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Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial

Primary Purpose

Shoulder Anterior Dislocation

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
SPASO method and FARES method
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Anterior Dislocation

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • shoulder anterior dislocation
  • conscious clear
  • communicable

Exclusion Criteria:

  • unconscious
  • non-communicable
  • humeral neck fracture
  • dislocation time > 24 hours
  • neurovascular compromise

Sites / Locations

  • National Taiwan University Hospital (NTUH)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPASO method, FARES method

Arm Description

Reduction method: SPASO method, FARES method

Outcomes

Primary Outcome Measures

Successful reduction rate

Secondary Outcome Measures

Full Information

First Posted
November 3, 2013
Last Updated
November 3, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01979237
Brief Title
Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial
Official Title
Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
Shoulder anterior dislocation is a major disease entity in emergency department. There are more than 10 reduction methods that have been reported. Traditional reduction methods require sedatives, which could cause adverse effects on the patients such as respiratory suppression and allergy. There are some reduction maneuvers reported recently which do not need sedatives prior to performing reduction, including FARES method and SPASO method. So far, there are no well-designed study to compare these two methods. Besides, in clinical experience, we found that combining these two methods could even get higher successful reduction rate. This study is aimed to compare these two methods as a prospective randomized design, and furthermore, to show that combining these two methods could get higher successful reduction rate.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SPASO method, FARES method
Arm Type
Experimental
Arm Description
Reduction method: SPASO method, FARES method
Intervention Type
Procedure
Intervention Name(s)
SPASO method and FARES method
Intervention Description
SPASO method and FARES method as shoulder dislocation reduction methods
Primary Outcome Measure Information:
Title
Successful reduction rate
Time Frame
Less than 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: shoulder anterior dislocation conscious clear communicable Exclusion Criteria: unconscious non-communicable humeral neck fracture dislocation time > 24 hours neurovascular compromise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu Hao Chang, Master
Phone
886-952537691
Email
aberchangtw@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital (NTUH)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial

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