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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07837583
Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
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).
Panoramica dello studio
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Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
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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.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
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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). |
Cosa sta misurando lo studio?
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Correlation Between Supraspinatus Shear Wave Velocity and MRI Goutallier Grade
Lasso di tempo: Baseline
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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
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Collaboratori e investigatori
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Completamento dello studio (Stimato)
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Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Lesioni alla spalla
- Dolore
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie del sistema nervoso
- Manifestazioni neuromuscolari
- Ferite e lesioni
- Condizioni patologiche, anatomiche
- Malattie articolari
- Rottura
- Lesioni al tendine
- Artralgia
- Atrofia
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Lesioni della cuffia dei rotatori
- Dolore alla spalla
- Atrofia muscolare
Altri numeri di identificazione dello studio
- US/SWE of Rotator Cuff Muscles
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .