Lumbar Radicular PainEpi-RéVNCT05505968
Interest of Virtual Reality Headset During Injection in Patients With Back Pain and Sciatica
A study testing Virtual Reality Headset in people with Lumbar Radicular Pain, run by CHU de Reims at 1 site in France.
Trial summary
For a few years, publications have been published concerning the use of virtual reality headsets in the field of medicine and particularly in various specialities. It has been evaluated in different studies on pain and anxiety in various medical situations. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lumbar Radicular Pain
- What is being tested?
- Virtual Reality Headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2022to 12 Jan 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18-90 years,
- Diagnosed with lomboradiculalgia requiring two epidural injection through the sacrococcygeal hiatus,
- Hospitalized in the Rheumatology Department of the University Hospital of Reims,
- Speak French language.
- Affiliated or beneficiary of a social security scheme
- Having given their written agreement to participate in the study (signature of the consent form)
Who cannot join
- Profound or total deafness,
- Visually impaired,
- Presence of contraindication to injection,
- Inability to answer the questionnaire due to severe cognitive impairment,
- Injection with and without virtual reality headset not performed by the same person,
- Vestibular pathologies,
Show all 13Show fewer
- Epilepsy,
- Claustrophobia,
- Use of nitrous oxide for injection.
- Premedication for infiltration (analgesic, anxiolytic)
- Patients under guardianship, curatorship, safeguard of justice
- Pregnant women
- Psychotic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Interest of a Virtual Reality Headset on Pain and Anxiety During Epidural Injection Through the Sacrococcygeal Hiatus in Patients With Lumbar Radicular Pain.
For a few years, publications have been published concerning the use of virtual reality headsets in the field of medicine and particularly in various specialities.
It has been evaluated in different studies on pain and anxiety in various medical situations.
Read more
A study has shown a correlation between a decrease in pain in a clinical way during a painful stimulation and a decrease in certain areas of the brain.
In this context, the use of the virtual reality headset could then be used in medical interventions that may be painful for the patient.
The lumbar radicular pain is a common disease in the world. The epidural injection is one of the treatment of this pathology. He may be performed to reduce the pain but sometimes this act is painful. Most of the time this procedure is performed without premedication.
To the knowledge of the investigators, there are currently no studies on the assessment of pain under a virtual reality headset during the performance of an epidural injection in rheumatology.
The aim of the study is to demonstrate that the Virtual Reality Headset can reduce the pain and the anxiety during an epidural injection.
Read the detailed description
Any patient who meets the inclusion criteria can be offered this study. The physician will verify with the data collected during the usual management of the patient whether the patient presents the inclusion criteria and no exclusion criteria. The questioning (history of the disease, treatments, etc.) and the clinical examination will be carried out within the framework of the usual management of the patient before his inclusion in the study.
After the patient's agreement and signature of the consent form, the patient will be randomized in one of the two groups :
- Group 1: Use of the virtual reality headset during the first epidural infiltration. The second infiltration will be performed without the virtual reality headset.
- Group 2: First epidural infiltration without the virtual reality headset. The second infiltration will be performed with the virtual reality headset.
The duration of participation in each of the two groups is 3 days:
- On the 1st day, the patients will have to fill in a questionnaire with socio-demographic data, pain related to the disease, their anxiety in general life, their anxiety before the infiltration.
The patient will choose, with the help of the doctor, the landscape that will be projected in the virtual reality headset, and then the helmet will be put in place, again with the help of the doctor.
Concerning the installation, the patient will be in prone position with the hands under the chin with the reality headset so that he cannot rest on the bed. The patient must be comfortable.
The first epidural infiltration will be performed with or without the virtual reality headset depending on the randomization group.
Then the patient will have to estimate his pain thanks to the numerical scale as well as his state of anxiety during the procedure. This part of the questionnaire will be completed after the first infiltration.
- On the 2nd day, there will be no infiltration and no questionnaire to fill in.
