Acupuncture for Individuals With Stable Angina (AIMS-A)
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|ClinicalTrials.gov Identifier: NCT02914834|
Recruitment Status : Terminated (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.)
First Posted : September 26, 2016
Results First Posted : October 7, 2021
Last Update Posted : October 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Angina, Stable Chest Pain Microvascular Angina Heart Failure||Other: Acupuncture Other: Non-pain related video health education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||March 16, 2020|
|Actual Study Completion Date :||March 16, 2020|
Experimental: Device Acupuncture
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
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.
- Feasibility of Study Protocol [ Time Frame: 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 [ Time Frame: 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.
- Average Pain Intensity From the McGill Pain Questionnaire [ Time Frame: 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) [ Time Frame: 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.
- Inflammatory Biomarkers Blood Test [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914834
|United States, Illinois|
|University of Illinois at Chicago College of Nursing|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Holli A DeVon, PhD||University of Illinois at Chicago|