Back to resultsThe Relationship Between Age and Carpal Tunnel Size
Primary Purpose
Carpal Tunnel
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Carpal Tunnel
Eligibility Criteria
Inclusion Criteria:
- Greater than age 18 having bilateral wrists amenable to ultrasound examination.
Exclusion Criteria:
- 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.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ultrasound
Arm Description
Ultrasound wrists to determine carpal tunnel size
Outcomes
Primary Outcome Measures
Size of carpal tunnel
using ultrasound imaging to determine size of carpal tunnel
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03294733
Brief Title
The Relationship Between Age and Carpal Tunnel Size
Official Title
The Relationship Between Age and Carpal Tunnel Size
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
ultrasound carpal tunnel size on subjects
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Other
Arm Description
Ultrasound wrists to determine carpal tunnel size
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Size of carpal tunnel
Description
using ultrasound imaging to determine size of carpal tunnel
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Greater than age 18 having bilateral wrists amenable to ultrasound examination.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Murray
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Relationship Between Age and Carpal Tunnel Size
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