QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
Ruth Chimenti
120 participants
May 22, 2025
INTERVENTIONAL
Summary
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/).
Eligibility
Inclusion Criteria8
- Clinical diagnosis of plantar fasciitis
- Duration of plantar fasciitis pain greater than or equal to 3 months
- Severity of plantar fasciitis pain greater than or equal to 3/10
- Clinical diagnosis of insertional Achilles tendinopathy:
- Duration of Achilles tendinopathy pain greater than or equal to 3 months
- Severity of Achilles tendon pain greater than or equal to 3/10
- Control group:
- Similar age, sex, and BMI as plantar fasciitis and Achilles tendinopathy groups
Exclusion Criteria9
- Younger than 18 years of age
- History of an invasive procedures to the foot and ankle on the side of interest
- History of lower extremity injections, dry needling, or EPAT/ESWT within past 3 months on the side of interest
- 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)
- Clinically unstable medical or psychiatric issues
- Pregnant or possibly pregnant
- Co-morbidities associated with changes in musculoskeletal imaging, including: Diagnosed systemic conditions affecting the foot and ankle (e.g., rheumatoid arthritis, spondyloarthropathy, gout) endocrine disorder with complications (e.g., uncontrolled Type I or II diabetes, diabetic peripheral neuropathy) Neuromuscular diseases (e.g., Charcot-Marie-Tooth (CMT) disease) Connective tissue disorder (e.g. Marfan's syndrome, Ehlers-Danlos) Osteoarthritis of the foot or ankle History of foot or ankle fracture Infection of the foot or ankle (e.g., infectious fasciitis, calcaneal osteomyelitis) within the past year 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 source of heel or foot pain (e.g., tarsal tunnel syndrome, peripheral neuropathy, lumbar radiculopathy, calcaneal stress fracture, Morton's neuroma, fibromyalgia) or co-occurring plantar fasciitis and Achilles tendinopathy (for the Achilles tendinopathy group).
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Interventions
An experienced physical therapist with expertise in dry needling will confirm study eligibility and complete a standard clinical exam for myofascial pain. Gold standard for diagnosing myofascial pain as defined by Travell and Simons will be used. The criteria for muscle trigger point (TrP) include: 1) a taut band of skeletal muscle that is tender to palpation, 2) sustained compression of the taut band reproduces or exacerbates the participant's symptoms. Healthy tissue is defined as no palpable taut band.
Shear wave elastography and b-mode ultrasound imaging techniques will capture the biomechanical and structural profile of foot and ankle muscle on the involved side.
T1rho and IDEAL sequences will be used to capture the biochemical and structural profile of foot and ankle muscles on the involved side
Locations(1)
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NCT06803056