Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Women with Stable Angina (AIMS-A)
Dates: 8/1/2016 - 2/28/2018
Co-Investigators: Holli DeVon, Alana Steffen, Judith Schlager, David Carley
Abstract: Over 15 million Americans have been diagnosed with ischemic heart disease (IHD) and two to three million American women are estimated to suffer from stable angina due to microvascular coronary dysfunction. The American Heart Association (AHA) predicts that the incidence of IHD, including stable angina, will rise 18% by 2030 due to the aging of baby boomers and the increasing prevalence of risk factors such as obesity and diabetes. Angina is associated with functional impairment and diminished quality of life (QoL). Stable angina can also be an antecedent of and/or a consequence of acute coronary syndrome (ACS) leading to increased disability or death. Our prior study of sex differences in symptoms following recovery from ACS demonstrated that women were more likely to have a higher number of symptoms and increased symptom severity compared to men. Patients continued to experience angina symptoms 6 months after discharge despite receiving guidelines-directed medical therapy. The aims of this pilot study are to test the feasibility and acceptability of acupuncture therapy for women with stable angina and to compute effect sizes for the between group differences in pre and post-test pain, associated symptoms, functional status, and quality of life in a cohort of women with stable angina. Twenty-six women will be recruited through social media advertisements and flyers placed on the UIC campus and surrounding communities. Those with a confirmed diagnosis of stable angina and treated with medical therapy for at least 6 months, will be randomly assigned to the acupuncture or attention control group. The acupuncture group will receive one treatment two times per week for 5 weeks, totaling 10 treatments. The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group. Upon completion of the study, the attention control group will then be offered the same acupuncture protocol as the intervention group. Pain and symptoms will be measured at 12 time points with the 1) pain now, 2) least pain, and 3) worst pain in the past 24 hour measures from PAINReportIt®, a computerized version of the McGill Pain Questionnaire. The Seattle Angina Questionnaire-7 and the American Heart Association Angina Log will also be used to measure symptoms. Functional status and QoL (from the Seattle Angina Questionnaire-7), and pain location, intensity, quality, and pattern (from PAINReportIt) will be analyzed at baseline and 5 weeks. Outcome measures for recruitment, retention, completion of data, and patient acceptability will be measured at the conclusion of the study. Feasibility, defined as recruitment and retention rates >80%, and acceptability will be analyzed using descriptive statistics. Effect sizes will be computed for differences in pre and post-test pain, symptoms, and QoL. The outcome variables of symptoms, functional status, and QoL will be analyzed using mixed regression models to determine if there were significant benefits of acupuncture if effect sizes are large.