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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.

使用外部多模式神经调节装置解决阿片类药物使用障碍：DuoTherm 的开发和临床评估，用于急性和慢性腰痛的阿片类药物节约。

基本信息

批准号：
10193957
负责人：
Amy Lynn Baxter
金额：
$ 8.94万
依托单位：
MMJ LABS, LLC
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 2023-03-31
项目状态：
已结题

项目摘要

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.

项目摘要本项目的目标是开发一种多模式神经调节阿片类药物保留装置，用于低血压。背部疼痛，证明有效的疼痛缓解，然后评估急性或慢性疼痛患者的阿片类药物减少情况。慢性背痛需要治疗疼痛和阿片类药物使用障碍（OUD）是错综复杂的相关：高达80%的患者开始依赖止痛药，无论是直接还是通过留在体内的药片。流通目前，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，慢性非癌症疼痛目前已知的是，阿片类药物治疗急性腰痛是一个因素，最终的OUD和流通中未使用的阿片类药物越来越多地因非医疗原因被滥用。为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。一个有效非药物止痛药可以减少急性疼痛的家庭阿片类药物处方，帮助慢性疼痛患者断奶。急性和慢性腰痛是最常见的短期和长期残疾的共同来源。一般来说，鸦片类药物是处方药，但并不比非处方药好。慢性腰痛的成瘾性解决方案。神经调节（冷、高频振动、低频全身振动、穴位按摩）、加热和支撑对许多人都有效，但目前没有一种设备结合这些多种形式的疼痛缓解。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态神经调节疼痛的最有效临床场景缓解其对初始和慢性阿片类药物使用的影响。随着时间的推移，慢性疼痛患者报告受益于多种疼痛缓解策略。因为拥有选项提高了控制的感觉，理想的疼痛缓解设备将包括多种疼痛缓解方式，以减少灾难化。为了缓解剧烈疼痛，我们创造了一个由NICHD资助的"嗡嗡声" 一种结合高频振动和冰的神经调节装置，现已被证明在28多个国家有效。独立的临床试验。为了解决腰痛问题，我们的"DuoTherm"设备结合了Buzzy 频率，冷，热，指压，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，对振动频率的明显偏好，以及对产品有强烈的商业欲望。该项目将开发和临床评估DuoTherm，创新的阿片类药物节省治疗。该患者控制的外部神经调节装置将旨在解决急性和慢性LBP。在验证DuoTherm有效缓解疼痛后与安慰剂相比，我们将测试有效的腰痛缓解装置是否会减少阿片类药物的使用。用于急性和慢性腰痛患者。