Low Back PainREVLOCNCT01407653
Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain
A study testing Virtual reality in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic low back pain and sciatica in adults represent a major medical and economic problem. During the chronic back pain (persisting continuously over 3 months), therapeutic responses to conventional pharmacologic type are often ineffective and the impact of pain is often heavy in terms of disability, social and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Virtual reality
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Apr 2015
- 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
- More than 18 and less than 60 years (inclusive)
- Chronic low back pain or chronic sciatica (between 3 months and 1 year of the current episode), without neurological deficit (low back pain more important than sciatica), common spinal origin, resistant to medical therapy, and the numerical pain scale > 30/100
- Written informed consent
- Membership or beneficiary of an insurance
Who cannot join
- Low back pain related to a spinal infectious disease, inflammatory, neoplasia, osteodystrophic, malformative and traumatic.
- Deficit sciatica (motor weakness and / or sensory)
- Low back pain secondary to failure of spinal intervention.
- Co-existence of pain of another etiology.
- Seizures.
- Psychiatric disorder, uncontrolled.
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- Visual disturbances (significant decrease in visual acuity without correction possibility, problems with re-cognition of color, visual field loss).
- Inclusion in another trial to evaluate new ways of treating pain
- Sick leave over 1 year
- Pregnant women
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain. A Randomized Controlled Trial Using a Modified ZELEN Method
Chronic low back pain and sciatica in adults represent a major medical and economic problem. During the chronic back pain (persisting continuously over 3 months), therapeutic responses to conventional pharmacologic type are often ineffective and the impact of pain is often heavy in terms of disability, social and professional avulsion and loss of quality of life. This failure has led in recent years to propose innovative strategies such as application of relaxation therapy techniques. An example is a virtual reality which is a technology to immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion combined with virtual reality can be effective on chronic pain. The main purpose is to measure the impact on the intensity of pain at 4 months after using of a new method for virtual environment, mimicking the colors from low to high frequencies (World Patent Filed, WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to therapeutic drugs.
Read the detailed description
Secondary objectives:
- Quantifying the effects in terms of disability associated with chronic pain
- Quantifying the effects on the cognitive (affect, anxiety, depression).
- Study the correlation between pain and oxidative stress.
Methods :a controlled, randomized single-center prospective trial, according to a ZELEN modified scheme
Intervention treatment : Pain treatment by a process of Virtual Reality 3D. The intervention protocol consists of 3 sessions of immersion in a 3D environment of 17 minutes per week for 4 consecutive weeks.
Conducting the study: an inclusion visit, then the intervention protocol for patients in the arm "Virtual Reality" during 4 weeks, and then a monthly follow-up visit for 4 months.
V0 - Inclusion Visit
- Physical examination
- Verification of eligibility
- Proposal of the trial cohort and collection of the informed consent, signed
- Inclusion
- Pain Numeric Scale
- Quebec questionnaire
- HAD questionnaire
- Blood samples for laboratory tests
- Randomization
- Proposal of the trial of virtual reality and collection of the informed consent, signed
Intervention protocol for patients randomized to Arm "virtual reality":
- Duration: 4 weeks
- 3 sessions per week of virtual reality (17 minutes of immersion and 15 minutes of rest)
- At each session: monitoring of heart rate during periods of rest and immersion) and control of blood pressure at the beginning and end of session.
M1 - 1 Month Visit
- Physical examination
- Pain Numeric Scale
- Quebec questionnaire
- HAD questionnaire
- Blood samples for laboratory tests M2 - 2 Month Visit
- Pain Numeric Scale
- Quebec questionnaire M3 - 3 Month Visit
- Pain Numeric Scale
- Quebec questionnaire M4 - 4 Month Visit
- Pain Numeric Scale
- Quebec questionnaire
- HAD questionnaire
- Conditions
- Low Back Pain
- Being tested
- Virtual reality, Usual care
- Keywords
- Low back pain, virtual reality
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityProcedure or surgery
3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks
Usual careProcedure or surgery
Classical care
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | Not described Receives: Procedure: Virtual reality |
| usual care | Other | Not described Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain in the last 48 hours
Low back pain in the last 48 hours assessed on a numerical pain scale (0 - 100) at 4 months
Measured: 4 months
Secondary outcomes (4)
Disability (Quebec questionnaire)
Evaluation by quality of life questionnaries
Measured: 1 month and 4 months
Anxiety and depression (HAD)
Evaluation by specific anxiety and depression questionnaries
Measured: 1 month and 4 months
Quality of life (SF-12)
Evaluation by quality of life questionnaries
Measured: at 1 and 4 months
Overall serum antioxidant defenses
Determination of AOPP and carbonyl compounds, markers of oxidative stress and the TAS (total antioxidant status) that assesses the overall serum antioxidant defenses
Measured: at inclusion (baseline) and 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- NEUROVIRTUAL, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Serge POIRAUDEAU, MD, PhD, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407653
- Sponsor's protocol ID
- P100302
- Acronym
- REVLOC
- Status last verified
- Oct 2025
- First submitted
- 30 May 2011
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain. A Randomized Controlled Trial Using a Modified ZELEN Method
- ClinicalTrials.gov ID
- NCT01407653
- Acronym / sponsor ID
- REVLOC / P100302
- Conditions
- Low Back Pain
- Keywords
- Low back pain, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- NEUROVIRTUAL, URC-CIC Paris Descartes Necker Cochin
- Study start
- Jun 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Aug 2011 (estimated)
- 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 and sciatica in adults represent a major medical and economic problem. During the chronic back pain (persisting continuously over 3 months), therapeutic responses to conventional pharmacologic type are often ineffective and the impact of pain is often heavy in terms of disability, social and professional avulsion and loss of quality of life. This failure has led in recent years to propose innovative strategies such as application of relaxation therapy techniques. An example is a virtual reality which is a technology to immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion combined with virtual reality can be effective on chronic pain. The main purpose is to measure the impact on the intensity of pain at 4 months after using of a new method for virtual environment, mimicking the colors from low to high frequencies (World Patent Filed, WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to therapeutic drugs.
