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

Abstract

Background 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. Methods 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. Discussion 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. Trial registration This study is prospectively registered at ClinicalTrials.gov (identifier: NCT05701891).

Development of a Multimodal, Personalized Intervention of Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low-Back Pain

“…VR and physiotherapy can strengthen each other as suggested in previous studies 22 , 23 and explicitly mentioned in the focus groups in this study. Learned principles through VR education can be made explicit for daily situations in conversation with a trained (physio)therapist, thereby enhancing patients' self-awareness.…”

“…The results of the pragmatic literature search yielded one relevant clinical guideline, 30 six RCTs, 15 , 21 , 22 , 42–44 three (systematic) reviews, 45–47 two other studies, 23 , 48 and one book 49 on VR and/or CLBP.…”

“…This mixed-methods study is part of the VARIETY project, which aims to investigate the (cost-)effectiveness of a personalized VR intervention integrated within a physiotherapy treatment for patients with CLBP in a large cluster RCT. 23 This study, which was conducted following the Medical Research Council (MRC) framework 24 and the best practice framework developed by the Virtual Reality Clinical Outcomes Research Experts (VR-CORE) international working group, 25 aimed at developing of our intervention in cocreation with the end users.…”

“… 22 This intervention will subsequently be evaluated for (cost-)effectiveness in a cluster randomized controlled trial (RCT). 23 …”

Effectiveness of pain education on pain, disability, quality of life and self-efficacy in chronic low back pain: A randomized controlled trial

“…The role of psychological factors in an individual's experience of LBP is reported to have a bearing on their function, pain perception, belief in self-efficacy, and quality of life [3,6,7]. The current multimodal interventions in the management of CLBP recommend approaches involving pain education programs delivered with standard physiotherapy care [8,9]. Pain education is a psychological approach that focuses on improving the knowledge and understanding of pain using biological and neurophysiological-biomechanical explanations to impart reconceptualization of beliefs about the experience of pain particularly when it is chronic [10].…”