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).

Engaging Education About Risks of Opioid Use With Patients Before Elective Surgery of the Lower Extremity Did Not Reduce Postoperative Opioid Utilization: A Randomized Controlled Trial.

INTRODUCTION: After elective orthopaedic surgery, many individuals go on to become long-term opioid users. Mitigating this risk has become a priority for surgeons, other members of the medical care team, and healthcare systems. The purpose of this study was to compare opioid utilization after lower extremity orthopaedic surgery between patients who received an interactive video education session highlighting the risks of opioid use and those who did not. METHODS: Patients undergoing elective surgery of the lower extremity in the orthopaedic clinic at the Brooke Army Medical Center between July 2015 and February 2017 were recruited at their preoperative appointment and randomized in a 1:1 ratio to receive a one-time interactive opioid education session or usual care education. Unique days' supply of opioids and unique prescriptions were compared using a generalized linear model. Individuals were also grouped by whether they had become long-term opioid users after surgery, and frequencies within each intervention group were compared. RESULTS: There were 120 patients, 60 randomized to each group and followed for 1 year. There were no significant differences between opioid days' supply (mean diff = 8.33, 95% confidence interval -4.21 to 20.87) and unique prescriptions after surgery (mean diff = 0.45, 95% confidence interval -0.25 to 1.15). Most participants did not have any opioids past the initial 30 days after surgery, regardless of intervention (n = 77), and only three became long-term opioid users (one in usual care and two in interactive education). Sixteen in usual education and 18 in enhanced education filled at least one prescription in 6 months or later after the surgical procedure. CONCLUSION: Opioid use beyond 30 days of surgery was no different for participants who received enhanced education compared with usual education. Few became long-term opioid users after surgery (2.5%), although 28.3% were still filling opioid prescriptions 6 months after surgery.