Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04781465 |
| Other study ID # |
RIVAGE |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2020 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Groupe Hospitalier Paris Saint Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
