NCT07433166

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
May 2026Jan 2027

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 9, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 19, 2026

Last Update Submit

April 4, 2026

Conditions

Keywords

carpal tunnelultrasoundpower doppler

Outcome Measures

Primary Outcomes (2)

  • Intraneural Vascularity

    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

    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 Outcomes (1)

  • Boston Carpal Tunnel Questionnaire

    Baseline, 3th and 6th months

Interventions

Doppler ultrasoundDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Carpal Tunnel Syndrome Patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 34261588BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian Neuropathy

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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