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

NCT ID: NCT04027998

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-03

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Carpal tunnel syndrome

group of carpal tunnel syndrome patients

strain and applied pressure measurement

Intervention Type DIAGNOSTIC_TEST

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

Control group

group of healthy controls

strain and applied pressure measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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strain and applied pressure measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokyo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yuichi Yoshii

Associate Professor, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuichi Yoshii

Role: PRINCIPAL_INVESTIGATOR

Tokyo Medical University Ibaraki Medical Center

Locations

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Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yuichi Yoshii

Role: CONTACT

81298871161 ext. 81298871161

Facility Contacts

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Yuichi Yoshii

Role: primary

81298871161

References

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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.

Reference Type DERIVED
PMID: 31926552 (View on PubMed)

Other Identifiers

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14-5

Identifier Type: -

Identifier Source: org_study_id

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