Evaluating Role of Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Correlation Between Supraspinatus Shear Wave Velocity and MRI Goutallier Grade
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
结局指标
主要结局
Correlation Between Supraspinatus Shear Wave Velocity and MRI Goutallier Grade
时间窗: 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.
次要结局
未报告次要终点
研究者
Mariam Magdy Gerges
Resident of Diagnostic and Interventional Radiology
Assiut University