Ultrasound Elastography of Carpal Tunnel Syndrome (UE-CTS)

Study on the Characteristics of Ultrasound Elastography in the Evaluation 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

Study Overview

• Status: Enrolling by invitation
• Conditions: Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Procedure: Ultrasound Elastography

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Vietnam
  • Da Nang, Vietnam, 55000
    • Da Nang family general Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation	Correlation coefficients (Pearson/Spearman) between ultrasound parameters (Stiffness, CSA) and: Electrophysiological severity (DML, SCV, SNAP amplitudes).; Clinical severity (Boston scores).	At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Cut-off Values	Optimal threshold values for SWE (kPa) and CSA (mm2) to distinguish CTS from controls and to classify severity.	At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)

Collaborators and Investigators

• Sponsor: Da Nang Family General Hospital
• Investigators: Study Director: Nguyen Do Ngoc Linh, MD, Da Nang family general Hospital

Publications and helpful links

General 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 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; Ultrasound Elastography
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 01/2025/BVGĐ-HĐĐĐ (Other Identifier: Da Nang Family General Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No