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

NCT ID: NCT03213847

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2017-11-25

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.

Conditions

Carpal Tunnel Syndrome Bilateral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Superb microvascular imaging (SMI) (Toshiba)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uşak University

OTHER

Sponsor Role: lead

Responsible Party

Ali Yavuz Karahan

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Usak

Uşak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28629689 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21076589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28538376 (View on PubMed)

Other Identifiers

SMI001

Identifier Type: -

Identifier Source: org_study_id