NCT06115187

Brief Summary

The aim of this study is to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and clinical parameters. The main questions it aims to answer are:

  • To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the patient's clinical complaints?
  • To what extent are the different ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome correlated with each other?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

October 24, 2023

Last Update Submit

September 5, 2025

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndromeUltrasoundEchogenicity

Outcome Measures

Primary Outcomes (6)

  • median nerve ultrasound

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

    3 months

  • median nerve ultrasound

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

    3 months

  • median nerve ultrasound

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

    3 months

  • median nerve ultrasound

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

    3 months

  • median nerve ultrasound

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

    3 months

  • median nerve ultrasound

    vertical thickness measurement of the median nerve at the level of the carpal tunnel

    3 months

Secondary Outcomes (8)

  • Visual analog scale

    3 months

  • Upper extremity nerve conduction studies

    3 months

  • Upper extremity nerve conduction studies

    3 months

  • Upper extremity nerve conduction studies

    3 months

  • Upper extremity nerve conduction studies

    3 months

  • +3 more secondary outcomes

Study Arms (1)

Patient group

Patients with carpal tunnel syndrome

Diagnostic Test: Nerve ultrasoundDiagnostic Test: Nerve conduction studies

Interventions

Nerve ultrasoundDIAGNOSTIC_TEST

Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels

Patient group
Nerve conduction studiesDIAGNOSTIC_TEST

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

Patient group

Eligibility Criteria

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

Patients with diagnosed CTS

You may qualify if:

  • Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
  • Agreeing to participate in the study

You may not qualify if:

  • Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy
  • Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis
  • Not agreeing to participate in the study
  • History of surgery due to CTS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Emre Ata, Assoc.Prof

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 2, 2023

Study Start

October 10, 2023

Primary Completion

January 15, 2025

Study Completion

March 1, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Dataset sharing is not planned

Locations

TU(1)