SR-SD: Self Reduction of Shoulder Dislocation

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02787395
• Collaborator: (none)
• Enrollment: 150
• Arms: 3
• Duration (Months): 24

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. rate of successfull self reduction [10 minutes]

   the number/rate of successful reductions using each technique will be calculated

Secondary Outcome Measures

1. pain using VAS during reduction [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 [10 minutes]

   patients will be asked to report their satisfaction from self reduction process using VAS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• anterior shoulder dislocation

• acute (24 hours) shoulder dislocation

Exclusion Criteria:

• shoulder fracture

• non-cooperative patient

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT02787395
• Other Study ID Numbers: TASMC-15-OC-0612-CTIL
• First Posted: Jun 1, 2016
• Last Update Posted: Jun 3, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Joint Dislocations; Shoulder Dislocation

Study Results

No Results Posted as of Jun 3, 2016