VR-integrated MBCT may improve functional disability and pain bothersomeness in patients with chronic non-specific low back pain (CNLBP) compared to usual care alone.
This protocol describes a randomized controlled trial to evaluate the efficacy and safety of an 8-week VR-integrated mindfulness-based cognitive therapy (VR-MBCT) as an adjunct to usual care in 214 patients with CNLBP. Primary outcomes are the proportions of patients achieving at least 30% improvement in functional disability (Oswestry Disability Index) and pain bothersomeness (0-10 scale) at week 8. The trial is open-label and will analyze data using intention-to-treat generalized estimating equations.
Evidence Score
Study Evidence
Study 1. Effect of virtual reality-integrated mindfulness-based cognitive therapy on pain and psychological symptoms in chronic non-specific low back pain: protocol for a randomized controlled trial.
observationalWang P, Yuan J, Gu Q, Dai G, Zhu X, Liu Z, Yu Y, Jin X ยท Frontiers in digital health (2026)
Result:
Mechanism Graph
Limitations
- โ Open-label design may introduce performance and detection bias
- โ Results not yet available; only protocol described
- โ Generalizability limited to patients from pain clinics in three hospitals
Frequently Asked Questions
What is the primary outcome of this trial?โผ
The primary outcomes are the proportions of patients achieving at least 30% improvement from baseline in functional disability (ODI) and self-reported back pain bothersomeness (0-10 scale) at week 8.
How long is the VR-MBCT intervention?โผ
The intervention lasts 8 weeks, with weekly in-clinic VR sessions supplemented by structured audio-guided home practice.
What is the sample size and randomization?โผ
The trial will recruit 214 patients with CNLBP, randomized 1:1 to VR-MBCT plus usual care or usual care alone, using stratified block randomization by center and age (โฅ60 vs <60).
What safety outcomes are being measured?โผ
Safety outcomes include VR-related adverse events such as vertigo, vomiting, nausea, headache, and falls.
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References
- 1.Wang P, Yuan J, Gu Q, Dai G, Zhu X, Liu Z, Yu Y, Jin X. "Effect of virtual reality-integrated mindfulness-based cognitive therapy on pain and psychological symptoms in chronic non-specific low back pain: protocol for a randomized controlled trial.." Frontiers in digital health, 2026. PMID: 42614598 DOI: 10.3389/fdgth.2026.1902063