QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
QUANTIFY
2 other identifiers
interventional
120
1 country
1
Brief 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/).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
October 7, 2025
October 1, 2025
1.1 years
December 12, 2024
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic Reference Test: Trigger point (TrP)
Travell and Simons' criteria will be used to identify active muscle trigger points (TrPs) as present or absent. The score will be "Yes" for present and "No" for absent.
Enrollment
Diagnostic Index Test: Imaging biosignature
The biosignature will include a combination of ultrasound and/or magnetic resonance imaging measures to capture biomechanical, biochemical, and structural profile of myofascial tissue. Current key candidate imaging biomarkers include: T1p of muscle and fascia, Elastic modulus of the muscle, Shear strain of the plantar fascia, Fat fraction of the muscle, and Thickness of the plantar fascia. The is currently no established scale for this biosignature, which will be developed as part of this study.
Enrollment
Secondary Outcomes (3)
Pain Intensity and Interference
Enrollment
Movement-evoked pain
Enrollment
Physical Function
Enrollment
Study Arms (1)
Diagnostic imaging
OTHERAll participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruth Chimentilead
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- Rochester Institute of Technologycollaborator
Study Sites (1)
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Sluka, PT, PhD
University of Iowa
- PRINCIPAL INVESTIGATOR
James Holmes, PhD
University of Iowa
- PRINCIPAL INVESTIGATOR
Ruth L Chimenti, PT, PhD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor, Physical Therapy and Rehabilitation Science
Study Record Dates
First Submitted
December 12, 2024
First Posted
January 31, 2025
Study Start
May 22, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be available within 1 year of completing the study or upon publication, whichever occurs first. The data will remain available for at least 10 years. The primary outcome data and accompanying metadata will be deposited into an NIH Helping End Addiction Long-term (HEAL) compliant data repository.
- Access Criteria
- The primary outcome data and accompanying metadata will be deposited into an NIH Helping End Addiction Long-term (HEAL) compliant data repository. In accordance with International Committee of Medical Journal Editors (ICMJE), we will prepare the primary analysis datasets for review and reproducibility by peer-reviewed journals. Publications will be made available to the public using open access publishing, so that they become immediately available to the public. All publications will be accessible through PubMed, Google Scholar, and through open access.
All data that is necessary to validate primary outcomes and publications will be preserved and shared to allow other researchers the ability to reproduce the data and obtain additional findings that can advance the results. To ensure that other users can efficiently and accurately use the dataset, as well as to prevent misinterpretation or misuse, we will provide metadata and associated documentation. Information needed to understand the meaning of variable names and information about coding for missing data will be recorded in data dictionaries and readme files that will subsequently be shared alongside final datasets. Protocols, methods, statistical analyses, and any other relevant documentation derived from notes during data collection will be incorporated into readme files that will accompany the data when shared.