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

据估计，有1亿美国人患有慢性疼痛，其中腰痛是最主要的 慢性疼痛的类型。事实上，下腰痛(LBP)是老年人残疾的头号原因 在全世界和美国，这种慢性病每年造成2.64亿个工作日的损失。 虽然3100万美国人患有慢性下腰痛(CLBP)，但今天最常见的 治疗下腰痛的处方药仍然是阿片类药物。然而，阿片类药物被发现是 对慢性阻塞性肺疾病无效。相反，阿片类药物提供适度的短期疼痛缓解，从而使它们 不适用于CLBP患者的日常生活。此外，阿片类药物使用者还受到 药物耐受性和随时间推移的疼痛控制效果下降。 相当一部分CLBP患者服用50毫克或更多的吗啡毫克当量 (MME)每日阿片类药物剂量。甚至比疏忽的风险显著增加 处方阿片类药物过量，每天服用50毫克或更多MME的人更有可能 体验死亡。 CLBP患者需要一种有效、安全和可获得的疼痛管理形式，以解决 疼痛的身体症状和心理症状，如抑郁和 焦虑。 我们将寻求为CLBP患者提供一种疼痛管理的替代方案，这些患者 每天超过50毫克吗啡毫克当量(MME)的阿片类药物剂量以减少用药 使用，增加疼痛管理，并提高整体功能。为了解决这些问题， 我们将开发、利用和增强一项新的科学使能技术，结合 有效的疼痛管理治疗：1)虚拟现实刺激患者的视觉、听觉、 和触觉领域，努力同时分散患者的注意力，并积极参与2) 生物反馈疗法，这将使患者有意识地自我调节他们的神经系统 通过练习控制呼吸和心率变异性来降低交感神经的音调。我们 利用新技术和经过验证的疗法来实现本提案的首要目标： 为CLBP患者提供每日50毫克或更多的MME阿片类药物剂量，以缓解阿片类药物的疼痛 旨在提高疼痛管理效率和降低健康风险的管理工具 并发症。 在第一阶段和第二阶段，我们将从一组CLBP患者中抽取样本 每日50毫克或以上的MME阿片类药物剂量。在第一阶段，接受我们干预的小组 阿片类药物将被比作只接受阿片类药物的一组。两组都将收到相同的 阿片类药物缩减指南，我们预计干预组将取得更大成功 减少阿片类药物的使用。我们的第二阶段试验将测试前两组和第三组 接受阿片类药物和虚假虚拟现实体验的小组，类似于目前的分心- 基于VR的急性疼痛管理。所有三组都将接受相同的阿片类药物 逐渐减少的指示。我们假设干预组的患者将观察到较轻的疼痛 得分，阿片类药物使用减少，功能增强，心理和生理状况改善 措施。我们的开发和研究重点是最大化疼痛管理效果 同时为CLBP患者提供非阿片类药物疼痛管理工具。

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.