Clinical trial NCT05946343: Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns
Official title: The Relationship Between Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Shoulder Pain
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle Activation Amplitude
timeFrame: baseline
Secondary outcomes:
measure: Differences in Muscle Activation Patterns by Tear Size
timeFrame: baseline
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References: