Ultrasound Elastography of Carpal Tunnel Syndrome

NCT07486284 | Enrolling By Invitation

• 1 other identifier: 01/2025/BVGĐ-HĐĐĐ
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome; Ultrasound Elastography

Outcome Measures

Primary Outcomes (3)

• 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.

  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

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

  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

  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.

  At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)

Secondary Outcomes (2)

• Correlation

  At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)

• Cut-off Values

  At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Healthy volunteers with no clinical symptoms of CTS.
• Normal electrodiagnostic results.

You may not qualify if:

• 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

Sponsors & Collaborators

• Da Nang Family General Hospital: lead

Study Sites (1)

Da Nang family general Hospital

Da Nang, 55000, Vietnam

Location

Related Publications (1)

• 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 guidelines for clinical evaluation and treatment", Cureus. 14(7). 3. Schrier, Verena JMM et al. (2020), "Shear wave elastography of the median nerve: a mechanical study", Muscle & Nerve. 61(6), tr. 826-833. 4. Sernik, Renato Antonio et al. (2023), "Shear wave elastography is a valuable tool for diagnosing and grading carpal tunnel syndrome", Skeletal radiology. 52(1), tr. 67-72. 5. Wu, Han et al. (2022), "Ultrasound and elastography role in pre-and post-operative evaluation of median neuropathy in patients with carpal tunnel syndrome", Frontiers in Neurology. 13, tr. 1079737.

  RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Nguyen Do Ngoc Linh, MD

  Da Nang Family General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 50 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: March 20, 2026
• Study Start: April 15, 2025
• Primary Completion: March 20, 2026
• Study Completion: April 15, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)