Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311461
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-02-21
Brief Title:
Effects of Acupuncture on Symptoms of Stable Angina
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Effects of Acupuncture on Symptoms of Stable Angina A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
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 75-10 hrs
The investigators will test the efficacy of acupuncture for stable anginachest pain syndrome to reduce pain and symptoms improve health-related quality of life reduce healthcare utilization and and improve patient related health outcomes
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 75-10 hrs
The investigators will test the efficacy of acupuncture for stable anginachest 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 REDCaps 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 025 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 600-1908 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 Alzheimers 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 sessions75 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
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 025 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 600-1908 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 Alzheimers 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 sessions75 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None