Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis

NCT04979117 | Completed

• 1 other identifier: ES01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnose Disease; Plantar Fasciitis

Keywords

superb microvascular imaging; diagnose; microvascularization; plantar fasciitis

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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

  Each participant will be assessed only one time at the admission time to the outpatient clinic

Study Arms (2)

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

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.

Device: Superb Microvascular Imaging (SMI) (Toshiba)

Interventions

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.

Participants with plantar fasciitis; Volunteers who has not foot complaints.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Patients who diagnosed as Plantar Fasciitis as the first group * Healthy participants as the second group

You may qualify if:

• Patients who diagnosed as Plantar Fasciitis
• Age between 18-45

You may not qualify if:

• History of foot trauma or surgery
• Diabetes mellitus
• Pregnancy,
• Rheumatological diseases
• For the second group:
• asymptomatic foot,
• no previous trauma or surgery on foot,
• no history of systemic inflammatory disorders.
• History of foot trauma or surgery
• Diabetes mellitus
• Pregnancy,
• Rheumatological diseases

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, 51700, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Disease

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ender Salbas, MD

  Omer Halisdemir University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine & Rehabilitation Specialist, MD

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 28, 2021
• Study Start: May 28, 2021
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)