Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 17, 2025
Open Peer Review Period: Nov 20, 2025 - Dec 4, 2025
Date Accepted: Dec 16, 2025
(closed for review but you can still tweet)
QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding a biosignature, Protocol for a cross-sectional diagnostic study
ABSTRACT
Background:
Myofascial pain remains an underdiagnosed contributor to musculoskeletal pain conditions, including plantar heel pain, the most common source of foot pain. The current standard for diagnosing myofascial pain is a clinical exam using manual palpation. Yet this approach lacks quantitative thresholds for precise assessment of myofascial pain, highlighting the need for validated biomarkers.
Objective:
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 other kinds of foot pain and matched pain-free controls. The study will also explore if the diagnostic accuracy is enhanced by creating a composite biosignature that includes psychological factors.
Methods:
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 tissues. The primary imaging outcomes will capture the biochemical (T1ρ of muscle and fascia), biomechanical (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 NIH HEAL Initiative Common Data Elements and additional psychological measures.
Results:
This study is supported by Grant R61AT012275 from the National Center for Complementary and Integrative Health (NCCIH) and National Institute of Neurological Disorders and Stroke (NINDS), awarded in September 2024. As of November 2025, 55 participants have been enrolled. Recruitment is ongoing and expected to complete by April 2026.
Conclusions:
This protocol provides novel mechanistic insights into myofascial pain through advanced imaging techniques, offering a biopsychosocial framework for better diagnosis and treatment of plantar heel pain and related conditions.
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