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

18 de septiembre de 2026 actualizado por: Mariam Magdy Gerges, Assiut University

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.

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).

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

70

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: CROSS_SECTIONAL

Cohortes e Intervenciones

Grupo / Cohorte
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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation Between Supraspinatus Shear Wave Velocity and MRI Goutallier Grade
Periodo de tiempo: 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.

Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de octubre de 2027

Finalización del estudio (Estimado)

1 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

18 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de septiembre de 2026

Publicado por primera vez (Actual)

23 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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