Advanced Imaging Techniques for Plantar Fasciitis

(QUANTIFY Trial)

Overseen By Jessica Danielson, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ruth Chimenti

Disqualifiers: Rheumatological conditions, Osteoarthritis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is to create a test that can accurately find and measure the problem areas in muscle and fascia tissue, also known as myofascial pain. The hypothesis is that a combination of imaging findings will be able to detect when myofascial pain is present. The goal is to improve management of myofascial pain by making better tools to find changes in the muscle and fascia tissues for a more personalized treatment. This project was funded by the HEAL initiative (https://heal.nih.gov/).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is advanced imaging for plantar fasciitis safe for humans?

Advanced imaging techniques like MRI and ultrasound are generally safe for humans, as they are noninvasive and have been used widely in both healthy volunteers and patients with conditions like plantar fasciitis. ^{1 2 3 4 5}

How is the treatment using advanced imaging techniques for plantar fasciitis different from other treatments?

This treatment is unique because it uses advanced imaging techniques like MRI and ultrasound to diagnose and evaluate plantar fasciitis, which helps in accurately identifying the condition and differentiating it from other foot issues. Unlike standard treatments that may focus on symptom relief, this approach aims to provide a precise diagnosis to guide effective treatment. ^{3 4 5 6 7}

What data supports the effectiveness of this treatment for plantar fasciitis?

Research shows that both MRI and ultrasound imaging are effective in diagnosing plantar fasciitis, which can help guide treatment decisions. MRI is particularly noted for its accuracy and sensitivity in detecting plantar fascia issues, making it a valuable tool in managing this condition. ^{3 4 5 7 8}

Who Is on the Research Team?

Kathleen Sluka, PT, PhD

Principal Investigator

University of Iowa

James Holmes, PhD

Principal Investigator

University of Iowa

Ruth L Chimenti, PT, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like Achilles Tendinopathy, Tendonitis, Hernia, or Plantar Fasciitis. Participants should be able to undergo imaging tests such as MRI and ultrasound. The study aims to include a diverse group of patients who have these musculoskeletal issues.

Inclusion Criteria

I have had Achilles tendon pain for 3+ months, rated 3/10 or more.

I match the age, sex, and BMI of those with plantar fasciitis or Achilles tendinopathy.

I have been diagnosed with plantar fasciitis, with pain lasting over 3 months and a pain level of at least 3 out of 10.

Exclusion Criteria

I am under 18 years old.

I have not had foot or ankle surgery or injections in my legs in the last 3 months.

Contraindications for MRI (e.g. non-MR compatible implanted devices, claustrophobia, inability to remain still comfortably for 1 hour in a supine position, body size too large for MR scanner)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle to develop a diagnostic imaging biosignature

Enrollment period

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinical exam
• Magnetic Resonance Imaging
• Ultrasound imaging

Trial Overview The QUANTIFY study is testing the effectiveness of using advanced imaging techniques like Magnetic Resonance Imaging (MRI) and Ultrasound to identify and measure myofascial pain areas in muscles and fascia tissue.

How Is the Trial Designed?

Group I: Diagnostic imaging Experimental Treatment 3 Interventions

All participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.

Who Is Running the Clinical Trial?

Ruth Chimenti

Lead Sponsor

Trials

4

Recruited

390+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Rochester Institute of Technology

Collaborator

Trials

15

Recruited

5,500+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Clinical utility of sonography in diagnosing plantar fasciitis. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Plantar fascia evaluation with a dedicated magnetic resonance scanner in weight-bearing position: our experience in patients with plantar fasciitis and in healthy volunteers. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Pathologic and post-operative conditions of the plantar fascia: review of MR imaging appearances. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[Magnetic resonance imaging of lesions of the superficial plantar fasciitis]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical And Plantar Fascial Morphologic Changes After Proximal Medial Gastrocnemius Release Treatment of Recalcitrant Plantar Fasciitis. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Sonographic evaluation of plantar fasciitis and relation to body mass index. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Fibrosis and adventitious bursae in plantar fat pad of forefoot: MR imaging findings in asymptomatic volunteers and MR imaging-histologic comparison. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Shear Wave Elastography (SWE) for the Evaluation of Patients with Plantar Fasciitis. [2020]