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

使用 TMC-CP01 对慢性腰痛患者进行阿片类药物缓解疼痛管理 - 基于 VANISH(虚拟自主神经调节诱导系统治疗)的计划

基本信息

  • 批准号:
    10512769
  • 负责人:
  • 金额:
    $ 98.96万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2019
  • 资助国家:
    美国
  • 起止时间:
    2019-09-30 至 2023-12-31
  • 项目状态:
    已结题

项目摘要

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.
据估计,1亿美国人患有慢性疼痛,腰痛是主要的 慢性疼痛的类型事实上,腰痛(LBP)是残疾的头号原因, 在世界和美国,这种慢性疾病每年造成2.64亿个工作日的损失。 虽然3100万美国人患有慢性腰痛(CLBP),但今天最常见的是 下背痛的处方药仍然是阿片类药物。然而,已经发现阿片类药物 对CLBP无效。相反,阿片类药物提供适度的短期疼痛缓解,使他们 不适合每天生活在CLBP中的患者。此外,阿片类药物使用者受到 药物耐受性和随着时间的推移降低的疼痛管理功效。 很大一部分CLBP患者服用的吗啡相当于50毫克或更多 (MME)每日阿片类药物剂量甚至超过了意外风险的显著增加 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、安全且易于使用的疼痛管理形式,以解决 疼痛的身体症状以及抑郁等心理症状, 焦虑 我们将寻求为CLBP患者提供一种疼痛管理替代方案, 超过50毫克吗啡毫克当量(MME)的每日阿片类药物剂量,以减少用药 使用,增加疼痛管理,并增加整体功能。为了解决这些问题, 我们将开发、利用和增强一种新的科学技术, 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 通过控制呼吸和心率变异性的练习来降低他们的交感神经张力。我们 利用新技术和经验证的疗法实现本提案的总体目标: 为CLBP患者提供50 mg或更多MME每日阿片类药物剂量,阿片类药物保留疼痛 旨在提高疼痛管理功效和降低健康风险的管理工具 并发症 在I期和II期,我们将从CLBP患者人群中抽样, 50 mg或更多MME每日阿片类药物剂量。在第一阶段,一组接受我们的干预, 将阿片类药物与仅接受阿片类药物的组进行比较。两组将获得相同的 阿片类药物减量指南,我们希望干预组取得更大的成功 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,以及第三组。 接受阿片类药物和虚拟现实体验的小组,类似于当前的分心- 用于急性疼痛管理的VR。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低的疼痛 评分,阿片类药物使用减少,功能增强,心理和生理改善 措施我们的开发和研究专注于最大限度地提高疼痛管理功效 同时为CLBP患者提供阿片类药物保留的疼痛管理工具。

项目成果

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