- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07752797
Assessment of Ultrasound Findings, Nerve Test Results, and Hand Function in Patients With Carpal Tunnel Syndrome
Association of Clinical Severity With Ultrasonographic, Electrophysiological, and Functional Parameters in Patients With Carpal Tunnel Syndrome: A Cross-Sectional Observational Study
Carpal tunnel syndrome is one of the most common conditions caused by compression of a nerve at the wrist. It can lead to numbness, tingling, pain, weakness, and difficulty performing daily activities. Although nerve conduction studies are widely used to confirm the diagnosis and assess disease severity, ultrasonography has become an increasingly important, non-invasive diagnostic tool. However, the relationship between ultrasound findings, nerve conduction study results, hand function, and symptom severity has not been fully clarified.
The purpose of this study is to investigate the relationship between the clinical severity of carpal tunnel syndrome and ultrasonographic, electrophysiological, and functional parameters. Participants with carpal tunnel syndrome will undergo ultrasonographic measurement of the median nerve, nerve conduction studies, hand grip strength assessment, pressure pain threshold measurement, and completion of the Boston Carpal Tunnel Questionnaire.
The investigators hypothesize that greater clinical severity will be associated with larger median nerve cross-sectional area, more severe electrophysiological abnormalities, reduced hand grip strength, lower pressure pain threshold, and poorer functional status. The findings of this study may improve the understanding of the relationship between structural, electrophysiological, and functional changes in carpal tunnel syndrome and contribute to clinical evaluation and patient management.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Küçükçekmece, Istanbul, Turquía (Türkiye), 34307
- Kanuni Sultan Suleyman Education and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults aged 18 years or older
- Clinical findings consistent with carpal tunnel syndrome
- Carpal tunnel syndrome confirmed by electroneuromyography
- Ability to understand and complete the study assessments
- Provision of written informed consent
Exclusion Criteria:
- Previous carpal tunnel release surgery
- History of fracture, major trauma, or surgery involving the assessed wrist or hand
- Cervical radiculopathy, brachial plexopathy, or other peripheral neuropathy affecting the upper extremity
- Polyneuropathy
- Inflammatory rheumatic disease or active infection involving the assessed upper extremity
- Severe neurological or musculoskeletal disorder that may affect hand function
- Inability to complete ultrasonographic, electrophysiological, functional, or questionnaire assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Mild Carpal Tunnel Syndrome
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Participants will undergo a standardized diagnostic assessment including ultrasonographic measurement of the median nerve cross-sectional area at the carpal tunnel inlet, nerve conduction study evaluation, hand grip strength measurement using a Jamar dynamometer, pressure pain threshold assessment using a digital algometer, and completion of the Boston Carpal Tunnel Questionnaire.
All assessments will be performed once during a single study visit.
No therapeutic intervention will be administered.
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Moderate Carpal Tunnel Syndrome
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Participants will undergo a standardized diagnostic assessment including ultrasonographic measurement of the median nerve cross-sectional area at the carpal tunnel inlet, nerve conduction study evaluation, hand grip strength measurement using a Jamar dynamometer, pressure pain threshold assessment using a digital algometer, and completion of the Boston Carpal Tunnel Questionnaire.
All assessments will be performed once during a single study visit.
No therapeutic intervention will be administered.
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Severe Carpal Tunnel Syndrome
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Participants will undergo a standardized diagnostic assessment including ultrasonographic measurement of the median nerve cross-sectional area at the carpal tunnel inlet, nerve conduction study evaluation, hand grip strength measurement using a Jamar dynamometer, pressure pain threshold assessment using a digital algometer, and completion of the Boston Carpal Tunnel Questionnaire.
All assessments will be performed once during a single study visit.
No therapeutic intervention will be administered.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Median Nerve Cross-Sectional Area Measured by Ultrasonography (mm²)
Periodo de tiempo: Baseline (prior to study assessments, during the single study visit)
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The median nerve cross-sectional area will be measured by high-resolution ultrasonography at the carpal tunnel inlet (pisiform level).
The mean of three measurements will be recorded in square millimeters (mm²).
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Baseline (prior to study assessments, during the single study visit)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Boston Carpal Tunnel Questionnaire Symptom Severity Score
Periodo de tiempo: Baseline (prior to study assessments, during the single study visit)
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Symptom severity will be assessed using the Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale.
Scores range from 1 to 5, with higher scores indicating greater symptom severity.
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Baseline (prior to study assessments, during the single study visit)
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Boston Carpal Tunnel Questionnaire Functional Status Score
Periodo de tiempo: Baseline (prior to study assessments, during the single study visit)
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Functional status will be assessed using the Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-FSS).
The questionnaire consists of 8 items evaluating difficulty in performing daily activities.
Each item is scored from 1 (no difficulty) to 5 (cannot perform the activity), and the final score is calculated as the mean of all items.
Higher scores indicate greater functional impairment.
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Baseline (prior to study assessments, during the single study visit)
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Hand Grip Strength Measured Using a Jamar Dynamometer (kg)
Periodo de tiempo: Baseline (prior to study assessments, during the single study visit)
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Maximum hand grip strength will be measured using a Jamar hydraulic hand dynamometer.
The mean of three measurements will be recorded in kilograms (kg).
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Baseline (prior to study assessments, during the single study visit)
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Pressure Pain Threshold Measured Using a Digital Algometer (kPa)
Periodo de tiempo: Baseline (prior to study assessments, during the single study visit)
|
Pressure pain threshold will be assessed using a digital pressure algometer.
The mean of three measurements will be recorded in kPa
|
Baseline (prior to study assessments, during the single study visit)
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PMR-KTS-2026-01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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