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Symptom Distribution and Pain Sensitization in Carpal Tunnel Syndrome

Evaluation of Central Sensitization Parameters Based on Extra Median Symptom Distribution in Carpal Tunnel Syndrome: A Cross-sectional Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07114913
Enrollment
80
Registered
2025-08-11
Start date
2025-06-21
Completion date
2026-03-01
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Central Sensitisation, Pain, Radiating

Keywords

carpal tunnel syndrome, central sensitization, central sensitization inventory, pressure pain threshold

Brief summary

This study aims to compare central sensitization parameters between carpal tunnel syndrome (CTS) patients with extra median symptom distribution and those with typical, median nerve-related symptoms. Extra median sensory spread, observed in some CTS patients beyond the anatomical boundaries of the median nerve, may reflect central sensitization mechanisms. Using the Central Sensitization Inventory and pressure pain threshold measurements, this study will assess whether extra median symptom patterns are associated with increased central sensitization.

Detailed description

Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy, typically presenting with numbness and tingling in the thumb, index, and middle fingers due to median nerve compression at the wrist. However, some patients report symptom spread beyond the median nerve distribution, involving ulnar regions of the hand, forearm, shoulder, or even scapular areas. This phenomenon, known as extra median symptom distribution, has been increasingly associated with central sensitization (CS).This study aims to compare central sensitization parameters between CTS patients with typical symptoms and those showing extra median spread. Pressure pain threshold (PPT) and Central Sensitization Inventory (CSI) scores will be used to evaluate sensitization levels. The initial hypothesis of this study was that patients with extra-median symptoms would exhibit lower PPT values and higher CSI scores, indicating greater central sensitivity. Findings may highlight the need to consider central mechanisms in CTS management and promote more personalized treatment approaches.

Interventions

DIAGNOSTIC_TESTNerve ultrasound

Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels

Upper extremity nerve conduction studies including median-ulnar sensory and motor responses

Pain pressure threshold is used to measure deep muscular tissue pain sensitivity.

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

* Having been diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings * Being between 18 and 65 years of age * Being literate * Agreeing to participate in the study

Exclusion criteria

* Having a history of concomitant diabetes, systemic inflammatory disease, active infection, or malignancy * Being \<18 and \>65 years of age * Being illiterate * Refusing to participate in the study * Having a disease associated with neuropathic pain, such as polyneuropathy, radiculopathy, or multiple sclerosis * History of injection or surgery for CTS within the last 6 months

Design outcomes

Primary

MeasureTime frameDescription
Pressure pain threshold3 monthsPain 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.
Katz hand diagram3 monthsThe Katz Hand Diagram is a self-reported symptom map used to support the diagnosis of Carpal Tunnel Syndrome (CTS). Patients are asked to mark areas on a standardized hand diagram where they experience pain, numbness, or tingling. This tool helps clinicians assess whether symptoms follow a median nerve distribution and is commonly used in both clinical and research settings due to its simplicity and diagnostic value.

Secondary

MeasureTime frameDescription
Median nerve motor conduction studies-amplitude measurement3 monthsAmplitude values obtained in bilateral median motor nerve conduction studies.
Median nerve sensory conduction studies-amplitude measurement3 monthsAmplitude values obtained in bilateral median sensory nerve conduction studies.
Median nerve conduction studies- conduction velocity measurement3 monthsConduction velocity values obtained in bilateral median motor and sensory nerve conduction studies.
Central sensitization inventory (CSI)3 monthsClinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis. The score range is between 0 and 100, and as the score increases, the severity of sensitization symptoms increases.
Visual analog scale3 monthsThe visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Median nerve ultrasound cross-sectional area measurement3 monthsMedian nerve cross-sectional area and echogenicity measurement
Median nerve conduction studies-latency measurement3 monthsLatency values obtained in bilateral median motor and sensory nerve conduction studies.
Short form-123 monthsThe 12-item Short Form Questionnaire (SF-12) is used for objective measurement of quality of life. The SF-12 provides two norm-based summary scores-Physical (PCS) and Mental (MCS)-each ranging from 0 to 100. Higher scores indicate better health, with 50 as the average based on U.S. norms.
Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS)3 monthsS-LANSS is a 7-question scale used to define pain of neuropathic origin. The score range is between 0-24 and a score of 12 points or more is in favor of the presence of neuropathic pain.
Boston Carpal Tunnel Questionnaire (BCTQ)3 monthsThe Boston Carpal Tunnel Questionnaire (BCTQ) includes two subscales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS consists of 11 items, each scored from 1 (no symptoms) to 5 (very severe symptoms), resulting in a total score range of 11 to 55 and an average score range of 1.0 to 5.0. The FSS contains 8 items, also scored from 1 (no difficulty) to 5 (unable to perform), yielding a total score range of 8 to 40 and an average score range of 1.0 to 5.0. Higher scores on both subscales indicate greater symptom severity or functional limitation.
hand grip strength3 monthsGrip 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.
Median nerve ultrasound echogenicity measurement3 monthsMedian nerve echogenicity measurement

Countries

Turkey (Türkiye)

Contacts

Primary ContactFeyza Nur Yücel, Specialist
dr.fny28@gamil.com(0216) 542 20 00
Backup ContactEmre Ata, Assoc. Prof
(0216) 542 20 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026