Currently submitted to: JMIR Research Protocols
Date Submitted: May 13, 2019
Open Peer Review Period: May 16, 2019 - May 30, 2019
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Acupuncture to Improve Symptoms for Stable Angina (AIMS-A): Study Protocol for a Randomized Controlled Trial
Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α).
The purpose of this study is 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 healthcare 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 (TCM) 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. Primary outcomes are anginal pain and quality of life.
Results will be available upon completion of the randomized controlled trial and the analysis of the data.
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 pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication.
ClinicalTrials.gov Identifier: NCT02914834
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