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

An estimatedmillion Americans suffer from chronic pain and low back pain is the leading type of chronic painIn factlow back painLBPis the number one cause of disability in the world and in the U Sthis chronic disease accounts formillion lost work days in one yearWhilemillion Americans suffer from chronic low back painCLBPtoday the most commonly prescribed drug for low back pain remains opioidsHoweveropioids have been found to be ineffective for CLBPRatheropioids provide modest short term pain relief that render them inadequate for patients living day to day with CLBPFurthermoreOpioids users are subject to drug tolerance and decreasing pain management efficacy over timeA significant portion of CLBP patients are on amg or more morphine milligram equivalentMMEdaily opioid dosageEven more than a significant increase in risk of inadvertent prescription opioid overdoseindividuals onmg or more MME a day are more likely to experience fatalityCLBP patients need an effectivesafeand accessible form of pain management that addresses both physical symptoms of pain as well as psychological symptoms such as depression and anxietyWe will seek to provide a pain management alternative for CLBP patients who are on a greater thanmg morphine milligram equivalentMMEdaily opioid dosage to reduce medication usageincrease pain managementand increase overall functionalityTo address these issueswe will developutilizeand augment one novel science enabling technology combined with validated pain management treatmentsvirtual reality to stimulate patientsvisualauditoryand haptic fields in effort to simultaneously distract and actively engage patients inbiofeedback therapywhich will allow patients to consciously self regulate their nervous system by paring down their sympathetic tone through exercises in controlling respiration and HRVWe leverage novel technology and validated therapy for the overarching aim of this proposalto provide CLBP patients on amg or more MME daily opioid dosage with an opioid sparing pain management tool aiming to increase pain management efficacy and decrease risk of health complicationsAcross both Phase I and Phase IIwe will sample from a population of CLBP patients on amg or more MME daily opioid dosageIn Phase I a group receiving our intervention with opioids will be compared to a group receiving just opioidsBoth groups will receive the same opioid tapering guidelines and we expect the intervention group to have greater success reducing opioid usageOur Phase II trial will test the two previous groups in addition to a third group receiving opioids and a sham virtual reality experiencesimilar to current distractionbased VR used for acute pain managementAll three groups will receive identical opioid tapering instructionsWe hypothesize patients in the intervention group will observe lower pain scoresless opioid usagegreater functionalityand improved psychological and physiological measuresOur development and research focus on maximizing pain management efficacy while providing an opioid sparing pain management tool for CLBP patients The proposed development and research is of high public health significanceas it will aim to provide an opioid sparing pain management tool to a greatly affect population of Chronic Low Back PainCLBPpatientsTo do sowe will develop and refine new technologies that include novel innovation in virtual reality therapy as augmented through biofeedbacka decades old validated pain management therapyin ways not possible beforeThe resultant knowledge will provide the foundation for further development of opioid sparing pain management tools that will greatly increase pain management efficacy while decreasing opioid usage and its associated risks for Chronic Low Back Pain patients