Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis

Plantar Fasciitis Clinical Trial

— SMI  

Official title:

Diagnostic Performance of Superb Microvascular Imaging Ultrasonography in Plantar Fasciitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979117
• Other study ID #: ES01
• Status: Completed
• Start date: May 28, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: December 2022
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnose Disease
• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Nigde Omer Halisdemir University	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Pain Score	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.	Each participant will be assessed only one time at the admission time to the outpatient clinic
Primary	Heel Tenderness Index (HTI)	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).	Each participant will be assessed only one time at the admission time to the outpatient clinic
Primary	Foot Function Index (FFI)	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.	Each participant will be assessed only one time at the admission time to the outpatient clinic
Primary	Ultrasonographic Evaluation; Superb Microvascular Imaging, GrayScale Imaging, Color Doppler Imaging, Power Doppler Imaging	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	Each participant will be assessed only one time at the admission time to the outpatient clinic