Superb Microvascular Imaging of Median Nerve in Carpal Tunnel Syndrome: A Novel Technique in Diagnostic Ultrasound

October 24, 2018 updated by: Ali Yavuz Karahan, Uşak University
The aim of the study was to determine whether there is a correlation between the increased intraneural flow as measured using Doppler ultrasound (US) and superb microvascular imaging (SMI) methods and the severity of CTS as measured by nerve conduction studies. Moreover, investigators investigated the association of increased intraneural flow with the cross sectional area of the median nerve. The null hypothesis that there is no correlation between increased intraneural flow and the severity of carpal tunnel syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thanks to ultrasound (US) has a low cost, portable, available and non-invasive, the use of diagnostic US in musculoskeletal diseases is rapidly growing in worldwide. Because it is easy to identify the limb structures such as muscle, tendon, and nerves and also, their pathologies, US is frequently used by physiatrists, orthopedics, rheumatologists, sports medicine and pain management physicians nowadays. Providing images of the median nerve (MN) and accompanying structures and give dynamic images about the anatomy of the carpal tunnel are the most superiorities of US in carpal tunnel syndrome (CTS) diagnosis. The diagnose of CTS based on history and physical examination and confirmed with electrodiagnostic studies. Although the specificity of nerve conduction tests is high, there is significant variability in sensitivity (62-85%). Therefore, US has been suggested as an additional or alternative diagnose of CTS. Especially measurement of the cross-sectional area (CSA) of the MN is significantly greater in CTS patients and shows a significant correlation with electrodiagnostic findings such as sensory nerve conduction velocity (SCV) and distal motor latency (DML). Because it enhances the diagnostic accuracy the detection of the epineural or intraneuronal blood flow, the three techniques of Doppler US, are more recently preferred. The contributions of color, power and spectral Doppler techniques in CTS diagnosis, were studied in various studies before. While for the detection of intraneural flow, the power Doppler (PD) seems to be the best way, the specify, sensitivity and diagnostic accuracy of each Doppler techniques were good in most studies.

Superb microvascular imaging (SMI) (Toshiba Medical Systems, Tokyo, Japan) is a new era in diagnostic ultrasound image processing technique. This new technology assigns accurate visualization of vascular structures with intensive clutter suppression to provide flow signals large to small vessels and represent this data at high frame rates. The both of the two modes (color SMI (cSMI) and the monochrome SMI (mSMI)) of the SMI, allows to visualizing lower velocity blood flows and smaller vessels without the use of contrast medium. To the best of our knowledge, there have been no clinical trials which studied of the healthy or injured median nerve blood flow with SMI.

The aim of the study was to compare the diagnostic value of Doppler US and SMI methods in CTS based on detection of increased intraneural flow. Moreover, investigators investigated the association of increased intraneural flow with the CSA of the MN. The null hypothesis that there is no difference between Doppler US and SMI methods in the detection of increased intraneural flow in CTS patients.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Uşak, Turkey, 64200
        • University of Usak

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who diagnosed as as mild, moderate or severe CTS with electromyography
  • Age between 18-45

Exclusion Criteria:

  • History of upper extremity trauma
  • Diabetes mellitus
  • Pregnancy,
  • Rheumatological diseases
  • Hypothyroidism

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Participants with carpal tunnel syndrome
Participants diagnosed with carpal tunnel syndrome; will be evaluated with Doppler ultrasound and superb microvascular imaging (SMI) ultrasound. The results of these two evaluations will be compared between each other in according to severity of carpal tunnel syndrome (severity will be determined by electromyography studies)
Device: Superb microvascular imaging (SMI) (Toshiba)
to determine whether there is a correlation between the increased intraneural flow as measured using Doppler US and SMI methods and the severity of CTS as measured by nerve conduction studies, we designed this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular blood flow images from median nerve (enterrapted in carpal tunnel) obtained with Power Doppler and Superb microvascular imaging.
Time Frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
Four-stage classify will be use for grading these images; Grade 0: No vascularity in MN, Grade 1: One or two focal color-encoded spots in MN, Grade 2: One linear color-encoded line or more than two focal color-encoded spots in MN, Grade 3: More than one linear color-encoded line in MN
Each participant will be assessed only one time at the admission time to the outpatient clinic

Collaborators and Investigators

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

Sponsor

Uşak University

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 (Actual)

October 20, 2017

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

November 25, 2017

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Anthropometric and demographic data included age, weight, height, body mass index (BMI), gender, occupation, medication history and hand dominance. Main outcomes of the study: correlation between the increased intraneural flow as measured using Doppler US and Superb microvascular imaging (SMI) methods.

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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