Clinical trial NCT02914834: Acupuncture for Individuals With Stable Angina
Official title: Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Angina, Stable
Chest Pain
Microvascular Angina
Heart Failure
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-09-26
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Study Protocol
timeFrame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
measure: Protocol Acceptability Scale for Treating Angina With Acupuncture
timeFrame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Secondary outcomes:
measure: Average Pain Intensity From the McGill Pain Questionnaire
timeFrame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
measure: Seattle Angina Questionnaire-7 (SAQ-7)
timeFrame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Other outcomes:
measure: Inflammatory Biomarkers Blood Test
timeFrame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
measure: Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP)
timeFrame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago College of Nursing
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Holli A DeVon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeVon HA, Uwizeye G, Cai HY, Shroff AR, Briller JE, Ardati A, Hoppensteadt D, Rountree L, Schlaeger JM. Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population. Acupunct Med. 2022 Apr;40(2):152-159. doi: 10.1177/09645284211055754. Epub 2021 Dec 2.