Feasibility Trial of a Novel Integrated Mindfulness and Acupuncture Program to Improve Outcomes after Spine Surgery (I-MASS)

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ABSTRACT Spine pain consistently ranks first or near the top in global rankings of disease burden, and epidemiological data suggest the burden is worsening. The number of low back surgeries has increased by 300% over the past 2 decades, accounting for approximately 30% of spine-related costs in the US. While it can provide cost- effective pain relief to some patients, up to 25% of those who undergo spine surgery will develop persistent pain requiring additional surgery, imaging, or other invasive interventions. Moreover, many patients will experience persistent opioid use, which carries significant risks of misuse, addiction, and overdose. Clinical practice guidelines strongly recommend the use of multimodal – or ‘mind and body’ – treatments for effective pain management after surgery. This approach combines interventions with analgesic or physical therapeutic inputs alongside interventions with psychological or behavioral inputs to better address the multifaceted risk factors for persistent pain and opioid use following surgery. Integration of Mindfulness delivered via mobile app (mHealth) with auricular Acupuncture (AA) in individuals undergoing Spine Surgery (I-MASS) is a highly promising multimodal treatment approach given the distinct yet complementary mechanisms by which mindfulness and AA influence pain after surgery. Establishing the effectiveness of I-MASS requires a rigorously designed pragmatic trial comparing it to usual medical care in adults who undergo spine surgery. However, trials of this size and scope require careful preparation. This proposed mixed methods R34 project is designed to answer important preparatory questions regarding the feasibility and acceptability of I-MASS through the following Specific Aims: 1) Conduct interviews with patient and care delivery stakeholders to refine and finalize the I-MASS intervention protocol by integrating mHealth mindfulness training and AA for use in patients age 18-80 undergoing spine surgery; 2) Conduct a single-site, exploratory randomized controlled clinical trial to assess the feasibility and acceptability of I-MASS in patients undergoing single-level laminectomy, discectomy or fusion; and 3) Use feasibility trial results to develop and submit a competitive research proposal to NIH for a multi-site, pragmatic, randomized comparative effectiveness clinical trial designed to rigorously evaluate I-MASS compared to mHealth mindfulness, AA, and usual care augmented with standard education. The results of this R34 project will provide the information needed to successfully execute on such a study and create new knowledge regarding the feasibility and acceptability of a highly innovative non-pharmacological multimodal approach designed to improve the lives of patients undergoing spine surgery.