Clinical trial NCT06867757: Targeted Realtime Assessment of Chronic Pain in Youth
Official title: Targeted Realtime Assessment of Chronic Pain (TRAC-Pain) in Youth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Musculoskeletal Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2025-03-10
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 14 - 24 year old adolescents with chronic widespread or chronic primary musculoskeletal pain

Brief summary: The purpose of this study is to evaluate the feasibility and acceptability of using wearable digital health technology for continuous monitoring of physiological, sleep, and physical activity data in adolescents with chronic musculoskeletal (MSK) pain. This research aims to develop objective digital endpoints of the pain experience to improve diagnosis, prevention, and treatment outcomes.

Detailed description: Up to 5% of adolescents (\~3.5 million in the US alone) suffer from high-impact chronic musculoskeletal (MSK) pain, affecting quality of life, school attendance, mood, and family function, and posing a significant economic burden of $19.5 billion annually in the US. A substantial proportion of these youths continue to suffer from pain into adulthood. Chronic MSK pain is characterized by a complex biological response, including physiological disturbances in cognition, sleep, and energy levels (fatigue), and is associated with impairments in both physical and emotional function. The chronic pain experience fluctuates over time with intra- and inter-daily variations and the occurrence of pain flares, contributing to unpredictability, uncertainty, and greater impairment.

Current gold standard self-report assessments are burdensome and fail to provide comprehensive, reliable measures of the pain experience due to inherent recall bias. A potential solution lies in the widespread adoption of digital health technologies, particularly wearable devices, which offer continuous monitoring of physiological, sleep, and physical activity data. This approach can yield unprecedented insights into individual health, informing diagnosis, prevention, monitoring, and treatment.

Through artificial intelligence (AI) and machine learning (ML), several groundbreaking digital biosignatures of human health have been developed by the research team, including those for glucose variability, preterm birth, panic attacks, fall risk, and surgical recovery. This real-time, personalized approach not only empowers patients but also enables healthcare providers to make more informed decisions, optimizing treatment strategies and improving outcomes. Despite these advancements, less than half of adolescents with chronic MSK pain who undergo pain treatment experience meaningful improvement.

The scientific rationale of this proposal is to overcome the limitations of self-report by integrating precise physiological, sleep, and physical activity measures from wearable devices with AI/ML to develop and validate a monitoring digital biosignature of the individual pain experience in youth with MSK pain. This biosignature will monitor the pain experience, track its progression, assess responses to interventions, and evaluate impacts on quality of life.

The research team is well positioned to execute these aims with: (1) a diverse, highly skilled team with expertise in digital technology, AI/ML, digital endpoint development, and clinical trials, alongside clinical expertise in chronic pain in youth and lived experience from patients, caregivers, and pain advocacy groups; (2) a centralized and standardized digital data collection, processing, and storage system via the scalable and secure My Personal Health Dashboard (MyPHD; Stanford); and (3) cutting-edge preliminary data supporting the capability to develop this digital health biosignature.

UG3/Discovery Phase: We will enroll up to 500 youth (ages 14-24) with chronic MSK pain, capturing continuous physiological (heart, respiratory), sleep, and physical (activity level, mobility, gait) activity metrics via wearables. Repeated intra-daily self-reports of the pain experience (pain interference, pain intensity, fatigue, mood, stress, pain flares) will be collected over 12 weeks. For a subset, data from physical and social stress tasks will also be gathered. The aim is to assess feasibility and relevance, develop a digital biosignature of the pain experience, and prepare for the UH3 phase through outreach and collaboration. Consultations with individuals with lived experience, those experiencing health disparities, and the FDA will ensure the relevance and acceptability of the biosignature and promote recruitment of underrepresented youth, coupled with scalability for clinical use.

UH3/Validation Phase: We will enroll up to 400 diverse youth with chronic MSK pain, capturing wearable and self-reported pain experience metrics over 12 weeks: a 4-week baseline followed by 8 weeks of abnormal reading-triggered alerts. The aim of this phase is to clinically validate the digital biosignature of the pain experience, and evaluate the accuracy and potential of an enhanced wellness alert system.

Significance and Clinical Impact: The successful development and validation of digital endpoints for the pain experience are crucial for advancing pain management. These endpoints promise to improve therapeutic development by providing robust, objective measures of treatment response. The outcomes of this study will be foundational for seeking regulatory approval for the commercialization of the associated software or for disseminating open-source analysis packages for future clinical trials.

Eligibility criteria: Inclusion Criteria:

* The patient has a diagnosis of Chronic widespread pain or Chronic primary musculoskeletal pain (other than orofacial) derived from ICD-11 (MG30.0; chronic primary pain is pain in 1 or more anatomic regions that persists for \> 3 months, is associated with significant distress or functional disability and cannot be better explained by another chronic pain condition (e.g., cancer)).
* Diagnosis of a secondary MSK pain condition (e.g., arthritis, lupus, sickle cell)

Exclusion Criteria:

* Significant cognitive impairment (e.g., unable to communicate)
* Hospitalization in the past 30 days for something other than their pain condition
* Currently undergoing treatment for cancer
* Currently pregnant or think you might become pregnant in the next 3 months

Primary outcomes:
measure: Pain, Enjoyment of Life, and General Activity (PEG) Scale
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
Secondary outcomes:
measure: Numeric Rating Scale (NRS) of Present Pain
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: Numeric Rating Scale (NRS) Fatigue
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: Numeric Rating Scale (NRS) Stress Level
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: Numeric Rating Scale (NRS) Activity Level
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: Numeric Rating Scale (NRS) Sleep Quality
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
Other outcomes:
measure: Adolescent Sleep Wake Scale - Short Form (ASWS-SF)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Adverse Events
timeFrame: As needed, from baseline to discharge, for a duration of 12 weeks
measure: Brief Pain Inventory Short Form (BPI-SF)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Child Activity Limitations Interview-9 (CALI-9)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: Healthcare Use Diary
timeFrame: As needed, from baseline to discharge, for a duration of 12 weeks
measure: McGill Pain Questionnaire 2 (SF-MPQ-2)
timeFrame: Baseline
measure: National Institute on Drug Abuse-2 (NIDA-2)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Net Promoter Score (NPS)
timeFrame: Discharge (at 12 weeks)
measure: Pain Catastrophizing Scale - Children (PCS-C)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Pain Flare
timeFrame: As needed, from baseline to discharge, for a duration of 12 weeks
measure: Pain Wellness Behaviors
timeFrame: As needed, from baseline to discharge, for a duration of 12 weeks
measure: Pain Wellness and Daily Events
timeFrame: As needed, from baseline to discharge, for a duration of 12 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: Patient-Reported Outcomes Measurement Information System Fatigue (PROMIS Fatigue)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Patient-Reported Outcomes Measurement Information System Physical Function Short Form 8c (PROMIS Physical Function)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Patient-Reported Outcomes Measurement Information System Stress Experiences Short Form 4a (PROMIS Stress)
timeFrame: Baseline and Discharge (at 12 weeks)
measure: Positive and Negative Affect Schedule - 10 Item (PANAS-10)
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: Social Determinants of Health (SDOH)
timeFrame: Baseline
measure: Theoretical framework of acceptability (TFA)
timeFrame: Discharge (at 12 weeks)
measure: Usage metrics
timeFrame: Daily from baseline to discharge, for a duration of 12 weeks
measure: World Health Organization Quality of Life 2 Item (WHOQOL-2)
timeFrame: Baseline and Discharge (at 12 weeks)
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: