Angina, Stable, Chest Pain, Heart Failure, Microvascular Angina
Conditions
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.
Interventions
OTHERAcupuncture
Standardized acupuncture treatment administered for 30 minutes each session
OTHERNon-pain related video health education
Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
Sponsors
National Institute of Nursing Research (NINR)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Acupuncture 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 | 12 |
| 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.
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. | 15 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 1 subject withdrew | 0 | 1 |
| Overall Study | Study halted due to COVID | 1 | 1 |
Baseline characteristics
| Characteristic | Device Acupuncture | Non-pain Related Video Health Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 11 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 15 |
| other Total, other adverse events | 0 / 12 | 0 / 15 |
| serious Total, serious adverse events | 0 / 12 | 0 / 15 |
Outcome results
Primary
Feasibility of Study Protocol
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Acupuncture | Feasibility of Study Protocol | Participants recruited | 12 Participants |
| Device Acupuncture | Feasibility of Study Protocol | Participants retained | 12 Participants |
| Device Acupuncture | Feasibility of Study Protocol | Participants completed | 11 Participants |
| Non-pain Related Video Health Education | Feasibility of Study Protocol | Participants recruited | 15 Participants |
| Non-pain Related Video Health Education | Feasibility of Study Protocol | Participants retained | 15 Participants |
| Non-pain Related Video Health Education | Feasibility of Study Protocol | Participants completed | 13 Participants |
Primary
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.
Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Population: Those completing the study protocol at 5 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Acupuncture | Protocol Acceptability Scale for Treating Angina With Acupuncture | 87.9 percentage of subjects who liked study |
| Non-pain Related Video Health Education | Protocol Acceptability Scale for Treating Angina With Acupuncture | 51.7 percentage of subjects who liked study |
Secondary
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.
Time frame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Acupuncture | Average Pain Intensity From the McGill Pain Questionnaire | Baseline Average pain intensity | 3.81 score on a scale | Standard Deviation 1.99 |
| Device Acupuncture | Average Pain Intensity From the McGill Pain Questionnaire | Completion Average pain intensity | 1.21 score on a scale | Standard Deviation 1.13 |
| Non-pain Related Video Health Education | Average Pain Intensity From the McGill Pain Questionnaire | Baseline Average pain intensity | 3.42 score on a scale | Standard Deviation 2.56 |
| Non-pain Related Video Health Education | Average Pain Intensity From the McGill Pain Questionnaire | Completion Average pain intensity | 2.97 score on a scale | Standard Deviation 1.96 |
Secondary
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.
Time frame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline symptoms | 55.00 score on a scale | Standard Deviation 20.23 |
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Quality of life | 54.55 score on a scale | Standard Deviation 23.9 |
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Functional status | 46.67 score on a scale | Standard Deviation 27.49 |
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline Total score | 29.29 score on a scale | Standard Deviation 13.01 |
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Symptoms | 72.73 score on a scale | Standard Deviation 15.55 |
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Total score | 56.44 score on a scale | Standard Deviation 19.74 |
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline Quality of Life | 20.83 score on a scale | Standard Deviation 26.82 |
| Device Acupuncture | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline Functional status | 16.67 score on a scale | Standard Deviation 15.18 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Symptoms | 56.15 score on a scale | Standard Deviation 8.7 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline Functional status | 29.78 score on a scale | Standard Deviation 26.77 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Functional status | 16.92 score on a scale | Standard Deviation 19.36 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline symptoms | 62.67 score on a scale | Standard Deviation 13.35 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline Quality of Life | 16.67 score on a scale | Standard Deviation 13.91 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Quality of life | 11.54 score on a scale | Standard Deviation 12.97 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Baseline Total score | 36.57 score on a scale | Standard Deviation 16.14 |
| Non-pain Related Video Health Education | Seattle Angina Questionnaire-7 (SAQ-7) | Completion Total score | 27.51 score on a scale | Standard Deviation 9.21 |
Other Pre-specified
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.
Time frame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Population: Overall number of participants analyzed differ based on difficulty drawing blood on subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Acupuncture | Inflammatory Biomarkers Blood Test | Mean change IL-2 | 0.394 pg/ml | Standard Deviation 22.523 |
| Device Acupuncture | Inflammatory Biomarkers Blood Test | Mean Change IL-4 | -1.444 pg/ml | Standard Deviation 2.724 |
| Device Acupuncture | Inflammatory Biomarkers Blood Test | Mean Change IL-6 | -.096 pg/ml | Standard Deviation 0.863 |
| Device Acupuncture | Inflammatory Biomarkers Blood Test | Mean Change IL-8 | 2.065 pg/ml | Standard Deviation 7.671 |
| Device Acupuncture | Inflammatory Biomarkers Blood Test | Mean Change IL-10 | 4.317 pg/ml | Standard Deviation 14.373 |
| Device Acupuncture | Inflammatory Biomarkers Blood Test | Mean Change IL-18 | 55.695 pg/ml | Standard Deviation 65.646 |
| Device Acupuncture | Inflammatory Biomarkers Blood Test | Mean change TNF-alpha | 6.312 pg/ml | Standard Deviation 25.37 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test | Mean Change IL-8 | 1.255 pg/ml | Standard Deviation 5.373 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test | Mean change IL-2 | 11.595 pg/ml | Standard Deviation 17.414 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test | Mean Change IL-18 | 16.540 pg/ml | Standard Deviation 68.665 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test | Mean Change IL-4 | -.818 pg/ml | Standard Deviation 2.306 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test | Mean Change IL-10 | 7.386 pg/ml | Standard Deviation 38.165 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test | Mean Change IL-6 | -.212 pg/ml | Standard Deviation 1.224 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test | Mean change TNF-alpha | 8.763 pg/ml | Standard Deviation 20.667 |
Other Pre-specified
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.
Time frame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Acupuncture | Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP) | -302.903 ng/ml | Standard Deviation 1049.445 |
| Non-pain Related Video Health Education | Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP) | -457.205 ng/ml | Standard Deviation 1416.052 |