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

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Diagnostic Test: strain and applied pressure measurement

• Registration Number: NCT04027998
• Lead Sponsor: Tokyo Medical University

Brief 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.

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 Timeline

• Study Start: 2015-04-03
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27
• Primary Completion: 2024-07-17
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carpal tunnel syndrome	strain and applied pressure measurement	group of carpal tunnel syndrome patients
Control group	strain and applied pressure measurement	group of healthy controls

Primary Outcome Measures

Name	Time	Method
applied pressure	through study completion, an average of 1 year	Change of the applied pressure from the inital measurement at 3, 6, 12months after the treatment
median nerve strain	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

Trial Locations

Locations (1)

Tokyo Medical University Ibaraki Medical Center; 🇯🇵 Ami, Ibaraki, Japan