QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
NCT ID: NCT06803056
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-05-22
2026-08-31
Brief Summary
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Detailed Description
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The goal is to develop a diagnostic imaging biosignature that will be able to distinguish between A-MTrP in individuals with plantar fasciitis compared to healthy tissue control (pain-free controls). The biosignature developed in this R61 phase will be screened for clinical utility and considered of interest for further study if it meets the following milestone criteria: area under the receiver operating characteristic curve (ROC AUC) \>0.7, sensitivity \>60%, and specificity \>60%. The ROC analysis will estimate diagnostic performance by comparing differences in biosignatures between tissue where myofascial pain is present vs. tissue where pain is absent.
The proposed sample size of 50 individuals with plantar fasciitis, 25 individuals with Achilles tendinopathy, and 25 matched controls was chosen to provide a confidence interval halfwidth of 0.10 for an AUC of 0.70, assuming 5 muscle measurements for each participant and an overall A-MTrPs prevalence of 0.36 in individuals with plantar fasciitis. Further assuming the 20 biomarkers to be considered in the R61 phase have AUCs uniformly distributed from 0.5 to 0.8, will have at least 85% power to obtain a biosignature meeting the milestone criteria.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic imaging
All participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.
Clinical exam
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.
Ultrasound imaging
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.
Magnetic Resonance Imaging
T1rho and IDEAL sequences will be used to capture the biochemical and structural profile of foot and ankle muscles on the involved side
Interventions
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Clinical exam
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.
Ultrasound imaging
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.
Magnetic Resonance Imaging
T1rho and IDEAL sequences will be used to capture the biochemical and structural profile of foot and ankle muscles on the involved side
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Rochester Institute of Technology
OTHER
Ruth Chimenti
OTHER
Responsible Party
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Ruth Chimenti
Assistant Professor, Physical Therapy and Rehabilitation Science
Principal Investigators
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Kathleen Sluka, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
James Holmes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Ruth L Chimenti, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Health Care
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202409110
Identifier Type: -
Identifier Source: org_study_id
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