Group-Based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care

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 do a pragmatic
clinical trial (PCT) with the goal of informing decision makers how this program can work in a real-life
clinical setting and its impact on outcomes. We propose a PCT of this program titled “OPTIMUM”
(Optimizing Pain Treatment In Medical settings Using Mindfulness). It will be conducted with three
health care system (HCS) sites (Boston Medical Center, MA, UPMC, Pittsburgh, PA, and Piedmont Health
Services, in partnership with the University of North Carolina, Chapel Hill). Our primary goal is to determine
the impact of this intervention under usual care circumstances. The rationale for this project is to inform key
decision-makers how nonpharmacologic treatment can be integrated into routine care and the impact of this
program on key outcomes. The specific aims UG3 Phase are the following: Aim 1: To plan and test a
mindfulness clinical pain program, OPTIMUM, in the 3-HCS sites prior to the full PCT during the first 12-
months of the project. Clearly defined milestones will be reached with guidance from the Collaboratory
Coordinating Center. The specific aims UH3 Phase are: Aim 2. To integrate and test an evidence-based
mindfulness clinical pain program, OPTIMUM, for patients with cLBP in the primary care setting. Four-
hundred-fifty persons with cLBP ≥ 18 years of age will be randomized to 1) OPTIMUM (n=225) + PCP Usual
Care; or 2) PCP Usual Care (n=225). Primary Hypothesis: patients in OPTIMUM will have significantly
reduced pain at completion of the program and 6- and 12-months later, as compared to PCP Usual Care.
Hypothesis 2: patients in OPTIMUM will have significantly improved physical and psychological
function at completion of the program and 6- and 12-months later, as compared to 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 as compared to those in PCP Usual Care. Aim 3. To evaluate use of
healthcare resources by patients as documented in the electronic health record. Hypothesis: patients in
OPTIMUM will have fewer emergency department visits, fewer hospitalizations, fewer imaging (CT/MRI), and
fewer procedures (injections, surgery) than PCP usual care. Aim 4. To evaluate PCP and practice site use of,
satisfaction with, and integration of OPTIMUM. Delivering a group mindfulness pain program in primary care
is innovative and we expect it will increase the quality of, and satisfaction with cLBP care.