- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Istanbul
-
Küçükçekmece, Istanbul, Turquie (Türkiye), 34307
- Kanuni Sultan Suleyman Education and Research Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Mild Carpal Tunnel Syndrome
|
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.
|
|
Moderate Carpal Tunnel Syndrome
|
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.
|
|
Severe Carpal Tunnel Syndrome
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Median Nerve Cross-Sectional Area Measured by Ultrasonography (mm²)
Délai: Baseline (prior to study assessments, during the single study visit)
|
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).
|
Baseline (prior to study assessments, during the single study visit)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Boston Carpal Tunnel Questionnaire Symptom Severity Score
Délai: Baseline (prior to study assessments, during the single study visit)
|
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.
|
Baseline (prior to study assessments, during the single study visit)
|
|
Boston Carpal Tunnel Questionnaire Functional Status Score
Délai: Baseline (prior to study assessments, during the single study visit)
|
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.
|
Baseline (prior to study assessments, during the single study visit)
|
|
Hand Grip Strength Measured Using a Jamar Dynamometer (kg)
Délai: Baseline (prior to study assessments, during the single study visit)
|
Maximum hand grip strength will be measured using a Jamar hydraulic hand dynamometer.
The mean of three measurements will be recorded in kilograms (kg).
|
Baseline (prior to study assessments, during the single study visit)
|
|
Pressure Pain Threshold Measured Using a Digital Algometer (kPa)
Délai: 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)
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PMR-KTS-2026-01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .