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

经皮耳迷走神经刺激治疗慢性腰痛

• 批准号: 9916746
• 负责人: JIAN KONG
• 金额: $ 25.2万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9916746
• 关键词: Affect; Aftercare; Amygdaloid structure; Analgesics; Anxiety; Back Pain; Behavior; Biological; Blood; Brain; Brain imaging; Brain region; Caring; Cerebrovascular Circulation; Chronic low back pain; Clinical; Clinical Research; Clinical assessments; Complex; Data; Development; Ear; Economics; Emotions; Financial cost; Functional Magnetic Resonance Imaging; Functional disorder; Hypothalamic structure; Immune; Immune system; Inflammatory Response; Insula of Reil; Lateral; Low Back Pain; Measurement; Medial; Mental Depression; Methods; Middle Hypothalamus; Moods; Neurosciences; Neurosecretory Systems; Nociception; Opioid; Opioid Analgesics; Outcome; Pain; Pain Management Method; Pain intensity; Patients; Peripheral; Pharmaceutical Preparations; Physicians; Pilot Projects; Play; Prefrontal Cortex; Public Health; Randomized; Reporting; Rest; Role; Sensory; Signal Transduction; Somatosensory Cortex; Symptoms; Testing; Therapeutic; Therapeutic Effect; Vagus nerve structure; Ventral Striatum; Visit; base; chronic pain; chronic pain management; cingulate cortex; comorbidity; conditioned pain modulation; disability; follow-up; imaging modality; inflammatory marker; insurance claims; midbrain central gray substance; neuroimaging; non-opioid analgesic; novel; novel therapeutics; opioid user; pain patient; pain relief; prescription opioid; pressure; putamen; reduce symptoms; social; treatment effect; vagus nerve stimulation; welfare

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.

总结 下背痛（LBP）是美国所有医生就诊的最常见原因之一。财务成本 与LBP护理相关的问题令人震惊。慢性腰痛（cLBP）的治疗方法还远远没有达到 满意保险索赔数据显示，阿片类药物是最常见的处方类药物， 超过一半的阿片类药物常规使用者报告使用它们治疗背痛。 与此同时，在近五年的时间里，几乎没有新的非阿片类和非成瘾性止痛药被开发出来。 因此，迫切需要开发用于慢性腰痛的新疗法。 迷走神经（VN）由一个复杂的网络组成，调节疼痛，情绪和神经内分泌， 免疫轴。研究表明，耳经皮迷走神经刺激（tVNS），一种非侵入性 治疗方法，可以诱导抗伤害感受，其可以影响外周和中枢伤害感受， 炎症反应、自主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可以显着减少慢性疼痛的症状和常见的合并症， 慢性疼痛，如抑郁和焦虑，从而支持其治疗cLBP的潜力。 本研究旨在探讨tVNS对慢性下腰痛的治疗效果及机制 痛苦慢性腰痛患者将随机接受真实的或假tVNS治疗， 一个月，三个月的随访。除了临床结果测量外， 将评估形态、定量感觉测试和血液炎症标志物。我们认为 这项研究如果成功，将为慢性腰痛提供新的治疗选择，减少阿片类药物的使用， 镇痛药在慢性疼痛管理中的应用，并加强我们对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。