Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active)
Open accessAbstract
BACKGROUND: Chronic 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/DESIGN: Pragmatic 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 REGISTRATION: Clinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante.
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There are several emerging interventions focusing on graded in-vivo exposure therapy (GET) for children and adolescents with chronic pain.
“Additionally, there are several emerging interventions focusing on graded in-vivo exposure therapy (GET) for children and adolescents with chronic pain [51]; (GET Living, NCT: 03699007).”
From Best-evidence for the rehabilitation of chronic pain part 1: Pediatric pain (2019) · cites this paper as [51]
The Background (‘Treatment of chronic pain’) describes a recently developed graded-exposure rehabilitation program with two treatment approaches for adolescents with chronic musculoskeletal pain. The Methods (‘Interventions’) details those approaches, but the paper does not establish that several distinct graded-exposure interventions are emerging for children and adolescents more broadly. Page numbers were not available in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measuredOne ongoing RCT in the Netherlands, "2B Active", combines GET and physical therapy to increase functioning by having patients complete activity exposures.
“One ongoing randomized controlled trial (RCT) in the Netherlands, “2B Active”, combines GET and physical therapy to increase functioning by having patients complete activity exposures [51].”
From Best-evidence for the rehabilitation of chronic pain part 1: Pediatric pain (2019) · cites this paper as [51]
The Methods > Interventions section describes graded exposure through feared activities and movements, and the Background > Aims section identifies reduced functional disability as the trial’s goal. But the protocol offers either graded exposure alone or graded exposure combined with physical training; the combination is reserved for adolescents with joint-hypermobility-related pain. Thus, it does not say the intervention combines both for every patient. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOver the last several years, effort has been made to develop interdisciplinary outpatient treatments, such as FIT Teens, 2B Active, and GET Living, and preliminary outcomes are promising.
“Over the last several years, effort has been made to develop interdisciplinary outpatient treatments, such as FIT Teens [49], 2B Active [51], and GET Living (NCT: 03699007), and preliminary outcomes are promising [51].”
From Best-evidence for the rehabilitation of chronic pain part 1: Pediatric pain (2019) · cites this paper as [51]
The Background (‘Treatment of chronic pain’; page unavailable) identifies 2B Active as a study of a newly developed multidisciplinary outpatient rehabilitation program. The Discussion calls multidisciplinary treatment promising, but this paper is a study protocol and does not report preliminary outcomes for 2B Active. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThere is one ongoing randomized controlled trial of multimodal pain rehabilitation for adolescents with chronic musculoskeletal pain in the Netherlands that combines GET and physical therapy, but does not specifically target patients with elevated fear avoidance.
“There is one ongoing randomized controlled trial of multimodal pain rehabilitation for adolescents with chronic musculoskeletal pain in the Netherlands that combines GET and physical therapy [17], but does not specifically target patients with elevated fear avoidance.”
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Self-citation
- Authors
- Dekker, C., Goossens, M. E. J. B., Bastiaenen, C. H. G., & Verbunt, J. A. M. C. F.
- Affiliations
- Maastricht University (NL)
- Maastricht University Medical Centre (NL)
- Corresponding author
- Dekker, Carolien
- Venue
- BMC Musculoskeletal Disorders
- Published
- 2016-07-28
- Volume
- 17
- Issue
- 1
- Pages
- 317-317
- ISSN
- 1471-2474 (ISSN-L)
- PMC
- PMC4964076
- OpenAlex
- W2487277524
- Cited by
- 23
- References
- 75
- Citations by year
- 2024: 1 · 2023: 1 · 2022: 1 · 2021: 4 · 2020: 5 · 2019: 7 · 2017: 2 · 2016: 1 · 2014: 1
- FWCI
- 2.69
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMC Musculoskeletal Disorders (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, cc-by)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Funders
- Fonds NutsOhra (1202-068)
- Stichting Vooruit
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pediatric Pain Management Techniques
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
- Keywords
- chronic musculoskeletal pain, adolescents, multimodal rehabilitation, outpatient rehabilitation, graded exposure, fear-avoidance model, pain catastrophizing, fear of pain, functional disability, parental involvement, exercise training, health-related quality of life, treatment costs, process evaluation
- MeSH terms
- Adolescent, Adult, Ambulatory Care, Avoidance Learning, Combined Modality Therapy, Depression, Disability Evaluation, Exercise Therapy, Female, Humans, Netherlands, Pain Measurement, Parents, Quality of Life, Treatment Outcome, Health Care Costs, Patient-Centered Care, Young Adult, Precision Medicine, Catastrophization, Chronic Pain, Musculoskeletal Pain
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