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.
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.
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.
- Conditions
- Carpal Tunnel Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Ultrasound of the wrist Receives: Other: Ultrasound of the wrist | |
| Participants with Carpal Tunnel Syndrome | Ultrasound 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.
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)
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.
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.
- First posted22 Apr 2016 (estimated)
- Study start24 Apr 2008
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter C. Amadio, M.D., Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Analysis of Human Carpal Tunnel Synovium
- ClinicalTrials.gov ID
- NCT02747836
- Acronym / sponsor ID
- 06-002950
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Apr 2008 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the ability of ultrasound to measure the movement of tendons and nerves within the human carpal tunnel.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Ultrasound of the wristUltrasound of the wrist |
| Participants with Carpal Tunnel Syndrome | – | Other: Ultrasound of the wristUltrasound of the wrist |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- The following disorders will be criteria for exclusion:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound of the wristusing sound waves to create images capturing the movement of the SSCT and flexor tendon and transformation of the median nerve in the wrist | Other | Healthy Volunteers, Participants with Carpal Tunnel Syndrome |
Primary outcome
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.
Measure and evaluate SSCT thickness
2 secondary outcomes
study the ability to detect differences in median nerve and tendon motion in the transverse plane of individuals with and without carpal tunnel syndrome
Time frame: 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.
Time frame: at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. deidentified IPD can be requested from the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.