Median Nerve Cross-Sectional Area and Body Weight in Carpal Tunnel Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorKayseri City Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
High-Resolution Ultrasonography and Electrophysiological Evaluation
Diagnostic testParticipants 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: CTS Patient Cohort1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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 enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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