Assessing the Comparability of 2D and 4D Ultrasound Measurements

Not Applicable

Withdrawn

• Conditions: Carpal Tunnel

• Registration Number: NCT02666911
• Lead Sponsor: Mayo Clinic

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 Description

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.

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07
• Study Start: 2018-01
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy Volunteers

Exclusion Criteria

• Cervical radiculopathy
• Rheumatoid arthritis
• Osteoarthritis
• Flexor tendinitis
• Gout
• Hemodialysis
• Sarcoidosis
• Peripheral nerve disease
• Amyloidosis
• Traumatic injury - same arm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)	1 year	the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3

Secondary Outcome Measures

Name	Time	Method
shape of median nerve	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)
motion of the median nerve	1 year	on cross sectional images, in mm from starting point, while the wrist is flexed