Median Nerve Strain and Applied Pressure Measurement in the Carpal Tunnel Syndrome Patients

April 25, 2022 updated by: Yuichi Yoshii, Tokyo Medical University
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin will be measured at the proximal part of the carpal tunnel. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin, and ratio of pressure-strain will be measured at the proximal part of the carpal tunnel. In addition, distal latencies in the motor and sensory nerve conductions studies and cross-sectional area of median nerve will be measured. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Ibaraki
      • Ami, Ibaraki, Japan, 300-0395
        • Recruiting
        • Tokyo Medical University Ibaraki Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

carpal tunnel syndrome patients and asymptomatic control

Description

Inclusion Criteria:

  • carpal tunnel syndrome patients and asymptomatic control

Exclusion Criteria:

  • Patients were excluded if there was a history of cervical radiculopathy, rheumatoid arthritis, gout, hemodialysis, sarcoidosis, amyloidosis, or traumatic injuries to the arm. Written consent was obtained from all study participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Carpal tunnel syndrome
group of carpal tunnel syndrome patients
Diagnostic test: strain and applied pressure measurement
Measurement of median nerve strain and applied pressure at proximal carpal tunnel level
Control group
group of healthy controls
Diagnostic test: strain and applied pressure measurement
Measurement of median nerve strain and applied pressure at proximal carpal tunnel level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
median nerve strain
Time Frame: through study completion, an average of 1 year
Change of the median nerve strain from the initial measurement at 3, 6, 12 months after the treatment
through study completion, an average of 1 year
applied pressure
Time Frame: through study completion, an average of 1 year
Change of the applied pressure from the inital measurement at 3, 6, 12months after the treatment
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo Medical University

Investigators

  • Principal Investigator: Yuichi Yoshii, Tokyo Medical University Ibaraki Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2015

Primary Completion (ANTICIPATED)

July 17, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (ACTUAL)

July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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