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Ultrasound Evaluation in Carpal Tunnel Syndrome

NCT07433166 — Not yet recruiting, 100 participants, SB Istanbul Education and Research Hospital

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

RegistryNCT07433166, acronym CTS-PD
StatusNot yet recruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorSB Istanbul Education and Research Hospital (Other)
ConditionsCarpal Tunnel Syndrome (CTS)
InterventionsDoppler ultrasound (Diagnostic test)
Datesstart 2026-05-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-02-25, last updated 2026-04-09

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-Summary

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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+Arms and interventions

  • Doppler ultrasound (Diagnostic test): The predictive power of cross-sectional area and intraneural blood flow measured by ultrasound on surgical outcomes will be tested.

+Outcome measures

Primary outcomes

  • Intraneural Vascularity [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 1. = Single vessel signal 2. = Multiple vessel signals 3. = Marked hypervascularity The total score ranges from 0 to 3. Higher scores indicate increased intraneural vascularity.
  • Cross sectional Area [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

  • Boston Carpal Tunnel Questionnaire [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.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Publications

  • Erickson M, Lawrence M, Lucado A. The role of diagnostic ultrasound in the examination of carpal tunnel syndrome: an update and systematic review. J Hand Ther. 2022 Apr-Jun;35(2):215-225. doi: 10.1016/j.jht.2021.04.014. Epub 2021 Apr 14. PMID 34261588

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