Ultrasound Analysis of Human Carpal Tunnel System

Carpal Tunnel Syndrome Clinical Trial

Official title:

Ultrasound Analysis of Human Carpal Tunnel Synovium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02747836
• Other study ID #: 06-002950
• Status: Recruiting
• Start date: May 2006
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Lindsey Hobbs
• Phone: 507-293-9765
• Email: hobbs.lindsey[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Other:
• Ultrasound of the wrist
using sound waves to create images capturing the movement of the SSCT and flexor tendon and transformation of the median nerve in the wrist

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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