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Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis (SMI)

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ClinicalTrials.gov Identifier: NCT04979117
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Ender Salbaş, Nigde Omer Halisdemir University

Brief Summary:
A prospective study will be conducted to evaluate the diagnostic performance of SMI, gray scale US, color Doppler US and Power Doppler US.

Condition or disease Intervention/treatment
Diagnose Disease Plantar Fasciitis Device: Superb Microvascular Imaging (SMI) (Toshiba)

Detailed Description:

Plantar fasciitis (PF) is a painful condition of the inferior and medial heel. Symptoms worsens with the first steps in the morning or after prolonged sitting and long periods of standing.

The diagnosis of PF is made according to the typical anamnesis and physical examination, based on the emerge of local point tenderness over the heel and proximal fascia due to the pressure applied by the physician. Heel pain exacerbates by the first steps in the morning or after rest and with prolonged standing. Unless there is an inflammatory disease such as spondyloarthropathy, there is no laboratory finding indicating plantar fasciitis. Imaging methods are very useful for making an accurate diagnosis. Because the main problem is in the soft tissue, plain radiography has limited diagnostic value, but can be helpful in identifying calcaneal stress fractures.

Magnetic resonance imaging (MRI) is very successful in showing the inflammatory process of soft tissue. However, it does not seem possible to use MRI scans routinely because of the cost and time it requires.

PF can be evaluated with ultrasonography with the advantages of being non-invasive, relatively inexpensive, easy to access and apply, and is increasingly used in clinical practice. Color Doppler evaluation is a very valuable part of musculoskeletal sonographic examination and facilitates the clinician's decision as an inflammation marker. Power Doppler US is quite sensitive to tissue or probe movement, especially at low pulsed repetition frequency (PRF). Flash artifacts may be observed. However, Doppler USG has limited sensitivity at low flows and small vessel structures.

Superb microvascular imaging (SMI) (Toshiba Medical Systems, Tokyo, Japan) is a new mode of vascular imaging that provides visualization of activity in microvascular structures or in structures that have low flow rate.

To the best of our knowledge, there are no studies comparing the diagnostic performance of the SMI modality in plantar fasciitis with color Doppler and gray scale US. Therefore, a prospective study will be conducted to evaluate the diagnostic performance of SMI, gray scale US, color Doppler US and Power Doppler US. The null hypothesis that there is no difference between Doppler US and SMI methods in the detection of increased inflammatory activity in plantar fasciitis patients.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Diagnostic Performance of Superb Microvascular Imaging Ultrasonography in Plantar Fasciitis
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants with plantar fasciitis

Participants with the diagnose of plantar fasciitis; typical anamnesis (exacerbating pain by the first steps in the morning or after rest and with prolonged standing).

The emerge of local point tenderness over the heel and proximal fascia due to the pressure applied by the physician.

Thickening of the plantar fascia greater than 4 mm in ultrasonographic evaluation. measurement

Device: Superb Microvascular Imaging (SMI) (Toshiba)
to determine whether there is a diagnostic value of SMI in Plantar Fasciitis and whether there is a superiority when compared Power Doppler and Color Doppler modalities.

Volunteers who has not foot complaints.
Volunteers who were not diagnosed with Plantar Fasciitis and without foot or heel pain when taking the first steps in the morning, with plantar fascia thickness less than 4 mm, painless, symptom-free and which had no additional rheumatic disease.
Device: Superb Microvascular Imaging (SMI) (Toshiba)
to determine whether there is a diagnostic value of SMI in Plantar Fasciitis and whether there is a superiority when compared Power Doppler and Color Doppler modalities.




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) Pain Score [ Time Frame: Each participant will be assessed only one time at the admission time to the outpatient clinic ]
    The patient will be asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line. This rating is then measured from the left edge gives the VAS score. A higher score indicates greater pain intensity and lower scores indicates less pain intensity.

  2. Heel Tenderness Index (HTI) [ Time Frame: Each participant will be assessed only one time at the admission time to the outpatient clinic ]
    Heel tenderness index (HTI) will be assessed by physician; based on assessing pain on palpation (0=no pain, 1=painful, 2=painful and winces, 3=painful, winces and withdraws).

  3. Foot Function Index (FFI) [ Time Frame: Each participant will be assessed only one time at the admission time to the outpatient clinic ]
    This index aims to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.

  4. Ultrasonographic Evaluation; Superb Microvascular Imaging, GrayScale Imaging, Color Doppler Imaging, Power Doppler Imaging [ Time Frame: Each participant will be assessed only one time at the admission time to the outpatient clinic ]
    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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Patients who diagnosed as Plantar Fasciitis as the first group
  • Healthy participants as the second group
Criteria

For the first group:

Inclusion Criteria:

  • Patients who diagnosed as Plantar Fasciitis
  • Age between 18-45

Exclusion Criteria:

  • History of foot trauma or surgery
  • Diabetes mellitus
  • Pregnancy,
  • Rheumatological diseases

For the second group:

Inclusion Criteria:

  • asymptomatic foot,
  • no previous trauma or surgery on foot,
  • no history of systemic inflammatory disorders.

Exclusion Criteria:

  • History of foot trauma or surgery
  • Diabetes mellitus
  • Pregnancy,
  • Rheumatological diseases

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): NCT04979117


Contacts
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Contact: Ender Salbas, MD +905556698639 drendersalbas@gmail.com
Contact: Ender Salbas, MD +905556698639 drender@yandex.com

Locations
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Turkey
Nigde Omer Halisdemir University Recruiting
Niğde, Turkey, 51700
Contact: Ender Salbas, MD    +905556698639    drendersalbas@gmail.com   
Sponsors and Collaborators
Nigde Omer Halisdemir University
Investigators
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Study Director: Ender Salbas, MD Omer Halisdemir University
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Responsible Party: Ender Salbaş, Physical Medicine & Rehabilitation Specialist, MD, Nigde Omer Halisdemir University
ClinicalTrials.gov Identifier: NCT04979117    
Other Study ID Numbers: ES01
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not want to share IPD with any researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ender Salbaş, Nigde Omer Halisdemir University:
superb microvascular imaging
diagnose
microvascularization
plantar fasciitis
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases