Ultrasound Analysis of Human Carpal Tunnel System

Ultrasound Analysis of Human Carpal Tunnel Synovium

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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Ultrasound of the wrist

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 257

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

120 volunteers without a history of carpal tunnel syndrome and 120 adult patients with carpal tunnel syndrome between the ages of 18 and 85 will be recruited. Patients and volunteers will be age and gender matched

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Ultrasound of the wrist	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
Participants with Carpal Tunnel Syndrome; Ultrasound of the wrist	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2008
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimated): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 06-002950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: deidentified IPD can be requested from the PI
• IPD Sharing Time Frame: at close of study
• IPD Sharing Access Criteria: upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR