An interventional study of Acupuncture and Attention control in Angina, Stable, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
Enrollment: The research specialist will explain the nature of the study, risks, benefits, voluntary nature of participation, and the right to discontinue participation at any time without consequences. After informed consent is obtained, participants will be randomized to the acupuncture or attention control group via REDCap's randomization module, based on the stratified, permuted block schedule prepared by our biostatistician. All participants will complete the following measures at baseline: pain now, worst pain, least pain, the Acute Coronary Syndrome Symptom Checklist, the Seattle Angina Questionnaire-7, and the PROMISv2 patient-reported outcomes instrument. Members of the treatment and control groups will report pain now, worst pain since last session, and average pain since last session following sessions 2-10 for the acupuncture group and sessions 2-5 for the control group (video sessions). All participants will complete the AHA Angina Log (diary of symptoms) and Froelicher Healthcare Utilization Questionnaire-Revised throughout the study.
Acupuncture Protocol. The 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 Medicine4. 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).
Acupuncture Point Prescription for Angina. The standardized point prescription uses acupuncture points on the front of the body to enable participants, many who are acupuncture naïve, to remain supine. This is aimed at reducing anxiety by enabling the participant to anticipate needle insertions.
Attention Control Health Videos Protocol. The attention control group will watch non-pain related Technology, Entertainment, Design Talk videos through an online link. The PIs have selected 23 general interest talks, varying from 6:00-19:08 minutes each. Topics do not contain content that could potentially improve pain. For example, titles include: 4 Questions You Should Always Ask Your Doctor; Why Our Screens Make Us Less Happy; Alzheimer's Is Not Normal Aging-And We Can Cure It; How Healthy Living Nearly Killed Me; What Makes a Good Life?; and Lessons from the Longest Study on Happiness. The videos will be accessed via a tablet, phone, or computer by the participant. Videos will be viewed from weeks 1-5 and will equate to the time the experimental group receives acupuncture (30-45 min. x 10 sessions=\~7.5 hrs. total). Research staff will make an appointment. with the participant at their convenience which may increase completion rates. Following the viewing session, participants will complete a 5-item survey on REDCap that will help confirm their understanding of the video. Four items are related to the content and the final question is an acceptability question: Did you enjoy watching this video? The Research Associate will contact the participant every Thursday or Friday via the preferred method (video call or phone call) and read and record applicable survey questions in REDCap. Standardized content of the videos helps assures fidelity to the control protocol and engagement with the RAs will control for expectancy, relationship, and context effects. Those participants who complete the control group protocol will then be offered the acupuncture protocol free of charge.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 112 is below the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Acupuncture
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.
Other: Attention control
The 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).
Viewing non-pain related TED talk videos over 5 weeks approximately equal to 10 hours of treatment for the acupuncture group.
Pain Now
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable right now
Time frame: Baseline to 10 weeks
Worst Pain
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable
Time frame: Baseline to 10 weeks
Least Pain
numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable
Time frame: Baseline to 10 weeks
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 weeks
Anginal Pain (Seattle Angina Questionnaire-7)
Participants will be asked: Over the past 4 weeks, on average, how many times have you had chest pain, chest tightness, or angina? 6 point scale. HIgher number is better.
Time frame: Baseline to 10 weeks
Number of Angina Attacks (From American Heart Association Angina Log)
How many times the participant has had angina
Time frame: Baseline to 10 weeks
Symptom Triggers (From American Heart Association Angina Log)
Participant will be Asked: What triggered the angina attack?
Time frame: Baseline to 10 weeks
Pain from Angina Attack (From American Heart Association Angina Log)
4-point scale. 1-little pain to 4-severe pain.
Time frame: Baseline to 10 weeks
Length of Angina Attack (American Heart Association Angina Log)
In minutes
Time frame: Baseline to 10 weeks
Self-treatment for Symptoms (From American Heart Association Angina Log)
Participants will be asked to list strategies they used to mitigate pain
Time frame: Baseline to 10 weeks
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)
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)
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)
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)
Patient Reported Outcomes (Patient Reported Outcomes Measurement Information System-29v.2
Participant's Assessment of their Outcomes - 6 domains. 5-point scale. Range of Scores 29-145. Higher score is better.
Time frame: Baseline and study completion (10 weeks)
Healthcare Utilization
Participants report how many healthcare encounters they have had since the last session
Time frame: Week 2 through Week 10
Ischemia on Electrocardiogram (ECG)
Evidence of Ischemia defined as inverted T wave and/or downsloping ST segment depression
Time frame: Baseline and study completion (10 weeks)
Plan to share: Yes — The dataset will include self-reported demographic information, clinical data, and biological data. The final dataset will be stripped of identifiers and made available to share with other qualified scientists or trainees.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: 2 years following termination of the study for a length of 5 years.
Access criteria: We will make the data available to qualified scientists, predoctoral students, or postdoctoral trainees only under a data-sharing agreement that provides for a commitment to: 1) use the data for research purposes only; 2) secure the dataset appropriately; 3) destroy or return the data after analyses are complete, 4) share the findings with the PIs; and 5) make every effort to present and publish findings with the scientific community.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2026, 32 months after the start.
Of 65 non-industry interventional studies with no phase under Angina, Stable, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 32 months is below that.
Counting every sponsor, half of 76 studies reached it within 35 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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