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

NCT06724679 | Recruiting

• 2 other identifiers: 49RC24_01762024-A01741-46
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Low Back Pain

Keywords

Functionnal Restauration Program; Chronic low Back Pain; Immersive Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Acceptance of the VR system

  a questionnaire based on the UTAUT 2 model

  5 weeks (last day of Functional restoration program)

Secondary Outcomes (3)

• Usability

  5 weeks (last day of Functional restoration program)

• Functional disability

  day 1 and day 35 (First and Last day of the functional restauration program)

• Patient pain

  day 1 and day 35 (First and Last day of the functional restauration program) and during VR session (before and after session)

Study Arms (1)

Experimental

EXPERIMENTAL

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

Interventions

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

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,

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead
• Centre Hospitalier de l'Universite Laval (CHUL): collaborator

Study Sites (5)

Les capucins

Angers, 49103, France

RECRUITING

CH Cholet

Cholet, 49325, France

RECRUITING

CH Laval

Laval, 53015, France

RECRUITING

CHU Rennes

Rennes, 35033, France

RECRUITING

Centre Hospitalier Bretagne Atlantique - Site de vannes

Vannes, 56017, France

RECRUITING

Related Publications (1)

• Champagne R, Ali P, Ronzi Y, Dinomais M. Study protocol: use of virtual reality in a functional restoration programme for the spine-single-arm acceptance study. BMJ Open. 2025 Nov 26;15(11):e106366. doi: 10.1136/bmjopen-2025-106366.

  PMID: 41298262 DERIVED

Study Officials

• Romain CHAMPAGNE, MD

  Hospital, Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain CHAMPAGNE, MD

CONTACT

2 43 66 55 68; champagne.rom@gmail.com

Anthéa LOIEZ

CONTACT

02 41 35 36 37; anthea.loiez@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study is a multicentric, prospective, exploratory interventional pilot trial aimed at assessing the feasibility of using an immersive VR device in a functional restoration program (FRP) for patients with chronic low back pain.

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 9, 2024
• Study Start: March 19, 2025
• Primary Completion: March 19, 2026
• Study Completion (Estimated): April 19, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)