RecruitingNot ApplicableNCT06724679

VRFR- Immersive Virtual Reality Use in a Spine Functional Restoration Program - A Feasibility Study

Sponsor

University Hospital, Angers

Enrollment

20 participants

Start Date

Mar 19, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Low-back Pain

Summary

This clinical trial investigates the feasibility of integrating immersive virtual reality (VR) technology into a functional restoration program (FRP) for patients with chronic low back pain (CLBP). The study aims to assess the acceptability, usability, and impact of a VR headset on both healthcare providers and patients participating in a group-based rehabilitation program. Chronic low back pain is a leading cause of functional disability worldwide and significantly impacts quality of life. Current rehabilitation strategies, including FRP, focus on improving physical functioning through multidisciplinary approaches. However, the role of emerging technologies, particularly VR, in enhancing these rehabilitation programs remains underexplored. VR has already shown promise in reducing chronic pain and improving motor abilities, but its application in a group rehabilitation context for CLBP is novel. The study will recruit healthcare providers and patients from several centers that are part of the Lombaction network. Participants will use a VR headset designed specifically to improve motor skills and reduce pain. The primary objective is to evaluate the acceptability of the VR device by healthcare providers and patients, as well as the usability and adherence to the VR program. Secondary objectives include assessing the impact of VR on kinesiophobia, pain, functional abilities, and motor imagery capabilities. This pilot study will provide valuable insights into the feasibility of incorporating VR into group-based rehabilitation programs, offering a foundation for larger comparative trials aimed at evaluating the long-term effectiveness of VR in improving rehabilitation outcomes for chronic low back pain.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

Caregivers involved in RFR programs at participating centers and likely to use the VR tool during the program.
Consent of the caregiver to participate in the study.
Aged between 18 and 65 years.
Diagnosed with chronic low back pain lasting more than three months, with secondary causes excluded.
Candidates for integration into an RFR program at one of the participating centers.
Affiliated with or beneficiaries of a social security scheme.
Provide informed consent to participate in the study

Exclusion Criteria10

Presence of any other condition incompatible with the RFR program.
Recent surgery or trauma (within the last month).
Contraindications for using the VR device, including unstable epilepsy, facial trauma within the last three months, hearing or visual impairments, or previous experiences of pain, dizziness, or nausea triggered by VR device use.
Visual impairments preventing the use of the VR device.
Pregnancy or breastfeeding.
Poor comprehension of the French language.
Incarceration by judicial or administrative decision.
Undergoing compulsory psychiatric treatment.
Subject to legal protection measures.
Incapable of providing informed consent.

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Interventions

OTHERUtilisability of an immersive VR device in a functional restoration program (FRP) for patients with chronic low back pain.

Patients participating will engage in three 20-minute VR sessions per week, in addition to the standard FRP program, for a duration of four to five weeks. The sessions will consist of a series of pre-programmed exercises designed to facilitate various trunk movements (flexion, extension, inclination, rotation) through exergames. Each exercise will last an average of 5 to 7 minutes. These exercises have been developed in collaboration between the company providing the VR device and the rehabilitation teams. Patients will be set up by a healthcare provider in a dedicated room for VR use. The provider will configure the device, assist the patient in donning it, and initiate the program, will remain present throughout the session to monitor for any adverse effect . While the specific exercises may vary, the total duration of the session will be 20 minutes, consisting of various exercises interspersed with breaks. The principal investigator will propose a standardized series of exercises,