Using virtual reality in a program to help restore function for chronic low back pain

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

This study is testing whether using virtual reality in a rehabilitation program can help people with chronic low back pain feel less afraid of moving, improve their motor skills, reduce pain, and boost their overall function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Angers (other gov)
• Locations: 5 sites (Angers and 4 other locations)
• Trial ID: NCT06724679 on ClinicalTrials.gov

What this trial studies

This clinical trial explores the feasibility of incorporating immersive virtual reality (VR) technology into a functional restoration program (FRP) for patients suffering from chronic low back pain (CLBP). The study aims to evaluate how acceptable and usable the VR headset is for both healthcare providers and patients participating in group rehabilitation. It will assess the impact of VR on reducing fear of movement, improving motor skills, alleviating pain, and enhancing overall functional abilities. The trial will involve multiple centers and focus on the integration of this innovative technology into existing rehabilitation strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with chronic low back pain lasting more than three months, who are eligible for a functional restoration program.

Not a fit: Patients with conditions incompatible with the functional restoration program or those who have contraindications for using the VR device may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve rehabilitation outcomes for patients with chronic low back pain by enhancing their functional capabilities and reducing pain.

How similar studies have performed: While the application of VR in rehabilitation is promising, this specific integration into a group-based functional restoration program for chronic low back pain is a novel approach.

Eligibility criteria

Caregiver Inclusion Criteria:

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.

Patient Inclusion Criteria:

* 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

Patient Exclusion Criteria:

* 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.

Where this trial is running

Angers and 4 other locations

• Les capucins — Angers, France (RECRUITING)
• CH Cholet — Cholet, France (RECRUITING)
• CH Laval — Laval, France (RECRUITING)
• CHU Rennes — Rennes, France (RECRUITING)
• Centre Hospitalier Bretagne Atlantique - Site de vannes — Vannes, France (RECRUITING)

Study contacts

• Principal investigator: Romain CHAMPAGNE, MD — Hospital, Laval
• Study coordinator: Romain CHAMPAGNE, MD

Conditions: Chronic Low Back Pain, Functionnal Restauration Program, Chronic low Back Pain, Immersive Virtual Reality