Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04979117 |
Other study ID # |
ES01 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.