TY  - JOUR
AU  - Schlaeger, Judith
AU  - Cai, Hui Yan
AU  - Steffen, Alana D
AU  - Angulo, Veronica
AU  - Shroff, Adhir R
AU  - Briller, Joan E
AU  - Hoppensteadt, Debra
AU  - Uwizeye, Glorieuse
AU  - Pauls, Heather A
AU  - Takayama, Miho
AU  - Yajima, Hiroyoshi
AU  - Takakura, Nobuari
AU  - DeVon, Holli A
PY  - 2019
DA  - 2019/07/29
TI  - Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial
JO  - JMIR Res Protoc
SP  - e14705
VL  - 8
IS  - 7
KW  - acupuncture
KW  - stable angina
KW  - ischemic heart disease
KW  - complementary medicine
AB  - Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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 
SN  - 1929-0748
UR  - http://www.researchprotocols.org/2019/7/e14705/
UR  - https://doi.org/10.2196/14705
UR  - http://www.ncbi.nlm.nih.gov/pubmed/31359872
DO  - 10.2196/14705
ID  - info:doi/10.2196/14705
ER  -