Clinical trial NCT06803056: QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
Official title: QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fasciopathy
Achilles Tendinopathy
Controls
Keywords: plantar fasciitis
achilles tendinitis
biomarker
myofascial
magnetic resonance imaging
ultrasound imaging
pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Rochester Institute of Technology
First posted: 2025-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will complete a clinical exam of the foot and ankle to identify painful myofascial tissue. All participants will subsequently have magnetic resonance imaging and ultrasound imaging of their foot and ankle.
Primary purpose: DIAGNOSTIC

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/).

Detailed description: 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. A cross-sectional study design approach with 3 groups: plantar fasciitis (n=50), Achilles tendinopathy (n=25), and pain-free controls (n=25) to test Specific Aim: 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 goal is to develop a diagnostic imaging biosignature that will be able to distinguish between A-MTrP in individuals with plantar fasciitis compared to healthy tissue control (pain-free controls). The biosignature developed in this R61 phase will be screened for clinical utility and considered of interest for further study if it meets the following milestone criteria: area under the receiver operating characteristic curve (ROC AUC) \>0.7, sensitivity \>60%, and specificity \>60%. The ROC analysis will estimate diagnostic performance by comparing differences in biosignatures between tissue where myofascial pain is present vs. tissue where pain is absent.

The proposed sample size of 50 individuals with plantar fasciitis, 25 individuals with Achilles tendinopathy, and 25 matched controls was chosen to provide a confidence interval halfwidth of 0.10 for an AUC of 0.70, assuming 5 muscle measurements for each participant and an overall A-MTrPs prevalence of 0.36 in individuals with plantar fasciitis. Further assuming the 20 biomarkers to be considered in the R61 phase have AUCs uniformly distributed from 0.5 to 0.8, we will have at least 85% power to obtain a biosignature meeting the milestone criteria.

Eligibility criteria: Inclusion criteria for plantar fasciitis group:

* 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

Inclusion criteria for Achilles tendinopathy group:

* 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

Exclusion criteria:

* Younger than 18 years of age
* History of an invasive procedures to the foot and ankle or history of lower extremity injections within past 3 months
* 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
* Co-morbidities associated with changes in musculoskeletal imaging, including rheumatological conditions (e.g., rheumatoid arthritis, spondyloarthropathy), osteoarthritis of the foot or ankle, diabetes, neuromuscular diseases (e.g., Charcot-Marie-Tooth), familial hypercholesterolemia, history of foot or ankle fracture, neoplasms involving the foot, plantar fibromatosis, recent (within the past 1 year) infection of the foot or ankle (e.g., infectious fasciitis, calcaneal osteomyelitis).
* 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.

Primary outcomes:
measure: Diagnostic Reference Test: Trigger point (TrP)
timeFrame: Enrollment
measure: Diagnostic Index Test: Imaging biosignature
timeFrame: Enrollment
Secondary outcomes:
measure: Pain Intensity and Interference
timeFrame: Enrollment
measure: Movement-evoked pain
timeFrame: Enrollment
measure: Physical Function
timeFrame: Enrollment
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
Study officials:
affiliation: University of Iowa
name: Kathleen Sluka, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: James Holmes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Ruth L Chimenti, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: