Clinical Trials Directory

Trials / Completed

CompletedNCT04979117

Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis

Diagnostic Performance of Superb Microvascular Imaging Ultrasonography in Plantar Fasciitis

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Nigde Omer Halisdemir University · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DEVICESuperb 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.

Timeline

Start date
2021-05-28
Primary completion
2022-12-27
Completion
2022-12-27
First posted
2021-07-28
Last updated
2022-12-28

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04979117. Inclusion in this directory is not an endorsement.