Clinical trial NCT04979117: Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis
Official title: Diagnostic Performance of Superb Microvascular Imaging Ultrasonography in Plantar Fasciitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnose Disease
Plantar Fasciitis
Keywords: superb microvascular imaging
diagnose
microvascularization
plantar fasciitis
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients who diagnosed as Plantar Fasciitis as the first group
* Healthy participants as the second group

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.

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.

Eligibility 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

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: Each participant will be assessed only one time at the admission time to the outpatient clinic
measure: Heel Tenderness Index (HTI)
timeFrame: Each participant will be assessed only one time at the admission time to the outpatient clinic
measure: Foot Function Index (FFI)
timeFrame: Each participant will be assessed only one time at the admission time to the outpatient clinic
measure: Ultrasonographic Evaluation; Superb Microvascular Imaging, GrayScale Imaging, Color Doppler Imaging, Power Doppler Imaging
timeFrame: Each participant will be assessed only one time at the admission time to the outpatient clinic
Secondary outcomes:
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
affiliation: Omer Halisdemir University
name: Ender Salbas, MD
role: STUDY_DIRECTOR
References: