Clinical Trial: Assessing the Comparability of 2D and 4D Ultrasound Measurements

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Assessing the Comparability of 2D and 4D Ultrasound Measurements of Human Carpal Tunnel Synovium, Median Nerve and Tendon Displacement

Brief Summary: Investigators will recruit 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury. Images will be captured twice, first with the 2D transducer and then with the 4D transducer and compared to images captured with the new 4D transducer, using the same movement data analysis protocols. Investigators will also assess the inter and intrarater reliability of the 4D transducer images, by using two different sonographers, both trained in the technique, measuring the same blinded images on separate occasions, at least two weeks apart. The overall goal of this project is to assess the reliability, or reproducibility, of measurements in normal subjects using a novel 4D ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect motion between SSCT, median nerve and tendon motion for the evaluation and diagnosis of patients with disorders affecting the carpal tunnel, especially carpal tunnel syndrome (CTS).

Detailed Summary: CTS can be diagnosed in many ways, but there are currently no non-invasive methods to assess the physiology within the carpal tunnel, which may help select treatment and predict treatment outcomes. The investigators have shown in preliminary work that differences in the motion of various structures within the carpal tunnel, including the median nerve, flexor tendons, and SSCT, vary in normal subjects and those with CTS. A clinical trial is already under way to assess conventional ultrasound imaging to predict outcomes of CTS treatments. In this study investigators wish to compare the current ultrasound methods, which involve moving two dimensional images, with a new technology which captures moving images in three dimensions (i.e., four dimensions, or 4D). If successful, a single 4D measurement could replace longitudinal and transverse 2D images, saving time and allowing better understanding of the relationship between displacements in both planes.
Sponsor: Mayo Clinic

Current Primary Outcome: shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3) [ Time Frame: 1 year ]

the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • motion of the median nerve [ Time Frame: 1 year ]
    on cross sectional images, in mm from starting point, while the wrist is flexed
  • shape of median nerve [ Time Frame: 1 year ]
    on cross sectional images, both cross sectional area in mm squared, and shape in terms of circularity (X axis divided by Y axis)


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: January 15, 2016
Date Started: January 2018
Date Completion: January 2019
Last Updated: March 25, 2017
Last Verified: March 2017