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NCT Number: NCT07170449

Investigation of the Relationship Between Ultrasonographic Parameters and Tactile Sensation in Carpal Tunnel Syndrome

The aim of this study was to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and the level of tactile sensation.

The primary questions the study aimed to answer are:

• To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the level of sensory complaints in the patient?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sultan Abdülhamit Han Trainin and Educational Hospital

Üsküdar, İ̇stanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Müyesser Cavlak, PhD

CONTACT

[email protected]

+905426406118

About this study

Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The etiology of CTS can be related to work, lifestyle, injury, or genetic predisposition. Exposure to vibrations or repetitive forceful angular movements is among the most common causes of CTS. Certain diseases, such as diabetes, pregnancy, and morbidity, are also thought to be associated with an increased risk of developing CTS. It accounts for 90% of all entrapment neuropathies. Its prevalence in the population is between 1% and 5%, and it is three times more common in women. In CTS, complaints related to motor and sensory deficits are observed in the first three fingers innervated by the median nerve and the radial aspect of the fourth finger. Diagnosis is made by corroborating clinical signs and symptoms with electrophysiological findings. However, recently, ultrasound (US) is frequently preferred for the diagnosis of CTS to evaluate the morphological and mechanical properties of the median nerve. US is considered a highly accurate, effective, and cost-effective diagnostic method for the diagnosis of CTS, with a short evaluation time . Sonographic measurements related to CTS can yield values such as the diameter of the nerve at the entrance and exit of the tunnel. CTS presents with a disturbance in tactile input, such as numbness and loss of sensation in the median nerve dermatom. This sensory loss can cause difficulty in using the patient's hand in activities of daily living. Sonography has recently become widely used in CTS patients. The fact that values measured by sonography can provide information about the clinical status of patients can be considered important data for healthcare professionals. Therefore, our study was designed to examine the relationship between sonographic measurements and tactile sensory levels in patients diagnosed with mild to moderate CTS based on electrodiagnostic tests.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Electrodiagnostic diagnosis of carpal tunnel syndrome with pain, numbness, burning, and tingling consistent with the median nerve dermatomal area lasting at least 6 weeks.
  • Literate
  • Agree to participate in the study

Exclusion criteria

  • Concomitant diabetes, systemic inflammatory disease, active infection, and history of malignancy
  • Being <18 and >65 years old
  • Being illiterate
  • Refusing to participate in the study
  • Having a disease with neuropathic pain, such as polyneuropathy, radiculopathy, or MS
  • Other concomitant upper extremity entrapment neuropathies (e.g., cubital tunnel syndrome)
  • Having undergone surgery for carpal tunnel syndrome
  • Rheumatoid arthritis, advanced hand osteoarthritis

Treatment and study plan

Nerve conduction studies

Diagnostic Test

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

Median nerve ultrasonography

Diagnostic Test

Median nerve sonographic cross-sectional area and echogenicity measurements

Sensory testing

Diagnostic Test

tactile sensory tests

Primary outcomes

  1. median nerve ultrasound

    Time frame: 3 Months

    Median nerve maximum cross-sectional area measurement at the level of the carpal tunnel (mm²)

  2. Pointed - blunt discrimination test

    Time frame: 3 Months

    The patient is asked to distinguish between a pointed and a blunt tip by touching the median nerve dermatome.

  3. Moved two point discrimination

    Time frame: 3 months

    The patient's finger is touched, starting from the distal tip and moving proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in mm.

  4. Fixed Two Point Discrimination Test

    Time frame: 3 months

    The patient's finger is touched starting from the distal tip and working proximally, and the patient is asked to distinguish between one and two dots. The distance between the last pair of dots the patient can distinguish is noted in millimeters.

  5. Semmes Weinstein Test

    Time frame: 3 months

    With the patient's eyes closed, monofilament is applied perpendicularly in a steady manner until the filament bends. Use a smooth motion to touch the skin with the filament, bend the filament for a full second, than lift from the skin. Patient raises hand to indicate that the monofilament touch sensation is perceived.

  6. median nerve ultrasound

    Time frame: 3 months

    Median nerve echogenicity at the level of the carpal tunnel (%)

  7. median nerve ultrasound

    Time frame: 3 months

    Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)

  8. median nerve ultrasound

    Time frame: 3 months

    Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)

  9. median nerve ultrasound

    Time frame: 3 months

    Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)

Secondary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire

    Time frame: 3 Months

    The scale consists of an 11-question Likert-style symptom severity scale and an 8-question functional status scale. The total score is divided by the number of questions to calculate the score. Higher scores are associated with increased symptom severity and poorer functional status.

  2. S-LANSS

    Time frame: 3 Months

    A score of 12 or more out of 24 on a 7-question scale is considered in favor of neuropathic pain.

  3. SF-12 (Short Form-12)

    Time frame: 3 months

    The SF-12 is a practical test consisting of seven questions that examine the life limits of the patient. The questionnaire includes questions aimed at understanding the physical and psychiatric effects. The results of the survey are calculated using two score calculation tools: physical (PCS-12) and mental (MCS-12). The highest score for the PCS-12 is 56.6, while the highest score for the MCS-12 is 60.7. Higher scores are comparable to a state of resilience and recovery, which can be compared to quality of life.

Study contacts

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

Feyza Nur Yücel, Specialist

CONTACT

[email protected]

5385577059 ext +90

Müyesser Cavlak, PhD

CONTACT

[email protected]

+905426406118

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
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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