Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07508397

Median Nerve Cross-Sectional Area and Body Weight in Carpal Tunnel Syndrome

This study aims to evaluate the diagnostic accuracy of ultrasonographic measurements of the median nerve in patients with Carpal Tunnel Syndrome (CTS). While ultrasound is a common diagnostic tool, various physical factors can influence its results. The researchers will investigate how a patient's absolute body weight and Body Mass Index (BMI) affect the size of the median nerve cross-sectional area across different stages of disease severity. The goal is to determine if absolute body weight plays a 'masking' role that could lead to more precise diagnostic interpretations in clinical practice.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and while electrodiagnostic studies (NCS/EMG) remain the gold standard, ultrasonography (USG) has gained popularity as a non-invasive diagnostic tool. However, the correlation between median nerve cross-sectional area (CSA) and electrophysiological severity can be inconsistent due to anthropometric variations.

In this prospective observational study involving 120 participants, the researchers will perform high-resolution ultrasonographic measurements of the median nerve at the level of the pisiform bone. All patients will undergo standardized nerve conduction studies to be classified into mild, moderate, or severe CTS stages according to AAEM criteria.

The study specifically focuses on the 'masking hypothesis,' which suggests that absolute body weight may have a more significant impact on nerve morphological changes than the ratio-based BMI, particularly during the progression from mild to moderate stages. By analyzing these relationships using non-parametric statistical methods, the study seeks to improve the reliability of USG-based diagnostics in diverse patient populations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 18 and 75 years.
  • Clinical diagnosis of Carpal Tunnel Syndrome (CTS) based on symptoms (numbness, tingling, nocturnal pain in the median nerve distribution).
  • Electrophysiological confirmation of CTS according to the American
  • Association of Neuromuscular & Electrodiagnostic Medicine (AAEM) criteria.
  • Ability to provide written informed consent.

Exclusion criteria

  • Secondary causes of CTS (e.g., Diabetes Mellitus, Hypothyroidism, Rheumatoid -Arthritis, Chronic Renal Failure).
  • Coexisting neurological conditions (e.g., Cervical Radiculopathy,
  • Polyneuropathy, Brachial Plexopathy).
  • History of previous wrist surgery, trauma, or local corticosteroid injection within the last 6 months.
  • Pregnancy or lactation.
  • Congenital anatomical variations such as a bifid median nerve or persistent median artery (detected during USG).

Treatment and study plan

High-Resolution Ultrasonography and Electrophysiological Evaluation

Diagnostic Test

Participants underwent a high-resolution ultrasonographic examination using a high-frequency linear probe to measure the median nerve cross-sectional area (CSA) at the level of the pisiform bone. Subsequently, standardized electrophysiological evaluations (motor distal latency and sensory conduction velocity) were performed to classify CTS severity according to AAEM criteria.

Other names: Ultrasonography, Nerve Conduction Studies (NCS)

Primary outcomes

  1. Median Nerve Cross-Sectional Area (CSA)

    Time frame: At the time of enrollment (single measurement)

    The cross-sectional area of the median nerve measured in square millimeters using high-resolution ultrasonography at the level of the pisiform bone. This measurement is the primary tool for morphological evaluation of the nerve.

Secondary outcomes

  1. Electrophysiological Severity Grading

    Time frame: At the time of enrollment (single measurement)

    The reported outcome is a single categorical variable representing CTS severity (Mild, Moderate, or Severe). This severity grade is determined by aggregating multiple standard Nerve Conduction Study (NCS) parameters (such as motor distal latency and sensory conduction velocity) into a single classification based on the established AAEM criteria.

  2. Anthropometric Measurements (Absolute Body Weight and BMI)

    Time frame: At the time of enrollment

    Measurement of the participant's absolute body weight (kg) and Body Mass Index to analyze their respective correlations with median nerve CSA and disease severity stages.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah Goktug Yazar, MD

CONTACT

[email protected]

+905309731140

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

The Relationship Between Ultrasonographic Median Nerve Cross-Sectional Area and Electrophysiological Severity in Carpal Tunnel Syndrome Diagnosis: The Masking Role of Body Weight

Acronym: CTS-US-WEIGHT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.