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Angina, StableEASENCT06311461

Effects of Acupuncture on Symptoms of Stable Angina

A study testing Acupuncture in people with Angina, Stable, run by University of California, Los Angeles at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Angina, Stable
What is being tested?
Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteUnited States
Study dates
1 Apr 2024to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 21 years of age minimum

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Holli A. DeVon, PhD contact

3109107283

hdevon@sonnet.ucla.edu

United States1 site, 1 recruiting
  • UCLA School of Nursing

    Los Angeles, California, 90095

    Holli DeVon, PhD, 310-910-7283, hdevon@sonnet.ucla.edu

    Peter Cabezas, 310-922-5835, pcabezas@sonnet.ucla.edu

    Recruiting

Other trials in United States

About this study

Official title: Effects of Acupuncture on Symptoms of Stable Angina: A Randomized Controlled 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

Read more

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.

Read the detailed description

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.

Conditions
Angina, Stable
Being tested
Acupuncture, Attention control
Medical subject headings
Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    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).

  • Attention controlOther

    Viewing non-pain related TED talk videos over 5 weeks approximately equal to 10 hours of treatment for the acupuncture group.

Study groups in NCT06311461
Study groupRoleWhat they receive
AcupunctureExperimentalParticipants 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.
Receives: Procedure: Acupuncture
Attention Control GroupActive comparatorThe 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.
Receives: Other: Attention control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Now

    numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable right now

    Measured: Baseline to 10 weeks

  2. Worst Pain

    numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable

    Measured: Baseline to 10 weeks

  3. Least Pain

    numeric rating scale 0-10, 0=no pain and 10=worst pain imaginable

    Measured: Baseline to 10 weeks

  4. 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),

    Measured: Baseline to 10 weeks

  5. 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.

    Measured: Baseline to 10 weeks

  6. Number of Angina Attacks (From American Heart Association Angina Log)

    How many times the participant has had angina

    Measured: Baseline to 10 weeks

  7. Symptom Triggers (From American Heart Association Angina Log)

    Participant will be Asked: What triggered the angina attack?

    Measured: Baseline to 10 weeks

  8. Pain from Angina Attack (From American Heart Association Angina Log)

    4-point scale. 1-little pain to 4-severe pain.

    Measured: Baseline to 10 weeks

  9. Length of Angina Attack (American Heart Association Angina Log)

    In minutes

    Measured: Baseline to 10 weeks

  10. Self-treatment for Symptoms (From American Heart Association Angina Log)

    Participants will be asked to list strategies they used to mitigate pain

    Measured: Baseline to 10 weeks

Secondary outcomes (7)
  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

    Measured: 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.

    Measured: 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)

    Measured: 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.

    Measured: Baseline and study completion (10 weeks)

  5. 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.

    Measured: Baseline and study completion (10 weeks)

  6. Healthcare Utilization

    Participants report how many healthcare encounters they have had since the last session

    Measured: Week 2 through Week 10

  7. Ischemia on Electrocardiogram (ECG)

    Evidence of Ischemia defined as inverted T wave and/or downsloping ST segment depression

    Measured: Baseline and study completion (10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06311461
Sponsor's protocol ID
22-001111
Other IDs
1R01NR020376-01A1
Acronym
EASE
Status last verified
Mar 2025
First submitted
21 Feb 2024
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Nelson KA, Mirzaei S, Schlaeger JM, Li H, Burke L, Cabezas P, Meinel M, Rountree L, Su S, DeVon HA. Designing an Attention Control Condition for a Randomized Controlled Trial Using TED Talks. West J Nurs Res. 2025 Aug;47(8):764-769. doi: 10.1177/01939459251342753. Epub 2025 May 26.

    PubMed 40415609

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Angina, Stable, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Holli A. DeVon, PhD (3109107283, hdevon@sonnet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Now (time frame: Baseline to 10 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06311461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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