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

Primary Purpose

Shoulder Impingement Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Blood Flow Restriction training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Blood flow restriction/ shoulder impingement syndrome

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CairoURecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Concentric

Isometric

Eccentric

Arm Description

Concentric group

Isometric group

Eccentric group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional assessment
By DASH questionnaire
Pain assessment
By visual analogue scale
Range of motion
By bubble inclinometer

Full Information

First Posted
January 11, 2023
Last Updated
September 22, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05695820
Brief Title
Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome
Official Title
Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
Blood flow restriction/ shoulder impingement syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Parallel Groups Clinical Trial
Masking
Participant
Masking Description
Sealed envelope
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concentric
Arm Type
Experimental
Arm Description
Concentric group
Arm Title
Isometric
Arm Type
Experimental
Arm Description
Isometric group
Arm Title
Eccentric
Arm Type
Experimental
Arm Description
Eccentric group
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction training
Intervention Description
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
Primary Outcome Measure Information:
Title
Muscle strength
Description
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
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Functional assessment
Description
By DASH questionnaire
Time Frame
20 minutes
Title
Pain assessment
Description
By visual analogue scale
Time Frame
15 minutes
Title
Range of motion
Description
By bubble inclinometer
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ma Gad, Msc
Phone
01223856774
Ext
+2
Email
ahmedgadmoussa031@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Sh Abd elsalam
Phone
01287232366
Ext
+2
Email
m.shawki@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Ma Gad
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
CairoU
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Ma Gad
Phone
01223856774
Ext
+2
Email
ahmedgadmoussa031@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Website

Learn more about this trial

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

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