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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05695820
Other study ID # P.T.REC/012/004174
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 13, 2023
Est. completion date February 28, 2024

Study information

Verified date February 2024
Source Cairo University
Contact Ahmed Ma Gad, Msc
Phone 01223856774
Email ahmedgadmoussa031@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
Blood Flow Restriction training
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

Locations

Country Name City State
Egypt CairoU Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle strength 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 Functional assessment By DASH questionnaire 20 minutes
Secondary Pain assessment By visual analogue scale 15 minutes
Secondary Range of motion By bubble inclinometer 20 minutes
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