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NCT Number: NCT07114913

Symptom Distribution and Pain Sensitization in Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome Central Sensitisation Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pain, Radiating Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Usküdar, 34100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Feyza Nur Yücel, Specialist

CONTACT

CONTACT

(0216) 542 20 00 ext. 90

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerve Ultrasound

Diagnostic Test

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

Nerve conduction studies

Diagnostic Test

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

Pressure pain threshold

Diagnostic Test

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

Primary outcomes

  1. Pressure pain threshold

    Time frame: 3 months

    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.

  2. Katz hand diagram

    Time frame: 3 months

    The 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 outcomes

  1. Central sensitization inventory (CSI)

    Time frame: 3 months

    Clinical 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.

  2. Visual analog scale

    Time frame: 3 months

    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. hand grip strength

    Time frame: 3 months

    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.

  4. Median nerve conduction studies-latency measurement

    Time frame: 3 months

    Latency values obtained in bilateral median motor and sensory nerve conduction studies.

  5. Median nerve motor conduction studies-amplitude measurement

    Time frame: 3 months

    Amplitude values obtained in bilateral median motor nerve conduction studies.

  6. Median nerve sensory conduction studies-amplitude measurement

    Time frame: 3 months

    Amplitude values obtained in bilateral median sensory nerve conduction studies.

  7. Median nerve conduction studies- conduction velocity measurement

    Time frame: 3 months

    Conduction velocity values obtained in bilateral median motor and sensory nerve conduction studies.

  8. Median nerve ultrasound cross-sectional area measurement

    Time frame: 3 months

    Median nerve cross-sectional area and echogenicity measurement

  9. Median nerve ultrasound echogenicity measurement

    Time frame: 3 months

    Median nerve echogenicity measurement

  10. Short form-12

    Time frame: 3 months

    The 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.

  11. Self Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS)

    Time frame: 3 months

    S-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.

  12. Boston Carpal Tunnel Questionnaire (BCTQ)

    Time frame: 3 months

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Ata, Assoc. Prof

CONTACT

(0216) 542 20 00 ext. 90

Feyza Nur Yücel, Specialist

CONTACT

[email protected]

(0216) 542 20 00 ext. 90

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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