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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The long-term objective is to reduce overall low back pain (LBP) burden by testing scalable, first-line, non-pharmacologic strategies that address the biopsychosocial aspects of acute/sub-acute LBP and prevent transition to chronic back pain.

The US is in the midst of an unprecedented pain management crisis. 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Duke University; Oregon Health and Science University; University of North Texas Health Science Center; University of Pittsburgh; University of Washington

Criteria

Inclusion Criteria:

• At least 18 years of age

• Acute or sub-acute low back pain

• Average low back pain severity ≥3 on the 0-10 numerical rating scale over 7 days

• Medium or high risk for persistent disabling back pain according to the STarT Back screening tool

• Ability to read and write fluently in English

Exclusion Criteria:

• Non-mechanical causes of low back pain

• Contraindications to study treatments (e.g,. surgical fusion of lumbar spine)

• Active management of current episode of low back pain by another healthcare provider

• Serious co-morbid health condition that either requires medical attention or has a risk for general health decline over the next year

• Pregnancy, current or planned during study period and nursing mothers

• Inability or unwillingness to give written informed consent