Plantar FasciopathyQUANTIFYNCT06803056
QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
A study testing Clinical exam, Ultrasound imaging and Magnetic Resonance Imaging in people with Plantar Fasciopathy and Achilles Tendinopathy, run by Ruth Chimenti at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciopathy, Achilles Tendinopathy, Controls
- What is being tested?
- Clinical exam, Ultrasound imaging and Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- Younger than 18 years of age
- History of an invasive procedures to the foot and ankle on the side of interest
- History of lower extremity injections, dry needling, or EPAT/ESWT within past 3 months on the side of interest
- 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
- Pregnant or possibly pregnant
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- Co-morbidities associated with changes in musculoskeletal imaging, including: Diagnosed systemic conditions affecting the foot and ankle (e.g., rheumatoid arthritis, spondyloarthropathy, gout) endocrine disorder with complications (e.g., uncontrolled Type I or II diabetes, diabetic peripheral neuropathy) Neuromuscular diseases (e.g., Charcot-Marie-Tooth (CMT) disease) Connective tissue disorder (e.g. Marfan's syndrome, Ehlers-Danlos) Osteoarthritis of the foot or ankle History of foot or ankle fracture Infection of the foot or ankle (e.g., infectious fasciitis, calcaneal osteomyelitis) within the past year Familial hypercholesterolemia Neoplasms involving the foot, Plantar fibromatosis
- 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 (for the Achilles tendinopathy group).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Health Care
Iowa City, Iowa, 52242
About this study
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/).
Read the 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, will have at least 85% power to obtain a biosignature meeting the milestone criteria.
- Conditions
- Plantar Fasciopathy, Achilles Tendinopathy, Controls
- Being tested
- Clinical exam, Ultrasound imaging, Magnetic Resonance Imaging
- Keywords
- plantar fasciitis, achilles tendinitis, biomarker, myofascial, magnetic resonance imaging, ultrasound imaging, pain
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examDiagnostic 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 imagingDiagnostic 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 ImagingDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Diagnostic imaging | Other | All participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle. Receives: Diagnostic Test: Clinical exam; Diagnostic Test: Ultrasound imaging; Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Reference Test: Trigger point (TrP)
Travell and Simons' criteria will be used to identify active muscle trigger points (TrPs) as present or absent. The score will be "Yes" for present and "No" for absent.
Measured: Enrollment
Diagnostic Index Test: Imaging biosignature
The biosignature will include a combination of ultrasound and/or magnetic resonance imaging measures to capture biomechanical, biochemical, and structural profile of myofascial tissue. Current key candidate imaging biomarkers include: T1p of muscle and fascia, Elastic modulus of the muscle, Shear strain of the plantar fascia, Fat fraction of the muscle, and Thickness of the plantar fascia. The is currently no established scale for this biosignature, which will be developed as part of this study.
Measured: Enrollment
Secondary outcomes (3)
Pain Intensity and Interference
The PEG (Pain, Enjoyment, General activity) is a three-item scale to assess pain intensity and interference. Each question is rated from 0 (least) to 10 (worst) and the scores are averaged to calculate a total PEG score.
Measured: Enrollment
Movement-evoked pain
Participants will rate their pain using a verbal numeric rating scale (0-10) during walking where "0" represents "no pain" and "10" represents "worst pain imaginable"
Measured: Enrollment
Physical Function
Participants will report their level of physical function using the PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function, Short form 6b. For PROMIS measures the general population mean is 50 with a standard deviation of 10. Impaired physical function would be indicated by a score less than 40.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start22 May 2025
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruth Chimenti
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Rochester Institute of Technology
- Responsible party
- Sponsor-investigator, Ruth Chimenti, University of Iowa
- Investigators
- Kathleen Sluka, PT, PhD, Principal investigator, University of IowaJames Holmes, PhD, Principal investigator, University of IowaRuth L Chimenti, PT, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803056
- Sponsor's protocol ID
- 202409110
- Other IDs
- R61AT012275
- Acronym
- QUANTIFY
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data that is necessary to validate primary outcomes and publications will be preserved and shared to allow other researchers the ability to reproduce the data and obtain additional findings that can advance the results. To ensure that other users can efficiently and accurately use the dataset, as well as to prevent misinterpretation or misuse, we will provide metadata and associated documentation. Information needed to understand the meaning of variable names and information about coding for missing data will be recorded in data dictionaries and readme files that will subsequently be shared alongside final datasets. Protocols, methods, statistical analyses, and any other relevant documentation derived from notes during data collection will be incorporated into readme files that will accompany the data when shared.
