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The effect of exercise therapy on pain and disability at shoulder impingement syndrome

Protocol summary

Study aim
Determination of exercise therapy on improvement of shoulder pain due to impingement syndrome
Design
The clinical trial had a control group, with parallel, double-blind, randomized. For randomization, random number table was used.30 patients were included in the study and were followed up for 6 months.
Settings and conduct
This study will be conducted in datgheib Yasaee Pain Clinic in Fasa, patients under 18 and over 85 years old and patients who are not satisfied with participation in the study will be excluded and patients are unaware of the outcomes and according to ODI patients announce their pain improvement rate.
Participants/Inclusion and exclusion criteria
Athlete males ages 18 to 45 , unilateral pain of acromones more than one week, pain during flexion and extension against resistance, positive Neer test, Hawkins and Supraspinatus Empty Can test, tenderness in Tuberosity Humorous. Exclusion criteria were: systemic diseases, neck pain during rest and pain during active movement of the neck, reversal of shoulder symptoms during active shoulder movements, history of pain or treatment of the neck in the past 12 months, history of vertebral and upper extremity surgery, fracture in the spine or upper extremity of the shoulder joint, positive sulcus sign, shift test, Active Compression Labral tests.
Intervention groups
In this study, the effect of exercise on shoulder pain due to shoulder impingement syndrome will be investigated. Including two groups, the first group will receive only medicine and the second group will receive medicine and exercise.
Main outcome variables
Age, sex, underlying disease, primary disability, patient satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220302054169N1
Registration date: 2022-07-26, 1401/05/04
Registration timing: registered_while_recruiting

Last update: 2022-07-26, 1401/05/04
Update count: 0
Registration date
2022-07-26, 1401/05/04
Registrant information
Name
Zahra Sadeghi mazidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 9963
Email address
z.sadeghi@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-25, 1401/05/03
Expected recruitment end date
2023-01-23, 1401/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise therapy on pain and disability at shoulder impingement syndrome
Public title
Exercise therapy in impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral acromial pain for more than one week Pain when flexion and abduction against resistance Neer, Hawkins, and Supraspinatous Empty Can be positive Tenderness of tuberosity of humerus
Exclusion criteria:
Systemic disease Neck pain at rest and active motion History of pain or treatment of neck at 12 months ago History of upper exterimities and vertebra Sulcus sign، shift test، Active Compression Labral were positive
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the simple randomization method, Randomization Unit: Individual, and the randomization tool: random number tables have been used which Odd numbers were placed in the exercise group and even numbers were placed in the drug group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participates were explained that was entered at this study and recieve exercise therapy
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶۸۶۶۸۸
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.FUMS.REC.1400.100

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
Pain score in Oswestry Disability Index questionnaire
Timepoint
Evaluation of pain improvement 6 weeks after exercise
Method of measurement
Oswestry Disability Index Questionnaire

Secondary outcomes

1

Description
Patient Satisfaction Score ( from 1 to 5 )
Timepoint
Pain score after 6 weeks of exercise
Method of measurement
The patients was asked to rate their satisfaction with exercise from 1 to 5

Intervention groups

1

Description
Intervention group: 15 patients with shoulder pain were exercises such as passive extension-mid deltoid stretch and were asked to perform 3 times a day for at least 10 minutes each time for 6 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Dastgheib Yasaee pain clinic in fasa
Full name of responsible person
Salman Vejdani
Street address
Fasa Ibn Sina Square
City
Fasa
Province
Fars
Postal code
ندارد
Phone
+98 71 5331 5014
Email
zasadeghi1376@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Zahra Sadeghi Mazidi
Street address
Ibn Sina squre
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Email
info@fums.ac.ir
Web page address
https://fums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
fasa university of medical science
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Zahra Sadeghi Mazidi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 73, Molavi Ave., Shahrak parvaz., FasaTown
City
Fasa
Province
Fars
Postal code
7461436745
Phone
+98 903 725 3473
Email
zasadeghi1376@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Zahra Sadeghi Mazidi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 73, Molavi Ave., Shahrak parvaz., FasaTown
City
Fasa
Province
Fars
Postal code
7461436745
Phone
+98 71 5333 9963
Email
zasadeghi1376@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Zahra Sadeghi Mazidi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 73, Molavi Ave., Shahrak parvaz., Fasa Town
City
Fasa
Province
Fars
Postal code
7461436745
Phone
+98 71 5333 9963
Email
zasadeghi1376@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
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
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
The use of data can be used for supplementary work and research expansion
From where data/document is obtainable
Zahra Sadeghi Mazidi 09037253473
What processes are involved for a request to access data/document
It does not need any details. The applicant can access the information after contacting Zahra Sadeghi
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