Brain Imaging-Acupuncture and Osteoarthritis

描述(由申请人提供)：越来越多的临床试验支持针灸作为治疗疼痛和其他疾病过程的一种医学治疗形式的使用。最近在动物和人类上的实验研究已经开始证明与针灸相关的一些可测量的生理效应，这表明神经生理学解释的可能性。此外，大脑研究继续发现一套复杂的内源性神经控制系统，因此，大脑在疼痛感知和控制的调制中发挥着重要作用已经变得明显。如果针灸能够被证明对大脑的特定区域有一致的效果，那么就有可能根据可测量的神经生理反应来探索针灸的潜在疗效。 脑功能成像的发展为研究人类大脑在受控条件下的活动提供了几种方法。测量脑血流量(CBF)变化的功能成像技术被认为反映了大脑功能中局部活动的增加。单光子发射计算机断层扫描(SPECT)和几种功能磁共振成像(f-MRI)方法开始定义CBF变化与疼痛体验相关的大脑区域，也有关于针灸的初步数据。但与疼痛和针灸有关的一致的路径和结构还没有被定义。为了仔细探索针灸疗法中脑血流变化的意义，脑部扫描应该与临床试验中的临床反应相关联，该临床试验环境是一种常见的、明确的、容易诊断的疼痛状况，已被证明对针灸有反应。最近发表的一项膝关节骨关节炎(OA)的对照但非盲目临床试验显示，与站立护理相比，它具有一定的疗效，很可能是一个很好的模式。 然而，在试图设计一项更大规模的确定性试验之前，需要关于特定模型的基本信息。所需要的信息包括：1)与正常受试者(没有疼痛)相同的针灸相比，针灸治疗膝骨性关节炎时，大脑中是否有任何一致的区域显示出CBF的变化；2)与接受安慰剂针刺的盲人对照组相比，针灸治疗膝骨性关节炎的患者组是否有一致的变化；3)由于SPECT和f-MRI在此类研究中的风险和益处有很大的不同，SPECT和f-MRI是否都能提供类似的信息。确定感兴趣的领域和使用的技术，将允许全面研究针灸疗法对脑血流的影响。

DESCRIPTION (provided by applicant): The use of acupuncture has been developing an increasing acceptance as a form of medical therapy to treat pain and other disease processes, supported by a growing number of clinical trials. Recent experimental studies in both animal and humans have begun to demonstrate some measurable physiologic effects that are associated with acupuncture, suggesting the possibility of a neurophysiologic explanation. In addition, brain research continues to uncover a complex set of endogenous neurologic control systems, such that it has become clear that the brain plays a major role in the modulation of pain perception and control. If acupuncture can be demonstrated to have a consistent effect on specific areas of the brain, it will become possible to explore the potential efficacy of acupuncture based on measurable neurophysiologic responses. The development of functional brain imaging has provided several methods of studying the activity of the human brain under controlled conditions. Functional imaging techniques that measure changes in cerebral blood flow (CBF) are thought to reflect focal increased activity in brain function. Single photon emission computed tomography (SPECT), and several methods of functional magnetic resonance imaging (f-MRI) begun to define the brain regions where changes in the CBF are associated with the experience of pain, with preliminary data on acupuncture as well. But consistent pathways and structures with pain and acupuncture have not been defined. In order to carefully explore the significance of changes that occur in CBF with acupuncture therapy, the brain scans should be correlated with clinical response in a clinical trial setting of a common, well defined, and easily diagnosed painful condition which has been shown to respond to acupuncture. A recently published controlled but unblinded clinical trial of osteoarthritis (OA) of the knee has shown some efficacy vs stand care, and is likely to be a good model. However, basic information is required about the specific model before trying to design a study larger definitive trial. The information required include: 1) If there are any consistent areas of the brain that show CBF changes when acupuncture is used in knee OA compared to identical acupuncture in normal subjects (without pain); 2) If there are consistent changes in the acupuncture treated knee OA group compared to a blinded control group treated with placebo acupuncture; and 3) since SPECT and f-MRI have substantially different risks and benefits for such a study, do both SPECT and f-MRI provide similar information. Defining the areas of interest and the techniques to use, will allow a comprehensive study of the effect on CBF of acupuncture therapy.