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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 1 trial group
Group A: Patients with Suspected Rotator Cuff Disorders

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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