This Competitive Revision proposal outlines a 1-year planning phase and 2-year clinical trial comparing different pain management pathways to improve clinical outcomes and reduce risk for long-term opioid use for patients following lumbar surgery. Currently, clinical outcomes following spine surgery are variable. One factor that detracts from clinical outcomes is opioid use. Most patients considering spine surgery have experience many years of back pain and rates of pre-surgical opioid use are high. Despite optimism that surgery will eliminate the need for opioids, most pre-surgical opioid users persist in long-term use after the procedure. There is also risk that patients who were not long-term users before surgery will become long-term users after surgery. Pre-surgical opioid use is predictive of worse functional outcomes, higher complication rates and greater costs after surgery. The premise of our project is that surgical outcomes can be improved and risk for post-surgery opioid use reduced through comprehensive, enriched pain management designed to enhance patients' ability and confidence in self-managing pain. Our Competitive Revision expands the scope of an ongoing clinical trial investigating similar interventions for patients pursuing non-surgical management for chronic back pain. The ongoing trial and this Competitive Revision are conducted in the Military Health System and investigate pragmatic, scalable strategies that can impact practice in both Military and civilian health systems. Following a planning year, our clinical trial will examine enriched pain management, which provides bio- psychosocially-informed, non-pharmacologic pain treatments threaded through the pre- and post-operative periods, tailored to individual patients and the intensity of their surgical procedure and designed to improve clinical outcomes, enhance patients' pain self-management skills and reduce risk for long-term opioid use post- surgery. We will compare the effectiveness of an enriched pain management pathway to a standard pathway. Our enriched pathway uses nonpharmacologic interventions grounded in a strong scientific premise to improve function and promote self-efficacy in non-opioid pain management. We will compare our treatment strategies in the overall cohort and explore in sub-groups of patients based on pre-operative long-term opioid use because we hypothesize that efficacious interventions may requiring tailoring to this particular factor. We will also explore the mechanisms of action of our pain management pathways through mediation analysis. We will also collect preliminary implementation metrics to inform future clinical studies and implementation efforts. Following the planning year we expect our clinical trial to have three specific aims. 1. Compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the MHS. Effectiveness will be based on post-surgery patient-centered outcomes and opioid use. We hypothesize the enriched pathway will provide superior outcomes vs. the standard pathway. 1a. Explore trial results in pre-specified sub-groups based on pre-surgical risk for persistent opioid use (high or low). We hypothesize that the enriched pathway will show larger effects for high risk patients. 2. Explore mediating effect of pain self-efficacy, catastrophizing and hyper-vigilance on post-surgery opioid use and outcomes. We hypothesize mediators will be identified that can improve pain management strategies. 3. Explore implementation outcomes of pain management pathways (acceptability, fidelity and feasibility). The results of this project will identify effective pain management strategies that can inform clinical practice and guidelines in Military and civilian health systems. Additional aims of the project will provide direction and insight to further improve pain management by identifying mechanisms of action.
Lumbar spine surgeries are increasing in frequency for patients with chronic back pain. Many patients undergo surgery after years of chronic pain, often managed with long-term opioid use. Despite optimism that surgery will eliminate the need for opioids, evidence shows this is not the case. The majority of pre-operative, long-term opioid users continue use after surgery. In addition, the clinical outcomes of spine surgery are highly variable and many patients experience persistent pain and disability. Being a pre-operative long-term opioid user is associated with worse clinical outcomes after surgery including risk that opioid use will continue or even increase. The goal of this project to improve outcomes and reduce risk for opioid use following lumbar spine surgery by providing better pain management pathways from the pre-operative preparation into the post-surgery rehabilitation period.