- On the 3rd day, the second epidural infiltration will be performed with or without virtual reality headset depending on the randomization group. Patients will be asked to fill in their anxiety status before the procedure, their pain during the procedure and the estimated anxiety during the procedure.
Both infiltrations will be performed by a person trained and experienced in performing infiltrations through the hiatus route.
The virtual reality headset used is provided by the company Healthy Mind and corresponds to a class 1 CE medical device. This virtual reality headset is a Pico G2 4K and corresponds to the model A7510 and is connected to a Bose Sound Link 2 AE headset, all connected to a tablet allowing to control the chosen universe.
There will be no remote monitoring of the patient.
- Conditions
- Lumbar Radicular Pain
- Being tested
- Virtual Reality Headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetOther
Also called Medical device
Virtual Reality Headset of the society Healthy Mind and is a CE Class 1 medical device. This virtual reality headset is a Pico G2 4K and corresponds to the model A7510 and is connected to a Bose Sound Link 2 AE headset.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality - Day1 | Experimental | Use of the virtual reality headset during the first epidural infiltration (Day 1). The second infiltration (Day 3) will be performed without the virtual reality headset. Receives: Other: Virtual Reality Headset |
| virtual reality - Day3 | Experimental | First epidural infiltration without the virtual reality headset (day 1). The second infiltration will be performed with the virtual reality headset (Day 3). Receives: Other: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory STAI-B (trait anxiety), STAI-A (state anxiety)
Measured: Day 1
State-Trait Anxiety Inventory
STAI-B (trait anxiety), STAI-A (state anxiety)
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start8 Aug 2022
- Primary completion22 Feb 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Radicular PainStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505968
- Sponsor's protocol ID
- PO22085*
- Acronym
- Epi-RéV
- Status last verified
- Jan 2024
- First submitted
- 16 Aug 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Javelot M, Chopin C, Bolko L, Hittinger A, Geoffroy M, Charlot I, Adeline F, Coutureau C, Duvivier A, Salmon JH. Effect of Virtual Reality on Pain and Anxiety During Epidural Steroid Injection in Patients with Lumbar Radicular Pain: An Open-Label Randomized Trial. Healthcare (Basel). 2025 Sep 22;13(18):2376. doi: 10.3390/healthcare13182376.
PubMed 41008506
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of a Virtual Reality Headset on Pain and Anxiety During Epidural Injection Through the Sacrococcygeal Hiatus in Patients With Lumbar Radicular Pain.
- ClinicalTrials.gov ID
- NCT05505968
- Acronym / sponsor ID
- Epi-RéV / PO22085*
- Conditions
- Lumbar Radicular Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 18 Aug 2022 (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.
For a few years, publications have been published concerning the use of virtual reality headsets in the field of medicine and particularly in various specialities.
It has been evaluated in different studies on pain and anxiety in various medical situations.
A study has shown a correlation between a decrease in pain in a clinical way during a painful stimulation and a decrease in certain areas of the brain.
In this context, the use of the virtual reality headset could then be used in medical interventions that may be painful for the patient.
The lumbar radicular pain is a common disease in the world. The epidural injection is one of the treatment of this pathology. He may be performed to reduce the pain but sometimes this act is painful. Most of the time this procedure is performed without premedication.
To the knowledge of the investigators, there are currently no studies on the assessment of pain under a virtual reality headset during the performance of an epidural injection in rheumatology.
The aim of the study is to demonstrate that the Virtual Reality Headset can reduce the pain and the anxiety during an epidural injection.
Detailed description
Any patient who meets the inclusion criteria can be offered this study. The physician will verify with the data collected during the usual management of the patient whether the patient presents the inclusion criteria and no exclusion criteria. The questioning (history of the disease, treatments, etc.) and the clinical examination will be carried out within the framework of the usual management of the patient before his inclusion in the study.
After the patient's agreement and signature of the consent form, the patient will be randomized in one of the two groups :
- Group 1: Use of the virtual reality headset during the first epidural infiltration. The second infiltration will be performed without the virtual reality headset.
