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临床试验/NCT02747836
NCT02747836招募中不适用

Ultrasound Analysis of Human Carpal Tunnel Synovium

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2008年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
360
试验地点
1
主要终点
Study the ability of ultrasound to detect differences in SSCT thickness in individuals with and without CTS.

研究概览

简要总结

This study evaluates the ability of ultrasound to measure the movement of tendons and nerves within the human carpal tunnel.

详细描述

The overall goal of this project is to develop a novel ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect differences between SSCT, median nerve and tendon motion for the evaluation and diagnosis of patients suspected of having carpal tunnel syndrome (CTS). CTS is usually diagnosed late in its evolution, by measuring electrophysiological changes in median nerve function. Once these changes have occurred, surgery is often the only effective treatment. At an earlier stage of evolution, non-surgical treatment might be more effective. Although ultrasonography and magnetic resonance imaging (MRI) have recently been used to measure changes in median nerve shape in CTS, such approaches also only capture late changes. Thus, a method for detection of CTS that could identify pathology before function or structure of the nerve is compromised could prevent significant morbidity and transition to a permanent neuropathy. One promising opportunity is presented in the subsynovial connective tissue (SSCT), which surrounds the tendons in the carpal tunnel. One of the most characteristic findings in surgically treated patients with CTS is a non-inflammatory fibrosis of the SSCT. Some investigators have suggested that the SSCT may be the cause of the nerve compression in CTS. In our previous work, the investigators have demonstrated differences in the mechanical properties, motion and thickness of the SSCT in patients with CTS compared to normals. More recently, an animal model has been described in which the structural changes in the SSCT have been shown to precede the changes in nerve function.

The investigators have demonstrated in cadaver studies that the normal SSCT can be imaged by ultrasound, and its motion, velocity, and thickness distinguished from that of the nearby tendon and nerve. Here the investigators propose to leverage this work, and study the ability of ultrasound to detect SSCT thickness and motion in individuals with and without CTS. Based on our preliminary research, the investigators formulate the following central hypothesis: An increase in SSCT thickness and changes in sliding velocities of the SSCT with respect to the corresponding tendon are indicative of CTS. In addition, this material property change at SSCT affects median nerve motions and transformations. This is because the SSCT becomes fibrotic in CTS, and the fibrosis alters the normal SSCT-median nerve-tendon functional relationship.

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

  • Patients will be selected from among those undergoing diagnostic work up for CTS in the pre-treatment period. CTS diagnosis will be confirmed clinically and by nerve conduction study

排除标准

  • The following disorders will be criteria for exclusion:
  • any history of cervical radiculopathy
  • rheumatoid arthritis
  • osteoarthritis
  • degenerative joint disease
  • flexor tendinitis
  • gout hemodialysis
  • sarcoidosis
  • peripheral nerve disease
  • amyloidosis
  • traumatic injuries to the ipsilateral arm

结局指标

主要结局

Study the ability of ultrasound to detect differences in SSCT thickness in individuals with and without CTS.

时间窗: at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.

Measure and evaluate SSCT thickness

次要结局

  • study the ability to detect differences in median nerve and tendon motion in the transverse plane of individuals with and without carpal tunnel syndrome(at time of enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.)
  • Study the ability of ultrasound to detect differences in SSCT motion in individuals with and without CTS.(at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter C. Amadio, M.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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