The Role of Context Effect in Acupuncture Treatment of Low Back/J.Kong

最近针对慢性下腰痛的大型随机对照试验(RCT)表明，针灸优于基于最优指南的主流护理和等待名单对照。然而，由于未能发现真针和假(安慰剂)针灸之间的显著临床差异，医学界对针灸作为一种治疗选择的接受受到了阻碍。重要的是，尽管它们的临床效果相似，但研究 来自我们和其他小组的研究发现，真实和虚假的针灸治疗通过不同的大脑机制产生治疗效果。 同时，以前的研究已经证明，环境(即治疗的广泛非特定影响，包括患者与医生的关系、期望、温暖、支持、关注和复杂的仪式)可以对许多障碍产生重大和有意义的影响。我们小组最近使用针灸作为治疗方法的RCT试验也表明，相对于有限提供者参与提供的治疗，具有增强上下文效应的治疗产生了显著的增加 临床益处。针灸疗效可以相对容易地根据背景而系统地改变，这使得针灸成为未来背景实验的理想选择。值得注意的是，两种背景条件(有限和增强)背后的神经纵向机制尚未被研究。 我们建议使用动脉自旋标记(ASL)和BOLD功能磁共振成像技术对cLBP患者进行一项新的机械性纵向2x2因子研究。80名慢性下腰痛患者将被随机分为五组：A)“增强背景”安慰剂(假针灸)；B)“有限背景”安慰剂(假针灸)；C)“增强背景”真针刺D)有限背景“真针刺”。终点将包括临床cLBP结果和神经成像。 生物标志物。我们相信，这项研究将阐明上下文效应和针灸的潜在机制，潜在地转化为cLBP临床治疗益处的最大化和/或替代疗法的使用。

Recent large randomized controlled trials (RCTs) for cLBP indicate that acupuncture is superior to both optimal guideline-based mainstream care and waitlist controls. Yet, the medical community's acceptance of acupuncture as a treatment option has been hampered by a failure to find significant clinical differences between verum and sham (placebo) acupuncture. Importantly, despite their similar clinical effect, studies from both our and other groups found that real and sham acupuncture treatments work through different brain mechanisms to produce treatment effect. In parallel, previous studies have demonstrated that context (i.e., the broad non-specific effects of treatment ncluding patient-practitioner relationship, expectation, warmth, support, attention, and elaborate ritual) can have significant and meaningful impact on many disorders. Recent RCT trials by our group using acupuncture as the method of treatment also demonstrated that, relative to treatment delivered with a limited provider engagement, treatment delivered with augmented context effect produces a significant increase in clinical benefit. The relative ease by which acupuncture efficacy can be systematically varied by context makes acupuncture an ideal choice for future context experiments. Notably, neural longitudinal mechanisms underlying the two context conditions (limited versus augmented) have yet to be studied. We propose to conduct a novel mechanistic longitudinal 2x2 factorial study on cLBP patients using the cutting edge neuroimaging technique of arterial spin labeling (ASL) and BOLD fMRI. Eighty patients with cLBP will be randomized to one of five arms: A) "augmented context" placebo (sham acupuncture); B) "limited context" placebo (sham acupuncture); C) "augmented context" verum acupuncture D) limited context" verum acupuncture. The endpoints will include both clinical cLBP outcomes and neuroimaging biomarkers. We believe that this study will elucidate the mechanisms underlying both context effect and acupuncture, potentially translating to maximization of clinical treatment benefits for cLBP and/or use of alternative treatments.