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: 10364125
• 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/10364125
• 关键词: 18 year old; Adult; Alprostadil; American; Autonomic nervous system; Biofeedback; Biometry; Bluetooth; Brain; Chronic; Clinic; Clinic Visits; Clinical Trials; Data; Development; Devices; Double-Blind Method; Electroencephalogram; Environment; Equilibrium; Family; Goals; Health; Health Technology; Home; Individual; Intervention; Life; Link; 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; Pharmacology; 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; Testing; Time; Touch sensation; Training; Training Support; Translating; Travel; United States National Institutes of Health; Universities; Walking; auditory feedback; barrier to care; chronic pain; chronic pain management; chronic pain patient; comparison group; cost; effective therapy; effectiveness testing; emotional distress; foot; handheld mobile device; improved; improved functioning; innovation; mHealth; mHealth self-management; meetings; mobile application; neurofeedback; novel; opioid abuse; pain outcome; pain reduction; pain self-management; patient registry; portability; randomized trial; 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