Trial Summary

Chronic low back pain is one of the most common conditions treated in primary care settings, yet treatment remains unsatisfactory for many patients. The opioid crisis has underscored the urgency of alleviating patients’ chronic low back pain with effective therapies, including evidence-based nonpharmacologic approaches. Mindfulness is effective for the treatment of chronic low back pain but remains underutilized as it has not been regularly integrated into the outpatient clinical setting. Mindfulness-based stress reduction is now recommended by the American College of Physicians for initial treatment of chronic low back pain. The primary goal of OPTIMUM is to determine the impact of a group-based mindfulness intervention under usual care circumstances. The implementation phase will integrate mindfulness-based stress reduction, delivered online, in a primary care setting with 450 patients 18 years of age or older who have chronic low back pain, comparing mindfulness plus usual care versus usual care alone. Among the hypotheses are that, compared with usual care, patients receiving the intervention will have improved pain intensity, pain interference, and improved psychological function at the completion of the program and at 6 and 12 months, and that patients will be less likely to start and more likely to reduce or stop an opioid prescription for chronic low back pain compared with those receiving usual care. Another aim of the trial is to evaluate the use of, satisfaction with, and integration of this innovative intervention delivered in a real-world setting.

NIH Project Information