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Self Reduction of Shoulder Dislocation (SR-SD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787395
Recruitment Status : Unknown
Verified May 2016 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Anterior Shoulder Dislocation Procedure: shoulder dislocation self reduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Milch
modified Milch technique for self reduction
Procedure: shoulder dislocation self reduction
shoulder dislocation self reduction using one of three methods in the study

Experimental: Boss Holtzach
Boss Holtzach technique for self reduction
Procedure: shoulder dislocation self reduction
shoulder dislocation self reduction using one of three methods in the study

Experimental: Stimson
Stimson technique for self reduction
Procedure: shoulder dislocation self reduction
shoulder dislocation self reduction using one of three methods in the study




Primary Outcome Measures :
  1. rate of successfull self reduction [ Time Frame: 10 minutes ]
    the number/rate of successful reductions using each technique will be calculated


Secondary Outcome Measures :
  1. pain using VAS during reduction [ Time Frame: 10 minutes ]
    patients will be asked to report pain levels using VAS during the self reduction procedure

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • anterior shoulder dislocation
  • acute (24 hours) shoulder dislocation

Exclusion Criteria:

  • shoulder fracture
  • non-cooperative patient
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02787395    
Other Study ID Numbers: TASMC-15-OC-0612-CTIL
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Joint Dislocations
Shoulder Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries