Clinical trial NCT04285112: SPRINT: Signature for Pain Recovery in Teens
Official title: SPRINT: Signature for Pain Recovery in Teens
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pain, Chronic
Pain
Joint Pain
Musculoskeletal Pain
Keywords: Pediatric pain
pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: The Hospital for Sick Children
name: University of Barcelona
name: Children's Hospital Medical Center, Cincinnati
First posted: 2020-02-26
Enrollment: 275
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with chronic primary musculoskeletal pain

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity and Unpleasantness
timeFrame: 3 months after baseline assessment
measure: Functional Disability
timeFrame: 3 months after baseline assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Barcelona
country: Spain
facility: University of Barcelona
Study officials:
affiliation: Stanford University
name: Laura E Simons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.