Rotator Cuff InjuriesNCT07837583
Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
An observational study of Rotator Cuff Injuries and Rotator Cuff Tear, run by Assiut University.
Trial summary
Rotator cuff disorders are among the most frequent musculoskeletal causes of shoulder pain, weakness, and limited movement. In many individuals with rotator cuff disease, the damaged muscles gradually shrink (muscle atrophy) and become replaced by fat tissue (fatty infiltration), particularly involving the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries, Rotator Cuff Tear, Muscular Atrophy
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients presenting to or referred to the Department of Diagnostic Radiology at Assiut University Hospitals with clinical suspicion of a rotator cuff disorder (shoulder pain, weakness, or restricted range of motion). Eligible participants include individuals who have undergone a shoulder MRI or CT examination within the previous 12 months that includes the standard oblique-sagittal plane required for evaluating supraspinatus and infraspinatus muscle quality.
Who may be able to join
- Age 18 years or older
- Clinical suspicion of a rotator cuff disorder (shoulder pain, weakness, and/or restricted range of motion)
- Available shoulder MRI or CT scan performed within the previous 12 months, including the oblique-sagittal plane required for assessment of the supraspinatus and infraspinatus muscles
- Eligible and willing to undergo a shoulder ultrasound examination with shear wave elastography
- Ability and willingness to provide written informed consent
Who cannot join
- History of previous shoulder surgery on the affected side
- Acute shoulder trauma, fracture, or glenohumeral dislocation
- Inflammatory or rheumatologic disease involving the shoulder (e.g., rheumatoid arthritis) that could confound the evaluation of muscle atrophy or fatty infiltration
- Time interval exceeding 12 months between the reference scan (MRI/CT) and the ultrasound examination
- Incomplete clinical or imaging records, or reference scan that is inconclusive or technically unassessable
- Inability to tolerate or complete the ultrasound and shear wave elastography examination
About this study
Official title: Evaluating Role of Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
Rotator cuff disorders are among the most frequent musculoskeletal causes of shoulder pain, weakness, and limited movement. In many individuals with rotator cuff disease, the damaged muscles gradually shrink (muscle atrophy) and become replaced by fat tissue (fatty infiltration), particularly involving the supraspinatus and infraspinatus muscles. These structural changes can impair shoulder function, reduce the likelihood of successful tendon repair surgery, and increase the risk of recurrent tears.
Magnetic resonance imaging (MRI) is the established standard for assessing rotator cuff muscle health, but it is expensive, time-consuming, and not suitable for all individuals. Musculoskeletal ultrasound offers an accessible, real-time alternative, and shear wave elastography (SWE) adds the capability to quantitatively measure tissue stiffness.
Read more
The purpose of this study is to evaluate the diagnostic accuracy and validity of combining conventional ultrasound with shear wave elastography to assess rotator cuff muscle quality, specifically fatty infiltration and muscle atrophy, in comparison with reference MRI or CT scans.
Participants aged 18 years or older with suspected rotator cuff disorders who have had a qualifying shoulder MRI or CT scan within the previous 12 months will undergo an ultrasound and shear wave elastography examination of the affected shoulder. Researchers will calculate shear wave velocity and muscle occupation ratios to assess muscle stiffness and volume, and compare these results to validated MRI grading scales (the Goutallier classification for fat infiltration and the Warner staging system for muscle atrophy).
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tear, Muscular Atrophy, Fatty Infiltration, Shoulder Pain
- Keywords
- Shear Wave Elastography, Musculoskeletal Ultrasound, Rotator Cuff Muscle Quality, Supraspinatus Muscle, Infraspinatus Muscle, Goutallier Classification, Shear Wave Velocity, Muscle Atrophy
- Medical subject headings
- Rotator Cuff Injuries, Muscular Atrophy, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Suspected Rotator Cuff Disorders | Adult patients aged 18 years or older presenting with clinical suspicion of a rotator cuff disorder (shoulder pain, weakness, and/or restricted range of motion) who have an available shoulder MRI or CT scan performed within the previous 12 months. All participants undergo high-resolution musculoskeletal ultrasound combined with shear wave elastography (SWE) to evaluate the supraspinatus and infraspinatus muscles for shear wave velocity (SWV), visual Goutallier stage, and muscle occupation ratio. These index test measurements are correlated with reference standard MRI/CT assessments (Goutallier grading for fatty infiltration, Warner stage for muscle atrophy, and occupation ratio). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Supraspinatus Shear Wave Velocity and MRI Goutallier Grade
Evaluates the diagnostic correlation between supraspinatus muscle shear wave velocity (SWV) and fatty infiltration staged on reference-standard MRI. Supraspinatus SWV is quantitatively measured in meters per second (m/s) using high-resolution ultrasound across four quadrants (anterosuperior, posterosuperior, anteroinferior, posteroinferior) to calculate the mean SWV (mSWV). MRI fatty infiltration is graded using the Goutallier classification (Grade 0: no fat; Grade 1: fatty streaks; Grade 2: <50% fat; Grade 3: 50% fat; Grade 4: >50% fat). The correlation between mSWV and Goutallier grade is assessed using Spearman's rank correlation coefficient, ranging from -1.0 to +1.0, where higher positive values reflect stronger agreement between increased shear wave stiffness and higher degrees of fatty degeneration.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Magdy Gerges, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837583
- Sponsor's protocol ID
- US/SWE of Rotator Cuff Muscles
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Role of Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
- ClinicalTrials.gov ID
- NCT07837583
- Acronym / sponsor ID
- US/SWE of Rotator Cuff Muscles
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tear, Muscular Atrophy, Fatty Infiltration, Shoulder Pain
- Keywords
- Shear Wave Elastography, Musculoskeletal Ultrasound, Rotator Cuff Muscle Quality, Supraspinatus Muscle, Infraspinatus Muscle, Goutallier Classification, Shear Wave Velocity, Muscle Atrophy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Sep 2026 (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 disorders are among the most frequent musculoskeletal causes of shoulder pain, weakness, and limited movement. In many individuals with rotator cuff disease, the damaged muscles gradually shrink (muscle atrophy) and become replaced by fat tissue (fatty infiltration), particularly involving the supraspinatus and infraspinatus muscles. These structural changes can impair shoulder function, reduce the likelihood of successful tendon repair surgery, and increase the risk of recurrent tears.
