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 trial aims to improve how doctors identify and understand myofascial pain, which occurs in muscles and connective tissues and is often linked to conditions like plantar fasciitis and Achilles tendinopathy. Researchers are testing whether advanced imaging techniques, such as MRI (Magnetic Resonance Imaging) and ultrasound, can more effectively detect problem areas in these tissues. The goal is to develop more personalized treatments for individuals with these types of pain. Ideal participants are those who have experienced plantar fasciitis or Achilles tendinopathy pain for at least three months with moderate pain levels. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to more effective pain management strategies.

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.

What prior data suggests that these imaging techniques are safe for diagnosing plantar fasciitis?

Research has shown that both MRI and ultrasound are safe and reliable for diagnosing plantar fasciitis. MRI accurately measures changes in the thickness of the plantar fascia, which is crucial for identifying this condition. Studies have not identified any major safety concerns with using MRI for this purpose.

Ultrasound is also considered safe. Between 2020 and 2022, 66 patients underwent ultrasound-guided procedures without major problems, indicating that ultrasound is well-tolerated and carries a low risk of side effects.

Both MRI and ultrasound effectively detect changes in the foot and ankle, making them safe options for diagnosing issues like plantar fasciitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using advanced imaging techniques for plantar fasciitis because these methods could offer more detailed insights than current standard options like X-rays or basic ultrasound. Unlike traditional treatments that primarily focus on symptom management, these imaging techniques—Magnetic Resonance Imaging (MRI) and advanced ultrasound—provide a clearer picture of the foot's soft tissues, potentially leading to more accurate diagnoses. This means that doctors could tailor treatments more effectively to each patient's specific condition, potentially improving outcomes and speeding up recovery times.

What evidence suggests that these imaging techniques are effective for diagnosing plantar fasciitis?

Research has shown that both MRI and ultrasound effectively diagnose plantar fasciitis. In this trial, all participants will undergo a clinical exam, MRI, and ultrasound imaging of the foot and ankle. An MRI provides a clear picture of the plantar fascia, a band of tissue in the foot, aiding doctors in accurately identifying any issues. Studies indicate that MRI can detect changes such as increased thickness of this tissue, a common sign of plantar fasciitis. Ultrasound also excels at diagnosing this condition, spotting changes in the plantar fascia and reliably measuring its thickness. Both methods help doctors assess the severity of the problem, leading to better treatment options. ^{4 6 7 8 9}

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

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5265197/

Imaging of plantar fascia disorders: findings on plain ... Several findings suggestive of plantar fasciitis can be detected on conventional radiographs. Despite this, plain radiography should not be used ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505625002163

A comparison of plantar fascia thickness measurements ... However, MRI provides clearer visualization of the plantar fascia and surrounding soft tissue structures, enabling a more objective and accurate assessment of ...

3. aafp.org aafp.org/pubs/afp/issues/2011/0915/p676.html

Diagnosis and Treatment of Plantar Fasciitis Ultrasonography and magnetic resonance imaging can be useful in diagnosing plantar fasciitis by showing increased plantar fascia thickness and ...

4. ortholazer.com ortholazer.com/blog/magnetic-resonance-imaging-and-clinical-outcomes-of-laser-therapy-ultrasound-therapy-and-extracorporeal-shock-wave-therapy-for-treatment-of-plantar-fasciitis-a-randomized-controlled-trial/

Magnetic Resonance Imaging and Clinical Outcomes of ... The thickness of the plantar fascia had decreased significantly on MRI in all 3 groups. The treatment success rate was 70.6% in the LLLT group, 65% in the ESWT ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28633773/

Magnetic Resonance Imaging and Clinical Outcomes of ... The thickness of the plantar fascia had decreased significantly on MRI in all 3 groups. The treatment success rate was 70.6% in the LLLT group, 65% in the ESWT ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12423429/

Validity of MRI and Ultrasound Volume Measurements ... The data of this study contribute that ultrasound and MRI measures of plantar fascia thickness and FDB muscle volume are highly reliable in ...

7. jfas.org jfas.org/article/S1067-2516(17)30132-1/abstract

Magnetic Resonance Imaging and Clinical Outcomes of ... The thickness of the plantar fascia had decreased significantly on MRI in all 3 groups. The treatment success rate was 70.6% in the LLLT group, 65% in the ESWT ...

8. jospt.org jospt.org/doi/10.2519/jospt.2023.0303

Heel Pain – Plantar Fasciitis: Revision 2023 When specifically looking for increased plantar fascia thickness, no significant differences have been found between diagnostic US and magnetic resonance ...

9. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiology.179.3.2027971

Plantar fasciitis: MR imaging.Radiology Thus, magnetic resonance (MR) imaging was used to develop objective morphologic criteria to establish a diagnosis of plantar fasciitis in eight patients.