Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain.

项目摘要 本项目的目标是开发一种用于低血压的多模式神经调节性阿片类药物节约装置。 背部疼痛，证明有效的疼痛缓解，然后评估阿片类药物的减少对急性或 慢性背痛出现在治疗中。疼痛和阿片类药物使用障碍(OUD)是错综复杂的关系： 高达80%的人开始依赖于开出止痛药的药物，要么直接服用，要么通过留在 发行量。目前，还没有经过验证的方法来帮助减少长期使用阿片类药物的患者 慢性非癌症疼痛。已知的是，处方阿片类药物治疗急性下腰痛是一个因素 最终，由于非医疗原因，流通中未使用的阿片类药物越来越多地被滥用。对于 已经依赖于慢性疼痛，减少的一个障碍是对持续或增加的疼痛的恐惧。一个 有效的非药物止痛药可以减少急性疼痛的家庭阿片类药物处方， 并帮助寻求断奶的慢性疼痛患者。急性和慢性下腰痛是最严重的 短期和长期残疾的常见来源。阿片类药物是常见的处方药，但并不比非阿片类药物好 令人上瘾的慢性下腰痛解决方案。神经调节(寒冷、高频振动、低频 全身振动、指压)、加热和支持对许多人来说都是有效的，但目前还没有一种设备结合在一起 这些止痛的多种方式。最近的一项研究发现，一种通过手术放置的神经调节装置 显著减少慢性下腰痛患者的阿片类药物使用。下背部疼痛将是 测试外部多模式神经调节性疼痛的最有效临床方案 缓释剂对首次和慢性阿片类药物使用的影响。 慢性疼痛的患者报告说，随着时间的推移，多种止痛策略都会受益。因为有了 选项提高了控制感，理想的止痛装置应结合多种疼痛 救济方式，以减少灾难。为了缓解剧痛，我们创造了一个由NICHD资助的“嗡嗡” 结合高频振动和冰的神经调节装置，现已被证明有效超过28 独立的临床试验。为了解决腰痛，我们的“DuoTherm”设备结合了Buzy 频率，冷，热，穴位，和两个额外的频率。32名受试者的初步数据 表现出显著和持续的疼痛减轻，对振动频率有明显的偏好，以及 对该产品有强烈的商业需求。该项目将开发并临床评估DuoTherm，以及 创新的阿片类药物节制疗法。这种患者控制的外部神经调节装置将是 旨在解决急性和慢性LBP。在验证了DuoTherm有效的止痛效果后 与安慰剂相比，我们将测试一种有效的下腰痛缓解设备是否减少阿片类药物的使用 适用于急、慢性腰痛患者。

Project Summary The goal of this project is to develop a multimodal neuromodulatory opioid-sparing device for low back pain, demonstrate effective pain relief, then evaluate opioid reduction for patients with acute or chronic back pain presenting for treatment. Pain and opioid use disorder (OUD) are intricately related: dependence begins for up to 80% with medications prescribed for pain, either directly or through pills left in circulation. Currently, there is no proven approach to help reduce long-term opioid use for patients with chronic non-cancer pain. What is known is that prescriptions of opioids for acute low back pain are a factor in eventual OUD, and unused opioids in circulation are increasingly abused for non-medical reasons. For the already dependent with chronic pain, one barrier to reduction is fear of ongoing or increasing pain. An effective non-pharmaceutical pain reliever could reduce home opioid prescriptions for acute pain, and aid chronic pain patients seeking to wean. Acute and chronic low back pain are among the most common sources of short and long term disability. Opioids are commonly prescribed, but no better than non- addictive solutions for chronic low back pain. Neuromodulation (cold, high frequency vibration, low frequency whole body vibration, acupressure), heat, and support are effective for many, but no current device combines these multiple modalities of pain relief. One recent study found a surgically placed neuromodulatory device significantly decreased opioid use for patients with chronic low back pain. Low back pain would be the most impactful clinical scenario in which to test an external multi-modal neuromodulatory pain reliever for its impact on initial and chronic opioid use. Patients with chronic pain report benefitting from multiple pain relief strategies over time. Because having options improves the perception of control, the ideal pain relief device would incorporate multiple pain relieving modalities to reduce catastrophizing. To relieve sharp pain, we created an NICHD-funded “Buzzy” neuromodulatory device combining high frequency vibration and ice, now proven effective in over 28 independent clinical trials. To address low back pain, our “DuoTherm” device incorporates the Buzzy frequency, cold, heat, acupressure, and two additional frequencies. Preliminary data from 32 subjects demonstrated substantial and sustained pain reduction, distinct preferences for vibration frequencies, and strong commercial desire for the product. This project will develop and clinically evaluate DuoTherm, an innovative opioid-sparing therapeutic. This patient-controlled external neuromodulation device will be designed to address acute and chronic LBP. After validating effective pain relief with DuoTherm compared to placebo, we will test whether an effective low back pain relief device reduces opioid use for acute and chronic low back pain patients.