Ultrasound Elastography of Carpal Tunnel Syndrome

N/AEnrolling By InvitationNCT07486284

Da Nang Family General Hospital80 enrolled

Overview

Carpal Tunnel Syndrome (CTS) is the most common peripheral nerve compression disorder in adults. Although electromyography (EMG) is the current gold standard for diagnosis, it is invasive, time-consuming, and may yield false-negative results. Ultrasound elastography, including shear wave elastography and strain elastography, enables non-invasive assessment of median nerve stiffness, reflecting fibrosis and edema. However, data on the combined use of elastography and microvascular imaging in CTS are still limited in Vietnam. This study aims to evaluate the value of advanced ultrasound techniques in diagnosing CTS and grading disease severity, as well as their correlation with clinical symptoms and EMG findings

Study Type

OBSERVATIONAL

Enrollment

Conditions

Carpal Tunnel Syndrome (CTS)

Interventions

Ultrasound ElastographyPROCEDURE

* Shear Wave Elastography (SWE): * Performed in the longitudinal plane at the carpal tunnel inlet. * A Region of Interest (ROI) of 1mm will be placed on the median nerve (excluding epineurium). * Stiffness will be measured in kilopascals (kPa). * Three measurements will be taken and averaged. * Strain Elastography (SE): * Assessed using a color map overlay (Blue/Green/Red). * Grading scale (1-4): Grade 1 (Soft/Red) to Grade 4 (Hardest/Blue).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria (Case Group) * Patients \>18 years old. * Clinical suspicion of CTS with at least one sign: numbness/pain in the median nerve distribution (digits 1, 2, 3, and lateral 4), nocturnal symptoms, or positive provocative tests (Tinel, Phalen, Durkan). * Confirmed diagnosis of CTS via Electrodiagnostic studies (NCS/EMG) based on American Academy of Neurology (AAN) and AANEM criteria. Inclusion Criteria (Control Group) * Healthy volunteers with no clinical symptoms of CTS. * Normal electrodiagnostic results. Exclusion Criteria: * Exclusion Criteria * History of prior CTS treatment (steroid injection, surgery). * Presence of cervical radiculopathy, polyneuropathy, or proximal median nerve entrapment. * Secondary causes of CTS identified on ultrasound (e.g., gouty tophi, ganglion cysts, tumors, tenosynovitis). * Anatomical variants such as a bifid median nerve or persistent median artery. * Refusal to participate in the study

Outcomes

Primary Outcomes

Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome

Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of shear wave elastography values (kPa) for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.