Sonographic Examination of Median Nerve Variations

Recruiting

• Conditions: Carpal Tunnel Syndrome

• Registration Number: NCT06538779
• Lead Sponsor: Yunus Burak Bayır

Brief Summary

The aim of the study is to evaluate the prevalence of bifid median nerve in patients diagnosed with carpal tunnel syndrome (CTS) and whether it has a higher prevalence in CTS patients than in asymptomatic individuals, and to evaluate the characteristics of the bifid median nerve found and whether median nerve variations are predisposing factors in the development of CTS.

Detailed Description

Patients diagnosed with carpal tunnel syndrome electrophysiologically who applied to Etlik City Hospital physical therapy outpatient clinic will be included in the study.There are no sensitive groups.The research period was determined as 1 year.The sample size was done using G Power 3.1.9.4 statistical power analysis program for Windows.Based on the study conducted by Walker FO et al., the number of patients that would provide a significant difference (with a margin of error of 5% Type 1 and 20% Type 2, a study power of 80% and a confidence interval of 95%) was found to be 129 patients in total.Demographic and clinical characteristics of patients who meet the inclusion criteria and fill out the "Informed Consent Forum" will be recorded.General pain of the patients will be evaluated with the Visual Analogue Scale (Global Pain), symptom severity and functional status will be evaluated with the Boston Carpal Tunnel Questionnaire, and hand grip strength measurement will be evaluated with a dynamometer.The patient hand diagram will be marked according to the patient's sensory symptoms.Median nerve cross-sectional area will be measured at the pisiform level with ultrasound, and distal motor latency and sensory nerve conduction velocity will be measured with EMG and recorded.Median nerve stiffness will be evaluated by real-time elastography.

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Study Start: 2024-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-25
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Having typical Carpal Tunnel Sydnrome symptoms lasting longer than 3 months
• Carpal tunnel syndrome diagnosed with EMG
• Being a male/female >18 years of age

Exclusion Criteria

• History of polyneuropathy, brachial plexopathy, thoracic outlet syndrome, or surgery in the wrist area
• Presence of inflammatory arthritis, hypothyroidism, pregnancy, rheumatological disorders, diabetes mellitus
• Presence of peripheral vascular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale(VAS)	This evaluation will be made and recorded at the beginning	The VAS used for pain assessment consists of a line drawn in the form of a ruler,and numbers from 0 to 10(with 0 as ''no pain'' and 10 as ''unbearable pain'') were asked to score.

Secondary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire	This evaluation will be made and recorded at the beginning.	symptom severity and functional status scale
Dynamometer	This evaluation will be made and recorded at the beginning.	Hand grip strength measurement test
Real-time elastography.	This evaluation will be made and recorded at the beginning.	Median nerve stiffness will be evaluated by real-time strain/sheer elastography.
Ultrasound	This evaluation will be made and recorded at the beginning.	Median nerve cross-sectional area measurement at the pisiform level.

Trial Locations

Locations (1)

Etlik City Hospital; 🇹🇷 Ankara, Turkey