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NCT Number: NCT06043141

Investigation of the Relationship Between Pain Sensitization and Diagnostic 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?

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Key information

Conditions

Central Sensitisation Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases 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, Uskudar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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 (PPT) is used to measure deep muscular tissue pain sensitivity.

Other names: PPT

Primary outcomes

  1. Pressure pian 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.

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.

  2. 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.

  3. 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).

  4. Upper extremity nerve conduction studies

    Time frame: 3 months

    Latency, conduction velocity and amplitude values obtained in bilateral median-ulnar motor and sensory nerve conduction studies.

  5. median nerve ultrasound

    Time frame: 3 months

    Median nerve cross-sectional area and echogenicity measurement

  6. Short form-12

    Time frame: 3 months

    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.

  7. 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 and a score of 12 points or more is in favor of the presence of neuropathic pain.

  8. Boston Carpal Tunnel Questionnaire (BCTQ)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
Sep 12, 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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