Effects of Acupuncture on Symptoms of Stable Angina
ConditionAngina, Stable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of California, Los Angeles
About this trial
The goal of this clinical trial is to determine if a standardized 12-point acupuncture protocol will reduce pain in participants with stable angina.
This study addresses the critical need to reduce persistent pain for angina. The investigators long-term goal is symptom management for diverse women and men with angina, targeting additional angina burden borne of social disadvantage
Participants will be randomized to a 10-acupuncture session protocol, two treatments per week for five weeks, or an attention control group. Participants will view designated, non-pain related Technology, Entertainment, Design Talks equal to the time spent receiving acupuncture (\~7.5-10 hrs.).
The investigators will test the efficacy of acupuncture for stable angina/chest pain syndrome to reduce pain and symptoms, improve health-related quality of life, reduce healthcare utilization and and improve patient related health outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of stable angina or chest pain syndrome for at least 1 month (pain, pressure, or discomfort in the chest or other areas of the upper body)
Treated with medical therapy for at least 1 month
Experiencing symptoms at least once per week
Speak and read English
Disqualifiers
Pregnancy as some acupuncture points included in the protocol are contraindicated in pregnancy
Physical or cognitive limitations that will prevent informed consent or completion of study tasks
Use of steroid or prescription analgesic medications
Concomitant biofeedback, professional massage and acupuncture.
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Procedure/SurgeryThe acupuncturist will swab each point with alcohol. Needles will be inserted and retained for 30 minutes. Each needle will be rotated 3 times to stimulate the qi in the meridian; 10 minutes after insertion, 20 minutes after insertion, and just prior to removal at 30 minutes. Needles will be inserted using the standards of clean needle technique established by the Council of Colleges of Acupuncture and Oriental Medicine. One size acupuncture needle, 0.25 diameter × 40 mm length, will be used. All acupuncture needles are sterile, disposable, and made of surgical stainless steel with stainless steel wound heads. Sessions will be repeated twice weekly (with at least 2 off days in between) for 5 weeks (10 sessions).
Attention control
Other interventionViewing non-pain related TED talk videos over 5 weeks approximately equal to 10 hours of treatment for the acupuncture group.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: AcupunctureExperimental treatment 1 intervention
Group B: Attention Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Now
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable right now
Time frame
Baseline to 10 weeks2
Worst Pain
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable
Time frame
Baseline to 10 weeks3
Least Pain
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable
Time frame
Baseline to 10 weeks4
Acute Coronary Syndrome like symptoms (ACS Symptom Checklist)
Change in Acute coronary syndrome type symptoms. (13 individual symptoms measured dichotomously, 0=no, did not experience, 1=yes, did experience),
Time frame
Baseline to 10 weeksSecondary outcomes
1
Functional Status Related to Angina (Seattle Angina Questionnaire-7)
Rate physical limitation due to chest pain chest tightness, or angina over the past 4 weeks
Time frame
Baseline and study completion (10 weeks)2
General Functional Status (PROMIS 29v.2)
Rate difficulty of performing 4 specific activities. 5-point scale 1-5 (low score is worse). Range of scores is 4-20.
Time frame
Baseline and study completion (10 weeks)3
Quality of Life (Seattle Angina Questionnaire-7)
Question: If you had to spend the rest of your life with your chest pain, chest tightness, or angina the way it is right now, how would you feel about that? (Range 1-5; low score is better)
Time frame
Baseline and study completion (10 weeks)4
Use of Nitrates and Analgesics (AHA Angina log)
Number of times participants treated their pain using nitrates or analgesics.
Time frame
Baseline and study completion (10 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
University of Illinois at Chicago
Collaborator
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov