Physiotherapy with integrated virtual reality for patients with complex chronic low back pain: protocol for a pragmatic cluster randomized controlled trial (VARIETY study)

BMC Musculoskeletal Disorders

Study Protocol

Raymond Ostelo¹  Harry van Goor²  Syl Slatman³  Jesper Knoop⁴  J. Bart Staal⁵ 

[1] Department of Health Sciences, Faculty of Science and Amsterdam Movement Science Research Institute, Vrije Universiteit, Amsterdam, the Netherlands;Department of Epidemiology and Data Science, Amsterdam UMC location Vrije Universiteit & Amsterdam Movement Sciences, Musculoskeletal Health, Amsterdam, the Netherlands;Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands;Research Group for Musculoskeletal Rehabilitation, HAN University of Applied Sciences, Nijmegen, the Netherlands;Biomedical Signals and Systems Group, Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, the Netherlands;Research Group for Musculoskeletal Rehabilitation, HAN University of Applied Sciences, Nijmegen, the Netherlands;Department of Health Sciences, Faculty of Science and Amsterdam Movement Science Research Institute, Vrije Universiteit, Amsterdam, the Netherlands;Research Group for Musculoskeletal Rehabilitation, HAN University of Applied Sciences, Nijmegen, the Netherlands;Radboud Institute for Health Sciences, IQ healthcare, Radboud University Medical Center, Nijmegen, the Netherlands;

关键词: Virtual reality (VR);    Physiotherapy;    Chronic low back pain;    Cluster randomized controlled trial (RCT);    Study protocol;   

DOI  :  10.1186/s12891-023-06232-0

 received in 2023-01-27, accepted in 2023-02-08,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundChronic low back pain (CLBP) is the most common chronic pain condition worldwide. Currently, primary care physiotherapy is one of the main treatment options, but effects of this treatment are small. Virtual Reality (VR) could be an adjunct to physiotherapy care, due to its multimodal features. The primary aim of this study is to assess the (cost-)effectiveness of physiotherapy with integrated multimodal VR for patients with complex CLBP, compared to usual primary physiotherapy care.MethodsA multicenter, two-arm, cluster randomized controlled trial (RCT) including 120 patients with CLBP from 20 physiotherapists will be conducted. Patients in the control group will receive 12 weeks of usual primary physiotherapy care for CLBP. Patients in the experimental group will receive treatment consisting of 12 weeks of physiotherapy with integrated, immersive, multimodal, therapeutic VR. The therapeutic VR consists of the following modules: pain education, activation, relaxation and distraction. The primary outcome measure is physical functioning. Secondary outcome measures include pain intensity, pain-related fears, pain self-efficacy and economic measures. Effectiveness of the experimental intervention compared to the control intervention on primary and secondary outcome measures will be analyzed on an intention-to-treat principle, using linear mixed-model analyses.DiscussionThis pragmatic, multicenter cluster randomized controlled trial, will determine the clinical and cost-effectiveness of physiotherapy with integrated, personalized, multimodal, immersive VR in favor of usual physiotherapy care for patients with CLBP.Trial registrationThis study is prospectively registered at ClinicalTrials.gov (identifier: NCT05701891).

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

40854_2023_451_Article_IEq4.gif