Targeted Real-Time Assessment of Chronic Pain (TRAC-Pain) in Youth: Protocol for a Digital Biosignature Development Through a Prospective Observational Cohort Study
Clinical Snapshot
PICO Framework
| P — Population | Youth aged 14-24 years with chronic musculoskeletal pain |
| I — Intervention | Continuous monitoring via Apple Watch with physiological, sleep, and activity metrics plus daily self-report surveys |
| C — Comparator | Gold-standard self-report pain measures |
| O — Outcomes | Development of digital biosignature for pain experience; feasibility, acceptability, and appropriateness of wearable technology monitoring |
Bottom Line
This protocol describes an innovative approach to chronic pain monitoring in youth using wearable technology to develop digital biosignatures. While the methodology appears sound with patient partnership and objective monitoring, this is a protocol paper with results pending. The study addresses a significant clinical need, as traditional self-report measures have limitations in real-time pain assessment. Key strengths include continuous physiological monitoring and gold-standard validation measures. However, concerns exist regarding recruitment methodology, confounding control, and generalisability. The planned sample size of 500 participants should provide adequate power for machine learning model development. Clinical applicability will depend on technology accessibility and validation of the digital biosignature against established pain measures. Australian clinicians should await results before considering implementation, particularly given potential cost and equity considerations for wearable technology in adolescent chronic pain management.
Key Findings
P Value: Not yet available
Effect Size: Not yet available - protocol paper with ongoing data collection
Primary Outcome: Development of digital biosignature for chronic pain experience in youth
Nnt Or Sensitivity: Model performance metrics (sensitivity/specificity) to be reported against gold-standard self-reports
Confidence Interval: Not yet available
Clinical Application
Requires access to compatible wearable technology and smartphone for data collection; 12-week compliance may be challenging Relevant to Australian paediatric pain services; Apple Watch availability and cost considerations for PBS/healthcare system implementation; alignment with RACGP chronic pain management guidelines for adolescents Youth aged 14-24 years with chronic musculoskeletal pain conditions
Abstract
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/84781.
References
- 1.Bailes, A. H., Shu, C. H., Chang, A., Masood, S., Jehl, N., Davis, A., Giberson, J., Cashman, C., Hill, A., Gill, J., McGinnis, R. S., McGinnis, E. W., Aghaeepour, N., & Simons, L. E. (2026). Targeted Real-Time Assessment of Chronic Pain (TRAC-Pain) in Youth: Protocol for a Digital Biosignature Development Through a Prospective Observational Cohort Study. JMIR Research Protocols, 15, e84781. https://doi.org/10.2196/84781
This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service