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

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?

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Diagnostic test: Nerve ultrasound; Diagnostic test: Nerve conduction studies

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Feyza Nur Yücel, Specialist; Phone Number: +90 5385577059; Email: dr.fny28@gmail.com
• Study Contact Backup: Name: Emre Ata, Assoc.Prof

Study Locations

• Turkey
  • Uskudar
    • Istanbul, Uskudar, Turkey
      • Recruiting
      • Saglik Bilimleri Universitesi
      • Contact: Feyza Nur Yücel, Specialist; Phone Number: +90 5385577059; Email: dr.fny28@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed CTS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient group; Patients with carpal tunnel syndrome	Diagnostic test: Nerve ultrasound; Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels; Diagnostic test: Nerve conduction studies; Upper extremity nerve conduction studies including median-ulnar sensory and motor responses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the carpal tunnel (mm²)	3 months
median nerve ultrasound	Median nerve echogenicity at the level of the carpal tunnel (%)	3 months
median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)	3 months
median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)	3 months
median nerve ultrasound	Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)	3 months
median nerve ultrasound	vertical thickness measurement of the median nerve at the level of the carpal tunnel	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Upper extremity nerve conduction studies	Bilateral median and ulnar sensorimotor latency measurement (msec)	3 months
Upper extremity nerve conduction studies	Bilateral median and ulnar motor amplitude measurement (mV)	3 months
Upper extremity nerve conduction studies	Bilateral median and ulnar sensory amplitude measurement ( µV)	3 months
Upper extremity nerve conduction studies	Bilateral median and ulnar sensorimotor conduction velocity measurement (m/sn)	3 months
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
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

Collaborators and Investigators

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Investigators: Study Chair: Emre Ata, Assoc.Prof, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Carpal tunnel syndrome; Echogenicity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 23-516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Dataset sharing is not planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No