Promoting Effective Self-Management of Chronic Pain with mHealth Neurofeedback

通过移动健康神经反馈促进慢性疼痛的有效自我管理

• 批准号: 10622471
• 负责人: ERIC B. ELBOGEN
• 金额: $ 40.25万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-16 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10622471
• 关键词: 18 year old; Adult; Alprostadil; American; Autonomic nervous system; Back; Biofeedback; Biometry; Bluetooth; Brain; Chronic; Chronic low back pain; Clinic; Clinic Visits; Clinical Trials; Collaborations; Data; Development; Devices; Double-Blind Method; Electroencephalography; Environment; Family; Goals; Health; Home; Individual; Intervention; Link; Low Back Pain; Measures; Mediating; Medical; Mobile Health Application; Names; Occupational; Outcome; Pain; Pain Clinics; Pain Research; Pain intensity; Pain interference; Pain management; Participant; Patient Education; Patients; Persons; Pharmacological Treatment; Physical Function; Physiological; Placebo Control; Placebo Control Effect; Placebos; Quality of life; Randomized; Randomized, Controlled Trials; Relaxation; Reporting; Research; Research Personnel; Risk; Role; Self Efficacy; Self Management; Serious Adverse Event; Signal Transduction; Speed; Technology; Testing; Time; Touch sensation; Training; Translating; Travel; United States National Institutes of Health; Universities; Visual; Vocation; Walking; auditory feedback; barrier to care; chronic pain; chronic pain management; chronic pain patient; comparison group; cost; effective therapy; effectiveness testing; emotional distress; foot; functional improvement; handheld mobile device; improved; innovation; mHealth; mHealth self-management; meetings; mobile application; neurofeedback; novel; opioid abuse; pain outcome; pain reduction; pain self-management; patient registry; pharmacologic; portability; randomized trial; randomized, clinical trials; safe patient; social; symptom self management; tool; validation studies

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.

摘要 五分之一的美国人患有慢性疼痛。存在许多药物疼痛干预措施，但会增加阿片类药物的风险 虐待迫切需要找到安全，方便和有效的治疗方法，让患者自我管理疼痛。 神经反馈或脑电图（EEG）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。虽然神经反馈传统上需要前往诊所， 在过去的十年中，便携式EEG耳机已经被验证可以读取脑波并通过 蓝牙到移动的设备。我们开发了一个移动的健康（mHealth）平台， 在家中进行神经反馈以自我管理疼痛。患有慢性疼痛的患者，大多数患有腰痛， 能够独立进行移动的神经反馈，使用三个月后， 更低的疼痛强度和更低的疼痛干扰。在当前的R01申请中，我们将进行双盲 随机对照试验，以测试移动的神经反馈对疼痛结果的影响。N=150名成人， 慢性下背痛将被随机分配到移动的神经反馈或安慰剂对照条件。每个 受试者将收到一个便携式EEG耳机和配备有称为的移动的应用程序（app）的移动终端 “移动的神经反馈”，并被要求完成10分钟的会议，每周至少4天，持续12周。 实验条件涉及一个移动的应用程序，该应用程序提供听觉反馈信号EEG alpha功率 高于阈值水平并表示生理放松状态。控制条件涉及视觉上的 将相同的移动的应用程序与预先记录的一组实际神经反馈会话相结合（即，安慰剂）。数据将 在0、3、6和9个月时采集。我们假设被随机分配到实验条件的参与者 将显示疼痛强度和疼痛干扰的更大降低以及速度的更大增加， 与对照条件下的参与者相比，在3、6和9个月时的身体功能和EEG α功率。 我们还假设疼痛自我效能感将介导参与者疼痛结果的变化 随机分配到实验条件下。这项研究是创新的，因为它测试了一种新的mHealth工具， 独特地使得患者能够容易且安全地进行疼痛的自我管理。这项研究进展 通过严格测试尖端，实用的移动健康工具的有效性，以提高生活质量， 慢性腰痛患者。移动的神经反馈使患者能够积极参与管理 他们自己的健康，因此显示出减少诊所就诊的希望。预期成果是制定一项 便携式，低成本，非药物干预开创了一个新的框架来治疗疼痛。通过应用 移动健康技术的自我管理疼痛治疗，这项研究进一步NINR的战略目标， 国家疼痛战略。如果这项研究产生积极的结果，它将证明移动的神经反馈 有可能从根本上改变患者有效自我管理慢性疼痛的能力。