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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome Bilateral
• Interventions: Device: Superb microvascular imaging (SMI) (Toshiba)

• Registration Number: NCT03213847
• Lead Sponsor: Uşak University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Study Start: 2017-10-20
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-25
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with carpal tunnel syndrome	Superb microvascular imaging (SMI) (Toshiba)	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)

Primary Outcome Measures

Name	Time	Method
Vascular blood flow images from median nerve (enterrapted in carpal tunnel) obtained with Power Doppler and Superb microvascular imaging.	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

Trial Locations

Locations (1)

University of Usak; 🇹🇷 Uşak, Turkey