Plantar Fasciopathy, Achilles Tendinopathy, Controls
Conditions
Keywords
plantar fasciitis, achilles tendinitis, biomarker, myofascial, magnetic resonance imaging, ultrasound imaging, pain
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, will have at least 85% power to obtain a biosignature meeting the milestone criteria.
Interventions
DIAGNOSTIC_TESTClinical 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_TESTUltrasound 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_TESTMagnetic 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
National Center for Complementary and Integrative Health (NCCIH)
Rochester Institute of Technology
Ruth Chimenti
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 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 * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Reference Test: Trigger point (TrP) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity and Interference | Enrollment | 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. |
| Movement-evoked pain | Enrollment | 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 |
| Physical Function | Enrollment | 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. |
Countries
United States
Contacts
Primary ContactJing Danielson, DDS
Backup ContactJessica Danielson, DDS
Outcome results
None listed