Promoting Effective Self-Management of Chronic Pain with mHealth Neurofeedback

摘要 五分之一的美国人患有慢性疼痛。存在许多药理疼痛干预措施，但会增加阿片类药物的风险 虐待。迫切需要为患者找到安全、可获得和有效的治疗方法来自我管理疼痛。 神经反馈，或脑电生物反馈，通过训练患者调节大脑来治疗疼痛 与生理放松有关的状态。尽管神经反馈传统上需要前往诊所，但在 在过去的十年里，便携式EEG耳机已经得到验证，可以读取脑电波并通过 蓝牙连接到移动设备。我们开发了移动健康(MHealth)平台，使慢性病患者能够 疼痛在家中进行神经反馈，自我管理疼痛。患有慢性疼痛的患者，大多数为下腰痛， 能够独立进行移动神经反馈，在使用三个月后，报告显示 较低的疼痛强度和较低的疼痛干扰。在目前的R01应用中，我们将进行双盲 随机对照试验，以测试移动神经反馈对疼痛结局的影响。N=150名成年人 慢性下腰痛将随机分配到运动神经反馈或安慰剂对照条件下。每个人 参赛者将获得便携式脑电耳机和配备移动应用程序(APP)的移动设备 “移动神经反馈”，并被要求在12周内每周至少4天完成10分钟的治疗。 实验条件包括一个移动应用程序，它提供听觉反馈信号EEG阿尔法功率 高于阈值的，表示生理上放松的状态。控制条件包括视觉上的 相同的移动应用程序连接到一组预先记录的实际神经反馈会话(即安慰剂)。数据将是 在0、3、6和9个月时收集。我们假设参与者随机进入实验状态 在测试中将显示疼痛强度和疼痛干扰的更大程度的降低和速度的更大提高 在3、6和9个月时与对照组的参与者进行身体功能和脑电阿尔法功率的比较。 我们还假设疼痛自我效能感将在参与者中调节疼痛结果的变化。 随机化到实验条件。这项研究具有创新性，因为它测试了一种新的mHealth工具， 独一无二的，使患者能够轻松、安全地自我管理疼痛。这项研究进展 通过严格测试尖端、实用的mHealth工具的有效性来提高 患有慢性腰背痛的患者。移动神经反馈使患者成为管理的积极参与者 他们自身的健康，因此显示出减少诊所就诊的希望。预期的结果是发展一种 便携式、低成本、非药物干预开创了治疗疼痛的新框架。通过应用 将mHealth技术用于自我管理的疼痛治疗，这项研究进一步促进了NINR和 美国国立卫生研究院国家疼痛战略。如果这项研究产生积极的结果，它将证明移动神经反馈 有可能从根本上改变患者有效自我管理慢性疼痛的能力。

ABSTRACT One in five Americans has chronic pain. Many pharmacological pain interventions exist but increase risk of opioid abuse. There is a critical need to find safe, accessible, and effective treatments for patients to self-manage pain. Neurofeedback, or electroencephalogram (EEG) biofeedback, treats pain by training patients to regulate brain states linked to physiological relaxation. Although neurofeedback has traditionally required travel to clinics, in the past decade, portable EEG headsets have been validated that read brainwaves and send signals via Bluetooth to mobile devices. We developed a mobile health (mHealth) platform enabling patients with chronic pain to conduct neurofeedback at home to self-manage pain. Patients with chronic pain, most with low back pain, were able to conduct mobile neurofeedback independently, and after three months of use, reported significantly lower pain intensity and lower pain interference. In the current R01 application, we will conduct a double-blind randomized controlled trial to test the effects of mobile neurofeedback on pain outcomes. N=150 adults with chronic low back pain will be randomly assigned to mobile neurofeedback or a placebo-control condition. Each participant will receive a portable EEG headset and mobile device outfitted with a mobile application (app) called ‘Mobile Neurofeedback’ and be asked to complete 10-minute sessions at least 4 days per week for 12 weeks. The experimental condition involves a mobile app that provides auditory feedback signaling EEG alpha power above a threshold level and denoting a physiologically relaxed state. The control condition involves a visually identical mobile app yoked to a pre-recorded set of actual neurofeedback sessions (i.e., placebo). Data will be collected at 0, 3, 6, and 9 months. We hypothesize that participants randomized to the experimental condition will show greater decrease in pain intensity and pain interference and greater increase in speed on a test of physical function and EEG alpha power at 3, 6, and 9 months compared to participants in the control condition. We also hypothesize that pain self-efficacy will mediate changes in pain outcomes among participants randomized to the experimental condition. This research is innovative because it tests a novel mHealth tool that uniquely enables self-management of pain to be performed easily and safely by patients. This study advances the field by rigorously testing effectiveness of a cutting-edge, practical mHealth tool to improve quality of life for patients with chronic low back pain. Mobile neurofeedback enables patients to be active participants in managing their own health and therefore shows promise to reduce clinic visits. The expected outcome is development of a portable, low-cost, non-pharmacological intervention pioneering a new framework to treat pain. By applying mHealth technology to a self-management pain treatment, this study furthers strategic goals of NINR and the NIH National Pain Strategy. If this study yields positive results, it would demonstrate that mobile neurofeedback has potential to fundamentally change patients’ ability to effectively self-manage chronic pain.