Schlaeger Judith, Cai Hui Yan, Steffen Alana D, Angulo Veronica, Shroff Adhir R, Briller Joan E, Hoppensteadt Debra, Uwizeye Glorieuse, Pauls Heather A, Takayama Miho, Yajima Hiroyoshi, Takakura Nobuari, DeVon Holli A
Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, United States.
Department of Acupuncture and Oriental Medicine, National University of Health Sciences, Lagrange, IL, United States.
JMIR Res Protoc. 2019 Jul 29;8(7):e14705. doi: 10.2196/14705.
Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha.
This study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables.
We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life.
This study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020.
We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14705.
针刺已在中国稳定型心绞痛患者中显示出生理镇痛作用。这些镇痛作用的一种推测作用机制是M1巨噬细胞、白细胞介素1β、白细胞介素-6、白细胞介素-18和肿瘤坏死因子α的下调。
本研究旨在测试一种为期10节、为期5周的针刺治疗方案，作为美国患者稳定型心绞痛症状的辅助治疗方法，美国患者在医疗保健系统和其他显著变量方面与中国患者不同。
我们正在对69名成年人进行一项随机对照试验（RCT）（35名分配到初始针刺组，34名分配到注意力控制组），这些成年人经医学确诊为稳定型心绞痛，其疼痛和相关症状未通过指南指导的药物治疗得到满意控制。实验组的参与者将接受标准化的中药穴位处方。注意力控制组将在5周内观看与疼痛无关的健康教育视频，时长与针刺组的10小时治疗时间相同。参与者将完成麦吉尔疼痛问卷和西雅图心绞痛问卷-7，并在基线和研究结束时测量炎症细胞因子。主要结局是心绞痛疼痛和生活质量。
本研究由美国国立卫生研究院下属的国立护理研究所在两年多的时间里提供资金支持。我们目前正在招募患者，预计2020年12月得出初步结果。
我们将生成关于可行性、可接受性、效应大小以及该方案未来全功率RCT方案修订的数据。研究结果将有助于确定持续性缺血症状患者是否经历由多种神经和免疫过程引起的促炎状态和痛觉过敏，而这些过程不一定能通过药物缓解。
国际注册报告识别码（IRRID）：DERR1-10.2196/14705
