Feasibility Study on an Immersive Virtual Reality Tool in the Treatment of Chronic Low Back Pain

NCT04781465 | Unknown

• 1 other identifier: RIVAGE
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Immersive Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Week 4

Secondary Outcomes (6)

• To evaluate patient satisfaction with the progress of the program

  Week 4

• To evaluate stakeholder satisfaction with the progress of the program

  Week 4

• Evaluate the improvement in pain

  Day 1

• Evaluate the improvement in pain

  Week 4

• Evaluate the overall improvement of the patient

  Day 1

Study Arms (1)

Immersive Virtual Reality

EXPERIMENTAL

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

Interventions

Immersive Virtual Reality DEVICE

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.

Immersive Virtual Reality

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Agnès PORTIER

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: January 7, 2020
• Primary Completion: September 6, 2021
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)