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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07508397
Acronym
CTS-US-WEIGHT
Enrollment
120
Registered
2026-04-02
Start date
2026-04-01
Completion date
2026-09-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Entrapment Neuropathies, Median Nerve Compression

Keywords

Ultrasonography, Median Nerve, Cross-Sectional Area, Body Weight, Body Mass Index (BMI), Electromyography, Diagnostic Accuracy, Physical and Rehabilitation Medicine

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTHigh-Resolution Ultrasonography and Electrophysiological Evaluation

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.

Sponsors

Kayseri City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Median Nerve Cross-Sectional Area (CSA)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

MeasureTime frameDescription
Electrophysiological Severity GradingAt 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.
Anthropometric Measurements (Absolute Body Weight and BMI)At the time of enrollmentMeasurement 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.

Contacts

CONTACTAbdullah Goktug Yazar, MD
dragyazar@gmail.com+905309731140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026