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

情境效应在针灸治疗腰痛中的作用/J.Kong

• 批准号: 8496732
• 负责人: BRUCE R ROSEN
• 金额: $ 42.74万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8496732
• 关键词: Acupuncture procedure; Attention; Back; Biological Markers; Brain; Caring; Chronic low back pain; Clinical; Clinical Treatment; Communities; Diagnostic Procedure; Disease; Failure; Functional Magnetic Resonance Imaging; Future; Guidelines; Health; Mainstreaming; Medical; Methods; Outcome; Patients; Placebos; Population; Provider; Randomized; Randomized Controlled Trials; Relative (related person); Ritual compulsion; Role; Spin Labels; Techniques; Translating; Work; alternative treatment; arm; base; chronic pain; clinical effect; expectation; neuroimaging; novel; relating to nervous system; research study; treatment effect

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.

最近的大型随机对照试验（RCT）cLBP表明，针灸是上级的最佳指南为基础的主流护理和候补对照。然而，医学界接受针灸作为一种治疗选择一直受到阻碍，未能找到显着的临床差异之间的verum和假（安慰剂）针灸。重要的是，尽管它们的临床效果相似， 从我们和其他小组的研究发现，真实的和假针灸治疗通过不同的大脑机制产生治疗效果。 同时，以前的研究表明，背景（即，治疗的广泛的非特异性效果（包括患者-医生关系、期望、温暖、支持、关注和精心制作的仪式）可以对许多疾病具有显著和有意义的影响。我们小组最近使用针灸作为治疗方法的RCT试验也表明，相对于有限的提供者参与提供的治疗，增强背景效应提供的治疗显著增加了 临床获益。针灸疗效可以系统地改变上下文的相对容易，使针灸成为未来上下文实验的理想选择。值得注意的是，神经纵向机制的两个上下文条件（有限与增强）尚未得到研究。 我们建议使用动脉自旋标记（ASL）和BOLD fMRI的尖端神经影像学技术对cLBP患者进行一项新的机制纵向2x2析因研究。80名cLBP患者将被随机分配到五个组之一：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”真针灸D）有限背景”真针灸。终点将包括临床cLBP结局和神经影像学 生物标志物。我们相信，这项研究将阐明背景效应和针灸的机制，可能转化为最大化的临床治疗效益cLBP和/或使用替代治疗。