Clinical Trial: Ultrasound Analysis of Human Carpal Tunnel System

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Ultrasound Analysis of Human Carpal Tunnel Synovium

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

Detailed Summary:

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
Sponsor: Mayo Clinic

Current Primary Outcome: Study the ability of ultrasound to detect differences in SSCT thickness in individuals with and without CTS. [ Time Frame: at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study. ]

Measure and evaluate SSCT thickness


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • study the ability to detect differences in median nerve and tendon motion in the transverse plane of individuals with and without carpal tunnel syndrome [ Time Frame: at time of enrollment. patients are enrolled only for the purpose of obtaining a single imaging study. ]
    measure displacement of tendons and nerves and the carpal tunnel in the dorsal-palmar and radioulnar directions
  • Study the ability of ultrasound to detect differences in SSCT motion in individuals with and without CTS. [ Time Frame: at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study. ]
    Measure and evaluate changes in sliding velocities of the SSCT with respect to the corresponding tendon


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: April 11, 2016
Date Started: May 2006
Date Completion: December 2018
Last Updated: April 21, 2016
Last Verified: April 2016