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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04027998
• Other study ID #: 14-5
• Status: Recruiting
• Start date: April 3, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Tokyo Medical University
• Contact: Yuichi Yoshii
• Phone: 81298871161
• Email: yy12721[@]yahoo.co.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: July 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• strain and applied pressure measurement
Measurement of median nerve strain and applied pressure at proximal carpal tunnel level

Locations

Country	Name	City	State
Japan	Tokyo Medical University Ibaraki Medical Center	Ami	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median nerve strain	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
Primary	applied pressure	Change of the applied pressure from the inital measurement at 3, 6, 12months after the treatment	through study completion, an average of 1 year