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Completed

NCT Number: NCT04979117

Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nigde Omer Halisdemir University

Niğde, 51700, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superb microvascular imaging (SMI) (Toshiba)

Device

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

Diagnostic Performance of Superb Microvascular Imaging Ultrasonography in Plantar Fasciitis

Acronym: SMI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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