Ultrasound Evaluation in Carpal Tunnel Syndrome (CTS-PD)

April 4, 2026 updated by: Baris Acar, SB Istanbul Education and Research Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Carpal Tunnel Syndrome Patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  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.
Baseline
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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3th and 6th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SB Istanbul Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTS-PD-DM-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing is not planned due to patient confidentially and instutional policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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