NCT02787395

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 22, 2016

Last Update Submit

June 1, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of successfull self reduction

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

    10 minutes

Secondary Outcomes (2)

  • pain using VAS during reduction

    10 minutes

  • patient satisfaction from self reduction process using VAS

    10 minutes

Study Arms (3)

Milch

EXPERIMENTAL

modified Milch technique for self reduction

Procedure: shoulder dislocation self reduction

Boss Holtzach

EXPERIMENTAL

Boss Holtzach technique for self reduction

Procedure: shoulder dislocation self reduction

Stimson

EXPERIMENTAL

Stimson technique for self reduction

Procedure: shoulder dislocation self reduction

Interventions

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

Boss HoltzachMilchStimson

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • shoulder fracture
  • non-cooperative patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2016

First Posted

June 1, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

June 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share