# Spinal Manipulation and Patient Self-Management to Prevent Back Pain Chronicity

> **NIH NIH UH3** · UNIVERSITY OF MINNESOTA · 2020 · $2,560,909

## Abstract

PROJECT SUMMARY
The US is in the midst of an unprecedented pain management crisis. Low back pain (LBP) is the most common
chronic pain condition in adults and the leading cause of disability worldwide. Guidelines have recommended
non-pharmacologic treatments like spinal manipulation and behavioral approaches for LBP for nearly a decade,
yet uptake and adherence has been poor. Moreover, little is known about the role of these treatments in the
secondary prevention of chronic LBP (cLBP), especially for patients with biopsychosocial risk factors. With
burgeoning costs, mounting evidence of ineffectiveness, and harms of commonly used drug treatments,
including opioids, there is a critical need for research on non-pharmacological treatments for cLBP prevention
that can be readily translated to practice.
The long-term objective is to reduce overall LBP burden by testing scalable, first-line, non-pharmacologic
strategies that address the biopsychosocial aspects of acute/sub-acute LBP and prevent transition to cLBP.
We propose a novel randomized hybrid trial addressing both effectiveness and implementation. A total of 1180
patients will be enrolled with nonspecific LBP of 2-12 weeks duration, at medium or high risk of developing
cLBP. This multi-site, predominantly pragmatic, phase III trial has two main aims. Aim 1 will assess the
effectiveness of Spinal Manipulation Therapy (SMT), Structured Self-Management (SSM), and SMT+SSM
relative to Usual Medical Care (UMC) in a randomized trial using a 2x2 factorial design. Physical therapists
(PT) and chiropractors (DC) will deliver SMT and SSM, and primary care clinicians will deliver UMC. Primary
outcomes are prevention of cLBP at 12 months; recovery from acute/sub-acute LBP at 6 months; and
cumulative reduction of pain and disability over 1 year. Secondary outcomes include PROMIS-29, productivity
loss, healthcare and medication use (including opioids). Aim 2 will use mixed methods to gather data about
influences on the interventions that could affect interpretation of results and future implementation. Qualitative
data will lend context regarding patients', providers', and health system leaders' perceptions of barriers and
facilitators; quantitative data collection will offer insight into intervention application, adherence, fidelity, and
provider confidence.
Aligned with the National Center for Complementary and Integrative Health's (NCCIH) Strategic Plan 2016,
this project can significantly transform LBP management by providing definitive and generalizable evidence
regarding front-line, non-pharmacologic interventions addressing physical and psychosocial factors for the
prevention of cLBP. Using PTs and DCs to empower patients to engage in healthy pain management
behaviors, we anticipate LBP-related disability, productivity loss, and reliance on continued healthcare and
medication use (including opioids) will be reduced.

## Key facts

- **NIH application ID:** 9986662
- **Project number:** 5UH3AT008769-03
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Gert Bronfort
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,560,909
- **Award type:** 5
- **Project period:** 2017-09-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986662

## Citation

> US National Institutes of Health, RePORTER application 9986662, Spinal Manipulation and Patient Self-Management to Prevent Back Pain Chronicity (5UH3AT008769-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9986662. Licensed CC0.

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