Publications
Amerian Z, Fleagle T, Tuladhar U, Watson R, Wong M, Van Gorp B, Smith BJ, Richards M, Hall M, Donnelly J, Danielson J, Leao RV, Stanley D, Magnotta V, Holmes JH, Sluka K, Chimenti RL. Quantitative Understanding of Advanced Novel Imaging Techniques for Fasciitis and Biosignature Yield (Quantify): Protocol for a Cross-Sectional Diagnostic Study. JMIR Res Protoc. 2026 Feb 11;15:e87613. doi: 10.2196/87613.
PubMed 41672492
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
- ClinicalTrials.gov ID
- NCT06803056
- Acronym / sponsor ID
- QUANTIFY / 202409110
- Conditions
- Plantar Fasciopathy, Achilles Tendinopathy, Controls
- Keywords
- plantar fasciitis, achilles tendinitis, biomarker, myofascial, magnetic resonance imaging, ultrasound imaging, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ruth ChimentiUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Rochester Institute of Technology
- Study start
- 22 May 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, will have at least 85% power to obtain a biosignature meeting the milestone criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic imaging | Other | Diagnostic Test: Clinical exam, Diagnostic Test: Ultrasound imaging, Diagnostic Test: Magnetic Resonance ImagingAll participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Clinical diagnosis of insertional Achilles tendinopathy:
- Duration of Achilles tendinopathy pain greater than or equal to 3 months
Key exclusion criteria (9 listed)
- Younger than 18 years of age
- History of an invasive procedures to the foot and ankle on the side of interest
- History of lower extremity injections, dry needling, or EPAT/ESWT within past 3 months on the side of interest
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examAn 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 | Diagnostic imaging |
| Ultrasound imagingShear 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 | Diagnostic imaging |
| Magnetic Resonance ImagingT1rho and IDEAL sequences will be used to capture the biochemical and structural profile of foot and ankle muscles on the involved side | Diagnostic test | Diagnostic imaging |
Primary outcome
Diagnostic Reference Test: Trigger point (TrP)
Time frame: Enrollment
Travell and Simons' criteria will be used to identify active muscle trigger points (TrPs) as present or absent. The score will be "Yes" for present and "No" for absent.
Diagnostic Index Test: Imaging biosignature
Time frame: Enrollment
The biosignature will include a combination of ultrasound and/or magnetic resonance imaging measures to capture biomechanical, biochemical, and structural profile of myofascial tissue. Current key candidate imaging biomarkers include: T1p of muscle and fascia, Elastic modulus of the muscle, Shear strain of the plantar fascia, Fat fraction of the muscle, and Thickness of the plantar fascia. The is currently no established scale for this biosignature, which will be developed as part of this study.
3 secondary outcomes
Pain Intensity and Interference
Time frame: Enrollment
Movement-evoked pain
Time frame: Enrollment
Physical Function
Time frame: Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 41672492Amerian Z, Fleagle T, Tuladhar U, Watson R, Wong M, Van Gorp B, Smith BJ, Richards M, Hall M, Donnelly J, Danielson J, Leao RV, Stanley D, Magnotta V, Holmes JH, Sluka K, Chimenti RL. Quantitative Understanding of Advanced Novel Imaging Techniques for Fasciitis and Biosignature Yield (Quantify): Protocol for a Cross-Sectional Diagnostic Study. JMIR Res Protoc. 2026 Feb 11;15:e87613. doi: 10.2196/87613.
- Individual participant dataSharing planned: Yes. All data that is necessary to validate primary outcomes and publications will be preserved and shared to allow other researchers the ability to reproduce the data and obtain additional findings that can advance the results. To ensure that other users can efficiently and accurately use the dataset, as well as to prevent misinterpretation or misuse, we will provide metadata and associated documentation. Information needed to understand the meaning of variable names and information about coding for missing data will be recorded in data dictionaries and readme files that will subsequently be shared alongside final datasets. Protocols, methods, statistical analyses, and any other relevant documentation derived from notes during data collection will be incorporated into readme files that will accompany the data when shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Sluka, PT, PhD principal investigator
University of Iowa
James Holmes, PhD principal investigator
University of Iowa
Ruth L Chimenti, PT, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical exam, Ultrasound imaging and Magnetic Resonance Imaging in people with Plantar Fasciopathy and Achilles Tendinopathy, run by Ruth Chimenti at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Reference Test: Trigger point (TrP) (time frame: Enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06803056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.