An observational study in Carpal Tunnel Syndrome, Entrapment Neuropathies and Median Nerve Compression, sponsored by Kayseri City Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Kayseri City Hospital · Observational
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.
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.
The study population consists of adult patients who were admitted to the Physical and Rehabilitation Medicine (PMR) outpatient clinic with complaints of hand numbness and tingling. The cohort includes individuals from a diverse range of occupational backgrounds and body compositions to evaluate the impact of anthropometric measurements on median nerve morphology.
Exclusion Criteria:
Patients aged 18-65 years who were clinically and electrophysiologically diagnosed with idiopathic Carpal Tunnel Syndrome. This single cohort includes patients across all severity stages (mild, moderate, and severe) to evaluate the relationship between median nerve morphology and anthropometric measurements.
Diagnostic Test: High-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.
Also known as: Ultrasonography, Nerve Conduction Studies (NCS)
Median Nerve Cross-Sectional Area (CSA)
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.
Time frame: At the time of enrollment (single measurement)
Electrophysiological Severity Grading
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.
Time frame: At the time of enrollment (single measurement)
Anthropometric Measurements (Absolute Body Weight and BMI)
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.
Time frame: At the time of enrollment
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared with other researchers to ensure the confidentiality and privacy of the study participants in accordance with local ethical guidelines and national data protection laws (KVKK). The aggregated results and statistical analyses will be made available through the final publication. Specific requests for data may be evaluated by the Principal Investigator upon reasonable request and institutional approval.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Kayseri City Hospital