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

Carpal Tunnel Syndrome Bilateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213847
• Other study ID #: SMI001
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: November 25, 2017

Study information

• Verified date: October 2018
• Source: Usak University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 25, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Carpal Tunnel Syndrome Bilateral
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	University of Usak	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Akcar N, Ozkan S, Mehmetoglu O, Calisir C, Adapinar B. Value of power Doppler and gray-scale US in the diagnosis of carpal tunnel syndrome: contribution of cross-sectional area just before the tunnel inlet as compared with the cross-sectional area at the tunnel. Korean J Radiol. 2010 Nov-Dec;11(6):632-9. doi: 10.3348/kjr.2010.11.6.632. Epub 2010 Oct 29. — View Citation

Chen J, Chen L, Wu L, Wang R, Liu JB, Hu B, Jiang LX. Value of superb microvascular imaging ultrasonography in the diagnosis of carpal tunnel syndrome: Compared with color Doppler and power Doppler. Medicine (Baltimore). 2017 May;96(21):e6862. doi: 10.1097/MD.0000000000006862. — View Citation

Orlandi D, Gitto S, Perugin Bernardi S, Corazza A, De Flaviis L, Silvestri E, Cimmino MA, Sconfienza LM. Advanced Power Doppler Technique Increases Synovial Vascularity Detection in Patients with Rheumatoid Arthritis. Ultrasound Med Biol. 2017 Sep;43(9):1880-1887. doi: 10.1016/j.ultrasmedbio.2017.05.004. Epub 2017 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular blood flow images from median nerve (enterrapted in carpal tunnel) obtained with Power Doppler and Superb microvascular imaging.	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