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Acupuncture for Individuals With Stable Angina (AIMS-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Judith Schlaeger, University of Illinois at Chicago

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 16, 2020
Actual Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Angina

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Illinois
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
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Principal Investigator: Holli A DeVon, PhD University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Judith Schlaeger, University of Illinois at Chicago:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Judith Schlaeger, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02914834    
Other Study ID Numbers: 2016-0642
R21NR017705-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2016    Key Record Dates
Results First Posted: October 7, 2021
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Microvascular Angina
Chest Pain
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Pain
Neurologic Manifestations