Anterior Shoulder DislocationPhase 4NCT05821517
METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)
A Phase 4 study testing Helmet virtual reality. and Administration of METHOXYFLURANE in people with Anterior Shoulder Dislocation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine. The success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Shoulder Dislocation
- What is being tested?
- Helmet virtual reality. and Administration of METHOXYFLURANE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2023to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant and/or breastfeeding women and women of childbearing age who do not have effective contraception (hormonal, mechanical or surgical).
- Patients with difficulties in understanding or using the devices studied.
- Patients with a contraindication to the use of one of the studied devices.
- Patients with a history of relevant shoulder surgery
- Presence of other associated trauma,
- Previous inclusion in the same study
Who cannot join
- Withdrawal of voluntary informed consent from the patient
- Violation of protocol
- Presence of a fracture associated with the dislocation (excluding Malgaigne's notches)
- Posterior, inferior or erecta dislocation
- Presence of initial vascular and nerve complications
- Any indication for surgical management
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital
Nice, 06000
Fanny Hamard, 0492038581, hamard.f@chu-nice.fr
laurent Bouchama, 0492038581, bouchama.l@chu-nice.fr
About this study
Official title: METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation
Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine.
The success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. However, there is no consensus on the optimal technique for reducing anterior shoulder dislocation or the analgesia associated with it.
Read more
Analgesia with METHOXYFLURANE showed a greater reduction in post-traumatic pain compared to standard analgesic treatment and faster action of METHOXYFLURANE. A retrospective study which has compared analgesia with METHOXYFLURANE and analgesic sedation with PROPOFOL found a shoulder reduction success rate of 80% and a reduction in the average length of stay in the emergency department.
Finally, the use of virtual reality in pain management is emerging in our practices by allowing pre- and per-procedure hypno-sedation-analgesia. However, the use of virtual reality headsets has not been studied in the management of anterior shoulder dislocation.
The use of these two techniques could therefore limit the use of procedural sedation in the context of shoulder dislocation reduction.
- Conditions
- Anterior Shoulder Dislocation
- Being tested
- Helmet virtual reality., Administration of METHOXYFLURANE, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmet virtual reality.Device
Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care
Administration of METHOXYFLURANEDrug
Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)
Standard of careDrug
An anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | An anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure. Receives: Drug: Standard of care |
| Medical device : VR headset | Experimental | Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care Receives: Device: Helmet virtual reality. |
| Medication : Methoxyflurane analgesia | Experimental | Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL) Receives: Drug: Administration of METHOXYFLURANE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the rate of procedural sedation of anterior shoulder dislocation
Rate of use of procedural sedation for anterior shoulder dislocation reduction in the interventional groups compared to the control group
Measured: Day 1 (day of reduction of anterior shoulder dislocation)
Secondary outcomes (6)
The amount of co-antalgesics administered
Posology of co-analgesic medications administered
Measured: 3 months
The duration of the procedure
Time lenght of the reduction procedure
Measured: Day 1 (day of change of anterior shoulder dislocation)
The dosage of drugs used in procedural sedation
Posology of sedative drugs administered for a procedural sedation
Measured: Day 1 (day of reduction of anterior shoulder dislocation)
The average length of stay in the emergency department
Average length of stay in the emergency department
Measured: 3 months
Patient satisfaction
Patient satisfaction at the end of care evaluated with a questionnaire EVA
Measured: 3 months
The rate of reduction-related complications
Complications related to the reduction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start30 Dec 2023
- Primary completion30 Dec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Shoulder DislocationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821517
- Sponsor's protocol ID
- 21-AOI-11
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation
- ClinicalTrials.gov ID
- NCT05821517
- Acronym / sponsor ID
- 21-AOI-11
- Conditions
- Anterior Shoulder Dislocation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Apr 2023 (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.
Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine.
The success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. However, there is no consensus on the optimal technique for reducing anterior shoulder dislocation or the analgesia associated with it.
Analgesia with METHOXYFLURANE showed a greater reduction in post-traumatic pain compared to standard analgesic treatment and faster action of METHOXYFLURANE. A retrospective study which has compared analgesia with METHOXYFLURANE and analgesic sedation with PROPOFOL found a shoulder reduction success rate of 80% and a reduction in the average length of stay in the emergency department.
Finally, the use of virtual reality in pain management is emerging in our practices by allowing pre- and per-procedure hypno-sedation-analgesia. However, the use of virtual reality headsets has not been studied in the management of anterior shoulder dislocation.
The use of these two techniques could therefore limit the use of procedural sedation in the context of shoulder dislocation reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Standard of careAn anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure. |
| Medical device : VR headset | Experimental | Device: Helmet virtual reality.Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care |
| Medication : Methoxyflurane analgesia | Experimental | Drug: Administration of METHOXYFLURANESelf administered inhalated methoxyflurane (maximal inhaled dose : 3 mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant and/or breastfeeding women and women of childbearing age who do not have effective contraception (hormonal, mechanical or surgical).
- Patients with difficulties in understanding or using the devices studied.
- Patients with a contraindication to the use of one of the studied devices.
- Patients with a history of relevant shoulder surgery
- Presence of other associated trauma,
Key exclusion criteria (6 listed)
- Withdrawal of voluntary informed consent from the patient
- Violation of protocol
- Presence of a fracture associated with the dislocation (excluding Malgaigne's notches)
- Posterior, inferior or erecta dislocation
- Presence of initial vascular and nerve complications
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 |
|---|---|---|
| Helmet virtual reality.Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care | Device | Medical device : VR headset |
| Administration of METHOXYFLURANESelf administered inhalated methoxyflurane (maximal inhaled dose : 3 mL) | Drug | Medication : Methoxyflurane analgesia |
| Standard of careAn anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure. | Drug | Standard of care |
Primary outcome
Decrease in the rate of procedural sedation of anterior shoulder dislocation
Time frame: Day 1 (day of reduction of anterior shoulder dislocation)
Rate of use of procedural sedation for anterior shoulder dislocation reduction in the interventional groups compared to the control group
6 secondary outcomes
The amount of co-antalgesics administered
Time frame: 3 months
The duration of the procedure
Time frame: Day 1 (day of change of anterior shoulder dislocation)
The dosage of drugs used in procedural sedation
Time frame: Day 1 (day of reduction of anterior shoulder dislocation)
The average length of stay in the emergency department
Time frame: 3 months
Patient satisfaction
Time frame: 3 months
The rate of reduction-related complications
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Helmet virtual reality. and Administration of METHOXYFLURANE in people with Anterior Shoulder Dislocation, run by Centre Hospitalier Universitaire de Nice 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 6 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: looking for participants now, as of the sponsor's last update on 4 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAMARD Fanny (04 92 03 85 81, hamard.f@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in the rate of procedural sedation of anterior shoulder dislocation (time frame: Day 1 (day of reduction of anterior shoulder dislocation)). 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 4 Dec 2025.