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Behavioural Intervention
Acupuncture for Angina (EASE Trial)
N/A
Recruiting
Led By Holli A. DeVon, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
21 years of age minimum
Experiencing symptoms at least once per week
Must not have
Physical or cognitive limitations that will prevent informed consent or completion of study tasks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 through week 10
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a specific acupuncture treatment can help reduce pain in people with stable angina. Participants will either receive the acupuncture treatment or watch TED Talks as a control group. The goal is
Who is the study for?
This trial is for English-speaking adults over 21 with stable angina or chest pain syndrome, treated medically for at least a month and experiencing symptoms weekly. It's not suitable for those who don't meet these criteria.
What is being tested?
The study tests if a specific acupuncture protocol can reduce pain in stable angina patients versus an attention control group watching educational videos. Participants will receive either ten acupuncture sessions or watch videos over five weeks.
What are the potential side effects?
Acupuncture may cause minor side effects like bruising, bleeding at the puncture sites, dizziness, or rare cases of infection. The attention control activity has no associated medical side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 21 years old.
Select...
I experience symptoms at least once a week.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can give informed consent and complete study tasks despite any limitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2 through week 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 through week 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute Coronary Syndrome like symptoms (ACS Symptom Checklist)
Anginal Pain (Seattle Angina Questionnaire-7)
Least Pain
+7 moreSecondary study objectives
Functional Status Related to Angina (Seattle Angina Questionnaire-7)
General Functional Status (PROMIS 29v.2)
Healthcare Utilization
+4 moreSide effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AcupunctureExperimental Treatment1 Intervention
Participants in the acupuncture group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. Acupuncture will be administered 2 times per week for 5 weeks for a total of 10 treatments.
Group II: Attention Control GroupActive Control1 Intervention
The attention control group will view non-pain related TED talk videos over 5 weeks approximately equal to 10 hours of treatment for the acupuncture group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,177 Total Patients Enrolled
University of Illinois at ChicagoOTHER
640 Previous Clinical Trials
1,568,596 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,604 Total Patients Enrolled
Holli A. DeVon, PhDPrincipal InvestigatorUniversity of California, Los Angeles