Recruiting

TRAC-PainWearable Devices and AI for Chronic Musculoskeletal Pain in Youth

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Muscular Diseases+5

+ Musculoskeletal Diseases

+ Neurologic Manifestations

From 14 to 24 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2025
See protocol details

Summary

Principal SponsorStanford University
Study ContactJeremy Giberson, MASMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTargeted Realtime Assessment of Chronic Pain (TRAC-Pain) in Youth
NCT06867757
Principal SponsorStanford University
Study ContactJeremy Giberson, MASMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsChronic PainMusculoskeletal Pain

Criteria

3 inclusion criteria required to participate
The patient has musculoskeletal pain in 1 or more anatomic regions.

Pain persists for > 3 months.

Pain is associated with significant distress or life interference.

5 exclusion criteria prevent from participating
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

Reports only headache, orofacial, or visceral pain

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Recruiting

Stanford University

Palo Alto, United StatesOpen Stanford University in Google Maps
Recruiting
One Study Center