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

NCT05946343 | Unknown

• 1 other identifier: 012/09978882023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Differences in Muscle Activation Patterns by Tear Size

  baseline

Study Arms (4)

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

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

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

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

Interventions

Surface Electromyography (sEMG) Assessment DIAGNOSTIC_TEST

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; Massive Rotator Cuff Tear Group; Medium Rotator Cuff Tear Group; Small Rotator Cuff Tear Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain

Interventions

Electromyography; Physical Examination

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: July 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)