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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

Yunus Burak Bayır

Investigators

  • 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 Şehir 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)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 25, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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