# Development of diagnostic and prognostic ultrasound imaging biomarkers for plantar heel pain

> **NIH NIH R61** · UNIVERSITY OF IOWA · 2024 · $1,467,542

## Abstract

Project Summary/Abstract
Myofascial pain remains an underdiagnosed contributor to a range of musculoskeletal pain conditions. The 
lack of validated biomarkers limits the ability to objectively detect myofascial pain, probe underlying pain 
mechanisms, and guide targeted treatments. This proposal will address this gap by quantifying the 
biochemical, biomechanical, and structural properties of myofascial pain using advanced, quantitative imaging 
techniques. As a model of myofascial pain, we have chosen plantar fasciitis, which affects 1 out of every 10 
adults. Our long-term goal is to enhance musculoskeletal pain management by creating better tools for 
detecting abnormal myofascial tissue that enable more individualized treatment. 
The objective of the R61 phase is to use novel imaging techniques to develop a diagnostic biosignature to 
objectively and accurately determine the location and severity of abnormal myofascial tissue. Our approach will 
use a cross-sectional study design with 3 groups: plantar fasciitis (n=50), Achilles tendinopathy (n=25), and 
pain-free controls (n=25) to test Specific Aim 1: Develop a diagnostic imaging biosignature of myofascial 
tissue to differentiate individuals with plantar fasciitis from other foot pain without a myofascial 
component (Achilles tendinopathy) and from matched pain-free controls.
The objective of the R33 phase is to use novel imaging techniques to develop a predictive biosignature to 
identify individuals most likely to respond to DN, and a response biosignature to guide dosing or continued use 
of DN for myofascial pain for individuals with plantar foot pain. Our approach will use a parallel-group, doubleblinded randomized controlled trial (RCT) design with imaging measured before, during (1 m.), and after 
treatment (3 & 6 m.). Participants will be randomized to one of two groups: 1) DN + standard care, or 2) Sham 
DN + standard care to test Specific Aim 2: Determine 2A) predictive (Independent variable: imaging 
biosignature; Primary outcome: Pain Intensity) and 2B) response (Independent variable: DN vs. Sham DN; 
Primary outcome: Imaging biosignature/biomarkers) imaging biosignatures in an RCT. 
Exploratory Aim 3: Will develop composite biosignatures, that combine multiple imaging biomarkers 
developed in Aims 1 or 2 with psychosocial factors, to enhance the diagnostic, predictive, or response 
capability for myofascial pain. 
Transition criteria. 1) Adequate recruitment with >90% of participants in each group enrolled; 2) Adequate 
representation with neither sex exceeding 60% of the sample; 3) Minimal missing data (<5%) for collected 
outcomes; 4) At least 2 diagnostic imaging biomarkers with an ROC AUC > 0.7 and FDRs < 0.1; 5-8) Submit 
DSMP, Study Accrual and Retention Plan, Final sample size and statistical analysis informed by mock 
recruitment, and R33 transition application, including implementation of an effective sham DN.

## Key facts

- **NIH application ID:** 10953166
- **Project number:** 1R61AT012275-01A1
- **Recipient organization:** UNIVERSITY OF IOWA
- **Principal Investigator:** Ruth Louise Porter Chimenti
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,467,542
- **Award type:** 1
- **Project period:** 2024-09-17 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10953166

## Citation

> US National Institutes of Health, RePORTER application 10953166, Development of diagnostic and prognostic ultrasound imaging biomarkers for plantar heel pain (1R61AT012275-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10953166. Licensed CC0.

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