Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program

An estimated 100 million Americans suffer from chronic pain and low back pain is the leading type of chronic pain. In fact, low back pain (LBP) is the number one cause of disability in the world and in the U.S. this chronic disease accounts for 264 million lost work days in one year. While 31 million Americans suffer from chronic low back pain (CLBP), today the most commonly prescribed drug for low back pain remains opioids. However, opioids have been found to be ineffective for CLBP. Rather, opioids provide modest short-term pain relief that render them inadequate for patients living day to day with CLBP. Furthermore, Opioids users are subject to drug tolerance and decreasing pain management efficacy over time. A significant portion of CLBP patients are on a 50mg or more-morphine milligram equivalent (MME) daily opioid dosage. Even more than a significant increase in risk of inadvertent prescription opioid overdose, individuals on 50mg or more MME a day are more likely to experience fatality. CLBP patients need an effective, safe, and accessible form of pain management that addresses both physical symptoms of pain as well as psychological symptoms such as depression and anxiety. We will seek to provide a pain management alternative for CLBP patients who are on a greater than 50mg morphine milligram equivalent (MME) daily opioid dosage to reduce medication usage, increase pain management, and increase overall functionality. To address these issues, we will develop, utilize, and augment one novel science-enabling technology combined with validated pain management treatments: 1) virtual reality to stimulate patients’ visual, auditory, and haptic fields in effort to simultaneously distract and actively engage patients in 2) biofeedback therapy, which will allow patients to consciously self-regulate their nervous system by paring down their sympathetic tone through exercises in controlling respiration and HRV. We leverage novel technology and validated therapy for the overarching aim of this proposal: to provide CLBP patients on a 50mg or more MME daily opioid dosage with an opioid-sparing pain management tool aiming to increase pain management efficacy and decrease risk of health complications. Across both Phase I and Phase II, we will sample from a population of CLBP patients on a 50mg or more MME daily opioid dosage. In Phase I a group receiving our intervention with opioids will be compared to a group receiving just opioids. Both groups will receive the same opioid tapering guidelines and we expect the intervention group to have greater success reducing opioid usage. Our Phase II trial will test the two previous groups in addition to a third group receiving opioids and a sham virtual reality experience, similar to current distraction- based VR used for acute pain management. All three groups will receive identical opioid tapering instructions. We hypothesize patients in the intervention group will observe lower pain scores, less opioid usage, greater functionality, and improved psychological and physiological measures. Our development and research focus on maximizing pain management efficacy while providing an opioid-sparing pain management tool for CLBP patients.