Acupuncture for Individuals With Stable Angina

NCT ID: NCT02914834

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2020-03-16

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Acupuncture

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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Standardized acupuncture treatment administered for 30 minutes each session

Non-pain related video health education

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.

Group Type: ACTIVE_COMPARATOR

Non-pain related video health education

Intervention Type: OTHER

Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.

Interventions

Acupuncture

Standardized acupuncture treatment administered for 30 minutes each session

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Judith Schlaeger

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holli A DeVon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago College of Nursing

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34856826 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21NR017705-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-0642

Identifier Type: -

Identifier Source: org_study_id