Self Reduction of Shoulder Dislocation

Anterior Shoulder Dislocation Clinical Trial

— SR-SD  

Official title:

Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02787395
• Other study ID #: TASMC-15-OC-0612-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 22, 2016
• Last updated: June 1, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• anterior shoulder dislocation

• acute (24 hours) shoulder dislocation

Exclusion Criteria:

• shoulder fracture

• non-cooperative patient

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Shoulder Dislocation
• Dislocations
• Shoulder Dislocation

Intervention

Procedure:
• shoulder dislocation self reduction
shoulder dislocation self reduction using one of three methods in the study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of successfull self reduction	the number/rate of successful reductions using each technique will be calculated	10 minutes	No
Secondary	pain using VAS during reduction	patients will be asked to report pain levels using VAS during the self reduction procedure	10 minutes	No
Secondary	patient satisfaction from self reduction process using VAS	patients will be asked to report their satisfaction from self reduction process using VAS	10 minutes	No