Trial Summary

Chronic low back pain (cLBP) is one of the most common conditions treated in the primary care setting, yet treatment remains unsatisfactory for many patients. The opioid crisis has underscored the urgency of alleviating patients’ cLBP with effective therapies, including evidence-based nonpharmacologic approaches. Mindfulness is effective for the treatment of cLBP yet remains underutilized as it has not been regularly woven into the outpatient clinical setting.

Mindfulness-based Stress Reduction (MBSR) is now recommended by the American College of Physicians for initial treatment of cLBP. The next necessary step is to conduct a pragmatic clinical trial (PCT) with the goal of informing decision makers how an MBSR program can work in a real-life clinical setting and its impact on outcomes. The primary goal of the OPTIMUM trial is to determine the impact of a telehealth-delivered group-based mindfulness intervention under usual care circumstances.

The aims of the UG3 planning phase include testing the mindfulness clinical pain program in three participating health care system sites during the first 12 months of the project. The aims of the UH3 implementation phase include integrating and testing the telehealth program with patients who have cLBP in the primary care setting. The study expects to randomize 450 patients with cLBP ≥18 years of age to the OPTIMUM plus PCP usual care arm (n=225) or to the PCP usual care only arm (n=225).

• Primary hypothesis: Patients in OPTIMUM will have significantly improved pain intensity and interference as measured by the PEG composite score at completion of the program and 6 and 12 months later compared with PCP usual care.
• Hypothesis 2: Patients in OPTIMUM will have significantly improved psychological function at completion of the program and 6 and 12 months later compared with PCP usual care.
• Hypothesis 3: Patients in OPTIMUM will be less likely to start and more likely to reduce or stop an opioid prescription for cLBP compared with those in PCP usual care.

Other aims of OPTIMUM include evaluating the use of healthcare resources by patients as documented in the electronic health record (EHR). It is expected that patients in OPTIMUM will have fewer emergency department visits, fewer hospitalizations, fewer imaging (CT/MRI), and fewer procedures (injections, surgery) than PCP usual care. A final aim is to evaluate the use of, satisfaction with, and integration of the OPTIMUM intervention. Delivering a group-based mindfulness pain program in primary care is innovative and is expected to increase the quality of and satisfaction with cLBP care.

NIH Project Information