Effects of Acupuncture on Symptoms of Stable Angina: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Worst Pain
研究概览
简要总结
The goal of this clinical trial is to determine if a standardized 12-point acupuncture protocol will reduce pain in participants with stable angina.
This study addresses the critical need to reduce persistent pain for angina. The investigators long-term goal is symptom management for diverse women and men with angina, targeting additional angina burden borne of social disadvantage
Participants will be randomized to a 10-acupuncture session protocol, two treatments per week for five weeks, or an attention control group. Participants will view designated, non-pain related Technology, Entertainment, Design Talks equal to the time spent receiving acupuncture (~7.5-10 hrs.).
The investigators will test the efficacy of acupuncture for stable angina/chest pain syndrome to reduce pain and symptoms, improve health-related quality of life, reduce healthcare utilization and and improve patient related health outcomes.
详细描述
Enrollment: The research specialist will explain the nature of the study, risks, benefits, voluntary nature of participation, and the right to discontinue participation at any time without consequences. After informed consent is obtained, participants will be randomized to the acupuncture or attention control group via REDCap's randomization module, based on the stratified, permuted block schedule prepared by our biostatistician. All participants will complete the following measures at baseline: pain now, worst pain, least pain, the Acute Coronary Syndrome Symptom Checklist, the Seattle Angina Questionnaire-7, and the PROMISv2 patient-reported outcomes instrument. Members of the treatment and control groups will report pain now, worst pain since last session, and average pain since last session following sessions 2-10 for the acupuncture group and sessions 2-5 for the control group (video sessions). All participants will complete the AHA Angina Log (diary of symptoms) and Froelicher Healthcare Utilization Questionnaire-Revised throughout the study.
Acupuncture Protocol. The acupuncturist will swab each point with alcohol. Needles will be inserted and retained for 30 minutes. Each needle will be rotated 3 times to stimulate the qi in the meridian; 10 minutes after insertion, 20 minutes after insertion, and just prior to removal at 30 minutes. Needles will be inserted using the standards of clean needle technique established by the Council of Colleges of Acupuncture and Oriental Medicine4. One size acupuncture needle, 0.25 diameter × 40 mm length, will be used. All acupuncture needles are sterile, disposable, and made of surgical stainless steel with stainless steel wound heads. Sessions will be repeated twice weekly (with at least 2 off days in between) for 5 weeks (10 sessions).
Acupuncture Point Prescription for Angina. The standardized point prescription uses acupuncture points on the front of the body to enable participants, many who are acupuncture naïve, to remain supine. This is aimed at reducing anxiety by enabling the participant to anticipate needle insertions.
Attention Control Health Videos Protocol. The attention control group will watch non-pain related Technology, Entertainment, Design Talk videos through an online link. The PIs have selected 23 general interest talks, varying from 6:00-19:08 minutes each. Topics do not contain content that could potentially improve pain. For example, titles include: 4 Questions You Should Always Ask Your Doctor; Why Our Screens Make Us Less Happy; Alzheimer's Is Not Normal Aging-And We Can Cure It; How Healthy Living Nearly Killed Me; What Makes a Good Life?; and Lessons from the Longest Study on Happiness. The videos will be accessed via a tablet, phone, or computer by the participant. Videos will be viewed from weeks 1-5 and will equate to the time the experimental group receives acupuncture (30-45 min. x 10 sessions=~7.5 hrs. total). Research staff will make an appointment. with the participant at their convenience which may increase completion rates. Following the viewing session, participants will complete a 5-item survey on REDCap that will help confirm their understanding of the video. Four items are related to the content and the final question is an acceptability question: Did you enjoy watching this video? The Research Associate will contact the participant every Thursday or Friday via the preferred method (video call or phone call) and read and record applicable survey questions in REDCap. Standardized content of the videos helps assures fidelity to the control protocol and engagement with the RAs will control for expectancy, relationship, and context effects. Those participants who complete the control group protocol will then be offered the acupuncture protocol free of charge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stable angina or chest pain syndrome for at least 1 month (pain, pressure, or discomfort in the chest or other areas of the upper body)
- •Treated with medical therapy for at least 1 month
- •Experiencing symptoms at least once per week
- •Speak and read English
- •21 years of age minimum
排除标准
- •Pregnancy as some acupuncture points included in the protocol are contraindicated in pregnancy
- •Physical or cognitive limitations that will prevent informed consent or completion of study tasks
- •Use of steroid or prescription analgesic medications
- •Concomitant biofeedback, professional massage and acupuncture.
结局指标
主要结局
Worst Pain
时间窗: Baseline to 10 weeks
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable
Least Pain
时间窗: Baseline to 10 weeks
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable
Acute Coronary Syndrome like symptoms (ACS Symptom Checklist)
时间窗: Baseline to 10 weeks
Change in Acute coronary syndrome type symptoms. (13 individual symptoms measured dichotomously, 0=no, did not experience, 1=yes, did experience),
Self-treatment for Symptoms (From American Heart Association Angina Log)
时间窗: Baseline to 10 weeks
Participants will be asked to list strategies they used to mitigate pain
Anginal Pain (Seattle Angina Questionnaire-7)
时间窗: Baseline to 10 weeks
Participants will be asked: Over the past 4 weeks, on average, how many times have you had chest pain, chest tightness, or angina? 6 point scale. HIgher number is better.
Pain Now
时间窗: Baseline to 10 weeks
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable right now
Number of Angina Attacks (From American Heart Association Angina Log)
时间窗: Baseline to 10 weeks
How many times the participant has had angina
Symptom Triggers (From American Heart Association Angina Log)
时间窗: Baseline to 10 weeks
Participant will be Asked: What triggered the angina attack?
Pain from Angina Attack (From American Heart Association Angina Log)
时间窗: Baseline to 10 weeks
4-point scale. 1-little pain to 4-severe pain.
Length of Angina Attack (American Heart Association Angina Log)
时间窗: Baseline to 10 weeks
In minutes
次要结局
- Patient Reported Outcomes (Patient Reported Outcomes Measurement Information System-29v.2(Baseline and study completion (10 weeks))
- Ischemia on Electrocardiogram (ECG)(Baseline and study completion (10 weeks))
- Functional Status Related to Angina (Seattle Angina Questionnaire-7)(Baseline and study completion (10 weeks))
- General Functional Status (PROMIS 29v.2)(Baseline and study completion (10 weeks))
- Quality of Life (Seattle Angina Questionnaire-7)(Baseline and study completion (10 weeks))
- Use of Nitrates and Analgesics (AHA Angina log)(Baseline and study completion (10 weeks))
- Healthcare Utilization(Week 2 through Week 10)
研究者
Holli A. DeVon PhD, RN, FAAN, FAHA
Professor
University of California, Los Angeles