Acupuncture for Individuals With Stable Angina (AIMS-A)

University of Illinois

Status: Terminated

Conditions: Microvascular Angina; Angina, Stable; Chest Pain; Heart Failure

Treatments: Other: Non-pain related video health education; Other: Acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02914834

R21NR017705-01A1 (U.S. NIH Grant/Contract)

2016-0642

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• provision of a verified diagnosis from a care provider
• male or female sex
• at least 21 years of age
• intermittent angina symptoms (pain, pressure, or discomfort in the chest or other areas of the upper body)
• medical confirmation of a diagnosis of stable angina for at least 6 months

medical confirmation of a diagnosis of chest pain including non-ischemic or ischemic cardiomyopathy

medical confirmation of a diagnosis of microvascular coronary dysfunction (MCD)

medical confirmation of a diagnosis of heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF) medical confirmation of chest discomfort.

Exclusion criteria

• pregnancy
• chronic obstructive pulmonary disease (COPD) causing pain or associated symptoms
• autoimmune dysfunction
• use of steroid medications
• concomitant physical therapy
• biofeedback
• massage
• additional acupuncture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Device Acupuncture

Experimental group

Description:

Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions

Treatment:

Other: Acupuncture

Non-pain related video health education

Active Comparator group

Description:

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.

Treatment:

Other: Non-pain related video health education