SPRINT: Signature for Pain Recovery IN Teens (SPRINT)

November 12, 2023 updated by: Laura E Simons, Stanford University
To identify biological and phenotypic prognostic markers of recovery vs. persistence of pain and functional disability in adolescents with chronic musculoskeletal pain.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Up to 5% of adolescents (~3.5 million in the US alone) suffer from high impact chronic musculoskeletal (MSK) pain, affecting all life domains and posing a significant economic burden. Current treatments for chronic MSK pain are suboptimal and have been tied to the opioid crisis. Only ~50% of adolescents with chronic MSK pain who present for multidisciplinary pain treatment recover, as measured by clinical endpoints of pain severity and functional disability. Discovery of robust markers of the recovery vs. persistence of pain and disability is essential to develop more resourceful and patient-specific treatment strategies and to conceive novel approaches that benefit patients who are refractory. Given that chronic pain is a biopsychosocial process, the discovery and validation of a prognostic and robust signature for pain recovery vs. persistence requires measurements across multiple dimensions in the same patient cohort in combination with a suitable 'big data' computational analysis pipeline for the extraction of reliable and cross-validated results from a multilayered and complex dataset. The research team is well positioned to execute the study aims with: (1) A highly skilled and experienced team of scientists and clinicians from Stanford University, University of Toronto/Hospital for Sick Children, and Cincinnati Children's Hospital Medical Center; (2) A standardized specimen collection, processing, storage, and distribution system, leveraging Stanford Biobank's platform, BioCatalyst, to aggregate the sample inventory with clinical annotations for an accessible, virtual biobank, within the Signature of Pain Recovery IN Teens (SPRINT) Biobank and Analysis Core (SBAC); (3) Cutting-edge preliminary data implicating novel candidates for neuroimaging, immune, quantitative sensory, and psychological markers for discovery; and (4) Expertise in machine learning approaches to extract reliable and prognostic bio-signatures from a large and complex data set. The research team expects that the results from this project will facilitate risk stratification in patients with chronic MSK, a more resourceful selection of patients who are likely to respond for undergoing current multidisciplinary pain treatment approaches, and new insight into biological and behavioral processes that may be exploited to develop novel strategies profiting those who are refractory.

For the R61/Discovery Phase Aim individuals will be thoroughly characterized via biological (i.e. brain structure and function, immune, sensory profiles), psychological state, and clinical endpoint (i.e., pain intensity, disability) data. Unbiased machine learning algorithms will identify a multivariate model comprised of the most prognostic biological, psychological, and clinical endpoints. The model will classify adolescents with and without resolving chronic MSK pain after a state-of-the art multidisciplinary pain treatment intervention. R33/Validation Phase Aim will validate the biological signature derived in the R61 study. This signature will be useful for a range of adolescent-based clinical trials in which identification of the highest risk individuals is necessary, providing a clinically actionable intervention algorithm.

Study Type

Observational

Enrollment (Estimated)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Jennifer Stinson, PhD
  • Spain
      • Barcelona, Spain
        • Active, not recruiting
        • University of Barcelona
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Laura Simons, PhD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Principal Investigator:
          • Robert Coghill, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adolescents with chronic primary musculoskeletal pain

Description

Inclusion Criteria:

  1. 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)
  2. Age between 11-18 years
  3. Moderate to Severe Functional Disability (FDI ≥13)
  4. English proficiency (reading, speaking)
  5. Moderate to severe average pain (VAS ≥30/100)

Exclusion Criteria:

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

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity and Unpleasantness
Time Frame: 3 months after baseline assessment
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
Time Frame: 3 months after baseline assessment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

The Hospital for Sick Children
University of Toronto
Children's Hospital Medical Center, Cincinnati
University of Barcelona

Investigators

  • Principal Investigator: Laura E Simons, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2020

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1006
  • 52963 (Other Identifier: Stanford)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After findings have been published or are submitted for publication, we will upload all data on applicable repositories.

IPD Sharing Access Criteria

Any interested party will need to submit a request to the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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