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临床试验/NCT05861349
NCT05861349已完成不适用

Utility of the Measurement of Median Nerve Stenosis for Diagnosis of Carpal Tunnel Syndrome

Jakub Antczak1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Jakub Antczak
入组人数
84
试验地点
1
主要终点
Difference in the cross-sectional area of median nerve in the site of its maximal compression

研究概览

简要总结

The goal of this observational study is to test the new kind of ultrasound-based measurements in patients with carpal tunnel syndrome. The main questions it aims to answer are:

  • Do the measurements of the size of the median nerve at the point where it is maximally compressed accurately diagnose carpal tunnel syndrome?
  • May these measurements accurately tell how severe is the carpal tunnel syndrome?

Participants will be asked to:

  • Undergo conduction studies of median and ulnar nerve.
  • Undergo ultrasound of the median nerve.
  • Fill out the Boston carpal tunnel questionnaire and a demographic questionnaire.

Researchers will compare the group of patients with carpal tunnel syndrome with healthy volunteers to see if respective measurements differ significantly between groups.

详细描述

Carpal tunnel syndrome (CTS) is the most common compression neuropathy. CTS results from the compression of the median nerve in the carpal tunnel. The main symptoms include pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. Nerve conduction studies (NCS) remain the method of choice in diagnosing CTS. However ultrasonography (US) is increasingly used along with or instead of NCS. Most frequently, the increase of the cross-sectional area of the median nerve at the inlet to the carpal tunnel is regarded as the marker of CTS. A number of other measurements such as median nerve mobility, volar bulging of flexor retinaculum and others were also studied to increase diagnostic sensitivity and specificity. In this study the investigators aim to assess the utility of measurements made at the point of the maximal stenosis of the median nerve in the tunnel to diagnose CTS. So far, there were only few studies, which visualized the maximal nerve stenosis, which is the essential pathological feature of CTS. In general, the group of patients with CTS and controls will undergo NCS of symptomatic median and ipsilateral ulnar nerves and US of the symptomatic median nerve with measurements of the cross-sectional area, diameter and echogenicity at various points, including the point of the maximal stenosis. The location of the maximal stenosis with respect to external (distal crease) and internal (wrist and hand bones and thenar musculature) will also be evaluated. Subjects will also be asked to fill out the Boston Carpal Tunnel Questionnaire (BCTQ) and a demographic questionnaire. US measurements will be compared between patients and healthy volunteers. US measurements, especially those made at the point of stenosis will be correlated among patients with clinical severity of CTS, reflected by the score in BCTQ and with the grade of electrophysiological severity as introduced by Padua et al. [1].

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms of CTS
  • Electrophysiologic and/or ultrasonographic confirmation of CTS diagnosis

排除标准

  • Psychiatric or cognitive conditions with may disturb participation in the study
  • Peripheral neuropathy in history
  • Fractures and severe trauma in the area of the wrist in history

结局指标

主要结局

Difference in the cross-sectional area of median nerve in the site of its maximal compression

时间窗: Through study completion, an average of 1 year.

Difference in the cross-sectional area of median nerve in the site of its maximal compression between patients with CTS and healthy controls.

Difference in the echogenicity of median nerve in the site of its maximal compression

时间窗: Through study completion, an average of 1 year.

Difference in the echogenicity of median nerve in the site of its maximal compression between patients with CTS and healthy controls.

Difference in the diameter of median nerve in the site of its maximal compression

时间窗: Through study completion, an average of 1 year.

Difference in the diameter of median nerve in the site of its maximal compression between patients with CTS and healthy controls.

次要结局

  • Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ score(Through study completion, an average of 1 year.)
  • Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ score(Through study completion, an average of 1 year.)
  • Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score(Through study completion, an average of 1 year.)
  • Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade(Through study completion, an average of 1 year.)
  • Correlation of the cross-sectional area of median nerve in the site of its maximal compression with CTS electrophysiological severity grade(Through study completion, an average of 1 year.)
  • Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade(Through study completion, an average of 1 year.)

研究者

发起方
Jakub Antczak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jakub Antczak

Principal Investigator

Jagiellonian University

研究点 (1)

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