Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2014-03-31
2015-07-31
Brief Summary
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Detailed Description
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This trial consists of 2 weeks of observation and medical therapy, 2 weeks of acupuncture intervention before EC, EC and acupuncture intervention, 7 weeks of additional intervention, and 5 weeks of follow-up. After randomization, participants receive 10 sessions of acupuncture treatments over 10 weeks. The outcome is assessed at 2, 4, 6, 8, and 16 week after randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Acupuncture + flecainide
The participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
Active Acupuncture
Active acupuncture treatment group consists of electroacupuncture (EA) and intradermal acupuncture (IDA). For EA treatment, unilateral PC5, PC6, ST36, and ST37 are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2 ± 0.5 cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2Hz, continuous wave current for 20 minutes. For IDA treatment, bilateral HT7 and TF4 are selected. Disposable, sterile, sticker-type needles (0.18 mm x 1.3 mm x 1.5mm) are used. Attached needles are maintained as long as possible.
flecainide
Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.
Sham acupuncture + flecainide
The participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
Sham acupuncture
For sham intervention, nonacupuncture points are used. As with active treatment group, two types of acupuncture, sham EA and sham IDA, compose the sham intervention. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.
flecainide
Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.
Interventions
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Active Acupuncture
Active acupuncture treatment group consists of electroacupuncture (EA) and intradermal acupuncture (IDA). For EA treatment, unilateral PC5, PC6, ST36, and ST37 are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2 ± 0.5 cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2Hz, continuous wave current for 20 minutes. For IDA treatment, bilateral HT7 and TF4 are selected. Disposable, sterile, sticker-type needles (0.18 mm x 1.3 mm x 1.5mm) are used. Attached needles are maintained as long as possible.
Sham acupuncture
For sham intervention, nonacupuncture points are used. As with active treatment group, two types of acupuncture, sham EA and sham IDA, compose the sham intervention. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.
flecainide
Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages in 20-75 years
* Resistant with antiarrhythmic drugs
* Written informed consent
Exclusion Criteria
* Severe valvular heart disease
* History of open heart surgery
* History of treatment for myocardial infarction (MI) within recent 6 weeks
* Patients under or requiring the administration of antiviral drugs
* 2nd degree atrioventricular block or more than two fascicular block
* Severe pulmonary, liver, or renal disease
* Previous acupuncture treatment for cardiovascular condition within 3 months
20 Years
75 Years
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Kyunghee University Medical Center
OTHER
Responsible Party
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Weon Kim
Professor
Principal Investigators
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Weon Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Locations
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Kyung Hee University Medical Center
Seoul, Dongdaemun-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Lee SM, Leem J, Park JH, Yoon KH, Woo JS, Lee JM, Kim JB, Kim W, Lee S. Close look at the experiences of patients enrolled in a clinical trial of acupuncture treatment for atrial fibrillation in Korea: a qualitative study nested within a randomised controlled trial. BMJ Open. 2017 Feb 3;7(2):e013180. doi: 10.1136/bmjopen-2016-013180.
Park J, Kim HS, Lee SM, Yoon K, Kim WS, Woo JS, Lee S, Kim JB, Kim W. Acupuncture antiarrhythmic effects on drug refractory persistent atrial fibrillation: study protocol for a randomized, controlled trial. Evid Based Complement Alternat Med. 2015;2015:613970. doi: 10.1155/2015/613970. Epub 2015 Feb 17.
Other Identifiers
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HI13C0580
Identifier Type: -
Identifier Source: org_study_id
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