ReductionEPOLUXNCT04823689
Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation
A study testing reductions in people with Reduction and Emergencies, run by Hopital Nord Franche-Comte at 1 site in France.
Trial summary
The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction, Emergencies, Anterior Shoulder Dislocation
- What is being tested?
- reductions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2021to 25 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiological confirmed anterior glenohumeral dislocation
- Patient affiliated or entitled to a social security scheme
- Oral informed consent form
Who cannot join
- Glenohumeral fracture or vasculoneural lesion associated
- Dislocation for more than 12 hours
- Homolateral shoulder surgery antecedent
- Contraindication to other analgesics (morphine, sedation)
- BMI > 40
- Patient < 18 year
- Pregnancy or nursing woment
- Person under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial
The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France.
In Nord Franche-Comte Hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres.
Read more
A retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. None prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation.
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
- Conditions
- Reduction, Emergencies, Anterior Shoulder Dislocation
- Being tested
- reductions
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reductionsProcedure or surgery
Two reduction techniques are compared: dorsal decubitus and ventral decubitus reduction. The dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient.
The ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal decubitus | Sham comparator | The dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient. Receives: Procedure: reductions |
| Ventral decubitus | Experimental | The ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula. Receives: Procedure: reductions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
The primary endpoint is the reduction time in minutes from inclusion of the patient after prior confirmation of the clinical and radiological diagnosis to the observed reduction.
Measured: 1 day
Secondary outcomes (4)
Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique
Failure rate of the ventral decubitus technique compared to the dorsal decubitus technique
Measured: 1 day
Evaluation of the consumption of sedative and analgesic treatments
Quantification of doses of analgesics and sedatives used
Measured: 1 day
Evaluation of the time spent in emergency department
Time spent in emergency department
Measured: 1 day
Evaluation of the pain felt before and after the intervention
Pain sensibility before, during et after the reduction techniques : visual analog pain scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start21 Jul 2021
- Primary completion10 Feb 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReductionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823689
- Sponsor's protocol ID
- 2019-01 - EPOLUX
- Acronym
- EPOLUX
- Status last verified
- Dec 2024
- First submitted
- 26 Mar 2021
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04823689
- Acronym / sponsor ID
- EPOLUX / 2019-01 - EPOLUX
- Conditions
- Reduction, Emergencies, Anterior Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 1 Apr 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.
The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France.
In Nord Franche-Comte Hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres.
A retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. None prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation.
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal decubitus | Sham comparator | Procedure: reductionsThe dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient. |
| Ventral decubitus | Experimental | Procedure: reductionsThe ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with radiological confirmed anterior glenohumeral dislocation
- Patient affiliated or entitled to a social security scheme
- Oral informed consent form
Key exclusion criteria (8 listed)
- Glenohumeral fracture or vasculoneural lesion associated
- Dislocation for more than 12 hours
- Homolateral shoulder surgery antecedent
- Contraindication to other analgesics (morphine, sedation)
- BMI > 40
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 |
|---|---|---|
| reductionsTwo reduction techniques are compared: dorsal decubitus and ventral decubitus reduction. The dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient. The ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula. | Procedure or surgery | Dorsal decubitus, Ventral decubitus |
Primary outcome
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.
Time frame: 1 day
The primary endpoint is the reduction time in minutes from inclusion of the patient after prior confirmation of the clinical and radiological diagnosis to the observed reduction.
4 secondary outcomes
Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique
Time frame: 1 day
Evaluation of the consumption of sedative and analgesic treatments
Time frame: 1 day
Evaluation of the time spent in emergency department
Time frame: 1 day
Evaluation of the pain felt before and after the intervention
Time frame: 1 day
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 27 Dec 2024.
- 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. 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 reductions in people with Reduction and Emergencies, run by Hopital Nord Franche-Comte 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 3 inclusion and 8 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 27 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus. (time frame: 1 day). 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 Dec 2024.