An interventional study of Immersive Virtual Reality in Chronic Low-back Pain, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Supportive care
Chronic low back pain is a major public health problem today, because of its prevalence and its socio-professional impact. Multiple drug or non-drug treatments exist but the pain chronicization mechanism makes the management of chronic low back pain patients difficult. Stress rehabilitation programs in specialized structures have been set up to try to improve the outcome of these patients. Likewise, home exercise is recommended. However, adherence to these exercises is generally poor. Recently, there has been a growing interest in the use of new technologies, based on the use of digital tools, in the management of pain. Thus, in patients with chronic low back pain, the attractiveness of the proposed exercise programs with new technologies, the possibility of progression in the same exercise and the possibility of customizing these exercises have been reported as being able to meet the expectations of patients. for the purpose of rehabilitation. In virtual reality, users interact in an environment simulated by a 3-dimensional computer. This technology uses multisensory resources allowing the user to feel totally immersed in the virtual environment. Virtual reality has shown a benefit in the management of pain in several indications.
In low back pain patients, pain avoidance mechanisms are put in place very early due to fear of situations or movements that may reproduce or intensify the pain. Thus, for fear of pain, individuals avoid certain movements, in particular lumbar flexion movements. This avoidance of the lumbar flexion movement actually worsens the pain phenomenon because of the musculoskeletal changes associated with it. Therefore, one of the therapeutic areas for the management of chronic low back pain would be to improve lumbar flexion capacities.
Thomas JS et al evaluated the benefits of a game of virtual reality baseball on improving lumbar flexion in a randomized study (virtual reality versus control). After 3 virtual reality sessions, the 2 groups were compared, there was no difference in the improvement in lumbar flexion or in the improvement in pain, probably due to the low number of sessions offered (only 3 ). Nevertheless, the harmlessness, feasibility and safety of the game were proven here. In addition, the perception of the game was positive by the participants and there was no aggravation of pain or side effects of virtual reality.
On a larger scale and more recently, France CR and Thomas JS have shown in a randomized study of 230 patients the value of an immersive virtual reality game based on the progression of lumbar flexion compared to another game that does not improve this parameter. This was a virtual reality-based rehabilitation program, carried out over 18 weeks with 3 then 2 then 1 session (s) per week; the primary endpoint was assessment of pain and disability one week after the program. There was a sharper decrease in pain and disability with play that specifically worked lumbar flexion. The progression of lumbar flexion was correlated with the decrease in pain and disability. The authors thus showed that an immersive virtual reality game combining: a way to distract the patient's attention, a target to be reached, and a progression of the lumbar flexion exercise in the game would improve pain and pain. handicap of chronic low back pain.
Virtual reality is a distraction technique, which combines visual and auditory, allowing immersion in a virtual world through a headset that transcribes a three-dimensional image. The diversion of attention by the use of virtual reality allows the patient to immerse himself in a fictitious environment thanks to a mask on the eyes that inhibits the vision of the outside world and a hearing headset reducing external sounds and reinforcing the mechanism of 'immersion. Our hypothesis is that the use of an immersive virtual reality tool would improve the rehabilitation care and the future of chronic low back pain patients, via this immersion capacity.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients are divided into groups of 3. Each group of patients will attend 2 days of care per week (for 4 weeks) Group N ° 1: Monday and Thursday. Group N ° 2: Tuesday and Friday. At each visit, the patient will participate in: \[a "Kinesitherapy" treatment and a "Virtual Immersion" treatment\] + \[a "Balneotherapy treatment or an" Adapted Physical Activity treatment). Each treatment lasts 1 hour 10 minutes. Each patient will therefore come to the center 8 times over 1 month, or 4 hours 40 minutes a week, not counting virtual reality. If the groups are not full or according to the advice of the healthcare team, only one group will be selected (always 3 patients) and will attend 3 days per week.
Device: Immersive Virtual Reality
Dedicated virtual reality sessions. * Duration 20 minutes per session. * The virtual reality session will be supervised by a health professional trained in this tool after 1.5 hours of training by the team responsible for the equipment (use of the equipment, and use of the 20 minutes of VR). This supervising professional may be a doctor, an occupational therapist, a caregiver or any other health professional trained in the tool under this protocol. * The exercises proposed will be standardized virtual reality exercises with the same exercises for all, but adapted to the level and abilities of each patient.
To assess attendance of a rehabilitation program for chronic low back pain patients integrating immersive virtual reality sessions
Patient attendance to an immersive virtual reality program
Time frame: Week 4
To assess adherence of a rehabilitation program for chronic low back pain patients integrating immersive virtual reality sessions
Patient adherence to an immersive virtual reality program
Time frame: Week 4
To evaluate patient satisfaction with the progress of the program
Satisfaction assessed by questionnaire
Time frame: Week 4
To evaluate stakeholder satisfaction with the progress of the program
Satisfaction assessed by questionnaire
Time frame: Week 4
Evaluate the improvement in pain
Numerical pain rating scale (0 : no pain / 10 : very strong pain)
Time frame: Day 1
Evaluate the improvement in pain
Numerical pain rating scale (0 : no pain / 10 : very strong pain)
Time frame: Week 4
Evaluate the overall improvement of the patient
Overall assessment scale for the pathology by the patient (0 : very unhappy -10 : very satisfied)
Time frame: Day 1
Evaluate the overall improvement of the patient
Overall assessment scale for the pathology by the patient (0 : very unhappy -10 : very satisfied)
Time frame: Week 4
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondation Hôpital Saint-Joseph