Magnetic resonance imaging (MRI) is the established standard for assessing rotator cuff muscle health, but it is expensive, time-consuming, and not suitable for all individuals. Musculoskeletal ultrasound offers an accessible, real-time alternative, and shear wave elastography (SWE) adds the capability to quantitatively measure tissue stiffness.
The purpose of this study is to evaluate the diagnostic accuracy and validity of combining conventional ultrasound with shear wave elastography to assess rotator cuff muscle quality, specifically fatty infiltration and muscle atrophy, in comparison with reference MRI or CT scans.
Participants aged 18 years or older with suspected rotator cuff disorders who have had a qualifying shoulder MRI or CT scan within the previous 12 months will undergo an ultrasound and shear wave elastography examination of the affected shoulder. Researchers will calculate shear wave velocity and muscle occupation ratios to assess muscle stiffness and volume, and compare these results to validated MRI grading scales (the Goutallier classification for fat infiltration and the Warner staging system for muscle atrophy).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Suspected Rotator Cuff Disorders | – | –Adult patients aged 18 years or older presenting with clinical suspicion of a rotator cuff disorder (shoulder pain, weakness, and/or restricted range of motion) who have an available shoulder MRI or CT scan performed within the previous 12 months. All participants undergo high-resolution musculoskeletal ultrasound combined with shear wave elastography (SWE) to evaluate the supraspinatus and infraspinatus muscles for shear wave velocity (SWV), visual Goutallier stage, and muscle occupation ratio. These index test measurements are correlated with reference standard MRI/CT assessments (Goutallier grading for fatty infiltration, Warner stage for muscle atrophy, and occupation ratio). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to or referred to the Department of Diagnostic Radiology at Assiut University Hospitals with clinical suspicion of a rotator cuff disorder (shoulder pain, weakness, or restricted range of motion). Eligible participants include individuals who have undergone a shoulder MRI or CT examination within the previous 12 months that includes the standard oblique-sagittal plane required for evaluating supraspinatus and infraspinatus muscle quality.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Clinical suspicion of a rotator cuff disorder (shoulder pain, weakness, and/or restricted range of motion)
- Available shoulder MRI or CT scan performed within the previous 12 months, including the oblique-sagittal plane required for assessment of the supraspinatus and infraspinatus muscles
- Eligible and willing to undergo a shoulder ultrasound examination with shear wave elastography
- Ability and willingness to provide written informed consent
Key exclusion criteria (6 listed)
- History of previous shoulder surgery on the affected side
- Acute shoulder trauma, fracture, or glenohumeral dislocation
- Inflammatory or rheumatologic disease involving the shoulder (e.g., rheumatoid arthritis) that could confound the evaluation of muscle atrophy or fatty infiltration
- Time interval exceeding 12 months between the reference scan (MRI/CT) and the ultrasound examination
- Incomplete clinical or imaging records, or reference scan that is inconclusive or technically unassessable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Supraspinatus Shear Wave Velocity and MRI Goutallier Grade
Time frame: Baseline
Evaluates the diagnostic correlation between supraspinatus muscle shear wave velocity (SWV) and fatty infiltration staged on reference-standard MRI. Supraspinatus SWV is quantitatively measured in meters per second (m/s) using high-resolution ultrasound across four quadrants (anterosuperior, posterosuperior, anteroinferior, posteroinferior) to calculate the mean SWV (mSWV). MRI fatty infiltration is graded using the Goutallier classification (Grade 0: no fat; Grade 1: fatty streaks; Grade 2: <50% fat; Grade 3: 50% fat; Grade 4: >50% fat). The correlation between mSWV and Goutallier grade is assessed using Spearman's rank correlation coefficient, ranging from -1.0 to +1.0, where higher positive values reflect stronger agreement between increased shear wave stiffness and higher degrees of fatty degeneration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries and Rotator Cuff Tear, run by Assiut University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Supraspinatus Shear Wave Velocity and MRI Goutallier Grade (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 23 Sep 2026.