Rotator Cuff TearsNCT05946343
Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns
An observational study of Rotator Cuff Tears and Rotator Cuff Injuries, run by Ahram Canadian University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain
- What is being tested?
- Surface Electromyography (sEMG) Assessment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: 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:
- Identifying differences in muscle activation patterns between varying tear sizes.
- Evaluating the potential of these activation patterns as an indicator for the severity of rotator cuff tears.
- Assessing the influence of muscle activation patterns on the functional capacity of the affected shoulder.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain
- Being tested
- Surface Electromyography (sEMG) Assessment
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Electromyography (sEMG) AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Surface Electromyography (sEMG) Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
Differences in Muscle Activation Patterns by Tear Size
Identification of differences in muscle activation patterns between varying tear sizes (small, medium, large, and massive).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946343
- Sponsor's protocol ID
- 012/09978882023
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05946343
- Acronym / sponsor ID
- 012/09978882023
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identifying differences in muscle activation patterns between varying tear sizes.
- Evaluating the potential of these activation patterns as an indicator for the severity of rotator cuff tears.
- Assessing the influence of muscle activation patterns on the functional capacity of the affected shoulder.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Small Rotator Cuff Tear Group | – | Diagnostic Test: Surface Electromyography (sEMG) AssessmentThe 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. |
| Medium Rotator Cuff Tear Group | – | Diagnostic Test: Surface Electromyography (sEMG) AssessmentThe 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 |
| Large Rotator Cuff Tear Group | – | Diagnostic Test: Surface Electromyography (sEMG) AssessmentThe 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 |
| Massive Rotator Cuff Tear Group | – | Diagnostic Test: Surface Electromyography (sEMG) AssessmentThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface Electromyography (sEMG) AssessmentSurface 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. | Diagnostic test | Large Rotator Cuff Tear Group, Massive Rotator Cuff Tear Group, Medium Rotator Cuff Tear Group, Small Rotator Cuff Tear Group |
Primary outcome
Muscle Activation Amplitude
Time frame: baseline
Muscle activation amplitude for the scapular and rotator cuff muscles (serratus anterior, upper and lower trapezius, supraspinatus, and infraspinatus) during functional tasks.
1 secondary outcome
Differences in Muscle Activation Patterns by Tear Size
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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Voll Non-Degradable Shoulder Spacer FIH Study
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Active, not recruitingPhase 2
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SMR Stemless Reverse vs SMR Reverse Shoulder System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears and Rotator Cuff Injuries, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Activation Amplitude (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.