Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles

NCT07837583 | Not Yet Recruiting

• 1 other identifier: US/SWE of Rotator Cuff Muscles
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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 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).

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Rotator Cuff Injuries; Muscular Atrophy; Shoulder Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Diagnostic and Interventional Radiology

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09