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

• Published in: BMC musculoskeletal disorders Vol. 24; no. 1; pp. 132 - 9
• Main Authors: Slatman, Syl, Ostelo, Raymond, van Goor, Harry, Staal, J Bart, Knoop, Jesper
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 20.02.2023; BioMed Central; BMC
• Subjects: Back pain; Care and treatment; Causes of; Chronic Disease; Chronic low back pain; Chronic pain; Chronic Pain - diagnosis; Chronic Pain - therapy; Clinical trials; Cluster randomized controlled trial (RCT); Computer applications; Exercise; Health aspects; Humans; Informed consent; Intervention; Low back pain; Low Back Pain - diagnosis; Low Back Pain - therapy; Multicenter Studies as Topic; Pain; Participation; Patient outcomes; Patients; Physical fitness; Physical therapy; Physical Therapy Modalities; Physiotherapy; Primary care; Questionnaires; Randomized Controlled Trials as Topic; Social networks; Study Protocol; Therapeutics, Physiological; Treatment Outcome; Virtual Reality; Virtual reality (VR); Netherlands; Study protocol; Chronic low back pain; Virtual reality (VR); Cluster randomized controlled trial (RCT); Physiotherapy
• ISSN: 1471-2474; 1471-2474
• DOI: 10.1186/s12891-023-06232-0

Chronic 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. A 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. This 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. This study is prospectively registered at ClinicalTrials.gov (identifier: NCT05701891).