Superb Microvascular Imaging Ultrasonography of Plantar Fasciitis

NCT ID: NCT04979117

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2022-12-27

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.

Conditions

Diagnose Disease; Plantar Fasciitis

Keywords

superb microvascular imaging; diagnose; microvascularization; plantar fasciitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Superb Microvascular Imaging (SMI) (Toshiba)

Intervention Type: 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.

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.

Superb Microvascular Imaging (SMI) (Toshiba)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• History of foot trauma or surgery
• Diabetes mellitus
• Pregnancy,
• Rheumatological diseases

For the second group:

• History of foot trauma or surgery
• Diabetes mellitus
• Pregnancy,
• Rheumatological diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Ender Salbaş

Physical Medicine & Rehabilitation Specialist, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ender Salbas, MD

Role: STUDY_DIRECTOR

Omer Halisdemir University

Locations

Nigde Omer Halisdemir University

Niğde, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ES01

Identifier Type: -

Identifier Source: org_study_id