Sonographic Examination of Median Nerve Variations

May 25, 2025 updated by: Yunus Burak Bayır

Sonographic Examination of Median Nerve Variations and Characteristics Observed in Healthy and Carpal Tunnel Syndrome Patients

The aim of the study is to evaluate the prevalence of bifid median nerve in patients diagnosed with carpal tunnel syndrome (CTS) and whether it has a higher prevalence in CTS patients than in asymptomatic individuals, and to evaluate the characteristics of the bifid median nerve found and whether median nerve variations are predisposing factors in the development of CTS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients diagnosed with carpal tunnel syndrome electrophysiologically who applied to Etlik City Hospital physical therapy outpatient clinic will be included in the study.There are no sensitive groups.The research period was determined as 1 year.The sample size was done using G Power 3.1.9.4 statistical power analysis program for Windows.Based on the study conducted by Walker FO et al., the number of patients that would provide a significant difference (with a margin of error of 5% Type 1 and 20% Type 2, a study power of 80% and a confidence interval of 95%) was found to be 129 patients in total.Demographic and clinical characteristics of patients who meet the inclusion criteria and fill out the "Informed Consent Forum" will be recorded.General pain of the patients will be evaluated with the Visual Analogue Scale (Global Pain), symptom severity and functional status will be evaluated with the Boston Carpal Tunnel Questionnaire, and hand grip strength measurement will be evaluated with a dynamometer.The patient hand diagram will be marked according to the patient's sensory symptoms.Median nerve cross-sectional area will be measured at the pisiform level with ultrasound, and distal motor latency and sensory nerve conduction velocity will be measured with EMG and recorded.Median nerve stiffness will be evaluated by real-time elastography.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: AYŞEGÜL YAMAN, SPECİALİST
  • Phone Number: 05052423917

Study Locations

  • Turkey
      • Ankara, Turkey, 06170
        • Recruiting
        • Etlik City Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

129 patients

Description

Inclusion Criteria:

  • Having typical Carpal Tunnel Sydnrome symptoms lasting longer than 3 months
  • Carpal tunnel syndrome diagnosed with EMG
  • Being a male/female >18 years of age

Exclusion Criteria:

  • History of polyneuropathy, brachial plexopathy, thoracic outlet syndrome, or surgery in the wrist area
  • Presence of inflammatory arthritis, hypothyroidism, pregnancy, rheumatological disorders, diabetes mellitus
  • Presence of peripheral vascular disease

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
normal median nerve in carpal tunnel syndrome
Patients' general pain will be assessed with Visual Analog Scale (Global Pain), symptom severity and functional status will be assessed with Boston Carpal Tunnel Questionnaire, hand grip strength will be measured with dynamometer. Patient hand diagram will be marked according to patient's sensory symptoms. Median nerve cross-sectional area measurement at pisiform level with ultrasound, distal motor latency and sensory nerve conduction velocity with emg will be performed and recorded. Median nerve stiffness will be assessed with real-time elastography.
Diagnostic test: elastography,usg
Patients' general pain will be assessed with Visual Analog Scale (Global Pain), symptom severity and functional status will be assessed with Boston Carpal Tunnel Questionnaire, hand grip strength will be measured with dynamometer. Patient hand diagram will be marked according to patient's sensory symptoms. Median nerve cross-sectional area measurement at pisiform level with ultrasound, distal motor latency and sensory nerve conduction velocity with emg will be performed and recorded. Median nerve stiffness will be assessed with real-time elastography.
median nerve variation in carpal tunnel syndrome
Patients' general pain will be assessed with Visual Analog Scale (Global Pain), symptom severity and functional status will be assessed with Boston Carpal Tunnel Questionnaire, hand grip strength will be measured with dynamometer. Patient hand diagram will be marked according to patient's sensory symptoms. Median nerve cross-sectional area measurement at pisiform level with ultrasound, distal motor latency and sensory nerve conduction velocity with emg will be performed and recorded. Median nerve stiffness will be assessed with real-time elastography.
Diagnostic test: elastography,usg
Patients' general pain will be assessed with Visual Analog Scale (Global Pain), symptom severity and functional status will be assessed with Boston Carpal Tunnel Questionnaire, hand grip strength will be measured with dynamometer. Patient hand diagram will be marked according to patient's sensory symptoms. Median nerve cross-sectional area measurement at pisiform level with ultrasound, distal motor latency and sensory nerve conduction velocity with emg will be performed and recorded. Median nerve stiffness will be assessed with real-time elastography.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale(VAS)
Time Frame: This evaluation will be made and recorded at the beginning
The VAS used for pain assessment consists of a line drawn in the form of a ruler,and numbers from 0 to 10(with 0 as ''no pain'' and 10 as ''unbearable pain'') were asked to score.
This evaluation will be made and recorded at the beginning

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Questionnaire
Time Frame: This evaluation will be made and recorded at the beginning.
symptom severity and functional status scale
This evaluation will be made and recorded at the beginning.
Dynamometer
Time Frame: This evaluation will be made and recorded at the beginning.
Hand grip strength measurement test
This evaluation will be made and recorded at the beginning.
Ultrasound
Time Frame: This evaluation will be made and recorded at the beginning.
Median nerve cross-sectional area measurement at the pisiform level.
This evaluation will be made and recorded at the beginning.
Real-time elastography.
Time Frame: This evaluation will be made and recorded at the beginning.
Median nerve stiffness will be evaluated by real-time strain/sheer elastography.
This evaluation will be made and recorded at the beginning.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yunus Burak Bayır

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: BAŞAK MANSIZ KAPLAN, ASSOC. PROF., Ankara Etlik City Hospital
  • Study Chair: Ebru KARACA UMAY, prof. dr., Ankara Etlik City Hospital
  • Study Chair: Ajda BAL, prof. dr., Ankara Etlik City Hospital
  • Study Chair: Selin ÇELEBİER, assistant dr, Ankara Etlik Sehir Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Median nerve variations

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings