Acupuncture for Individuals With Stable Angina (AIMS-A)

Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Chest Pain; Angina, Stable; Microvascular Angina
• Intervention / Treatment: Other: Acupuncture; Other: Non-pain related video health education

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Acupuncture; Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions	Other: Acupuncture; Standardized acupuncture treatment administered for 30 minutes each session
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Study Protocol	Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.	After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Protocol Acceptability Scale for Treating Angina With Acupuncture	Protocol Acceptability Scale for Treating Angina with Acupuncture is a 9-item instrument used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study and did not like acupuncture", and 2 means "liked the study and liked acupuncture". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 9 questions in each arm, divided the total score for the 9 questions by the maximum possible points for the measure (18 x number of participants in each arm), and converted the total mean scores to percentage of participants who liked the study/liked acupuncture in each arm.	After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Intensity From the McGill Pain Questionnaire	Average Pain Intensity from the McGill Pain Questionnaire is the average of pain now, least pain in the past 24 hours, and worst pain in the past 24 hours. Average Pain Intensity is scored on a 0 to 10 Likert type scale with 0 = no pain and 10 = excruciating pain. Pain intensity is the pre-specified outcome measure, while pain now and least and worst pain are values used to calculate average pain intensity and were not specified outcome measures.	From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Seattle Angina Questionnaire-7 (SAQ-7)	The instrument consists of 7 items measuring functional status, symptoms, and quality of life on participants. Item responses are coded sequentially from worst to best status and range from 1 to 6, except Quality of Life (range 1-5). Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.	From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Biomarkers Blood Test	Inflammatory biomarkers between the acupuncture and control group [interleukin (IL)- 2, IL-4, IL-6, IL-8, IL-10, IL-18; tumor necrosis factor alpha (TNF-α)]. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.	From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP)	Inflammatory biomarker CRP between the acupuncture and control group. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.	From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Holli A DeVon, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: August 13, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Microvascular Angina
• Other Study ID Numbers: 2016-0642; R21NR017705-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No