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Self Reduction of Shoulder Dislocation (SR-SD)

Primary Purpose

Anterior Shoulder Dislocation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
shoulder dislocation self reduction
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Shoulder Dislocation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • shoulder fracture
  • non-cooperative patient

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Milch

    Boss Holtzach

    Stimson

    Arm Description

    modified Milch technique for self reduction

    Boss Holtzach technique for self reduction

    Stimson technique for self reduction

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    pain using VAS during reduction
    patients will be asked to report pain levels using VAS during the self reduction procedure
    patient satisfaction from self reduction process using VAS
    patients will be asked to report their satisfaction from self reduction process using VAS

    Full Information

    First Posted
    May 22, 2016
    Last Updated
    June 1, 2016
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02787395
    Brief Title
    Self Reduction of Shoulder Dislocation
    Acronym
    SR-SD
    Official Title
    Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Shoulder Dislocation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Milch
    Arm Type
    Experimental
    Arm Description
    modified Milch technique for self reduction
    Arm Title
    Boss Holtzach
    Arm Type
    Experimental
    Arm Description
    Boss Holtzach technique for self reduction
    Arm Title
    Stimson
    Arm Type
    Experimental
    Arm Description
    Stimson technique for self reduction
    Intervention Type
    Procedure
    Intervention Name(s)
    shoulder dislocation self reduction
    Intervention Description
    shoulder dislocation self reduction using one of three methods in the study
    Primary Outcome Measure Information:
    Title
    rate of successfull self reduction
    Description
    the number/rate of successful reductions using each technique will be calculated
    Time Frame
    10 minutes
    Secondary Outcome Measure Information:
    Title
    pain using VAS during reduction
    Description
    patients will be asked to report pain levels using VAS during the self reduction procedure
    Time Frame
    10 minutes
    Title
    patient satisfaction from self reduction process using VAS
    Description
    patients will be asked to report their satisfaction from self reduction process using VAS
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: anterior shoulder dislocation acute (24 hours) shoulder dislocation Exclusion Criteria: shoulder fracture non-cooperative patient

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Self Reduction of Shoulder Dislocation

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