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Trial record 4 of 203 for:    Carpal Tunnel Syndrome

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

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ClinicalTrials.gov Identifier: NCT03213847
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Ali Yavuz Karahan, 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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Bilateral Device: Superb microvascular imaging (SMI) (Toshiba) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Superb Microvascular Imaging of Median Nerve in Carpal Tunnel Syndrome: A Novel Technique in Diagnostic Ultrasound
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : November 20, 2017
Estimated Study Completion Date : November 25, 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213847


Contacts
Contact: Ali Y Karahan, M.D. +905386921934 ali.karahan@usak.edu.tr

Locations
Turkey
University of Usak Recruiting
Uşak, Turkey, 64200
Contact: Ali Y Karahan    +905386921934    ali.karahan@usak.edu.tr   
Sponsors and Collaborators
Uşak University

Publications:
Responsible Party: Ali Yavuz Karahan, Associate professor, Uşak University
ClinicalTrials.gov Identifier: NCT03213847     History of Changes
Other Study ID Numbers: SMI001
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ali Yavuz Karahan, Uşak University:
Carpal Tunnel Syndrome
Superb microvascular imaging
Doppler ultrasound
Ultrasound
Median Nerve Entrapment
Diagnoses Disease

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries