Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06803056

QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers

Led by Ruth Chimenti · Updated on 2025-10-07

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

R

Ruth Chimenti

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying myofascial pain, a condition affecting muscle and fascia tissue, to develop a new test that can accurately detect and measure problem areas related to this pain. The study aims to create better tools that help identify changes in muscle and fascia tissues, which could lead to more personalized treatment for people with myofascial pain. The project is funded by the HEAL initiative and focuses on plantar fasciitis, Achilles tendinopathy, and pain-free controls to compare tissue differences. Participants will undergo a clinical exam by a physical therapist specializing in dry needling to confirm myofascial pain presence. They will also receive magnetic resonance imaging (MRI) and ultrasound imaging of their foot and ankle, including advanced techniques like shear wave elastography and special MRI sequences called T1rho and IDEAL to capture detailed biomechanical, biochemical, and structural profiles of the muscles involved. The study includes three groups: plantar fasciitis, Achilles tendinopathy, and healthy controls. During the study, researchers will assess muscle trigger points and develop an imaging biosignature to distinguish affected tissue from healthy tissue. They will measure pain intensity, interference with daily activities, movement-evoked pain, and physical function at enrollment. The data collected will help evaluate the accuracy of the diagnostic imaging test. Participants' involvement includes clinical exams and imaging procedures, and the study expects to complete by August 2026.

CONDITIONS

Brief Title

QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of plantar fasciitis with pain lasting 3 months or more and pain severity of at least 3 out of 10
  • Clinical diagnosis of insertional Achilles tendinopathy with pain lasting 3 months or more and pain severity of at least 3 out of 10
  • Control participants matched by age, sex, and BMI to the plantar fasciitis and Achilles tendinopathy groups
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Younger than 18 years of age
  • History of invasive procedures to the foot and ankle on the side of interest
  • History of lower extremity injections, dry needling, or EPAT/ESWT within the past 3 months on the side of interest
  • Contraindications for MRI, including non-MR compatible implants, claustrophobia, inability to remain still for 1 hour, or body size too large for the scanner
  • Clinically unstable medical or psychiatric conditions
  • Pregnant or possibly pregnant
  • Co-morbidities affecting musculoskeletal imaging such as rheumatoid arthritis, spondyloarthropathy, gout, uncontrolled diabetes, diabetic neuropathy, neuromuscular diseases, connective tissue disorders, osteoarthritis, recent foot or ankle infection, familial hypercholesterolemia, neoplasms involving the foot, plantar fibromatosis
  • Control group only: Persistent or recurrent leg pain in the past 6 months
  • Plantar fasciitis and Achilles tendinopathy groups only: Other sources of heel or foot pain or co-occurring plantar fasciitis and Achilles tendinopathy (for Achilles tendinopathy group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

Duration - Single visit at enrollment

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

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

University of Iowa Health Care

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

J

Jing Danielson, DDS

J

Jessica Danielson, DDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Quantitative Understanding of Advanced Novel Imaging Techniques for Fasciitis and Biosignature Yield (Quantify): Protocol for a Cross-Sectional Diagnostic Study.

Zahra Amerian, Timothy Fleagle, Utsav Tuladhar...

https://pubmed.ncbi.nlm.nih.gov/41672492