Targeted Realtime Assessment of Chronic Pain in Youth

NCT06867757 | Recruiting

• 2 other identifiers: 77005UG3NS139943
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Pain, Enjoyment of Life, and General Activity (PEG) Scale

  The PEG scale, a subset of the Brief Pain Inventory (BPI), evaluates pain intensity and its impact on enjoyment of life and general activity using a ranked scale (score 0 = "no interference" to 10 = "highest level of interference") with a higher score reflecting greater disruption in daily functioning.

  Daily from baseline to discharge, for a duration of 12 weeks

Secondary Outcomes (5)

• Numeric Rating Scale (NRS) of Present Pain

  Daily from baseline to discharge, for a duration of 12 weeks

• Numeric Rating Scale (NRS) Fatigue

  Daily from baseline to discharge, for a duration of 12 weeks

• Numeric Rating Scale (NRS) Stress Level

  Daily from baseline to discharge, for a duration of 12 weeks

• Numeric Rating Scale (NRS) Activity Level

  Daily from baseline to discharge, for a duration of 12 weeks

• Numeric Rating Scale (NRS) Sleep Quality

  Daily from baseline to discharge, for a duration of 12 weeks

Other Outcomes (24)

• Adolescent Sleep Wake Scale - Short Form (ASWS-SF)

  Baseline and Discharge (at 12 weeks)

• Adverse Events

  As needed, from baseline to discharge, for a duration of 12 weeks

• Brief Pain Inventory Short Form (BPI-SF)

  Baseline and Discharge (at 12 weeks)

Study Arms (1)

TRAC-Pain Cohort

For 12 weeks, participants will wear a smartwatch for continuous physiological, sleep, and physical activity monitoring, and complete daily self-reported surveys on pain, mood, and stress. At the end of the study, participants will complete a stress task (Trier Social Stress Task) and a functional task (Sit-to-Stand Test) along with a feedback interview.

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

14 - 24 year old adolescents with chronic musculoskeletal pain

You may qualify if:

• 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.

You may not qualify if:

• 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
• Currently pregnant or think you might become pregnant in the next 3 months

Sponsors & Collaborators

• Stanford University: lead
• Wake Forest University Health Sciences: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Jeremy Giberson, MAS

CONTACT

650-723-5814; jgiberso@stanford.edu

Sahrish Masood, BHSc

CONTACT

sahrishm@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative, and Pain Medicine (Pediatric)

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)