NCT04285112

Brief Summary

To identify biological and phenotypic prognostic markers of recovery vs. persistence of pain and functional disability in adolescents with chronic musculoskeletal pain.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

4.7 years

First QC Date

February 23, 2020

Last Update Submit

September 4, 2025

Conditions

Pain, ChronicPainJoint PainMusculoskeletal Pain

Keywords

Pediatric painpain

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity and Unpleasantness

    Pain Intensity and Unpleasantness on visual analogue scale(VAS). VAS scores range from 0 to 100 with higher scores indicating worse pain.

    3 months after baseline assessment

  • Functional Disability

    Functional Disability Inventory (FDI) total score. FDI scores range from 0 to 60 with higher scores indicating higher levels of functional disability.

    3 months after baseline assessment

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents with chronic primary musculoskeletal pain

You may qualify if:

  • The child 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., arthritis, lupus)
  • Age between 11-18 years
  • Moderate to Severe Functional Disability (FDI ≥13)
  • English proficiency (reading, speaking)
  • Moderate to severe average pain (VAS ≥30/100)

You may not qualify if:

  • Significant cognitive impairment (e.g., severe brain injury)
  • Claustrophobia
  • Significant medical disease (e.g., systemic or central nervous system)
  • Severe psychiatric or neurological conditions (e.g., eating disorder, psychosis)
  • Pregnancy
  • MRI incompatibility (braces, pacemaker)
  • Weight \> 285 lbs.
  • History of \> 1 month opioid treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Palo Alto, California, 94304, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

University of Barcelona

Barcelona, Spain

Location

Related Publications (1)

  • Simons L, Moayedi M, Coghill RC, Stinson J, Angst MS, Aghaeepour N, Gaudilliere B, King CD, Lopez-Sola M, Hoeppli ME, Biggs E, Ganio E, Williams SE, Goldschneider KR, Campbell F, Ruskin D, Krane EJ, Walker S, Rush G, Heirich M. Signature for Pain Recovery IN Teens (SPRINT): protocol for a multisite prospective signature study in chronic musculoskeletal pain. BMJ Open. 2022 Jun 8;12(6):e061548. doi: 10.1136/bmjopen-2022-061548.

    PMID: 35676017DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Chronic PainPainArthralgiaMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesMuscular Diseases

Study Officials

  • Laura E Simons, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 26, 2020

Study Start

September 28, 2020

Primary Completion

June 26, 2025

Study Completion

December 1, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Resource sharing plan. Scientific resources produced in the course of this work are valuable for the scientific community. We are committed to open access publication and data sharing. After findings have been published or are submitted for publication, we will upload all data on applicable repositories (https://www.nature.com/sdata/policies/repositories). Potential current repositories include: OpenPain http://www.openpain.org/, OpenNeuro https://openneuro.org/, Open Science Framework https://osf.io/, flowrepository http://flowrepository.org/, ImmPort https://www.immport.org/shared/home.

Time Frame
After findings have been published or are submitted for publication, we will upload all data on applicable repositories.
Access Criteria
Any interested party will need to submit a request to the study team.

Locations

CA(1)US(2)ES(1)