Detailed description
Secondary objectives:
- Quantifying the effects in terms of disability associated with chronic pain
- Quantifying the effects on the cognitive (affect, anxiety, depression).
- Study the correlation between pain and oxidative stress.
Methods :a controlled, randomized single-center prospective trial, according to a ZELEN modified scheme
Intervention treatment : Pain treatment by a process of Virtual Reality 3D. The intervention protocol consists of 3 sessions of immersion in a 3D environment of 17 minutes per week for 4 consecutive weeks.
Conducting the study: an inclusion visit, then the intervention protocol for patients in the arm "Virtual Reality" during 4 weeks, and then a monthly follow-up visit for 4 months.
V0 - Inclusion Visit
- Physical examination
- Verification of eligibility
- Proposal of the trial cohort and collection of the informed consent, signed
- Inclusion
- Pain Numeric Scale
- Quebec questionnaire
- HAD questionnaire
- Blood samples for laboratory tests
- Randomization
- Proposal of the trial of virtual reality and collection of the informed consent, signed
Intervention protocol for patients randomized to Arm "virtual reality":
- Duration: 4 weeks
- 3 sessions per week of virtual reality (17 minutes of immersion and 15 minutes of rest)
- At each session: monitoring of heart rate during periods of rest and immersion) and control of blood pressure at the beginning and end of session.
M1 - 1 Month Visit
- Physical examination
- Pain Numeric Scale
- Quebec questionnaire
- HAD questionnaire
- Blood samples for laboratory tests M2 - 2 Month Visit
- Pain Numeric Scale
- Quebec questionnaire M3 - 3 Month Visit
- Pain Numeric Scale
- Quebec questionnaire M4 - 4 Month Visit
- Pain Numeric Scale
- Quebec questionnaire
- HAD questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Procedure: Virtual reality |
| usual care | Other | Procedure: Usual care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- More than 18 and less than 60 years (inclusive)
- Chronic low back pain or chronic sciatica (between 3 months and 1 year of the current episode), without neurological deficit (low back pain more important than sciatica), common spinal origin, resistant to medical therapy, and the numerical pain scale > 30/100
- Written informed consent
- Membership or beneficiary of an insurance
Key exclusion criteria (11 listed)
- Low back pain related to a spinal infectious disease, inflammatory, neoplasia, osteodystrophic, malformative and traumatic.
- Deficit sciatica (motor weakness and / or sensory)
- Low back pain secondary to failure of spinal intervention.
- Co-existence of pain of another etiology.
- Seizures.
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 |
|---|---|---|
| Virtual reality3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks | Procedure or surgery | virtual reality |
| Usual careClassical care | Procedure or surgery | usual care |
Primary outcome
Low back pain in the last 48 hours
Time frame: 4 months
Low back pain in the last 48 hours assessed on a numerical pain scale (0 - 100) at 4 months
4 secondary outcomes
Disability (Quebec questionnaire)
Time frame: 1 month and 4 months
Anxiety and depression (HAD)
Time frame: 1 month and 4 months
Quality of life (SF-12)
Time frame: at 1 and 4 months
Overall serum antioxidant defenses
Time frame: at inclusion (baseline) and 1 month after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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.
Serge POIRAUDEAU, MD, PhD principal investigator
Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 20 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Low back pain in the last 48 hours (time frame: 4 months). 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 20 Nov 2025.