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_TEST
    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 — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    T1rho 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 imaging
    All 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Jessica Danielson, DDS
319-335-9791
Jessica Danielson, DDS
319-356-1722
Ruth L Chimenti, PT, PhD (PRINCIPAL_INVESTIGATOR)
Kathleen A Sluka, PT, PhD (PRINCIPAL_INVESTIGATOR)
James Holmes, PhD (PRINCIPAL_INVESTIGATOR)

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