An observational study in Diagnose Disease and Plantar Fasciitis, sponsored by Nigde Omer Halisdemir University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Nigde Omer Halisdemir University · Observational
A prospective study will be conducted to evaluate the diagnostic performance of SMI, gray scale US, color Doppler US and Power Doppler US.
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.
235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 36 observational studies indexed under Fasciitis.
Browse Fasciitis studies →Nigde Omer Halisdemir University is the lead sponsor of 89 studies on the registry; 30 are open to participants now.
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For the first group:
Inclusion Criteria:
Exclusion Criteria:
For the second group:
Inclusion Criteria:
Exclusion Criteria:
Participants with the diagnose of plantar fasciitis; typical anamnesis (exacerbating pain by the first steps in the morning or after rest and with prolonged standing). The emerge of local point tenderness over the heel and proximal fascia due to the pressure applied by the physician. Thickening of the plantar fascia greater than 4 mm in ultrasonographic evaluation. measurement
Device: Superb Microvascular Imaging (SMI) (Toshiba)
Volunteers who were not diagnosed with Plantar Fasciitis and without foot or heel pain when taking the first steps in the morning, with plantar fascia thickness less than 4 mm, painless, symptom-free and which had no additional rheumatic disease.
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.
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.
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
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).
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
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.
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
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
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
Plan to share: No — We do not want to share IPD with any researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Nigde Omer Halisdemir University