Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome

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: Recruiting
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Other: Blood Flow Restriction training

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 (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Ma Gad, Msc; Phone Number: +2 01223856774; Email: ahmedgadmoussa031@gmail.com
• Study Contact Backup: Name: Mohammed Sh Abd elsalam; Phone Number: +2 01287232366; Email: m.shawki@pt.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • CairoU
    • Contact: Ahmed Ma Gad; Phone Number: +2 01223856774; Email: ahmedgadmoussa031@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concentric; Concentric group	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
Experimental: Isometric; Isometric group	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
Experimental: Eccentric; Eccentric group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	By bubble inclinometer	20 minutes
Pain assessment	By visual analogue scale	15 minutes
Functional assessment	By DASH questionnaire	20 minutes

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ahmed Ma Gad, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): 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 (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Blood flow restriction/ shoulder impingement syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• 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