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Acupuncture for Individuals With Stable Angina (AIMS-A)

Primary Purpose

Angina, Stable, Chest Pain, Microvascular Angina

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Non-pain related video health education
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina, Stable

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Illinois at Chicago College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device Acupuncture

Non-pain related video health education

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Feasibility of Study Protocol
Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% 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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 13, 2016
Last Updated
October 4, 2021
Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT02914834
Brief Title
Acupuncture for Individuals With Stable Angina
Acronym
AIMS-A
Official Title
Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Research activity halted due to the Coronavirus Disease 2019 (COVID-19) pandemic. We were obliged to stop the in-person study in March 2020 due to the mandated lockdowns as a result of COVID.
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina, Stable, Chest Pain, Microvascular Angina, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device Acupuncture
Arm Type
Experimental
Arm Description
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Arm Title
Non-pain related video health education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Standardized acupuncture treatment administered for 30 minutes each session
Intervention Type
Other
Intervention Name(s)
Non-pain related video health education
Intervention Description
Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
Primary Outcome Measure Information:
Title
Feasibility of Study Protocol
Description
Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.
Time Frame
After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Title
Protocol Acceptability Scale for Treating Angina With Acupuncture
Description
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.
Time Frame
After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Secondary Outcome Measure Information:
Title
Average Pain Intensity From the McGill Pain Questionnaire
Description
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.
Time Frame
From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Title
Seattle Angina Questionnaire-7 (SAQ-7)
Description
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.
Time Frame
From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Other Pre-specified Outcome Measures:
Title
Inflammatory Biomarkers Blood Test
Description
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.
Time Frame
From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Title
Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP)
Description
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.
Time Frame
From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holli A DeVon, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago College of Nursing
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34856826
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.
Results Reference
derived

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Acupuncture for Individuals With Stable Angina

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