- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02787395
Self Reduction of Shoulder Dislocation (SR-SD)
June 1, 2016 updated by: Tel-Aviv Sourasky Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- anterior shoulder dislocation
- acute (24 hours) shoulder dislocation
Exclusion Criteria:
- shoulder fracture
- non-cooperative patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Milch
modified Milch technique for self reduction
|
shoulder dislocation self reduction using one of three methods in the study
|
|
Experimental: Boss Holtzach
Boss Holtzach technique for self reduction
|
shoulder dislocation self reduction using one of three methods in the study
|
|
Experimental: Stimson
Stimson technique for self reduction
|
shoulder dislocation self reduction using one of three methods in the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of successfull self reduction
Time Frame: 10 minutes
|
the number/rate of successful reductions using each technique will be calculated
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain using VAS during reduction
Time Frame: 10 minutes
|
patients will be asked to report pain levels using VAS during the self reduction procedure
|
10 minutes
|
|
patient satisfaction from self reduction process using VAS
Time Frame: 10 minutes
|
patients will be asked to report their satisfaction from self reduction process using VAS
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Anticipated)
June 1, 2017
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
May 22, 2016
First Submitted That Met QC Criteria
May 25, 2016
First Posted (Estimate)
June 1, 2016
Study Record Updates
Last Update Posted (Estimate)
June 3, 2016
Last Update Submitted That Met QC Criteria
June 1, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-15-OC-0612-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Shoulder Dislocation
-
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-
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