Trials / Terminated
TerminatedNCT02914834
Acupuncture for Individuals With Stable Angina
Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- University of Illinois at Chicago · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This RCT aims to determine if it is possible to perform acupuncture on men and women diagnosed with stable angina who have symptoms, chest pain, and/or chest discomfort. The investigators want to determine if acupuncture reduces the pain and other symptoms of angina, chest pain, and chest discomfort. The investigators also want to examine whether this study is acceptable to the participants, and by carrying out this study the investigators will be able to tell how many participants they will need in a future larger study to further test acupuncture to reduce the symptoms of angina in women.
Detailed description
The investigators are conducting a RCT aimed at gathering feasibility, and initial efficacy for a randomized controlled trial (RCT) to test the effect of acupuncture on anginal symptoms, chest pain, and chest discomfort in men and women. The investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for men and women with stable angina, chest pain, and chest discomfort. This study will include 69 community dwelling men and women with a medically confirmed diagnosis of stable angina, chest pain which includes non-ischemic or ischemic cardiomyopathy, microvascular coronary dysfunction (MCD), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), or chest discomfort whose pain and associated symptoms have not been completely controlled with guideline-directed medical management. The investigators will use a randomized attention control design with 13 men and women assigned to initial acupuncture and 13 to control. Participants in the experimental group will receive a standardized acupuncture point prescription two treatments per week, for 5 weeks. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Acupuncture | Standardized acupuncture treatment administered for 30 minutes each session |
| OTHER | Non-pain related video health education | Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion. |
Timeline
- Start date
- 2019-05-15
- Primary completion
- 2020-03-16
- Completion
- 2020-03-16
- First posted
- 2016-09-26
- Last updated
- 2021-10-07
- Results posted
- 2021-10-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02914834. Inclusion in this directory is not an endorsement.