- Group 2: First epidural infiltration without the virtual reality headset. The second infiltration will be performed with the virtual reality headset.
The duration of participation in each of the two groups is 3 days:
- On the 1st day, the patients will have to fill in a questionnaire with socio-demographic data, pain related to the disease, their anxiety in general life, their anxiety before the infiltration.
The patient will choose, with the help of the doctor, the landscape that will be projected in the virtual reality headset, and then the helmet will be put in place, again with the help of the doctor.
Concerning the installation, the patient will be in prone position with the hands under the chin with the reality headset so that he cannot rest on the bed. The patient must be comfortable.
The first epidural infiltration will be performed with or without the virtual reality headset depending on the randomization group.
Then the patient will have to estimate his pain thanks to the numerical scale as well as his state of anxiety during the procedure. This part of the questionnaire will be completed after the first infiltration.
- On the 2nd day, there will be no infiltration and no questionnaire to fill in.
- On the 3rd day, the second epidural infiltration will be performed with or without virtual reality headset depending on the randomization group. Patients will be asked to fill in their anxiety status before the procedure, their pain during the procedure and the estimated anxiety during the procedure.
Both infiltrations will be performed by a person trained and experienced in performing infiltrations through the hiatus route.
The virtual reality headset used is provided by the company Healthy Mind and corresponds to a class 1 CE medical device. This virtual reality headset is a Pico G2 4K and corresponds to the model A7510 and is connected to a Bose Sound Link 2 AE headset, all connected to a tablet allowing to control the chosen universe.
There will be no remote monitoring of the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality - Day1 | Experimental | Other: Virtual Reality HeadsetUse of the virtual reality headset during the first epidural infiltration (Day 1). The second infiltration (Day 3) will be performed without the virtual reality headset. |
| virtual reality - Day3 | Experimental | Other: Virtual Reality HeadsetFirst epidural infiltration without the virtual reality headset (day 1). The second infiltration will be performed with the virtual reality headset (Day 3). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 18-90 years,
- Diagnosed with lomboradiculalgia requiring two epidural injection through the sacrococcygeal hiatus,
- Hospitalized in the Rheumatology Department of the University Hospital of Reims,
- Speak French language.
- Affiliated or beneficiary of a social security scheme
Key exclusion criteria (13 listed)
- Profound or total deafness,
- Visually impaired,
- Presence of contraindication to injection,
- Inability to answer the questionnaire due to severe cognitive impairment,
- Injection with and without virtual reality headset not performed by the same person,
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 Reality HeadsetAlso: Medical deviceVirtual Reality Headset of the society Healthy Mind and is a CE Class 1 medical device. This virtual reality headset is a Pico G2 4K and corresponds to the model A7510 and is connected to a Bose Sound Link 2 AE headset. | Other | virtual reality - Day1, virtual reality - Day3 |
Primary outcome
State-Trait Anxiety Inventory
Time frame: Day 1
State-Trait Anxiety Inventory STAI-B (trait anxiety), STAI-A (state anxiety)
State-Trait Anxiety Inventory
Time frame: Day 3
STAI-B (trait anxiety), STAI-A (state anxiety)
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 21 Jan 2026.
- Results publication: PubMed 41008506Javelot M, Chopin C, Bolko L, Hittinger A, Geoffroy M, Charlot I, Adeline F, Coutureau C, Duvivier A, Salmon JH. Effect of Virtual Reality on Pain and Anxiety During Epidural Steroid Injection in Patients with Lumbar Radicular Pain: An Open-Label Randomized Trial. Healthcare (Basel). 2025 Sep 22;13(18):2376. doi: 10.3390/healthcare13182376.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Headset in people with Lumbar Radicular Pain, run by CHU de Reims 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 6 inclusion and 13 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 21 Jan 2026. 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?
State-Trait Anxiety Inventory (time frame: Day 1). 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?
On the ClinicalTrials.gov record for NCT05505968, which also lists 1 linked publication.
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 21 Jan 2026.