Chronic Low-back PainRIVAGENCT04781465
Feasibility Study on an Immersive Virtual Reality Tool in the Treatment of Chronic Low Back Pain
A study testing Immersive Virtual Reality in people with Chronic Low-back Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Immersive Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Immersive Virtual Reality
- Keywords
- Immersive Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 4
Secondary outcomes (6)
To evaluate patient satisfaction with the progress of the program
Satisfaction assessed by questionnaire
Measured: Week 4
To evaluate stakeholder satisfaction with the progress of the program
Satisfaction assessed by questionnaire
Measured: Week 4
Evaluate the improvement in pain
Numerical pain rating scale (0 : no pain / 10 : very strong pain)
Measured: Day 1
Evaluate the improvement in pain
Numerical pain rating scale (0 : no pain / 10 : very strong pain)
Measured: Week 4
Evaluate the overall improvement of the patient
Overall assessment scale for the pathology by the patient (0 : very unhappy -10 : very satisfied)
Measured: Day 1
Evaluate the overall improvement of the patient
Overall assessment scale for the pathology by the patient (0 : very unhappy -10 : very satisfied)
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start7 Jan 2020
- Primary completion6 Sep 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès PORTIER, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781465
- Sponsor's protocol ID
- RIVAGE
- Acronym
- RIVAGE
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on an Immersive Virtual Reality Tool in the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04781465
- Acronym / sponsor ID
- RIVAGE / RIVAGE
- Conditions
- Chronic Low-back Pain
- Keywords
- Immersive Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality | Experimental | Device: Immersive Virtual RealityThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual RealityDedicated 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. | Device | Immersive Virtual Reality |
Primary outcome
To assess attendance of a rehabilitation program for chronic low back pain patients integrating immersive virtual reality sessions
Time frame: Week 4
Patient attendance to an immersive virtual reality program
To assess adherence of a rehabilitation program for chronic low back pain patients integrating immersive virtual reality sessions
Time frame: Week 4
Patient adherence to an immersive virtual reality program
6 secondary outcomes
To evaluate patient satisfaction with the progress of the program
Time frame: Week 4
To evaluate stakeholder satisfaction with the progress of the program
Time frame: Week 4
Evaluate the improvement in pain
Time frame: Day 1
Evaluate the improvement in pain
Time frame: Week 4
Evaluate the overall improvement of the patient
Time frame: Day 1
Evaluate the overall improvement of the patient
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnès PORTIER principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Chronic Low-back Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess attendance of a rehabilitation program for chronic low back pain patients integrating immersive virtual reality sessions (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.