Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
Carpal Tunnel Syndrome, Ultrasound Elastography
Brief summary
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
Interventions
PROCEDUREUltrasound Elastography
* 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).
Sponsors
Da Nang Family General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome | At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026) | 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. |
| Diagnostic Accuracy of Strain Elastography (SE) for Carpal Tunnel Syndrome | At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026) | Sensitivity, specificity, and AUC of strain elastography grading for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard. |
| Diagnostic Accuracy of Median Nerve Cross-Sectional Area (CSA) for Carpal Tunnel Syndrome | At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026) | Sensitivity, specificity, and AUC of median nerve cross-sectional area (mm²) measured at the carpal tunnel inlet for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation | At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026) | Correlation coefficients (Pearson/Spearman) between ultrasound parameters (Stiffness, CSA) and: * Electrophysiological severity (DML, SCV, SNAP amplitudes). * Clinical severity (Boston scores). |
| Cut-off Values | At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026) | Optimal threshold values for SWE (kPa) and CSA (mm2) to distinguish CTS from controls and to classify severity. |
Countries
Vietnam
Contacts
STUDY_DIRECTORNguyen Do Ngoc Linh, MD
Da Nang Family General Hospital
Outcome results
None listed