A Method for Evaluating Acupuncture Therapy in Pain Management

描述（由申请人提供）：针灸已越来越多地用作治疗包括疼痛在内的临床疾病的补充和替代医学的方式。然而，针灸治疗的临床效果仍然难以评估。在寻找针灸治疗的信息和临床相关的结果测量时，重要的是区分临床结果测量和反映针灸对生物学效应的那些测量（例如，生物标志物）和/或生理反应。一个翻译工具，用于评估针灸治疗的有效性，应预期弥合差距之间的差距，针灸的临床前和临床研究，以及传统医学和替代医学。在这方面，定量感觉测试（QST）是一个公认的心理物理结果的措施，已被广泛用于评估临床疼痛的传统药物的效果。QST提供了关于疼痛强度和疼痛影响的有价值的信息，当与其他临床工具（例如，疼痛量表），可以用作标准的研究和临床工具。迄今为止，QST很少被用作临床针灸治疗的结果测量。在此应用中，我们建议开发一种新的方法来评估针灸治疗的有效性，通过整合独特的心理物理特征的QST反应（QST反应）与疼痛症状缓解的临床证据（临床反应）。这一方法将用于区分针灸的生理和生物效应及其对临床疼痛症状缓解的影响。本研究将通过一系列综合性和互补性的实验来检验这一方法，具体目标如下：（1）评估QST作为评估针灸与“假”针灸对临床疼痛的影响的工具：（2）探讨QST在“针灸信徒”和“针灸非信徒”之间针灸结果测量中的作用;（3）使用标准QST方案比较针灸与常规药物对临床疼痛的影响;以及（4）比较QST反应和伤害感受的生物标志物（例如，白细胞介素）和抗伤害感受（例如，疼痛受试者在针灸治疗前后的血清中的-内啡肽水平。这项研究项目将产生有价值的信息，研究和临床评估工具，可用于比较针灸（其他形式的替代医学以及）和传统医学之间的临床疼痛的治疗效果。 公共卫生相关性：近年来，针灸作为治疗许多临床疾病的补充和替代医学的方式在美国得到了普及。 包括疼痛在内的症状。然而，针灸治疗的临床效果仍然难以评估。在这个项目中，将开发一种新的方法来评估针灸治疗的有效性。这种新的方法可以用来比较针灸（其他形式的替代医学以及）和传统医学之间的临床疼痛的治疗效果。

DESCRIPTION (provided by applicant): Acupuncture has been increasingly used as a modality of complementary and alternative medicine for treating clinical conditions including pain. However, the clinical effectiveness of acupuncture therapy remains difficult to assess. In search for informative and clinically relevant outcome measures for acupuncture therapy, it is important to make a distinction between clinical outcome measures and those measures reflective of the acupuncture's effect on biological (e.g., biomarkers) and/or physiological responses. A translational tool useful to assess the effectiveness of acupuncture therapy should be expected to bridge the gap between preclinical and clinical studies of acupuncture as well as between conventional medicine and alternative medicine. In this regard, quantitative sensory testing (QST) is a well-recognized psychophysical outcome measure that has been extensively used to assess the effect of conventional medicine on clinical pain. QST provides valuable information on both pain intensity and pain affect and, when combined with other clinical tools (e.g., pain inventory), can be used as a standard research and clinical tool. To date, QST has rarely been used as an outcome measure for clinical acupuncture therapy. In this application, we propose to develop a new approach to evaluating the effectiveness of acupuncture therapy by integrating the unique psychophysical features of QST responses (QST responders) with clinical evidence for pain symptom relief (clinical responders). This approach will be used to differentiate between the acupuncture's physiological and biological effect and its effect on clinical pain symptom relief. This proposed approach will be examined through a set of integrated and complementary experiments as outlined in four specific aims: (1) To evaluate QST as an assessment tool for the effect of acupuncture versus "sham" acupuncture on clinical pain; (2) To explore the role of QST in acupuncture outcome measures between "acupuncture believers" and "acupuncture non-believers"; (3) To compare the effect of acupuncture versus conventional medicine on clinical pain using a standard QST protocol; and (4) To compare changes in QST responses and biomarkers for nociception (e.g., interleukins) and antinociception (e.g., ¿-endorphin) in pain subjects before and after acupuncture therapy. This research project will yield valuable information on a research and clinical assessment tool that could be used to compare the therapeutic effect on clinical pain between acupuncture (other forms of alternative medicine as well) and conventional medicine. PUBLIC HEALTH RELEVANCE: In recent years, acupuncture has gained its popularity in the United States of America as a modality of complementary and alternative medicine for treating many clinical conditions including pain. However, the clinical effectiveness of acupuncture therapy remains difficult to assess. In this project, a new approach will be developed to evaluate the effectiveness of acupuncture therapy. This new approach could be used to compare the therapeutic effects on clinical pain between acupuncture (other forms of alternative medicine as well) and conventional medicine.