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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01979237
First received: November 3, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Shoulder Anterior Dislocation
Procedure: SPASO method and FARES method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Successful reduction rate [ Time Frame: Less than 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPASO method, FARES method
Reduction method: SPASO method, FARES method
Procedure: SPASO method and FARES method
SPASO method and FARES method as shoulder dislocation reduction methods

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • shoulder anterior dislocation
  • conscious clear
  • communicable

Exclusion Criteria:

  • unconscious
  • non-communicable
  • humeral neck fracture
  • dislocation time > 24 hours
  • neurovascular compromise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979237

Contacts
Contact: Shu Hao Chang, Master 886-952537691 aberchangtw@gmail.com

Locations
Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01979237     History of Changes
Other Study ID Numbers: 201307037RINC
Study First Received: November 3, 2013
Last Updated: November 3, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Dislocations
Shoulder Dislocation
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 19, 2014