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NCT Number: NCT07433166

Ultrasound Evaluation in Carpal Tunnel Syndrome

This prospective cohort study aims to evaluate median nerve cross-sectional area and intraneural vascularity using power Doppler ultrasonography in patients with carpal tunnel syndrome. Ultrasonographic findings will be compared between diabetic and non-diabetic patients. Clinical severity and electrophysiological findings will be correlated with ultrasonographic parameters.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) 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–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinically and electrophysiologically confirmed carpal tunnel syndrome
  • symptom duration > 3 months
  • written informed consent

Exclusion criteria

  • previous wrist surgery
  • cervical radiculopathy
  • inflammatory arthritis
  • pregnancy

Treatment and study plan

Doppler Ultrasound

Diagnostic Test

The predictive power of cross-sectional area and intraneural blood flow measured by ultrasound on surgical outcomes will be tested.

Primary outcomes

  1. Intraneural Vascularity

    Time frame: Baseline

    Intraneural blood flow will be evaluated using power Doppler ultrasonography at the level of the carpal tunnel inlet. The presence and degree of intraneural vascularity will be graded using a semi-quantitative scoring system:

    0 = No detectable intraneural flow

    • = Single vessel signal
    • = Multiple vessel signals
    • = Marked hypervascularity

    The total score ranges from 0 to 3. Higher scores indicate increased intraneural vascularity.

  2. Cross sectional Area

    Time frame: baseline

    The cross-sectional area of the median nerve will be measured using ultrasonography at the level of the pisiform bone (carpal tunnel inlet) and proximal to transvers carpal ligament. Measurements will be obtained by tracing the inner border of the hyperechoic epineurium.

    Values will be recorded in square millimeters (mm²). Higher values indicate greater nerve swelling.

Secondary outcomes

  1. Boston Carpal Tunnel Questionnaire

    Time frame: Baseline, 3th and 6th months

    Change in Symptom Severity Score of the Boston Carpal Tunnel Questionnaire The Boston Carpal Tunnel Questionnaire is a patient-reported outcome measure consisting of 11 questions assessing symptom severity. Each item is scored from 1 (no symptoms) to 5 (most severe symptoms). The total score ranges from 11 to 55. Higher scores indicate worse symptom severity.

Sponsors and collaborators

Lead sponsor

SB Istanbul Education and Research Hospital

Other

Registry information

Official study title

Prospective Evaluation of Median Nerve Cross-Sectionall Area and Power Doppler Signal Changes in Patients With Carpal Tunnel Syndrome

Acronym: CTS-PD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Apr 9, 2026

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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