# Prognostic biomarkers for high-impact chronic pain: Development and validation

> **NIH NIH R61** · STANFORD UNIVERSITY · 2020 · $7,255,401

## Abstract

PROJECT SUMMARY
 Chronic pain represents a public health crisis that affects more than 100 million Americans and costs over
$500 billion dollars annually. Chronic musculoskeletal pain conditions comprise 70-80% of all chronic pain. An
estimated 8% of US adults suffer from high-impact chronic pain, or pain associated with substantially restricted
work, social, and self-care activities for six or more months. Chronic pain—and high-impact chronic pain in
particular—is often treated with prescription opioids and is linked to opioid-use disorder. Multidisciplinary
chronic pain treatments show incomplete recovery at the population level. However, subgroups of individuals
completely respond, do not change, or even worsen following pain management. Thus, robust and validated
diagnostic and prognostic biomarkers are needed to identify those with high-impact chronic pain and determine
the trajectory of outcome (i.e., recovery versus persistence), respectively. Therefore, our overall goal is to
discover and validate diagnostic and prognostic biomarkers for musculoskeletal high-impact chronic pain. This
goal will require comprehensive, multidimensional assessments with an integrated dataset and a sophisticated
computational analysis pipeline to yield reliable and validated diagnostic and prognostic biomarkers. To this
end, we have assembled an interdisciplinary research and clinical team to implement the HEAL initiative. The
goal of this initiative is to elucidate diagnostic and prognostic biomarker signatures of chronic pain by
integrating CNS, multiomic, sensory, functional, psychosocial, and demographic domains. We will achieve this
goal through two specific aims: (1) develop diagnostic and prognostic markers of musculoskeletal high-impact
chronic pain following multidisciplinary pain treatment (R61 Discovery Phase) and (2) analytically validate the
multimodal signatures developed in the first aim (R33 Validation Phase). This proposal will yield valid and
clinically useful diagnostic and prognostic biomarker signatures to facilitate risk and treatment stratification in
patients with musculoskeletal chronic pain. Such biomarkers are essential to develop safer, more effective
patient-specific treatment strategies, particularly for those who are refractory to current pain management
options. We will also identify potentially modifiable biological and behavioral factors that can change the course
of the pain trajectory and thereby reduce the impact of chronic pain on the individual and society as a whole.

## Key facts

- **NIH application ID:** 10157953
- **Project number:** 1R61NS118651-01A1
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** SEAN C MACKEY
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $7,255,401
- **Award type:** 1
- **Project period:** 2020-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157953

## Citation

> US National Institutes of Health, RePORTER application 10157953, Prognostic biomarkers for high-impact chronic pain: Development and validation (1R61NS118651-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10157953. Licensed CC0.

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