Protocol summary

Study aim
Comparison of passive shoulder abduction with and without traction in patients who suffering shoulder pain with subacromial impingement syndrome who referred to the sports medicine department of Taleghani Hospital in Tehran in 2021-2022
Design
Clinical trial without control group, not blind, on 50 patients, Randomization does not apply in this study.
Settings and conduct
People with shoulder pain referred to the sports medicine department of Taleghani Hospital in Tehran are examined by a sports medicine specialist, and if at least three of the five tests are positive, they are diagnosed with subacromial shoulder impingement and are included in the study. In the next step, passive shoulder abduction with and without traction is measured for them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Shoulder pain 2- Age 20 -70 years Exclusion criteria: 1- Any musculoskeletal disorder of the upper limb that interferes with movement or examination
Intervention groups
People with shoulder pain are examined by a sports medicine specialist, and if at least three of the five tests are positive, they are diagnosed with subacromial shoulder impingement and are included in the study. In the next step,passive shoulder abduction with and without traction is measured for them.
Main outcome variables
Passive shoulder abduction range of motion without pain; Passive shoulder abduction range of motion with traction without pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201216049730N2
Registration date: 2021-10-12, 1400/07/20
Registration timing: prospective

Last update: 2021-10-12, 1400/07/20
Update count: 0
Registration date
2021-10-12, 1400/07/20
Registrant information
Name
Mohammad Hassabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8869 2273
Email address
hassabi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Passive Shoulder Abduction With and Without Traction in People Who Suffering Shoulder Pain with Subacromial Impingement Syndrome
Public title
Passive Shoulder Abduction With and Without Traction and Subacromial Impingement Syndrome
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with shoulder pain Age 20 to 70 years
Exclusion criteria:
Any musculoskeletal disorders of the upper extremities that interfere with movement or examination Reluctance to cooperate
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave., Yemen St., Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1370

Health conditions studied

1

Description of health condition studied
Subacromial Impingement Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Passive shoulder abduction range of motion without pain without traction
Timepoint
After performing initial clinical testes
Method of measurement
by goniometer

2

Description
Passive shoulder abduction range of motion with traction, no pain
Timepoint
After performing initial clinical testes
Method of measurement
by goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 50 people who have at least 3 positive tests (out of 5 tests Neer, Hwakin-kennedy, Painfull arc, Empty can, external rotation resistance) and are diagnosed with subacromial impingement syndrome. Then the patient's passive abduction without pain is first examined and the range of painless abduction (until the onset of pain) is measured and recorded by the goniometer in degrees. In the next step, the hand is given a traction and the amplitude of painless passive abduction is measured again by a goniometer.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Seyedeh Sara Shams
Street address
Arabi Ave, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
sarashams6990@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyedeh Sara Shams
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Arabi Ave.
City
Tehran
Province
Tehran
Postal code
198577443
Phone
+98 21 2243 9770
Email
sarashams6990@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyedeh Sara Shams
Position
Specialized Resident in Sports Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Taleghani Hospital, Arabi Ave., Yemen Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
sarashams6990@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyedeh Sara Shams
Position
Specialized Resident in Sports Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Taleghani Hospital, Arabi Ave., Yemen Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
sarashams6990@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyedeh Sara Shams
Position
Specialized Resident in Sports Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Taleghani Hospital, Arabi Ave., Yemen Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
sarashams6990@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data is available for use in future studies
From where data/document is obtainable
Seyedeh Sara Shams Shahid Beheshti University of Medical Sciences sarashams6990@gmail.com 00989363857943
What processes are involved for a request to access data/document
To receive the data, they can email sarashams6990@gmail.com or call 00989363857943 and the information will be sent to them after confirmation.
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