NCT03581123

Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain

Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.

Detailed description

The long-term goal is to reduce overall low back pain (LBP) burden by evaluating, first-line, non-drug treatment strategies that address the biological, psychological and social aspects of acute LBP and prevent transition to chronic back pain. The study will also assess barriers and facilitators that impact future implementation of the non-drug treatments into clinical practice. The US faces an unprecedented pain management crisis. LBP is the most common chronic pain condition in adults and one of the leading causes of disability worldwide. Guidelines have recommended non-drug treatments like spinal manipulation and behavioral and selfcare approaches for LBP for nearly a decade, yet uptake and adherence has been poor. Little is known about the role of these treatments in the secondary prevention of chronic LBP, especially for patients at risk of developing severe low back pain. Due to high societal costs, and side effects of commonly used drug treatments, including opioids, there is a critical need for research on how well non-drug treatments work for preventing serious chronic LBP.

Conditions

• Acute Pain
• Low Back Pain, Mechanical

Interventions

Type	Name	Description
BEHAVIORAL	Supported-Self Management (SSM)	Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
OTHER	Spinal Manipulation Therapy (SMT)	SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
COMBINATION_PRODUCT	SMT + SSM	Combination Treatment
DRUG	Standard Medical Care (SMC)	Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.

Timeline

• Start date: 2018-11-01
• Primary completion: 2024-06-12
• Completion: 2024-06-12
• First posted: 2018-07-10
• Last updated: 2025-10-16
• Results posted: 2025-10-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study