Trial reportBMC musculoskeletal disorders2026
Physiotherapy with integrated virtual reality for patients with severe chronic low back pain: cluster-randomized controlled trial (VARIETY).
Trial report in BMC musculoskeletal disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05701891 (The), which is not on this map. Cited by 1 paper.
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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.
The (Cost-)Effectiveness of an Innovative, Personalised Intervention of Therapeutic VirtuAl Reality IntEgrated Within physioTherapY for a Subgroup of Complex Chronic Low Back Pain Patients
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
introductionChronic low back pain (CLBP) is a leading cause of disability worldwide. Physiotherapy is a common treatment, but its effect on physical functioning is generally modest, particularly for patients with severe complaints (i.e., high levels of disability and pain). Virtual Reality (VR) may complement physiotherapy, yet evidence for its effectiveness remains limited. The aim of this study was to assess the effectiveness and feasibility of a VR intervention integrated within physiotherapy for people with severe CLBP.
methodsA cluster-RCT across Dutch physiotherapy practices was conducted. Patients in the control group received 12 weeks of usual care following physiotherapy guidelines. Patients in the intervention group received similar usual care, enhanced with integrated, home-based VR consisting of pain education, exercise therapy, and relaxation modules. The primary outcome was physical functioning at three months. Secondary outcomes included feasibility, pain intensity, and catastrophizing. Analyses were conducted using linear mixed-effect models accounting for clustering by physiotherapy practice.
resultsTwenty-five patients participated in the intervention group and seven in the VARIETY control group, instead of the planned sample size of 120 participants. Due to poor recruitment (n = 7), we supplemented the VARIETY control group with 18 historical controls from two comparable trials (total control n = 25), effectiveness analyses are therefore exploratory. Between-group differences were neither statistically significant nor clinically relevant for all outcome measures, compared to the VARIETY control group (e.g., ODI mean difference at three months: -4.80, 95%CI: -17.78;8.18), or the total control group (-8.80, 95%CI: -20.17;2.57). The intervention group showed greater improvements from baseline in physical functioning (42%), compared to the VARIETY control group (26%). The intervention was considered feasible and safe to use in practice. DISCUSSION: This study found limited support for the use of VR as an adjunct to physiotherapy for people with severe CLBP. Given the use of external control data and the limited sample size, the effectiveness results should be interpreted cautiously. Further well-powered trials should reconsider study procedures to optimize patient recruitment and corroborate VR's clinical effectiveness in physiotherapy.
trial registrationThe study was registered with ClinicalTrials.gov on 2022-12-02 (reference number: NCT05701891).
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