Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns

The Relationship Between Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns: A Cross-Sectional Study

Rotator cuff tears are common musculoskeletal injuries that can lead to altered scapular and rotator cuff muscle activation patterns and reduced function. This study aims to investigate the relationship between rotator cuff tear severity and scapular and rotator cuff muscle activation patterns.

The primary objective of this study is to determine whether a relationship exists between the severity of rotator cuff tears and the activation patterns of scapular and rotator cuff muscles. Secondary objectives include:

1. Identifying differences in muscle activation patterns between varying tear sizes.
2. Evaluating the potential of these activation patterns as an indicator for the severity of rotator cuff tears.
3. Assessing the influence of muscle activation patterns on the functional capacity of the affected shoulder.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Shoulder Pain; Rotator Cuff Tears
• Intervention / Treatment: Diagnostic test: Surface Electromyography (sEMG) Assessment

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population for this research will be individuals between the ages of 18-60 years with a diagnosis of rotator cuff tears confirmed by magnetic resonance imaging (MRI). Participants will be recruited from orthopaedics and hospitals in the local area.

Participants will be stratified based on tear size (small, medium, large, or massive) as determined by MRI.

Participants will be fully informed of the objectives, procedures, potential risks, and benefits of the study, as well as their right to withdraw from the study at any time without penalty. Informed consent will be obtained from all participants prior to their enrolment in the study.

The study population will be diverse in terms of age, sex, tear size, and symptom severity, which will enable the findings to be generalized to a broader population with rotator cuff tears.

Description

Inclusion Criteria:

• Age between 18 and 60 years.
• Diagnosis of rotator cuff tear confirmed by a qualified orthopedic surgeon.
• MRI scan showing the size of the tear (small, medium, large, or massive).
• Ability to provide informed consent and comply with the study protocol.

Exclusion Criteria:

• History of shoulder surgery or other shoulder disorders unrelated to rotator cuff tears.
• Presence of neurological, cardiovascular, or respiratory disorders that could influence muscle activation patterns.
• Contraindications for sEMG assessment, such as skin allergies or infections.
• Inability to perform the required functional tasks due to severe pain or disability.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Small Rotator Cuff Tear Group; The Cofield classification system is a commonly cited classification system for full-thickness rotator cuff tears. It is based on the size of the tear. Small tear: Less than 1 cm.	Diagnostic test: Surface Electromyography (sEMG) Assessment; Surface electromyography (sEMG) will be used to assess the activation patterns of scapular and rotator cuff muscles during functional tasks, such as shoulder flexion, abduction, and external rotation. The sEMG assessment will be conducted using a wireless sEMG system with a sampling rate of 2000 Hz and a bandwidth of 20-500 Hz. Pre-gelled, disposable, self-adhesive Ag/AgCl electrodes will be placed on the muscle belly according to SENIAM guidelines, with an inter-electrode distance of 20 mm.
Medium Rotator Cuff Tear Group; The Cofield classification system is a commonly cited classification system for full-thickness rotator cuff tears. It is based on the size of the tear. Medium tear: 1-3 cm	Diagnostic test: Surface Electromyography (sEMG) Assessment; Surface electromyography (sEMG) will be used to assess the activation patterns of scapular and rotator cuff muscles during functional tasks, such as shoulder flexion, abduction, and external rotation. The sEMG assessment will be conducted using a wireless sEMG system with a sampling rate of 2000 Hz and a bandwidth of 20-500 Hz. Pre-gelled, disposable, self-adhesive Ag/AgCl electrodes will be placed on the muscle belly according to SENIAM guidelines, with an inter-electrode distance of 20 mm.
Large Rotator Cuff Tear Group; The Cofield classification system is a commonly cited classification system for full-thickness rotator cuff tears. It is based on the size of the tear. Large tear: 3-5 cm	Diagnostic test: Surface Electromyography (sEMG) Assessment; Surface electromyography (sEMG) will be used to assess the activation patterns of scapular and rotator cuff muscles during functional tasks, such as shoulder flexion, abduction, and external rotation. The sEMG assessment will be conducted using a wireless sEMG system with a sampling rate of 2000 Hz and a bandwidth of 20-500 Hz. Pre-gelled, disposable, self-adhesive Ag/AgCl electrodes will be placed on the muscle belly according to SENIAM guidelines, with an inter-electrode distance of 20 mm.
Massive Rotator Cuff Tear Group; The Cofield classification system is a commonly cited classification system for full-thickness rotator cuff tears. It is based on the size of the tear. Massive tear: Greater than 5 cm	Diagnostic test: Surface Electromyography (sEMG) Assessment; Surface electromyography (sEMG) will be used to assess the activation patterns of scapular and rotator cuff muscles during functional tasks, such as shoulder flexion, abduction, and external rotation. The sEMG assessment will be conducted using a wireless sEMG system with a sampling rate of 2000 Hz and a bandwidth of 20-500 Hz. Pre-gelled, disposable, self-adhesive Ag/AgCl electrodes will be placed on the muscle belly according to SENIAM guidelines, with an inter-electrode distance of 20 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Activation Amplitude	Muscle activation amplitude for the scapular and rotator cuff muscles (serratus anterior, upper and lower trapezius, supraspinatus, and infraspinatus) during functional tasks.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Muscle Activation Patterns by Tear Size	Identification of differences in muscle activation patterns between varying tear sizes (small, medium, large, and massive).	baseline

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): January 15, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Pain
• Other Study ID Numbers: 012/09978882023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No