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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Median Nerve Cross-Sectional Area (CSA) [Срок оценки: At the time of enrollment (single measurement)]

Вторичные конечные точки (2)

• Electrophysiological Severity Grading [Срок оценки: At the time of enrollment (single measurement)]
• Anthropometric Measurements (Absolute Body Weight and BMI) [Срок оценки: At the time of enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Cartwright MS, Hobson-Webb LD, Boon AJ, Alter KE, Hunt CH, Flores VH, Werner RA, Shook SJ, Thomas TD, Primack SJ, Walker FO; American Association of Neuromuscular and Electrodiagnostic Medicine. Evidence-based guideline: neuromuscular ultrasound for the diagnosis of carpal tunnel syndrome. Muscle Nerve. 2012 Aug;46(2):287-93. doi: 10.1002/mus.23389. PMID 22806381
• Jablecki CK, Andary MT, Floeter MK, Miller RG, Quartly CA, Vennix MJ, Wilson JR; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome [RETIRED]. Report of the American Association of Electrodiagnostic Medicine, American Academy of Neurology PMID 12058083

Идентификаторы

NCT: NCT07508397 · 2025-427

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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