Comparison of sensitivity and specificity of ultrasonography and plain radiographic image in diagnosis of shoulder dislocation reduction in Rasool akram haospital patients in 2014-2015
Objectives: Comparison of sensitivity and specificity of ultrasonography and plain radiographic image in diagnosis of shoulder dislocation reduction.
Design:The randomized clinical trial in the emergency department of Rasoul Akram hospital.
Setting and conduct: Patients complaining shoulder pain and with probable diagnosis of shoulder dislocation admitted in Emergency Department of Rasoul Akram hospital will be recruited. Standard imagings including AP, Lateral, And Scapular Y views will be conducted to confirm the dislocation. After physical exam and imaging, and confirmation of the diagnosis of shoulder dislocation, the patients will be randomized to two groups and after reducton imaging in one group and sonographic exam in another group will be done to confirm the reduction. After confirmation of reduction, patients will be discharged from emergency department and will be evaluated with an orthopedist within 24 hour time.
Participants including major eligibility criteria:Inclusion criteria: Complaint of shoulder pain and probable diagnosis of shoulder dislocation.
Exclusion criteria: Patients younger than 18 years and older than 65 years old; Multiple Trauma patients; Patients with unstable hemodynamic.
Interventions: Intervention Group: Patients in this group will be evaluated with sonography to confirm reduction.
Control Group: Patients in this group will be evaluated with imaging to confirm reduction.
Main outcome measures (variable): Confirmation of successful reduction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401068104N9
Registration date:2015-02-08, 1393/11/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-08, 1393/11/19
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sensitivity and specificity of ultrasonography and plain radiographic image in diagnosis of shoulder dislocation reduction in Rasool akram haospital patients in 2014-2015
Public title
Comparison of sensitivity and specificity of ultrasonography and plain radiographic image in diagnosis of shoulder dislocation reduction
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Complaint of shoulder pain and probable diagnosis of shoulder dislocation.
Exclusion criteria: Patients younger than 18 years and older than 65 years old; Multiple Trauma patients; Patients with unstable hemodynamic.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat highway, next to Milad Hospital
City
Tehran
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
105/372
Health conditions studied
1
Description of health condition studied
shoulder dislocation
ICD-10 code
S43.0
ICD-10 code description
Dislocation of shoulder joint
Primary outcomes
1
Description
Successful Reduction of shoulder dislocation
Timepoint
After reduction
Method of measurement
according to imaging or sonography and comparing with the imaging before procedure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Patients in this group will be evaluated with sonography to confirm reduction.
Category
Diagnosis
2
Description
Control Group: Patients in this group will be evaluated with imaging to confirm reduction.