TRAC-PainWearable Devices and AI for Chronic Musculoskeletal Pain in Youth
Data Collection
Collected from today forward - ProspectiveMuscular Diseases+5
+ Musculoskeletal Diseases
+ Neurologic Manifestations
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 28, 2025
Actual date on which the first participant was enrolled.Up to 5% of adolescents, around 3.5 million in the US, experience high-impact chronic musculoskeletal (MSK) pain. This condition affects their quality of life, school attendance, mood, and family function, and poses a significant economic burden. Current self-report assessments for this pain are burdensome and unreliable due to recall bias. This study aims to overcome these limitations by using wearable devices and artificial intelligence (AI) to develop a digital biosignature of the individual pain experience. This biosignature will help monitor the pain experience, track its progression, assess responses to interventions, and evaluate impacts on quality of life. This approach promises to improve therapeutic development by providing robust, objective measures of treatment response. The study will enroll up to 500 youth aged 14-24 with chronic MSK pain. Participants will wear devices that continuously measure physiological (heart, respiratory), sleep, and physical (activity level, mobility, gait) activity. They will also provide repeated intra-daily self-reports of their pain experience over 12 weeks. The primary outcome of the study is the Pain, Enjoyment of Life, and General Activity (PEG) Scale, a subset of the Brief Pain Inventory (BPI). This scale evaluates pain intensity and its impact on enjoyment of life and general activity using a ranked scale, with a higher score reflecting greater disruption in daily functioning.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 24 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location