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electro-acupuncture (EA) intervention for Congenital Heart Defects
N/A
Waitlist Available
Led By David A Rosen, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 hours after weaning from cardiopulmonary bypass
Awards & highlights
Study Summary
This trial will study whether electro-acupuncture can help ease pain for children undergoing surgery for their congenital heart defects.
Eligible Conditions
- Congenital Heart Defects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 hours after weaning from cardiopulmonary bypass
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 hours after weaning from cardiopulmonary bypass
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Troponin level
Secondary outcome measures
Evaluate Acute Kidney Injury
Evaluate the incidence and severity of pain in the post operative period
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: electro-acupuncture (EA) interventionActive Control1 Intervention
Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects will receive electro-acupuncture (EA) (treatment) mixed frequency( continuous plus dense disperse) will be at 2Hz and 100 Hz the amplitude will be 1000 microA.
Group II: sham electro acupuncturePlacebo Group1 Intervention
Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects Receive sham (control) will not have stimulation.
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Who is running the clinical trial?
West Virginia UniversityLead Sponsor
176 Previous Clinical Trials
60,106 Total Patients Enrolled
David A Rosen, MDPrincipal InvestigatorWest Virginia University
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