AzTrials
AzTrials

Carpal Tunnel SyndromeNCT02747836

Ultrasound Analysis of Human Carpal Tunnel System

An observational study of Carpal Tunnel Syndrome, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Ultrasound of the wrist
How many people
257 participants
Where
1 siteUnited States
Study dates
24 Apr 2008to 12 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • The following disorders will be criteria for exclusion:
  • any history of cervical radiculopathy
  • rheumatoid arthritis
  • osteoarthritis
  • degenerative joint disease
  • flexor tendinitis
Show all 11Show fewer
  • gout hemodialysis
  • sarcoidosis
  • peripheral nerve disease
  • amyloidosis
  • traumatic injuries to the ipsilateral arm

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Ultrasound of the wrist
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound of the wristOther

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

Study groups in NCT02747836
Study groupRoleWhat they receive
Healthy VolunteersUltrasound of the wrist
Receives: Other: Ultrasound of the wrist
Participants with Carpal Tunnel SyndromeUltrasound of the wrist
Receives: Other: Ultrasound of the wrist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study the ability of ultrasound to detect differences in SSCT thickness in individuals with and without CTS.

    Measure and evaluate SSCT thickness

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

Secondary outcomes (2)
  1. 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

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

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study start24 Apr 2008
  3. Primary completion12 Jan 2026
  4. Study completion12 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747836
Sponsor's protocol ID
06-002950
Status last verified
Mar 2026
First submitted
11 Apr 2016
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: deidentified IPD can be requested from the PI

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study the ability of ultrasound to detect differences in SSCT thickness in individuals with and without CTS. (time frame: at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in