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

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

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?

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Central Sensitisation
• Intervention / Treatment: Diagnostic test: Nerve ultrasound; Diagnostic test: Nerve conduction studies; Diagnostic test: Pressure pain threshold

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Feyza Nur Yücel, specialist; Phone Number: 90 5385577059; Email: dr.fny28@gmail.com

Study Locations

• Turkey
  • Uskudar
    • Istanbul, Uskudar, Turkey
      • Recruiting
      • Sultan Abdülhamid Han Training and Research Hospital
      • 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 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

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; Diagnostic test: Pressure pain threshold; Pain pressure threshold (PPT) is used to measure deep muscular tissue pain sensitivity.; Other Names: PPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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
Upper extremity nerve conduction studies	Latency, conduction velocity and amplitude values obtained in bilateral median-ulnar motor and sensory nerve conduction studies.	3 months
median nerve ultrasound	Median nerve cross-sectional area and echogenicity measurement	3 months
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• 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: 23-517

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