QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers

NCT06803056 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-07

No results posted yet for this study

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/).

Conditions

  • Plantar Fasciopathy
  • Achilles Tendinopathy
  • Controls

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • Rochester Institute of Technology

    collaborator OTHER
  • Ruth Chimenti

    lead OTHER

Principal Investigators

  • Kathleen Sluka, PT, PhD · University of Iowa

  • James Holmes, PhD · University of Iowa

  • Ruth L Chimenti, PT, PhD · University of Iowa

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06803056 on ClinicalTrials.gov