家庭脑电图神经反馈治疗慢性疼痛：随机对照临床试验。

IF 4 2区医学 Q1 CLINICAL NEUROLOGY

Journal of Pain Pub Date : 2024-08-21 DOI:10.1016/j.jpain.2024.104651

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引用次数: 0

摘要

这项平行、双臂、盲法随机对照优越性试验研究了在常规治疗的基础上，主动脑电图神经反馈（EEG NFB）治疗慢性疼痛是否比假对照 EEG NFB 更安全、更有效。116 名慢性疼痛患者被随机分配（1:1）到常规护理加≥ 32 次主动脑电图神经反馈（EEG NFB）疗程（相对于 C4 的阿尔法功率上调）或常规护理加≥ 32 次假对照脑电图神经反馈（EEG NFB）疗程。按方案进行的分析表明，在主要结果--简短疼痛清单（BPI）平均疼痛（平均差异[95% CI]：-0.04 [-0.39 至 0.31]，P=0.90）或任何次要结果方面，组间差异均无显著性。但是，主动-EEG NFB 组 44% 的参与者和对照-EEG NFB 组 45% 的参与者报告 BPI 平均疼痛至少有中度（≥30%）、临床上重要的改善。两组的治疗突发不良事件数量相似（p = 0.83），且无严重不良事件。事后分析显示，在训练期间，两组的相对α功率都有类似的上调，积极EEG组在100%的时间内都获得了一致的积极奖励，而对照EEG组则在约25%的时间内获得了一致的积极奖励，这表明存在部分积极的假干预。在常规护理的基础上，本研究中使用的主动-EEG 无创脑电图干预并不比假性对照-EEG 无创脑电图干预更有优势。不过，两组中都有很大一部分参与者表示疼痛强度有了临床意义上的降低。部分活跃的假干预可能掩盖了组间差异。该干预措施无重大副作用，未发现任何安全问题。展望：这项研究是首次尝试对阿尔法脑电图 NFB 治疗慢性疼痛进行适当盲法、随机、假对照试验。研究结果可能会引起慢性疼痛患者和参与慢性疼痛治疗的临床医生的兴趣，并为未来脑电图 NFB 试验的设计提供参考。试验注册：澳大利亚-新西兰临床试验注册中心（ANZCTR）：ACTRN12621000667819。

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Home-based EEG Neurofeedback for the Treatment of Chronic Pain: A Randomized Controlled Clinical Trial

This parallel, 2-arm, blinded, randomized controlled superiority trial examined whether, when added to usual care, active-electroencephalography neurofeedback (EEG NFB) was safe and more effective than sham control-EEG NFB for chronic pain. In total, 116 participants with chronic pain were randomly assigned (1:1) to usual care plus ≥32 sessions of active-EEG NFB upregulating relative alpha power over C4 or usual care plus ≥32 sessions of sham control-EEG NFB. Per-protocol analyses revealed no significant between-group differences in the primary outcome, Brief Pain Inventory average pain (mean difference [95% confidence interval]: −.04 [−.39 to .31], P = .90), or any secondary outcomes. However, 44% of participants in the active-EEG NFB group and 45% in the control-EEG NFB group reported at least a moderate (≥30%), clinically important improvement in Brief Pain Inventory average pain. The number of treatment-emergent adverse events were similar in both groups (P = .83), and none were serious. Post hoc analyses revealed similar upregulated relative alpha power in both groups during training, with concordant positive rewards delivered to the active-EEG group 100% of the time and the control-EEG group ∼25% of the time, suggesting a partially active sham intervention. When added to usual care, the active-EEG NFB intervention used in this study was not superior to the sham control-EEG NFB intervention. However, a large proportion of participants in both groups reported a clinically important reduction in pain intensity. A partially active sham intervention may have obscured between-group differences. The intervention was free of important side effects, with no safety concerns identified.

Perspective

This study is the first attempt at an appropriately blinded, randomized, sham-controlled trial of alpha EEG NFB for the treatment of chronic pain. The findings may interest people living with chronic pain, clinicians involved in chronic pain management, and may inform the design of future EEG NFB trials.

Trial Registration

Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000667819.

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来源期刊

Journal of Pain 医学-临床神经学

CiteScore

6.30

自引率

7.50%

发文量

441

审稿时长

42 days

期刊介绍： The Journal of Pain publishes original articles related to all aspects of pain, including clinical and basic research, patient care, education, and health policy. Articles selected for publication in the Journal are most commonly reports of original clinical research or reports of original basic research. In addition, invited critical reviews, including meta analyses of drugs for pain management, invited commentaries on reviews, and exceptional case studies are published in the Journal. The mission of the Journal is to improve the care of patients in pain by providing a forum for clinical researchers, basic scientists, clinicians, and other health professionals to publish original research.