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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR017705-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Acupuncture | Experimental | Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions |
|
| Non-pain related video health education | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Standardized acupuncture treatment administered for 30 minutes each session |
|
| 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) |
| 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. |
| 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 |
Inclusion criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Holli A DeVon, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago College of Nursing | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34856826 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
27 subjects recruited and enrolled, 24 subjects completed the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Non-pain Related Video Health Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | After 10th acupuncture treatment, at 5 weeks post-baseline (study completion) |
|
Adverse Event data were collected over the duration of the 5-week study protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Schlaeger, PhD | University of Illinois Chicago | 3124134669 | jschlaeg@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2019 | Jul 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D002637 | Chest Pain |
| D017566 | Microvascular Angina |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Non-pain related video health education | Other | Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion. |
|
| 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 |
| 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. | Those completing the study protocol at 5 weeks | Posted | Number | percentage of subjects who liked study | After 10th acupuncture treatment, at 5 weeks post-baseline (study completion) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks |
|
|
|
| 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. | Overall number of participants analyzed differ based on difficulty drawing blood on subjects. | Posted | Mean | Standard Deviation | pg/ml | From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ng/ml | From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D014652 |
| Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Baseline symptoms |
|
| Completion Symptoms |
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| Baseline Quality of Life |
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| Completion Quality of life |
|
| Baseline Total score |
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| Completion Total score |
|
| Mean Change IL-4 |
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| Mean Change IL-6 |
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| Mean Change IL-8 |
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| Mean Change IL-10 |
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| Mean Change IL-18 |
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| Mean change TNF-alpha |
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