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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05946343
• Other study ID #: 012/09978882023
• Status: Recruiting
• Start date: July 15, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: July 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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