Study on the Characteristics of Ultrasound Elastography in the Evaluation of Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))