AIMS-A: Acupuncture for Individuals With Stable Angina

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02914834
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Angina, Stable; Chest Pain; Microvascular Angina; Heart Failure	Other: Acupuncture; Other: Non-pain related video health education	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)
• Actual Study Start Date: May 15, 2019
• Actual Primary Completion Date: Mar 16, 2020
• Actual Study Completion Date: Mar 16, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Feasibility of Study Protocol [After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)]

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

2. Protocol Acceptability Scale for Treating Angina With Acupuncture [After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)]

   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

1. Average Pain Intensity From the McGill Pain Questionnaire [From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks]

   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.

2. Seattle Angina Questionnaire-7 (SAQ-7) [From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks]

   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.

Other Outcome Measures

1. Inflammatory Biomarkers Blood Test [From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks]

   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.

2. Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP) [From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago College of Nursing	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• University of Illinois at Chicago
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Holli A DeVon, PhD, University of Illinois at Chicago

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 28, 2019

More Information

Publications

None provided.

• Responsible Party: Judith Schlaeger, Assistant Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT02914834
• Other Study ID Numbers: 2016-0642; R21NR017705-01A1
• First Posted: Sep 26, 2016
• Last Update Posted: Oct 7, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Angina Pectoris; Angina, Stable; Microvascular Angina; Chest Pain

Study Results

Participant Flow

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.
Period Title: Overall Study
STARTED	12	15
COMPLETED	11	13
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education	Total
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.	Total of all reporting groups
Overall Participants	12	15	27
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 66.7%	11 73.3%	19 70.4%
>=65 years	4 33.3%	4 26.7%	8 29.6%
Sex: Female, Male (Count of Participants)
Female	8 66.7%	9 60%	17 63%
Male	4 33.3%	6 40%	10 37%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 33.3%	5 33.3%	9 33.3%
Not Hispanic or Latino	8 66.7%	10 66.7%	18 66.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 50%	8 53.3%	14 51.9%
White	4 33.3%	3 20%	7 25.9%
More than one race	1 8.3%	2 13.3%	3 11.1%
Unknown or Not Reported	1 8.3%	2 13.3%	3 11.1%
Region of Enrollment (Count of Participants)
United States	12 100%	15 100%	27 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.
Measure Participants	12	15
Participants recruited	12 100%	15 100%
Participants retained	12 100%	15 100%
Participants completed	11 91.7%	13 86.7%

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Those completing the study protocol at 5 weeks

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.
Measure Participants	11	13
Number [percentage of subjects who liked study]	87.9	51.7

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.
Measure Participants	11	13
Baseline Average pain intensity	3.81 (1.99)	3.42 (2.56)
Completion Average pain intensity	1.21 (1.13)	2.97 (1.96)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.
Measure Participants	11	13
Baseline Functional status	16.67 (15.18)	29.78 (26.77)
Completion Functional status	46.67 (27.49)	16.92 (19.36)
Baseline symptoms	55.00 (20.23)	62.67 (13.35)
Completion Symptoms	72.73 (15.55)	56.15 (8.70)
Baseline Quality of Life	20.83 (26.82)	16.67 (13.91)
Completion Quality of life	54.55 (23.90)	11.54 (12.97)
Baseline Total score	29.29 (13.01)	36.57 (16.14)
Completion Total score	56.44 (19.74)	27.51 (9.21)

5. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed differ based on difficulty drawing blood on subjects.

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.
Measure Participants	6	11
Mean change IL-2	0.394 (22.523)	11.595 (17.414)
Mean Change IL-4	-1.444 (2.724)	-.818 (2.306)
Mean Change IL-6	-.096 (.863)	-.212 (1.224)
Mean Change IL-8	2.065 (7.671)	1.255 (5.373)
Mean Change IL-10	4.317 (14.373)	7.386 (38.165)
Mean Change IL-18	55.695 (65.646)	16.540 (68.665)
Mean change TNF-alpha	6.312 (25.370)	8.763 (20.667)

6. Other Pre-specified Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Acupuncture	Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session	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. 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.
Measure Participants	6	11
Mean (Standard Deviation) [ng/ml]	-302.903 (1049.445)	-457.205 (1416.052)

Adverse Events

Time Frame	Adverse Event data were collected over the duration of the 5-week study protocol
Arm/Group Title	Device Acupuncture		Non-pain Related Video Health Education
Arm/Group Description	Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session		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. 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.
All Cause Mortality
	Device Acupuncture		Non-pain Related Video Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/15 (0%)
Serious Adverse Events
	Device Acupuncture		Non-pain Related Video Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Device Acupuncture		Non-pain Related Video Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.