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Investigation of the effect of limb immobilization in external rotation on recurrent anterior shoulder dislocation in patients admitted to hospitals of Mashhad University of Medical Sciences

Protocol summary

Study aim
The effect of limb immobilization in external rotation on recurrent anterior shoulder dislocation
Design
In this study, all patients with anterior shoulder dislocation referring to Imam Reza, Shahid Kamiab and Hasheminejad hospitals enter the study after obtaining informed consent. Using random numbers and envelope method, Patients will be divided into intervention and control groups.
Settings and conduct
In the intervention group, immobilization is performed as an external rotation and in the control group, immobilization is performed as an internal rotation (commonly used method) for 4 weeks. The range of shoulder movement questionnaire is completed for each patient immediately after removal of the brace, 3 months, one year and two years after the immobilization, the Oxford questionnaire is completed 3 months, one year and 2 years after the immobilization. Patients are followed up for dislocation recurrence within two years. Patients' comfort in each brace is assessed through a questionnaire.
Participants/Inclusion and exclusion criteria
inclusion criteria: Shoulder dislocation Exclusion criteria: A history of shoulder dislocation, Fracture of the scapular and humerus, History of underlying diseases affecting study outcomes such as osteoporosis and inflammatory and autoimmune diseases.
Intervention groups
Intervention group: After the shoulder is placed back in position, the immobilization is in a rotational state outward and at a distance from the axis of the body, and armpit cushion is used for the injuerd. Control group: After the shoulder is placed back in position, the immobilization is routine and is rotated indoors and spaced apart from the axis of the body.
Main outcome variables
recurrent anterior shoulder dislocation, shoulder range of motion; the quality of patient's life; patients' comfort in brace

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171205037766N1
Registration date: 2018-08-01, 1397/05/10
Registration timing: retrospective

Last update: 2018-08-01, 1397/05/10
Update count: 0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Mohamadkazem Khalesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 1344
Email address
khalesimk921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
2014-08-23, 1393/06/01
Actual recruitment end date
2016-06-19, 1395/03/30
Trial completion date
empty
Scientific title
Investigation of the effect of limb immobilization in external rotation on recurrent anterior shoulder dislocation in patients admitted to hospitals of Mashhad University of Medical Sciences
Public title
The effect of limb immobilization in external rotation in anterior shoulder dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Anterior shoulder dislocation
Exclusion criteria:
A history of shoulder dislocation Fracture of the scapular and humerus History of underlying diseases affecting study outcomes such as osteoporosis and inflammatory and autoimmune diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is applied. Selective treatment is placed in sealed envelopes. Type of treatment is determined by random selection of envelopes.
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Approval date
2012-06-23, 1391/04/03
Ethics committee reference number
IR.MUMS.REC.1391.94

Health conditions studied

1

Description of health condition studied
Shoulder dislocation
ICD-10 code
S43.0
ICD-10 code description
Subluxation and dislocation of shoulder joint

Primary outcomes

1

Description
recurrent anterior shoulder dislocation
Timepoint
Following up with patients is carried out for at least 2 years.
Method of measurement
Physical examination

2

Description
Shoulder range Of motion
Timepoint
For each patient, immediately after removing the brace, 3 months, one year, and 2 years after immobilization.
Method of measurement
Range Of Motion Shoulder (ROM) questionnaire completed by the researcher.

3

Description
Quality of life in patients with shoulder problems
Timepoint
Three months, one year and two years after immobilization.
Method of measurement
Oxford Shoulder questionnaire

4

Description
Evaluation of patients' comfort in brace
Timepoint
After the end of treatment
Method of measurement
Visual Analog Scale (VAS) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the shoulder is placed back in position, the immobilization is in a rotational state outward and at a distance from the axis of the body and an armpit cushion is placed for the injured.
Category
Treatment - Devices

2

Description
Control group: After the shoulder is placed back in position, the immobilization is routine and is rotated indoors and spaced apart from the axis of the body.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Mohammad Kazem Khalesi
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Email
KhalesiMK921@mums.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Hashemi Nezhad Hospital
Full name of responsible person
Mohammad Kazem Khalesi
Street address
Shahid Hashemi Nezhad Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3273 7015
Email
KhalesiMK921@mums.ac.ir

3

Recruitment center
Name of recruitment center
Shahid Kamyab Hospital
Full name of responsible person
Mohammad Kazem Khalesi
Street address
Shahid Kamyab Hospital, Nakhrisi junction, Fadaeian Eslam St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3802 6351
Email
KhalesiMK921@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Kazem Khalesi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2610
Email
khalesimk921@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Kazem Khalesi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2610
Email
khalesimk921@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Kazem Khalesi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2610
Email
khalesimk921@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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