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

NCT03213847 | Completed

• 1 other identifier: SMI001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome Bilateral

Keywords

Carpal Tunnel Syndrome; Superb microvascular imaging; Doppler ultrasound; Ultrasound; Median Nerve Entrapment; Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants with carpal tunnel syndrome

OTHER

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)

Interventions

Superb microvascular imaging (SMI) (Toshiba) 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

Participants with carpal tunnel syndrome

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

University of Usak

Uşak, 64200, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28629689 BACKGROUND

• 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.

  PMID: 21076589 BACKGROUND

• 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.

  PMID: 28538376 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: prospective cohort study

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: October 20, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 25, 2017
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)