Anterior Shoulder DislocationSR-SDNCT02787395
Self Reduction of Shoulder Dislocation
A study testing shoulder dislocation self reduction in people with Anterior Shoulder Dislocation, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent dislocations. Following a first dislocation recurrence rates of up to 80% have been reported. Many patients will seek medical assistance for reduction of the shoulder after each of these recurrent dislocations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Shoulder Dislocation
- What is being tested?
- shoulder dislocation self reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- anterior shoulder dislocation
- acute (24 hours) shoulder dislocation
Who cannot join
- shoulder fracture
- non-cooperative patient
About this study
Official title: Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder
Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent dislocations. Following a first dislocation recurrence rates of up to 80% have been reported. Many patients will seek medical assistance for reduction of the shoulder after each of these recurrent dislocations. The investigators describe the results of reduction of anterior glenohumeral dislocation using a modified self manipulated Milch technique that can be performed by the patients themselves after simple guidance and demonstration. This method is directed to patients who are not willing or cannot have surgical stabilization and may be in a place where medical assistance is not available.
- Conditions
- Anterior Shoulder Dislocation
- Being tested
- shoulder dislocation self reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder dislocation self reductionProcedure or surgery
shoulder dislocation self reduction using one of three methods in the study
| Study group | Role | What they receive |
|---|---|---|
| Milch | Experimental | modified Milch technique for self reduction Receives: Procedure: shoulder dislocation self reduction |
| Boss Holtzach | Experimental | Boss Holtzach technique for self reduction Receives: Procedure: shoulder dislocation self reduction |
| Stimson | Experimental | Stimson technique for self reduction Receives: Procedure: shoulder dislocation self reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of successfull self reduction
the number/rate of successful reductions using each technique will be calculated
Measured: 10 minutes
Secondary outcomes (2)
pain using VAS during reduction
patients will be asked to report pain levels using VAS during the self reduction procedure
Measured: 10 minutes
patient satisfaction from self reduction process using VAS
patients will be asked to report their satisfaction from self reduction process using VAS
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787395
- Sponsor's protocol ID
- TASMC-15-OC-0612-CTIL
- Acronym
- SR-SD
- Status last verified
- May 2016
- First submitted
- 22 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder
- ClinicalTrials.gov ID
- NCT02787395
- Acronym / sponsor ID
- SR-SD / TASMC-15-OC-0612-CTIL
- Conditions
- Anterior Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 1 Jun 2016 (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.
Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent dislocations. Following a first dislocation recurrence rates of up to 80% have been reported. Many patients will seek medical assistance for reduction of the shoulder after each of these recurrent dislocations. The investigators describe the results of reduction of anterior glenohumeral dislocation using a modified self manipulated Milch technique that can be performed by the patients themselves after simple guidance and demonstration. This method is directed to patients who are not willing or cannot have surgical stabilization and may be in a place where medical assistance is not available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milch | Experimental | Procedure: shoulder dislocation self reductionmodified Milch technique for self reduction |
| Boss Holtzach | Experimental | Procedure: shoulder dislocation self reductionBoss Holtzach technique for self reduction |
| Stimson | Experimental | Procedure: shoulder dislocation self reductionStimson technique for self reduction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- anterior shoulder dislocation
- acute (24 hours) shoulder dislocation
Key exclusion criteria (2 listed)
- shoulder fracture
- non-cooperative patient
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 |
|---|---|---|
| shoulder dislocation self reductionshoulder dislocation self reduction using one of three methods in the study | Procedure or surgery | Boss Holtzach, Milch, Stimson |
Primary outcome
rate of successfull self reduction
Time frame: 10 minutes
the number/rate of successful reductions using each technique will be calculated
2 secondary outcomes
pain using VAS during reduction
Time frame: 10 minutes
patient satisfaction from self reduction process using VAS
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing shoulder dislocation self reduction in people with Anterior Shoulder Dislocation, run by Tel-Aviv Sourasky Medical Center.
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 2 inclusion and 2 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
rate of successfull self reduction (time frame: 10 minutes). 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 3 Jun 2016.