Abstract
Chronic low back pain (cLBP) significantly impacts quality of life, highlighting the need for safe, home-based, non-pharmacological therapies. This study (NCT04409353) evaluated three interventions utilizing Virtual Reality (VR) for managing cLBP. 385 participants were randomized across three groups: Skills-Based VR (biofeedback, interoceptive training, and relaxation), Distraction VR (immersive 360-degree videos), and Sham VR (2D videos). The primary outcome was the change in PROMIS Pain Interference (PI). Secondary outcomes included the change in physical function, anxiety, depression, sleep disturbance, opioid use, and Fitbit-measured steps and sleep efficiency. No significant differences were observed between active VR (Skills-Based and Distraction) and Sham VR for the primary or most secondary outcomes. Secondary findings indicated a greater reduction in daily opioid use in the Distraction VR group compared to Sham VR (p = 0.009), and exploratory analyses revealed that baseline anxiety significantly predicted PROMIS-PI improvement within the Skills-Based VR (p = 0.025) group. Depression symptoms showed no such association. Adverse events were predominantly mild and self-limited, with cybersickness being the most common. Neither active VR program outperformed Sham VR for the primary outcome. High adherence across groups underscored the feasibility of home-based VR. Future studies, powered to test anxiety-moderated treatment effects and opioid-use reduction as primary outcomes, are warranted.
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Data availability
Per NIH and BACPAC consortium data-sharing requirements, deidentified datasets containing participant characteristics and PROs are published on the Vivli platform (https://doi.org/10.25934/PR00011733).
Code availability
The underlying code used for study is not publicly available but may be made available to qualified researchers on reasonable request from the corresponding author.
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Acknowledgements
This work is primarily supported by the NIH/NIAMS Award Number UH3AR076573. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. NIAMS had no role in the design of the study, and did not have a role in the analysis, interpretation of data, or decision to submit results for publication. AppliedVR provided the VR devices and software for the trial through grant budgetary support. However, the company was not involved in the conduct of the study, data analysis, interpretation, or the decision to submit the findings for publication. The study received additional support from the Marc and Sheri Rapaport Fund for Digital Health Science and Precision Health at Cedars-Sinai and NIH National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number UL1TR001881.
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B.M.R.S. wrote the main manuscript text. S.A.E. prepared Figure 1. S.Y.C. performed statistical analyses and prepared Table 1 and Figures 2-3. B.M.R.S., S.A.E., S.Y.C., S.P., M.L.I., S.V., J.T., F.A., M.A.V., Z.K., T.N., M.T., L.R., M.V., O.L., I.D., T.V., and J.F. reviewed the manuscript.
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The authors have no conflicts of interest to declare. AppliedVR, the manufacturer of RelieVRx, participated in the Cedars-Sinai Accelerator in partnership with Techstars in 2016; however, none of the authors are employed by AppliedVR, hold equity in the company, receive royalties from the company, or benefit financially from the Cedars-Sinai Accelerator. One author (B.S.) serves on the Editorial Board of npj Digital Medicine but had no involvement in the review, handling, or decision-making related to this manuscript.
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Spiegel, B.M.R., Eberlein, S.A., Persky, S. et al. Randomized-controlled trial of skills-based vr vs. distraction vr vs. sham VR for chronic low back pain. npj Digit. Med. (2026). https://doi.org/10.1038/s41746-026-02437-4
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DOI: https://doi.org/10.1038/s41746-026-02437-4
