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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02914834
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : September 4, 2019
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)
Estimated Enrollment : 69 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 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. McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ) is a well validated and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative pain.

  2. McGill Pain Questionnaire [ Time Frame: after the 10th acupuncture treatment of week 10 ]
    The McGill Pain Questionnaire (MPQ) is a valid and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative, pain.

  3. McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  4. McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  5. McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  6. McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  7. McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  8. McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  9. McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  10. McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment of week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  11. McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  12. McGill Pain Questionnaire [ Time Frame: before 2nd acupuncture treatment of week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  13. McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  14. McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 1 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  15. McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  16. McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 2 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  17. McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  18. McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 3 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  19. McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  20. McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 4 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  21. McGill Pain Questionnaire [ Time Frame: after 1st acupuncture treatment week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

  22. McGill Pain Questionnaire [ Time Frame: after 2nd acupuncture treatment week 5 ]
    The McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.


Secondary Outcome Measures :
  1. Seattle Angina Questionnaire-7 (SAQ-7) [ Time Frame: Before first acupuncture treatment of week one ]
    The instrument consists of 7 items in 5 domains (Physical Limitation, Angina Stability, Angina Frequency, and Quality of Life) measuring the impact of angina on participants' health status. 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.

  2. Seattle Angina Questionnaire-7 (SAQ-7) [ Time Frame: after the 2nd acupuncture treatment of week 5 ]
    The instrument consists of 7 items in 5 domains (Physical Limitation, Angina Stability,


Other Outcome Measures:
  1. My Angina Log, American Heart Association [ Time Frame: completed with each event of angina symptoms from date of randomization to 5 weeks (study completion) ]
    My angina log is a self-report log of angina symptoms to be completed when angina symptoms occur. It is a record of when angina occurs, what initiated and relieved the symptoms.

  2. Inflammatory biomarkers blood test [ Time Frame: from date of randomization to 5 weeks (study completion) ]
    Inflammatory biomarkers between the acupuncture and control group (IL-1β, IL- 2, IL-6, IL1B, IL-2, IL-6, IL-8, IL-10, and IL-18; CRP, TNF-α)



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
  • 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


Contacts
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Contact: Holli A DeVon, PhD (312) 413-5362 hdevon1@uic.edu
Contact: Judith M Schlaeger, PhD (312) 413-4669 jschlaeg@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago College of Nursing Recruiting
Chicago, Illinois, United States, 60612
Contact: Veronica Angulo, BS    312-996-0470    vangul1@uic.edu   
Contact: Judith schlaeger, PhD    7083341097 ext schlaeger    jschlaeg@uic.edu   
Principal Investigator: Judith M Schlaeger, PhD         
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

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Responsible Party: Judith Schlaeger, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02914834     History of Changes
Other Study ID Numbers: 2016-0642
R21NR017705-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: One year after study completion deidentified data will be completed.

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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
Chest Pain
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms