Quantitative Understanding of Advanced Novel Imaging Techniques for Fasciitis and Biosignature Yield (Quantify):...

Myofascial pain remains an underdiagnosed contributor to musculoskeletal pain conditions, including plantar heel pain, which is the most common source of foot pain. The current standard for diagnosing myofascial pain is a clinical examination using manual palpation. However, this approach lacks quantitative thresholds for precise assessment of myofascial pain, highlighting the need for validated biomarkers.

This protocol describes the development of a diagnostic imaging biosignature of myofascial pain using both ultrasound and magnetic resonance imaging to differentiate individuals with plantar heel pain from those with other kinds of foot pain and matched pain-free controls. The study will also explore whether diagnostic accuracy is enhanced by creating a composite biosignature that includes psychological factors.

In this cross-sectional study, 100 participants will be recruited: 50 with plantar heel pain, 25 with insertional Achilles tendinopathy, and 25 pain-free controls. Participants will undergo a clinical examination of 5 calf and foot muscles to identify sites of abnormal myofascial tissue. The primary imaging outcomes will capture biochemical properties (T1ρ of muscle and fascia), biomechanical properties (shear wave speed of the muscle, shear strain of the plantar fascia during passive movement), and structural profile (fat fraction of the muscle, thickness of the plantar fascia). Patient-reported outcomes will include the National Institutes of Health's Helping to End Addiction Long-term (HEAL) Initiative Common Data Elements and additional psychological measures.

This study is supported by grant R61AT012275 from the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke, awarded in September 2024. Participant enrollment began in May 2025. As of November 2025, a total of 55 participants have been enrolled. Enrollment is expected to conclude no later than July 2026. The anticipated study completion date is August 2026. Data will be shared within 1 year of completing the study or upon publication, whichever occurs first.

This protocol provides novel mechanistic insight into myofascial pain through advanced imaging techniques, offering a biopsychosocial framework for improving the diagnosis and treatment of plantar heel pain and related conditions. We anticipate that combining imaging and psychosocial measures will improve the diagnostic accuracy of the biosignature and provide a more comprehensive understanding of myofascial pain.

ClinicalTrials.gov NCT06803056; https://clinicaltrials.gov/study/NCT06803056; OSF Registries osf.io/nxqfj; https://osf.io/nxqfj.

DERR1-10.2196/87613.