Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome
February 24, 2025 updated by: Ahmed Mahmoud Gad Moussa, Cairo University
Purpose of the study: This study compares effects of isometric, concentric and eccentric exercises for shoulder muscles by using low load blood flow restriction training on pain, strength and function in patients with SIS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted at El hadra university hospital, Alexandria, Egypt.
Study Design: Randomized Parallel Groups Clinical Trial.
Participants: Sixty patients of both genders with unilateral shoulder impingement syndrome, with age range from 30-40 years will be randomly assigned to 1 of 3 groups.
All patients will be referred by the orthopedic surgeon who will diagnose shoulder impingement syndrome based on clinical and radiological examination.
Group 1: twenty patients will receive concentric training of rotator cuff muscles while applying blood flow restriction for 4 weeks.
Group 2: twenty patients will receive eccentric training of rotator cuff muscles while applying blood flow restriction for 4 weeks.
Group 3: twenty patients will receive isometric training of rotator cuff muscles while applying blood flow restriction for 4 weeks.
The assessment for all groups will be done at baseline and after 4 weeks.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- CairoU
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
Age range 30-40 years. - Pain localized to the proximal anterolateral shoulder region, - Positive for pain on at least one of the following three impingement tests: Hawkins-Kennedy, Neers, Jobes and Positive for pain on at least one of the following four tests: Painful arc, drop arm test, lift off test, and resisted external rotation (Fatima et al., 2021
Exclusion Criteria:
- Large, full-thickness rotator cuff tear, Moderate, severe glenohumeral or acromioclavicular joint osteoarthritis. - Glenohumeral joint instability including previous shoulder dislocation/subluxation. - Previous shoulder fracture. - Current neck pain/dysfunction with a somatic or radicular referral pattern indicative of cervical spine rather than shoulder as primary source of symptoms and/or pathology. - Neurological deficits of the upper limb. - Systemic inflammatory arthritic conditions (Fatima et al., 2021).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Concentric
Concentric group
|
It is a method that involves reducing blood flow to a muscle by the application of an external constricting device, such as a blood pressure cuff or tourniquet, to provide mechanical compression of the underlying blood vessels.
BFR is applied aiming to enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet
|
|
Experimental: Isometric
Isometric group
|
It is a method that involves reducing blood flow to a muscle by the application of an external constricting device, such as a blood pressure cuff or tourniquet, to provide mechanical compression of the underlying blood vessels.
BFR is applied aiming to enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet
|
|
Experimental: Eccentric
Eccentric group
|
It is a method that involves reducing blood flow to a muscle by the application of an external constricting device, such as a blood pressure cuff or tourniquet, to provide mechanical compression of the underlying blood vessels.
BFR is applied aiming to enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: 20 minutes
|
All HHD assessments will be done in the form of three trials of 3 seconds of maximal isometric contraction and a 10-second rest period between each measurement.
The mean peak force, will be recorded in kilograms (Kgs), and used as the strength measure
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: 20 minutes
|
By bubble inclinometer
|
20 minutes
|
|
Pain assessment
Time Frame: 15 minutes
|
By visual analogue scale
|
15 minutes
|
|
Functional assessment
Time Frame: 20 minutes
|
By DASH questionnaire
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ahmed Ma Gad, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2023
Primary Completion (Actual)
February 28, 2024
Study Completion (Actual)
February 28, 2024
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
January 13, 2023
First Posted (Actual)
January 25, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Website
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.