Effects of Acupuncture on Symptoms of Stable Angina: A Randomized Controlled Trial

针灸对稳定型心绞痛症状的影响：一项随机对照试验

基本信息

批准号：
10588045
负责人：
HOLLI A DEVON
金额：
$ 78.59万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-19 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10588045
关键词：
Academic Medical Centers Acupuncture Points Acupuncture Therapy Address Adult American American Heart Association Analgesics Area Arrhythmia Atrial Fibrillation Autonomic nervous system Black Populations Blood Vessels Brain Stem Cardiac Cardiology Cardiovascular system Charge Chest Pain Chinese Chinese Traditional Medicine Clinic Complementary therapies Control Groups Coronary Data Diagnosis Dimensions Disease Elements Emotional Stress Enrollment Exercise Exertion Frequencies Goals Guidelines Health Healthcare Heart Arrest Heart Diseases Heart Rate Heart failure Hospitalization Hospitals Hour Hyperalgesia Immune Infarction Inflammatory Integrative Therapy Ischemia Location McGill Pain Scale Measures Mediating Medical Menopausal Status Minority Groups Modeling Myocardial Infarction Myocardial Ischemia Obstruction Outcome Outcome Measure Pain Pain intensity Participant Patient Care Patient-Focused Outcomes Patients Pattern Persistent pain Pharmaceutical Preparations Pharmacotherapy Physiological Pilot Projects Placebo Effect Population Prevalence Process Prospective Studies Protocols documentation Psyche structure Qualifying Quality of life Questionnaires Randomized Randomized, Controlled Trials Recording of previous events Reporting Research Science Severities Standardization Statistical Methods Symptoms Syndrome Testing Treatment Protocols United States Woman Work associated symptom attentional control blood pressure reduction care outcomes disability efficacy evaluation efficacy testing experience experimental group functional status group intervention health assessment health care service utilization health inequalities health related quality of life health service use impaired functional status improved innovation men mortality neural novel pain reduction pain symptom primary outcome recruit secondary outcome sex social disparities symptom management symptom treatment symptomatic improvement treatment effect treatment group video session

项目摘要

Abstract Despite a notable 32.7% decline in mortality from ischemic heart disease (IHD) since 1999, the prevalence of stable angina has not decreased. Stable angina is defined as predictable chest pain on exertion or under mental or emotional stress. Stable angina signifies partial obstruction of coronary flow or microvascular changes and comes with substantial lifetime consequences including heart failure, atrial fibrillation, reinfarction, and cardiac arrest. Nearly 9 million Americans have stable angina and heart disease is now the leading disability-adjusted disease globally. Stable angina is associated with multiple symptoms, impaired functional status, and reduced health-related quality of life (HRQoL). The aims of this randomized controlled trial are to test the efficacy of acupuncture for stable angina/chest pain syndrome on pain and symptom control, health- related quality of life, healthcare utilization, PROMIS measured patient health outcomes and to describe the duration of the acupuncture treatment and placebo effects for up to 12 weeks. One hundred twelve patients hospitalized with IHD and experiencing symptoms of stable angina will be recruited from 2 academic medical centers. Those with a confirmed diagnosis of stable angina, experiencing symptoms at least once per week, and treated with medical therapy for at least 1 month, will be randomly assigned to acupuncture or an attention control group. Participants in the acupuncture group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. Acupuncture will be administered 2 times per week for 5 weeks for a total of 10 treatments. The attention control group will view non-pain related TED Talk videos over 5 weeks approximately equal to the 10 hours of treatment for the acupuncture group. The participants will then meet with research staff to answer questions related to the videos. Upon completion of the study, the attention control group will be offered the same acupuncture protocol as the intervention group at no charge. The McGill Pain Questionnaire and the American Heart Association (AHA) Angina Log will be used to measure pain location, intensity, quality, pattern and associated symptoms. Froelicher’s Healthcare Utilization Questionnaire-Rev. will be used to assess healthcare use. The Seattle Angina Questionnaire-7 will be used to measure symptoms other than pain, functional status, and HRQoL. The PROMIS-29v2 will assess patient-reported health outcomes. Participants will complete measures of anginal pain (pain now, worst pain, & pain since the last session) and the AHA Angina Log before each acupuncture treatment. Pain will be measured after each treatment. Research staff will contact participants weekly for up to 12 weeks or until pain returns to baseline to assess the frequency and severity of anginal attacks. The outcome variables of pain, symptoms, functional status, healthcare utilization, HRQoL, and PROMIS health outcomes will be analyzed using mixed regression models to determine the efficacy of acupuncture. Symptom management is critical for reducing disability and improving health outcomes for those with angina.

抽象的尽管自 1999 年以来，缺血性心脏病 (IHD) 死亡率显着下降了 32.7%，但稳定型心绞痛没有减少。稳定型心绞痛定义为在劳累时或劳累时出现可预测的胸痛。精神或情绪压力。稳定型心绞痛意味着冠状动脉血流或微血管部分阻塞。变化并带来严重的终生后果，包括心力衰竭、心房颤动、再梗塞、近 900 万美国人患有稳定型心绞痛，心脏病现在是最主要的疾病。全球范围内的残疾调整疾病与多种症状、功能受损有关。健康相关生活质量 (HRQoL) 下降。这项随机对照试验的目的是测试针灸治疗稳定型心绞痛/胸痛综合征对疼痛和症状控制、健康的功效相关的生活质量、医疗保健利用率，PROMIS 测量患者的健康结果并描述针灸治疗和安慰剂效应的持续时间长达 12 周。因 IHD 住院且出现稳定型心绞痛症状的患者将从 2 名学术医疗人员中招募那些确诊为稳定型心绞痛、每周至少出现一次症状的人，并接受至少 1 个月的药物治疗，将被随机分配到针灸或护理对照组的针灸组参与者将接受标准化的中医治疗。中医穴位治疗，每周2次，持续5周，共10次。注意力对照组将在大约 5 周内观看与疼痛无关的 TED 演讲视频。相当于针灸组 10 小时的治疗时间，然后参与者将进行研究。研究完成后，注意力控制组将被工作人员回答与视频相关的问题。免费提供与干预组相同的针灸方案。美国心脏协会 (AHA) 心绞痛日志将用于测量疼痛位置、强度、质量、模式和相关症状将用于 Froelicher 的医疗保健利用调查问卷。西雅图心绞痛问卷 7 将用于评估医疗保健使用情况。 PROMIS-29v2 将评估患者报告的健康结果。参与者将完成心绞痛的测量（现在的疼痛、最严重的疼痛以及自上次会议以来的疼痛）以及每次针灸治疗前都会测量 AHA 心绞痛日志。研究人员将每周联系参与者长达 12 周或直到疼痛恢复到基线以评估心绞痛发作的频率和严重程度，结果变量包括疼痛、症状、功能状态、将使用混合回归模型分析医疗保健利用率、HRQoL 和 PROMIS 健康结果确定针灸的疗效对于减少残疾和改善症状至关重要。心绞痛患者的健康结果。