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The Relationship Between Age and Carpal Tunnel Size

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294733
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Peter M. Murray, Mayo Clinic

Brief Summary:
Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Procedure: Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: ultrasound carpal tunnel size on subjects
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Relationship Between Age and Carpal Tunnel Size
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 1, 2020


Arm Intervention/treatment
Ultrasound
Ultrasound wrists to determine carpal tunnel size
Procedure: Ultrasound
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 Measures :
  1. Size of carpal tunnel [ Time Frame: Baseline ]
    using ultrasound imaging to determine size of carpal tunnel



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294733


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Peter M Murray Mayo Clinic
Additional Information:
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Responsible Party: Peter M. Murray, Chair, Orthopedic Department Mayo Clinic Florida, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03294733    
Other Study ID Numbers: 17-002345
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries