Ultrasound Analysis of Human Carpal Tunnel System

NCT02747836 | Completed

• 1 other identifier: 06-002950
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• study the ability to detect differences in median nerve and tendon motion in the transverse plane of individuals with and without carpal tunnel syndrome

  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.

  at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.

Study Arms (2)

Healthy Volunteers

Ultrasound of the wrist

Other: Ultrasound of the wrist

Participants with Carpal Tunnel Syndrome

Ultrasound of the wrist

Other: Ultrasound of the wrist

Interventions

Ultrasound of the wrist OTHER

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

Healthy Volunteers; Participants with Carpal Tunnel Syndrome

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 22, 2016
• Study Start: April 24, 2008
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: at close of study
• Access Criteria: upon request

Locations

US (1)