Effects of Acupuncture on Symptoms of Stable Angina

NCT06311461 | Recruiting DMC

• 2 other identifiers: 22-0011111R01NR020376-01A1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Angina, Stable

Outcome Measures

Primary Outcomes (10)

• Pain Now

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

  Baseline to 10 weeks

• Worst Pain

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

  Baseline to 10 weeks

• Least Pain

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

  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),

  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.

  Baseline to 10 weeks

• Number of Angina Attacks (From American Heart Association Angina Log)

  How many times the participant has had angina

  Baseline to 10 weeks

• Symptom Triggers (From American Heart Association Angina Log)

  Participant will be Asked: What triggered the angina attack?

  Baseline to 10 weeks

• Pain from Angina Attack (From American Heart Association Angina Log)

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

  Baseline to 10 weeks

• Length of Angina Attack (American Heart Association Angina Log)

  In minutes

  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

  Baseline to 10 weeks

Secondary Outcomes (7)

• Functional Status Related to Angina (Seattle Angina Questionnaire-7)

  Baseline and study completion (10 weeks)

• General Functional Status (PROMIS 29v.2)

  Baseline and study completion (10 weeks)

• Quality of Life (Seattle Angina Questionnaire-7)

  Baseline and study completion (10 weeks)

• Use of Nitrates and Analgesics (AHA Angina log)

  Baseline and study completion (10 weeks)

• Patient Reported Outcomes (Patient Reported Outcomes Measurement Information System-29v.2

  Baseline and study completion (10 weeks)

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Attention Control Group

ACTIVE COMPARATOR

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

Interventions

Acupuncture PROCEDURE

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).

Acupuncture

Attention control OTHER

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

Attention Control Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age minimum

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Illinois at Chicago: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UCLA School of Nursing

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40415609 DERIVED

Related Links

• DeVon Publications

MeSH Terms

Conditions

Angina, Stable

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Holli A. DeVon, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holli A. DeVon, PhD

CONTACT

3109107283; hdevon@sonnet.ucla.edu

Peter Cabezas

CONTACT

310-922-5835; pcabezas@sonnet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 15, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, 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.

Locations

US (1)