Targeted Real-Time Assessment of Chronic Pain (TRAC-Pain) in Youth: Protocol for a Digital Biosignature Development...

Approximately 1 in 5 children and adolescents live with chronic pain, with musculoskeletal (MSK) pain being one of the most prevalent subtypes. Unfortunately, some studies show that less than half of youth (<18 years) experience improvements with existing evidence-based treatments. Self-report measures-the current gold standard for monitoring the pain experience-are limited in their use as a single point-of-care assessment and their vulnerability to recall bias. The ubiquitous adoption of wearable technology presents a promising solution for improved monitoring of the pain experience via real-time tracking through a multisystemic lens.

The purpose of this study is (1) to develop a digital biosignature of the pain experience in youth with chronic MSK pain and (2) to assess the feasibility, acceptability, and appropriateness of the captured data for future applications.

All aspects of this study were designed in partnership with people with lived experience and patient advocacy partners. This is a longitudinal observational cohort study, with all study activities taking place remotely over a 12-week period. Up to 500 youth (between 14 and 24 years old) with chronic MSK pain will be enrolled through a multipronged recruitment strategy to ensure a representative sample. The participants will wear an Apple Watch throughout the study to continuously monitor physiological, sleep, and physical activity metrics. In addition, participants will complete brief "daily check-in" surveys that include gold-standard measures of the pain experience (eg, pain interference, mood, fatigue) and the option to report a "pain flare" (ie, a temporary but noticeable worsening of the usual pain symptoms). Participants will also complete a modified online Trier Social Stress Test and a 30-second sit-to-stand task to capture individual responses to standardized challenges. Traditional machine learning and deep representation learning methods will be used to develop a digital biosignature of the pain experience. The accuracy of the biosignature will be assessed through measures of model performance as compared to gold-standard self-reports.

This study was funded in September 2024, with data collection beginning in March 2025. As of December 15, 2025, 190 participants are enrolled, with data collection and analysis ongoing.

This is the first study to leverage wearable health technology for real-time monitoring of the pain experience in youth with chronic MSK pain. The resulting digital end points are expected to heighten the rigor of clinical trials and provide opportunities for individually tailored interventions. The second phase of this study will investigate the implementation of "wellness alerts" triggered by abnormal smartwatch readings. Alerts would empower users toward preemptive self-management strategies, thereby enhancing self-efficacy in those living with chronic MSK pain.

DERR1-10.2196/84781.