Clinical trial NCT06311461: Effects of Acupuncture on Symptoms of Stable Angina
Official title: Effects of Acupuncture on Symptoms of Stable Angina: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Angina, Stable
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: National Institute of Nursing Research (NINR)
First posted: 2024-03-15
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain Now
timeFrame: Baseline to 10 weeks
measure: Worst Pain
timeFrame: Baseline to 10 weeks
measure: Least Pain
timeFrame: Baseline to 10 weeks
measure: Acute Coronary Syndrome like symptoms (ACS Symptom Checklist)
timeFrame: Baseline to 10 weeks
measure: Anginal Pain (Seattle Angina Questionnaire-7)
timeFrame: Baseline to 10 weeks
measure: Number of Angina Attacks (From American Heart Association Angina Log)
timeFrame: Baseline to 10 weeks
measure: Symptom Triggers (From American Heart Association Angina Log)
timeFrame: Baseline to 10 weeks
measure: Pain from Angina Attack (From American Heart Association Angina Log)
timeFrame: Baseline to 10 weeks
measure: Length of Angina Attack (American Heart Association Angina Log)
timeFrame: Baseline to 10 weeks
measure: Self-treatment for Symptoms (From American Heart Association Angina Log)
timeFrame: Baseline to 10 weeks
Secondary outcomes:
measure: Functional Status Related to Angina (Seattle Angina Questionnaire-7)
timeFrame: Baseline and study completion (10 weeks)
measure: General Functional Status (PROMIS 29v.2)
timeFrame: Baseline and study completion (10 weeks)
measure: Quality of Life (Seattle Angina Questionnaire-7)
timeFrame: Baseline and study completion (10 weeks)
measure: Use of Nitrates and Analgesics (AHA Angina log)
timeFrame: Baseline and study completion (10 weeks)
measure: Patient Reported Outcomes (Patient Reported Outcomes Measurement Information System-29v.2
timeFrame: Baseline and study completion (10 weeks)
measure: Healthcare Utilization
timeFrame: Week 2 through Week 10
measure: Ischemia on Electrocardiogram (ECG)
timeFrame: Baseline and study completion (10 weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Nursing
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Holli A. DeVon, PhD
role: PRINCIPAL_INVESTIGATOR
References: