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Enrolling by Invitation

NCT Number: NCT07486284

Ultrasound Elastography of Carpal Tunnel Syndrome

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

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Da Nang family general Hospital

Da Nang, 55000, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound Elastography

Procedure
  • 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 outcomes

  1. 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)

    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.

  2. 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)

    Sensitivity, specificity, and AUC of strain elastography grading for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.

  3. 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)

    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 outcomes

  1. Correlation

    Time frame: 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).

  2. 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)

    Optimal threshold values for SWE (kPa) and CSA (mm2) to distinguish CTS from controls and to classify severity.

Sponsors and collaborators

Lead sponsor

Da Nang Family General Hospital

Other

Registry information

Official study title

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

Acronym: UE-CTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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