Study Overview: This multicentric, prospective, exploratory, interventional pilot study aims to assess the feasibility of integrating an immersive virtual reality (VR) headset into a functional restoration program (FRP) for patients with chronic low back pain (CLBP). Chronic low back pain is a leading cause of disability, and although current FRP approaches have demonstrated benefits, there is limited research on the integration of emerging technologies like VR into these rehabilitation programs. The primary focus of this study is to evaluate the acceptability and usability of VR technology among both healthcare providers and patients involved in group-based FRP rehabilitation. Secondary objectives include assessing the potential effects of VR on reducing kinesiophobia, improving motor imagery abilities, reducing pain, and enhancing overall functional capabilities. Study Objectives: Primary Objective: To assess the acceptability of the immersive VR headset for healthcare providers managing patients with CLBP in the context of a group-based FRP. Secondary Objectives: - To evaluate the usability and adherence of patients to the VR program.- To measure the effects of the VR sessions on kinesiophobia, motor imagery abilities, pain levels, and functional capacities. - To explore the factors influencing healthcare providers' and patients' acceptance of the VR device in this rehabilitation setting. Study Design: This study is designed as a pilot, multicentric, prospective, and interventional trial. Participants will be recruited from healthcare centers within the Lombaction network, a research-driven initiative for the management and evaluation of CLBP. Patients will receive standard FRP rehabilitation, along with 3 weekly VR sessions designed to enhance motor function and reduce pain through specific exercises targeting the spine and trunk. The VR system used is an immersive, wireless headset, designed to allow a wide variety of movement and requires no external controllers. Intervention: Patients will receive the standard FRP rehabilitation, which includes a combination of physiotherapy, hydrotherapy, occupational therapy, adapted physical activity, and therapeutic education workshops. The VR intervention will involve the use of a headset with pre-programmed exergames designed to improve trunk movement (flexion, extension, rotation, etc.). Each session will last 20 minutes, with exercises lasting 5-7 minutes each, aligned with current best practices in rehabilitation. The VR device is designed to be intuitive, requiring minimal setup, and will be used in a dedicated space at the rehabilitation center. In addition to the regular rehabilitation program, participants will engage in VR sessions three times per week for the duration of the FRP, which lasts 4-5 weeks. The VR sessions are intended to complement and enhance the physical rehabilitation by promoting movement, addressing kinesiophobia, and providing immersive, distraction-based pain management. Data Collection: Data will be collected at several points throughout the study: Baseline: At the beginning of the FRP, all patients will complete several questionnaires, including the Dallas Pain Questionnaire (DPQ), Tampa Scale for Kinesiophobia (TSK), Low Back Imagery Questionnaire, and a Visual Analog Scale (VAS) to assess pain. During the program: Patients will complete VAS assessments before and after each VR session. Weekly adherence data will be collected, noting whether the VR session was completed and the reasons for any missed sessions. End of the program: At the end of the FRP, participants will complete the same questionnaires as at baseline, as well as an additional acceptability questionnaire, and the System Usability Scale (SUS) to assess the usability of the VR device. Conclusion. This pilot study is designed to explore the feasibility of incorporating immersive VR technology into an existing FRP for patients with chronic low back pain. The results will provide valuable insights into the acceptability, usability, and potential therapeutic effects of VR in a group rehabilitation setting. If successful, this study could pave the way for larger trials to evaluate the long-term benefits of VR in the management of chronic low back pain and its integration into multidisciplinary rehabilitation programs.
