communications · 2020Article
- Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design.Contemporary clinical trials communications · 2019Article
- Best-Evidence for the Rehabilitation of Chronic Pain Part 1: Pediatric Pain.Journal of clinical medicine · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with CMP compared with care as usual. METHODS/
designPragmatic multicentre parallel group randomized controlled trial. Randomization by minimization (ratio 1:1) and treatment allocation will be concealed, computer-generated and performed by an independent organization. After randomization, data collection and researchers remain blinded. Inclusion of 124 adolescents and their parents is intended. This sample size is based on a 25 % difference in group mean on the primary outcome, with α = 5 %, β = 80 % and expected 15 % loss to follow up. Study population are adolescents (12-21 years) with CMP with an indication for outpatient rehabilitation treatment in the Netherlands. The intervention group receives a Multimodal Rehabilitation Program (MRP), a multidisciplinary outpatient individual rehabilitation program. MRP consists of 2 different treatment approaches: A graded exposure module or a combination module of graded exposure and physical training. Selection of a module depends on the needs of the patient. To both modules a parent module is added. The control group receives care as usual, which is the care currently provided in Dutch rehabilitation centres. Treatment duration varies between 7 and 16 weeks, depending on treatment allocation. Self-reported measurements are at baseline, and at 2, 4, 10 and 12 months after start of treatment. Intention to treat analysis for between group differences on all outcome variables will be performed. Primary outcome is functional disability (Functional Disability Inventory). Secondary outcome variables are fear of pain, catastrophizing, perceived harmfulness, pain intensity, depressive symptoms, and quality of life. Total direct and indirect costs and health related quality of life will be measured. Process evaluation focuses on protocol adherence, patient centeredness and treatment expectations. DISCUSSION: A pragmatic approach was chosen, to ensure that results obtained are most applicable to daily practice.
trial registrationClinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.