QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- Ruth Chimenti
- Study ID
- NCT06803056
- Status
- Recruiting
Conditions
- Achilles Tendinopathy
- Controls
- Plantar Fasciopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Clinical exam — DIAGNOSTIC_TESTAn 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 — DIAGNOSTIC_TESTShear 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 — DIAGNOSTIC_TESTT1rho and IDEAL sequences will be used to capture the biochemical and structural profile of foot and ankle muscles on the involved side
Study Details
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/).
Key Dates
- Start date
- May 22, 2025
- Status verified
- Oct 2025
- Primary completion
- Jul 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Other: Diagnostic imagingAll participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.
Primary Outcome Measure
Diagnostic Reference Test: Trigger point (TrP) [ Time Frame: Enrollment ]
Central Contacts
- Jing Danielson, DDS319-356-1722
- Jessica Danielson, DDS319-356-9791
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa Health Care | Iowa City | Iowa | 52242 | Ruth L Chimenti, PT, PhD (PRINCIPAL_INVESTIGATOR) Kathleen A Sluka, PT, PhD (PRINCIPAL_INVESTIGATOR) James Holmes, PhD (PRINCIPAL_INVESTIGATOR) |
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