Clinical Trial Finder

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.

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.#46; 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.

Arms

Other: Diagnostic imaging

All participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.

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