Pre-operative Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome. Does it Affect The Operative Procedure?

March 16, 2017 updated by: Ahmad Allam, Minia University
Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Abstract Objective: To assess the surgical importance and added value of superficial ultrasonography in assessment of the median nerve in CTS.

Methods: The study was conducted on thirty patients with CTS with electrophysiological confirmation; twelve males and eighteen females with mean age 43.93±4.51 (range 35-52y), and another thirty normal subjects; fifteen males and fifteen females, with their mean age 36.7±4.86 (range 29-45y). The cross sectional area (CSA) and flattening ratio (FR) at different levels were measured on both groups. Data from the study and control groups were compared. The accuracy of the ultrasonographic diagnostic criteria for CTS was evaluated using receiver operating characteristic (ROC) analysis. All the patients had surgical carpal tunnel release and the operative details were correlated with the ultrasonographic data.

Study Type

Observational

Enrollment (Actual)

60

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Thirty patients diagnosed as CTS were referred from the orthopedic clinics Another thirty healthy asymptomatic persons were included in this study as a control group

Description

Inclusion Criteria:

  • Carpal tunnel syndrome

Exclusion Criteria:

  • bifid median nerve, carpal tunnel mass lesions, persistent median artery

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ultrasonography
diagnostic tool
Diagnostic test: ultrasonography
ultrasonography of median nerve
operative release
Diagnostic test: ultrasonography
ultrasonography of median nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cross sectional area
Time Frame: three minutes
three minutes
flattening ratio
Time Frame: three minutes
three minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
cross sectional area difference
Time Frame: three minutes
three minutes

Collaborators and Investigators

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

Sponsor

Minia University

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 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minia University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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