Clinical trial NCT04781465: Feasibility Study on an Immersive Virtual Reality Tool in the Treatment of Chronic Low Back Pain
Official title: Feasibility Study on an Immersive Virtual Reality Tool in the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Immersive Virtual Reality
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Man or woman whose age ≥ 18 years and \<60 years
* French-speaking patient
* Affiliated with social security or, failing that, with another health insurance system.
* Non-specific low back pain +/- radiculalgia, mechanical, evolving for at least 3 months
* Patient able to understand and respond to simple instructions
* Numerical assessment scale for lumbar pain greater than or equal to 4/10
* Patient having given free, informed and express consent.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patients with nausea, vomiting, dizziness
* Visual disturbance or hearing impairment, vestibular disorder or other disorder which, according to the investigator, makes it impossible to use a virtual reality mask or headset
* Concomitant monitoring of another rehabilitation process (physiotherapy, occupational therapy, osteopathy, or other)
* Patients with a history of neurological disorders such as epilepsy
* Major cervical or lumbar osteoarthritis or severe scoliosis making it impossible to mobilize the spinal segment concerned
* Biological inflammatory syndrome or inflammatory nature of pain
* Fibromyalgia / chronic diffuse pain syndrome
* Psychiatric pathology, except depression if the disease is controlled
* Symptomatic back pain due to neoplasia / infection / underlying vertebral fracture
* Recent spine surgery \<6 months
* Active neoplasia
* Refusal to follow the entire rehabilitation program
* Geographical distance not allowing travel to a rehabilitation center
* Spinal infiltration less than 1 month old
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under legal protection.

Primary outcomes:
measure: To assess attendance of a rehabilitation program for chronic low back pain patients integrating immersive virtual reality sessions
timeFrame: Week 4
measure: To assess adherence of a rehabilitation program for chronic low back pain patients integrating immersive virtual reality sessions
timeFrame: Week 4
Secondary outcomes:
measure: To evaluate patient satisfaction with the progress of the program
timeFrame: Week 4
measure: To evaluate stakeholder satisfaction with the progress of the program
timeFrame: Week 4
measure: Evaluate the improvement in pain
timeFrame: Day 1
measure: Evaluate the improvement in pain
timeFrame: Week 4
measure: Evaluate the overall improvement of the patient
timeFrame: Day 1
measure: Evaluate the overall improvement of the patient
timeFrame: Week 4
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
state: Ile De France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Agnès PORTIER
role: PRINCIPAL_INVESTIGATOR
References: