Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Investigation of the Relationship Between Pain Sensitization and Ultrasonographic and Electrodiagnostic Parameters in Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043141
• Other study ID #: 23-517
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: March 30, 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 observational, cross-sectional study is to investigate the relationship between pain sensitization and ultrasonographic and nerve conduction studies in patients diagnosed with carpal tunnel syndrome (CTS).

The main questions it aims to answer are:

• Can threshold values be determined ultrasonographically and electrodiagnostically in patients who develop pain sensitization?

• Are pressure pain threshold values and central sensitization inventory scores correlated with ultrasonographic and nerve conduction studies of the median nerve?

Description:

Carpal tunnel syndrome (CTS) is the most common nerve entrapment and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. Its incidence varies between 6.3-11.7% in the general population. 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. However, it has been reported that these complaints in most patients are not limited to the innervation area of the median nerve but also spread to other neighboring areas. This has been found to be associated with the development of central sensitization in CTS patients, and extra-median symptoms are suggested to be a clinical marker of pain sensitization. The term central sensitization is explained as an increase in pain sensitivity due to the amplification of neuron-derived signals in the central nervous system.Research shows that ongoing damage to the median nerve stimulates neurons located in the central nervous system, advancing the central sensitization process. Although the diagnosis of CTS is made electrodiagnostically with typical clinical findings, in recent years ultrasound has been frequently used in the diagnosis of CTS because it is non-invasive, fast and reliable. Cross-sectional area and echogenicity of the median nerve are the most frequently evaluated parameters at the carpal tunnel with ultrasound. Studies focus on the clinical relationship of central sensitization in CTS, but its relationship with ultrasonographic and electrodiagnostic data is not yet known.Based on this, this study aimed to investigate the relationship between pain sensitization and electrodiagnostic and ultrasonographic parameters in patients diagnosed with CTS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 30, 2024
• Est. primary completion date: February 1, 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
• Central Sensitisation
• 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
• Pressure pain threshold
Pain pressure threshold (PPT) is used to measure deep muscular tissue pain sensitivity.

Locations

Country	Name	City	State
Turkey	Sultan Abdülhamid Han Training and Research Hospital	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	Pressure pian threshold	Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity.	3 months
Secondary	Central sensitization inventory (CSI)	Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.	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
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	Latency, conduction velocity and amplitude values obtained in bilateral median-ulnar motor and sensory nerve conduction studies.	3 months
Secondary	median nerve ultrasound	Median nerve cross-sectional area and echogenicity measurement	3 months
Secondary	Short form-12	The 12-item Short Form Questionnaire (SF-12) is used for objective measurement of quality of life. Low scores are associated with poor in quality of life.	3 months
Secondary	Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS)	S-LANSS 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.	3 months
Secondary	Boston Carpal Tunnel Questionnaire (BCTQ)	The 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); higher scores indicate worse symptoms or function.	3 months