Carpal TunnelNCT03294733
The Relationship Between Age and Carpal Tunnel Size
A study testing Ultrasound in people with Carpal Tunnel, run by Mayo Clinic at 1 site in United States.
Trial summary
Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 1 Feb 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than age 18 having bilateral wrists amenable to ultrasound examination.
Who cannot join
- Active carpal tunnel syndrome,
- history of carpal tunnel syndrome
- any prior arm or hand surgery (including previous carpal tunnel release for any reason or previous surgery on the volar wrist)
- distal radius fracture deformity
- rheumatoid arthritis
- open wounds or lesions of the hand or forearm
- known congenital deformities of the upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.
Read the detailed description
Participants will be taken to a hand examination room where a portable ultrasound (US) machine is present. A previously determined wrist will be examined for each of the participants. The US will be used to obtain measurements of the subjects carpal tunnel and median nerve at multiple levels in order to define its size.
- Conditions
- Carpal Tunnel
- Being tested
- Ultrasound
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
This ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Other | Ultrasound wrists to determine carpal tunnel size Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of carpal tunnel
using ultrasound imaging to determine size of carpal tunnel
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start22 May 2017
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal TunnelStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ultrasound carpal tunnel size on subjects
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter M. Murray, Mayo Clinic
- Investigators
- Peter M Murray, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294733
- Sponsor's protocol ID
- 17-002345
- Status last verified
- Feb 2020
- First submitted
- 19 Sep 2017
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Age and Carpal Tunnel Size
- ClinicalTrials.gov ID
- NCT03294733
- Acronym / sponsor ID
- 17-002345
- Conditions
- Carpal Tunnel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 27 Sep 2017 (actual)
- 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.
Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.
Detailed description
Participants will be taken to a hand examination room where a portable ultrasound (US) machine is present. A previously determined wrist will be examined for each of the participants. The US will be used to obtain measurements of the subjects carpal tunnel and median nerve at multiple levels in order to define its size.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ultrasound carpal tunnel size on subjects
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Other | Procedure: UltrasoundUltrasound wrists to determine carpal tunnel size |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Greater than age 18 having bilateral wrists amenable to ultrasound examination.
Key exclusion criteria (7 listed)
- Active carpal tunnel syndrome,
- history of carpal tunnel syndrome
- any prior arm or hand surgery (including previous carpal tunnel release for any reason or previous surgery on the volar wrist)
- distal radius fracture deformity
- rheumatoid arthritis
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 |
|---|---|---|
| UltrasoundThis ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer | Procedure or surgery | Ultrasound |
Primary outcome
Size of carpal tunnel
Time frame: Baseline
using ultrasound imaging to determine size of carpal tunnel
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 26 Feb 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Peter M Murray principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Carpal Tunnel, 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 7 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 26 Feb 2020. 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?
Size of carpal tunnel (time frame: Baseline). 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 26 Feb 2020.