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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01979237
Other study ID # 201307037RINC
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 3, 2013
Last updated November 3, 2013
Start date November 2013

Study information

Verified date October 2013
Source National Taiwan University Hospital
Contact Shu Hao Chang, Master
Phone 886-952537691
Email aberchangtw@gmail.com
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- shoulder anterior dislocation

- conscious clear

- communicable

Exclusion Criteria:

- unconscious

- non-communicable

- humeral neck fracture

- dislocation time > 24 hours

- neurovascular compromise

Study Design

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


Intervention

Procedure:
SPASO method and FARES method
SPASO method and FARES method as shoulder dislocation reduction methods

Locations

Country Name City State
Taiwan National Taiwan University Hospital (NTUH) Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful reduction rate Less than 30 minutes No