Correlation of Different Ultrasonographic Indices With Clinical Parameters in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Correlation of Different Ultrasonographic Indices With Clinical Parameters in Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115187
• Other study ID #: 23-516
• Status: Recruiting
• Start date: October 10, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Feyza Nur Yücel, Specialist
• Phone: 5385577059
• Email: dr.fny28[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and clinical parameters.

The main questions it aims to answer are:

• To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the patient's clinical complaints?

• To what extent are the different ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome correlated with each other?

Description:

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. In CTS, neuropathic complaints such as numbness, burning and tingling in the palmar face of the first two fingers, which are the innervation area of the median nerve, and fatigue in the hand are the most common symptoms. In the diagnosis of CTS, the diagnosis is made electrodiagnostically along with typical clinical findings. However, in recent years, ultrasound has become one of the most preferred methods in the diagnosis of CTS because it is non-invasive, rapid and correlates with electrodiagnostic methods. Diameter, cross-sectional area and echogenicity of the median nerve at the carpal tunnel entrance are the most frequently evaluated parameters in ultrasonographic examination. In different studies, it is aimed to increase the power of ultrasonography in the diagnosis of CTS with various indices created in addition to standardized measurements. The most commonly used ultrasonographic indices, which have been shown to be correlated with electrodiagnostic diagnostic methods, are the wrist-forearm median nerve cross-sectional area ratio, the ratio of median nerve cross-sectional area to carpal tunnel area at the carpal tunnel entry level, and echogenicity assessment. Although the relationship of these indexes, which are reported to have sufficient diagnostic sensitivity and specificity, with the patient's clinical complaints is shown on a measurement basis, there is not enough data on the comparison of different formulas and their correlation with the patient's clinical complaints, including neuropathic pain.Based on this, this study aimed to investigate the relationship between ultrasonographic indices used in patients diagnosed with CTS and clinical parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings

• Agreeing to participate in the study

Exclusion Criteria:

• Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy

• Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis

• Not agreeing to participate in the study

• History of surgery due to CTS

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Nerve ultrasound
Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels
• Nerve conduction studies
Upper extremity nerve conduction studies including median-ulnar sensory and motor responses

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the carpal tunnel (mm²)	3 months
Primary	median nerve ultrasound	Median nerve echogenicity at the level of the carpal tunnel (%)	3 months
Primary	median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)	3 months
Primary	median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)	3 months
Primary	median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)	3 months
Primary	median nerve ultrasound	vertical thickness measurement of the median nerve at the level of the carpal tunnel	3 months
Secondary	Visual analog scale	The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).	3 months
Secondary	Upper extremity nerve conduction studies	Bilateral median and ulnar sensorimotor latency measurement (msec)	3 months
Secondary	Upper extremity nerve conduction studies	Bilateral median and ulnar motor amplitude measurement (mV)	3 months
Secondary	Upper extremity nerve conduction studies	Bilateral median and ulnar sensory amplitude measurement ( µV)	3 months
Secondary	Upper extremity nerve conduction studies	Bilateral median and ulnar sensorimotor conduction velocity measurement (m/sn)	3 months
Secondary	Self Leeds Assessment of Neuropathic Symptoms and Sign	Self Leeds Assessment of Neuropathic Symptoms and Sign is a 7-question scale used to define pain of neuropathic origin and a score of 12 points or more is in favor of the presence of neuropathic pain.The total score ranges from 0 to 24, and higher scores are associated with an increase in neuropathic complaints.	3 months
Secondary	Boston Carpal Tunnel Questionnaire	he Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Two subscores are calculated: Symptom Severity Scale (SSS) and Functional Status Scale (FSS); SSS score range is 11-55, FSS score range is 8-40 and higher scores indicate worse symptoms or function.	3 months
Secondary	hand grip strength	Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer.	3 months