Study protocol: use of virtual reality in a functional restoration programme for the spine-single-arm acceptance...

Chronic low back pain (CLBP) is a leading cause of disability worldwide, significantly affecting patients' quality of life. Functional restoration programmes (FRPs) are recommended to improve functional abilities and alleviate kinesiophobia, but the integration of emerging technologies like immersive virtual reality (VR) remains underexplored. VR has shown potential in reducing pain and enhancing motor imagery (MI), but its application in group-based rehabilitation for CLBP is novel. This study protocol aims to assess the feasibility and acceptability of adding immersive VR to multicentre FRPs for CLBP.

This multicentric, prospective, single-arm exploratory pilot study assesses the acceptance of incorporating an immersive VR headset into FRP for patients with CLBP. Participants will include healthcare providers and patients from centres in the Lombaction network. Patients will engage in standard FRP alongside three weekly VR sessions targeting trunk mobility and pain reduction. The primary objective is to evaluate the acceptance of the VR device among healthcare providers and patients (Unified Theory of Acceptance and Use of Technology 2-based questionnaire). Secondary outcomes include acceptability, usability (System Usability Scale), adherence, safety and effects on kinesiophobia, MI, pain levels and functional capacities. Data collection includes baseline and post-intervention questionnaires, adherence monitoring and standardised scales (eg, Tampa Scale for Kinesiophobia, Dallas Pain Questionnaire).

Ethical approval was granted by Comité de Protection des Personnes Sud-Est VI on 10 January 2025; all participants will provide written informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summaries to participating centres.

NCT06724679.