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

NCT04027998 | Unknown

• 1 other identifier: 14-5
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Carpal tunnel syndrome

group of carpal tunnel syndrome patients

Diagnostic Test: strain and applied pressure measurement

Control group

group of healthy controls

Diagnostic Test: strain and applied pressure measurement

Interventions

strain and applied pressure measurement DIAGNOSTIC_TEST

Measurement of median nerve strain and applied pressure at proximal carpal tunnel level

Carpal tunnel syndrome; Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

carpal tunnel syndrome patients and asymptomatic control

You may qualify if:

• carpal tunnel syndrome patients and asymptomatic control

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokyo Medical University: lead

Study Sites (1)

Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, 300-0395, Japan

RECRUITING

Related Publications (1)

• Yoshii Y, Tung WL, Yuine H, Ishii T. Postoperative diagnostic potentials of median nerve strain and applied pressure measurement after carpal tunnel release. BMC Musculoskelet Disord. 2020 Jan 11;21(1):22. doi: 10.1186/s12891-019-3033-y.

  PMID: 31926552 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Yuichi Yoshii

  Tokyo Medical University Ibaraki Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuichi Yoshii

CONTACT

81298871161; yy12721@yahoo.co.jp

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 22, 2019
• Study Start: April 3, 2015
• Primary Completion: July 17, 2024
• Study Completion: December 31, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)