Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial.

BACKGROUND: The prevalence of chronic pain conditions is growing. Low back pain was the primary cause of disability worldwide out of 156 conditions assessed between 1990 and 2016, according to the Global Burden of Disease Study. Conventional medical approaches have failed to identify effective and long-lasting approaches for the management of chronic pain, and often fail to consider the multiple domains that influence overall health and can contribute to the pain experience. Leading international organizations that focus on pain research have stated the importance of considering these other domains within holistic and multidisciplinary frameworks for treating pain. While the research behind the theoretical link between these domains and chronic pain outcomes has expanded greatly over the last decade, there have been few practical and feasible methods to implement this type of care in normal clinical practice. METHODS: The purpose of this manuscript is to describe an implementation protocol that is being used to deliver a complex holistic health intervention at multiple sites within a large government health system, as part of a larger multisite trial for patients with chronic low back pain. The Move to Health program developed by the US Army Medical Command was tailored for specific application to patients with low back pain and begins by providing an empirical link between eight different health domains (that include physical, emotional, social, and psychological constructs) and chronic low back pain. Through a six-step process, a health coach leverages motivational interviewing and information from a personal health inventory to guide the patient through a series of conversations about behavioral lifestyle choices. The patient chooses which domains they want to prioritize, and the health coach helps implement the plan with the use of SMART (Specific, Measurable, Attainable, Realistic, Time-bound) goals and a series of resources for every domain, triaged from self-management to specialist referral. DISCUSSION: Complex interventions described in clinical trials are often challenging to implement because they lack sufficient details. Implementation protocols can improve the ability to properly deliver trial interventions into regular clinical practice with increased fidelity. TRIAL REGISTRATION: Implementation of this intervention protocol was developed for a clinical trial that was registered a priori (clinicaltrials.gov #NCT04172038).

The influence of a MOBile-based video Instruction for Low back pain (MOBIL) on initial care decisions made by primary care providers: a randomized controlled trial.

BACKGROUND: Adherence to guidelines for back pain continues to be a challenge, prompting strategies focused on improving education around biopsychosocial frameworks. OBJECTIVE: Assess the influence of an interactive educational mobile app for patients on initial care decisions made for low back pain by the primary care provider. The secondary aim was to compare changes in self-reported pain and function between groups. METHODS: This was a randomized controlled trial involving patients consulting for an initial episode of low back pain. The intervention was a mobile video-based education session (Truth About Low Back Pain) compared to usual care. The app focused on addressing maladaptive beliefs typically associated with higher risk of receiving low-value care options. The primary outcome was initial medical utilization decisions made by primary care practitioners (x-rays, MRIs, opioid prescriptions, injections, procedures) and secondary outcomes included PROMIS pain interference and physical function subscales at 1 and 6 months, and total medical costs. RESULTS: Of 208 participants (71.2% male; mean age 35.4 years), rates of opioid prescriptions, advanced imaging, analgesic patches, spine injections, and physical therapy use were lower in the education group, but the differences were not significant. Total back-related medical costs for 1 year (mean diff = $132; P = 0.63) and none of the 6-month PROMIS subscales were significantly different between groups. Results were no different in opioid-naïve subjects. Instead, prior opioid use and high-risk of poor prognosis on the STarT Back Screening Tool predicted 1-year back pain-related costs and healthcare utilization, regardless of intervention. CONCLUSION: Factors that influence medical treatment decisions and guideline-concordant care are complex. This particular patient education approach directed at patients did not appear to influence healthcare decisions made by primary care providers. Future studies should focus on high-risk populations and/or the impact of including the medical provider as an active part of the educational process. TRIAL REGISTRATION: clinicaltrials.gov NCT02777983 .

Does Engaging Patients with Relevant Education About Long-Term Opioid Use Before Spine Surgery Affect Long-term Opioid Use? A Randomized Controlled Trial.

STUDY DESIGN: Parallel-arm randomized controlled trial. OBJECTIVE: To assess the effectiveness of an enhanced video education session highlighting risks of opioid utilization on longterm opioid utilization after spine surgery. SUMMARY OF BACKGROUND DATA: Long-term opioid use occurs in more than half of patients undergoing spine surgery and strategies to reduce this use are needed. METHODS: Patients undergoing spine surgery at Brooke Army Medical Center between July 2015 and February 2017 were recruited at their preoperative appointment, receiving the singlesession interactive video education or control at that same appointment. Opioid utilization was tracked for the full year after surgery from the Pharmacy Data Transaction Service of the Military Health System Data Repository. Self-reported pain also collected weekly for 1 and at 6months. RESULTS: A total of 120 participants (40 women, 33.3%) with a mean age of 45.9 ±â€Š10.6 years were randomized 1:1 to the enhanced education and usual care control (60 per group). In the year following surgery the cohort had a mean 5.1 (standard deviation [SD] 5.9) unique prescription fills, mean total days' supply was 88.3 (SD 134.9), and mean cumulative morphine milligrams equivalents per participant was 4193.0 (SD 12,187.9) within the year after surgery, with no significant differences in any opioid use measures between groups. Twelve individuals in the standard care group and 13 in the enhanced education group were classified with having long-term opioid utilization. CONCLUSION: The video education session did not influence opioid use after spine surgery compared to the usual care control. There was no significant difference in individuals classified as long-term opioid users after surgery based on the intervention group. Prior opioid use was a strong predictor of future opioid use in this cohort. Strategies to improve education engagement, understanding, and decision- making continue to be of high importance for mitigating risk of long-term opioid use after spine surgery.Level of Evidence: 1.