Diagnose DiseaseSMINCT04979117
Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis
An observational study of Diagnose Disease and Plantar Fasciitis, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnose Disease, Plantar Fasciitis
- What is being tested?
- Superb Microvascular Imaging (SMI) (Toshiba)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2021to 27 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Patients who diagnosed as Plantar Fasciitis as the first group * Healthy participants as the second group
Who may be able to join
- Patients who diagnosed as Plantar Fasciitis
- Age between 18-45
- asymptomatic foot,
- no previous trauma or surgery on foot,
- no history of systemic inflammatory disorders.
Who cannot join
- History of foot trauma or surgery
- Diabetes mellitus
- Pregnancy,
- Rheumatological diseases
- For the second group:
- History of foot trauma or surgery
Show all 9Show fewer
- Diabetes mellitus
- Pregnancy,
- Rheumatological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of Superb Microvascular Imaging Ultrasonography in Plantar Fasciitis
A prospective study will be conducted to evaluate the diagnostic performance of SMI, gray scale US, color Doppler US and Power Doppler US.
Read the 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
- Diagnose Disease, Plantar Fasciitis
- Being tested
- Superb Microvascular Imaging (SMI) (Toshiba)
- Keywords
- superb microvascular imaging, diagnose, microvascularization, plantar fasciitis
- Medical subject headings
- Fasciitis, Plantar, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superb Microvascular Imaging (SMI) (Toshiba)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with plantar fasciitis | 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 Receives: Device: Superb Microvascular Imaging (SMI) (Toshiba) | |
| Volunteers who has not foot complaints. | 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. Receives: Device: Superb Microvascular Imaging (SMI) (Toshiba) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: Each participant will be assessed only one time at the admission time to the outpatient clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start28 May 2021
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnose DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ender Salbaş, Nigde Omer Halisdemir University
- Investigators
- Ender Salbas, MD, Study director, Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979117
- Sponsor's protocol ID
- ES01
- Acronym
- SMI
- Status last verified
- Dec 2022
- First submitted
- 16 Jul 2021
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not want to share IPD with any researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Superb Microvascular Imaging Ultrasonography in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT04979117
- Acronym / sponsor ID
- SMI / ES01
- Conditions
- Diagnose Disease, Plantar Fasciitis
- Keywords
- superb microvascular imaging, diagnose, microvascularization, plantar fasciitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with plantar fasciitis | – | Device: Superb Microvascular Imaging (SMI) (Toshiba)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 |
| Volunteers who has not foot complaints. | – | 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Patients who diagnosed as Plantar Fasciitis as the first group * Healthy participants as the second group
Key inclusion criteria (5 listed)
- Patients who diagnosed as Plantar Fasciitis
- Age between 18-45
- asymptomatic foot,
- no previous trauma or surgery on foot,
- no history of systemic inflammatory disorders.
Key exclusion criteria (9 listed)
- History of foot trauma or surgery
- Diabetes mellitus
- Pregnancy,
- Rheumatological diseases
- History of foot trauma or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Participants with plantar fasciitis, Volunteers who has not foot complaints. |
Primary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
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.
Heel Tenderness Index (HTI)
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
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).
Foot Function Index (FFI)
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
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.
Ultrasonographic Evaluation; Superb Microvascular Imaging, GrayScale Imaging, Color Doppler Imaging, Power Doppler Imaging
Time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No. We do not want to share IPD with any researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ender Salbas, MD study director
Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnose Disease and Plantar Fasciitis, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Score (time frame: Each participant will be assessed only one time at the admission time to the outpatient clinic). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.