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

N/ANot Yet RecruitingNCT07837583

Assiut University70 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rotator Cuff Injuries Rotator Cuff Tear Muscular Atrophy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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