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Enrolling by invitation NCT07486284

Ultrasound Elastography of Carpal Tunnel Syndrome

— Observational Carpal Tunnel Syndrome (CTS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound Elastography.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome (CTS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study on the Characteristics of Ultrasound Elastography in the Evaluation of Carpal Tunnel Syndrome

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

Interventions

  • Procedure Ultrasound 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).

Primary outcome measures

  • Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome [Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
  • Diagnostic Accuracy of Strain Elastography (SE) for Carpal Tunnel Syndrome [Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
  • Diagnostic Accuracy of Median Nerve Cross-Sectional Area (CSA) for Carpal Tunnel Syndrome [Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
Secondary outcome measures (2)
  • Correlation [Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
  • Cut-off Values [Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Vietnam · 1 center
  • Da Nang family general Hospital — Da Nang

Publications

  • 1. El-Shewi, Islam El-Hefnawi et al. (2024), "Role of conventional ultrasound and shear wave elastography of median nerve in diagnosis and differentiation of carpal tunnel syndrome severity in correlation with electrodiagnostic studies", Egyptian Journal of Radiology and Nuclear Medicine. 55(1), tr. 53. 2. Joshi, Aditya et al. (2022), "Carpal tunnel syndrome: pathophysiology and comprehensive guid

Identifiers

NCT: NCT07486284 · 01/2025/BVGĐ-HĐĐĐ · 01/2025/BVGĐ-HĐĐĐ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