NCT05695820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

January 11, 2023

Last Update Submit

February 24, 2025

Conditions

Keywords

Blood flow restriction/ shoulder impingement syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Functional assessment

    20 minutes

  • Pain assessment

    15 minutes

  • Range of motion

    20 minutes

Study Arms (3)

Concentric

EXPERIMENTAL

Concentric group

Other: Blood Flow Restriction training

Isometric

EXPERIMENTAL

Isometric group

Other: Blood Flow Restriction training

Eccentric

EXPERIMENTAL

Eccentric group

Other: Blood Flow Restriction training

Interventions

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

ConcentricEccentricIsometric

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CairoU

Cairo, Egypt

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ahmed Ma Gad

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Parallel Groups Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc degree in physical therapy

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 25, 2023

Study Start

February 13, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations