Pain, ChronicSPRINTNCT04285112
SPRINT: Signature for Pain Recovery IN Teens
An observational study of Pain, Chronic and Pain, run by Stanford University at 4 sites in 3 countries.
Trial summary
To identify biological and phenotypic prognostic markers of recovery vs. persistence of pain and functional disability in adolescents with chronic musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic, Pain, Joint Pain
- How many people
- 275 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 28 Sep 2020to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents with chronic primary musculoskeletal pain
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Stanford University
Palo Alto, California, 94304
About this study
To identify biological and phenotypic prognostic markers of recovery vs. persistence of pain and functional disability in adolescents with chronic musculoskeletal pain.
Read the 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.
- Conditions
- Pain, Chronic, Pain, Joint Pain, Musculoskeletal Pain
- Keywords
- Pediatric pain, pain
- Medical subject headings
- Chronic Pain, Pain, Arthralgia, Musculoskeletal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start28 Sep 2020
- Primary completion26 Jun 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, The Hospital for Sick Children, University of Barcelona, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Laura E Simons, Stanford University
- Investigators
- Laura E Simons, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285112
- Sponsor's protocol ID
- 2019-1006
- Other IDs
- 52963
- Acronym
- SPRINT
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2020
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
White JN, King CD, Coghill RC, Lopez-Sola M, Moayedi M, Stinson JN, Angst MS, Gaudilliere B, Aghaeepour N, Simons LE. Identification of high-impact chronic pain in adolescents with musculoskeletal pain. Pain. 2026 Aug 19. doi: 10.1097/j.pain.0000000000004092. Online ahead of print.
PubMed 42663526Simons 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.
PubMed 35676017
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPRINT: Signature for Pain Recovery IN Teens
- ClinicalTrials.gov ID
- NCT04285112
- Acronym / sponsor ID
- SPRINT / 2019-1006
- Conditions
- Pain, Chronic, Pain, Joint Pain, Musculoskeletal Pain
- Keywords
- Pediatric pain, pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Toronto, The Hospital for Sick Children, University of Barcelona, Children's Hospital Medical Center, Cincinnati
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify biological and phenotypic prognostic markers of recovery vs. persistence of pain and functional disability in adolescents with chronic musculoskeletal pain.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with chronic primary musculoskeletal pain
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Derived from this study: PubMed 42663526White JN, King CD, Coghill RC, Lopez-Sola M, Moayedi M, Stinson JN, Angst MS, Gaudilliere B, Aghaeepour N, Simons LE. Identification of high-impact chronic pain in adolescents with musculoskeletal pain. Pain. 2026 Aug 19. doi: 10.1097/j.pain.0000000000004092. Online ahead of print.
- Derived from this study: PubMed 35676017Simons 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura E Simons, PhD principal investigator
Stanford University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Pain, run by Stanford University at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity and Unpleasantness (time frame: 3 months after baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04285112, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.