Treatment of chronic low back pain with transcutaneous auricular vagus nerve stimulation

摘要 腰痛(LBP)是美国所有医生就诊的最常见原因之一。财务成本 与LBP的护理相关的问题是令人震惊的。慢性下腰痛(CLBP)的治疗方法远远不是 令人满意。保险索赔数据显示，阿片类药物是最常见的处方药物类别 背部疼痛，超过一半的常规阿片类药物使用者报告使用它们治疗背痛。 与此同时，近五年来，几乎没有新的非阿片类药物和非成瘾止痛药被开发出来 几十年；因此，迫切需要开发治疗慢性下腰痛的新疗法。 迷走神经(VN)由一个复杂的网络组成，它调节疼痛、情绪和神经内分泌- 免疫轴。研究表明，耳廓经皮迷走神经刺激(TVNS)是一种无创的 治疗方法，可以诱导抗伤害性感觉，这可能会影响外周和中枢伤害性感觉， 炎症反应、自主神经活动和疼痛相关行为。临床研究和我们的初步研究 还表明，tVNS可以显著减少慢性疼痛的症状和常见的 治疗慢性疼痛，如抑郁和焦虑，从而证实了其治疗慢性下腰痛的潜力。 本研究旨在探讨TVNS对慢性腰背痛的治疗作用及其机制。 疼痛。慢性下腰痛患者将随机接受真实或虚假的TVNS治疗 一个月，并进行三个月的随访。除了临床结果测量外，多重脑成像 将评估医疗模式、定量感觉测试和血液炎症标记物。我们相信 这项研究如果成功，将为慢性下腰痛提供新的治疗选择，减少阿片类药物的使用 止痛药在慢性疼痛治疗中的作用，并加深我们对tVNS潜在机制的理解 治疗，以及慢性疼痛的病理生理学和发展。

Summary Low back pain (LBP) is one of the most common reasons for all physician visits in the USA. The financial costs associated with the care of LBP are staggering. The treatments for chronic low back pain (cLBP) are far from satisfactory. Insurance claims data reveal that opioids are the most commonly prescribed class of drug for back pain, and more than half of regular opioid users reported using them for the treatment of back pain. Meanwhile, few new non-opioid and non-addictive pain medications have been developed in nearly five decades; thus, there is an urgent need for the development of new therapies for chronic low back pain. The vagus nerve (VN) consists of a complex network that regulates pain, mood, and the neuro-endocrine- immune axis. Studies suggest that auricular transcutaneous vagus nerve stimulation (tVNS), a non-invasive therapeutic method, can induce antinociception, which may affect peripheral and central nociception, inflammatory responses, autonomic activity, and pain-related behavior. Clinical studies and our pilot study have also shown that tVNS can significantly reduce symptoms of chronic pain and common comorbidities of chronic pain, such as depression and anxiety, thereby endorsing its potential for the treatment of cLBP. This proposal aims to investigate the treatment effect and underlying mechanism of tVNS on chronic low back pain. Patients with chronic low back pain will be randomized to either real or sham tVNS treatment for one month, with a three-month follow up. In addition to clinical outcome measurements, multiple brain imaging modalities, Quantitative Sensory Testing, and blood inflammation markers will be assessed. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of tVNS treatment, as well as the pathophysiology and development of chronic pain.