Protocol summary

Study aim
Evaluation of myofascial release on shoulder impingement syndrome.
Design
Nonrandomised , unblinded quasi experimental before and after
Settings and conduct
At first should measure shoulder abduction range of motion via Clinometer aplication and measure pain via Visual Analog Scale (VAS) and disability via Shoulder Pain And Disablility Index (SPADI) ;Then therapist should do myofascial release in involved upper extrimity wich take near one hour and after that should measure previous mesurments again.
Participants/Inclusion and exclusion criteria
Men with shoulder impingement syndrome who are between 18 to 65 years old.
Intervention groups
Involved upper arm myofascial release.
Main outcome variables
Pain,Range of Motion, Disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200724048189N1
Registration date: 2020-08-09, 1399/05/19
Registration timing: prospective

Last update: 2020-08-09, 1399/05/19
Update count: 0
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Mahmood Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3567 8456
Email address
m_sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Myofascial release effect on pain , disability Index and shoulder abduction in men With shoulder impingement syndrome
Public title
Myofascial release effect on shoulder impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men between 18 & 65 years old Patients who have shoulder pain for at least 1 week and an intensity of at least 4 on Visual Analog Scale (VAS) during arm elevation. Patients who have 3 of 5 positive sign of shoulder impingement syndrome , including : • Hawkins-Kennedy test . • NEER test . •Job/Empty can test . • External rotation lag sign . • patient had pain after 60°of elevation.
Exclusion criteria:
Acute cervical disk herniation. Disorders of the acromioclavicular joint . Calcifying tendonitis. History of trauma , fracture , dislocation or sub dislocation or surgery in neck upper extremity or thoracic spine in last years ago . Shoulder instability. Frozen shoulder . Fibromyalgia. Corticosteroid injection on the shoulder within 1 year of the study.
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Quasi experimental before and after

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
N.270, 28 Dead End, Askarie St, Isfahan, IRAN
City
Isfahan
Province
Isfehan
Postal code
8199796381
Approval date
2020-07-24, 1399/05/03
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.220

Health conditions studied

1

Description of health condition studied
Shoulder Impingement Syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder

Primary outcomes

1

Description
Shoulder abduction
Timepoint
Before intervention and after intervention
Method of measurement
Clinometer Application

2

Description
Pain
Timepoint
Before intervention and after intervention
Method of measurement
Visual Analogue Scale

3

Description
Pain and disability
Timepoint
Before intervention and after intervention
Method of measurement
Shoulder Pain And Disability Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Upper arm myofascial release wich takes one hour
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mahmood Sadeghi
Street address
No 270, Dead End 28, Askarie St
City
Isfahan
Province
Isfehan
Postal code
8199796381
Phone
+98 31 3567 8456
Email
Mmahmood110@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
No. 270, Dead End 28., Askarie St
City
Isfahan
Province
Isfehan
Postal code
8199796381
Phone
+98 31 3567 8456
Email
Mmahmood110@yahoo.co
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahmood Sadeghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Askarie
City
Isfahan
Province
Isfehan
Postal code
8199796381
Phone
+98 31 3567 8456
Fax
Email
m_sadeghi@rehab.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmood Sadeghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Askarie
City
Isfahan
Province
Isfehan
Postal code
8199796381
Phone
+98 31 3567 8456
Fax
Email
m_sadeghi@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmood Sadeghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Askarie
City
Isfahan
Province
Isfehan
Postal code
8199796381
Phone
+98 31 3567 8456
Fax
Email
m_sadeghi@rehab.mui.ac.ir

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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people are not identified.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
This data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any kind of analysis on the delivered data is allowed.
From where data/document is obtainable
Email : Mmahmood110@yahoo.com Address : NO 270, Dead End 28, Askarie St, Isfahan, Iran, Postal code:8199796381,Telephone :00983135678456 Mobile : 00989131151114
What processes are involved for a request to access data/document
The documents will be sent as a PDF file via email no later than one week after the request.
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