Traditional Chinese Medicine for Fibromyalgia: A Whole Systems Trial

中医治疗纤维肌痛：全系统试验

• 批准号: 8244416
• 负责人: Scott David Mist
• 金额: $ 13.25万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8244416
• 关键词: Acupuncture procedure; Address; Aftercare; Area; Arizona; Attention; Biological Markers; Caring; Characteristics; Chinese Traditional Medicine; Clinical; Clinical Research; Comorbidity; Conflict (Psychology); Data; Development; Diagnosis; Diagnostic Procedure; Direct Costs; Disease; Dorsal; Drops; Education; Effectiveness; Elements; Evidence based treatment; Exclusion Criteria; Expectancy; Expenditure; Fatigue; Fellowship; Fibromyalgia; Functional disorder; Future; Goals; Grant; Health Sciences; Herb; Individual; Institution; Intervention; Investigation; Left; Life; Measures; Mental Depression; Mentors; Methodology; Methods; Michigan; Modeling; National Center for Complementary and Alternative Medicine; Nociception; Oregon; Outcome; Pain; Pain Measurement; Participant; Patients; Phase; Phase II Clinical Trials; Physical Function; Population; Process; Publishing; Quality of life; Questionnaires; Randomized; Reflex action; Reporting; Research; Research Design; Research Personnel; Research Priority; Running; Sample Size; Science; Secondary pain; Services; Sleep; Staging; Statistical Models; Surveys; Symptoms; System; Techniques; Testing; Time; Training; Translational Research; Treatment outcome; Universities; Woman; Work; Writing; base; clinically relevant; coping; design; evidence base; experience; impression; improved; medical attention; neuroimaging; public health relevance; research to practice; responsible research conduct; skills; success; systems research; treatment response

DESCRIPTION (provided by applicant): This five-year project has two main components: a mentored training plan and a research plan. It addresses the research priorities of NCCAM in three manners. First, it is the critical initial phase in assessing the effectiveness of Traditional Chinese Medicine (TCM) for the treatment of fibromyalgia. Second, the use of nociceptive dorsal reflex testing represents the use of state-of-the-art techniques in translational research. Lastly, during the mentored training, Dr. Mist will obtain the experiences and skills to make the transition from postdoctoral fellowship to independent investigator. He will be mentored in three main areas by four mentors. Dr. Kim Dupree Jones (primary mentor at Oregon Health & Science University) will mentor the candidate in fibromyalgia pathophysiology, study design, recruitment strategies, and current research in fibromyalgia. Dr. Rick Harris (University of Michigan) will supplement this with a focus on pain assessment in fibromyalgia, neuroimaging, and TCM approaches. The second area is whole systems design and analysis led by Dr. Mikel Aickin (University of Arizona). Dr. Aickin will focus on training in early phase study design, design adaptive allocation, and statistical analysis of whole systems research. The third area is the development of skills in study design, acquisition and processing of neuroimaging data and will be led by Dr. Wei Huang (Oregon Health & Science University) with the assistance of Dr. Harris. In addition, training in the responsible conduct of research and in professional development components such as running a research group, grant writing, and other important components for success will be emphasized. The primary hypothesis for this line of research is that whole systems TCM will provide significant pain reduction for women with fibromyalgia. This study represents one vital stage in assessing this hypothesis. Dr. Mist will conduct a feasibility/acceptability study of whole systems TCM for the treatment of fibromyalgia. The study will compare measures of fibromyalgia physical functioning and symptoms among participants who will receive either whole systems TCM or fibromyalgia education for 10 weeks. Comparisons will occur at end of treatment and one month post treatment. Nociceptive flexion reflex threshold will be evaluated as a possible objective pain outcome variable for a future study. Exploratory analysis of frequent pain, sleep, depression, and fatigue measures (1-3 times per day) will be modeled. Finally, exemplars of responders, non-responders and individuals with specific TCM diagnoses will be evaluated for inclusion/exclusion criteria in future R01 studies. This research represents the next logical step in a long-term investigation of the whole systems TCM for fibromyalgia as well as a search for possible mechanisms of action for components of the treatment. PUBLIC HEALTH RELEVANCE: This project will assess the feasibility and accessibility of whole systems Traditional Chinese medicine for the treatment of fibromyalgia as well as enhance understanding of effectiveness. It will also confirm previous research on nociceptive dorsal reflex threshold biomarkers in fibromyalgia populations providing greater confidence in it use.

描述（由申请人提供）：这个为期五年的项目有两个主要组成部分：指导培训计划和研究计划。它通过三种方式解决了 NCCAM 的研究重点。首先，这是评估中药治疗纤维肌痛疗效的关键初始阶段。其次，伤害性背反射测试的使用代表了转化研究中最先进技术的使用。最后，在指导培训期间，Mist 博士将获得从博士后研究员过渡到独立研究者的经验和技能。他将在三个主要领域得到四位导师的指导。 Kim Dupree Jones 博士（俄勒冈健康与科学大学的主要导师）将在纤维肌痛病理生理学、研究设计、招募策略和纤维肌痛当前研究方面指导候选人。 Rick Harris 博士（密歇根大学）将补充这一点，重点关注纤维肌痛、神经影像学和中医方法的疼痛评估。第二个领域是由 Mikel Aickin 博士（亚利桑那大学）领导的整个系统设计和分析。 Aickin 博士将重点培训早期研究设计、设计自适应分配以及整个系统研究的统计分析。第三个领域是神经影像数据的研究设计、采集和处理技能的发展，将由黄伟博士（俄勒冈健康与科学大学）领导，并在哈里斯博士的协助下。此外，还将强调负责任的研究行为和专业发展方面的培训，例如管理研究小组、资助写作和其他成功的重要组成部分。该研究的主要假设是，整个系统的中医将为患有纤维肌痛的女性提供显着的疼痛减轻。这项研究代表了评估这一假设的一个重要阶段。 Mist 博士将对整个系统的中医治疗纤维肌痛进行可行性/可接受性研究。该研究将比较接受为期 10 周的全系统中医治疗或纤维肌痛教育的参与者的纤维肌痛身体机能和症状测量结果。比较将在治疗结束时和治疗后一个月进行。伤害性屈曲反射阈值将被评估为未来研究中可能的客观疼痛结果变量。将对频繁的疼痛、睡眠、抑郁和疲劳测量（每天 1-3 次）进行探索性分析。最后，将在未来的 R01 研究中评估有反应者、无反应者和具有特定中医诊断的个体的纳入/排除标准。这项研究代表了对纤维肌痛整个中医系统的长期研究以及寻找治疗成分的可能作用机制的下一个合乎逻辑的步骤。 公共卫生相关性：该项目将评估整个系统的中医药治疗纤维肌痛的可行性和可及性，并增强对有效性的了解。它还将证实之前关于纤维肌痛人群伤害性背反射阈值生物标志物的研究，为其使用提供更大的信心。