Abstract | BACKGROUND: METHODS/DESIGNS: This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein ( hs-CRP). Safety will be assessed at every visit. DISCUSSION: TRIAL REGISTRATION: Clinical Research Information Service: KCT0000169.
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Authors | Joo-Hee Kim, Hyun Jung Jung, Tae-Hun Kim, Seunghoon Lee, Jung-Eun Kim, Kyung-Won Kang, So-Young Jung, Ae-Ran Kim, Hyo-Ju Park, Mi-Suk Shin, Kyung-Min Shin, Hee-Jung Jung, Seung-Deok Lee, Kwon-Eui Hong, Sun-Mi Choi |
Journal | Trials
(Trials)
Vol. 14
Pg. 303
(Sep 22 2013)
ISSN: 1745-6215 [Electronic] England |
PMID | 24053577
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Acupuncture, Ear
- Adult
- Aged
- Blood Pressure
- Blood Pressure Monitoring, Ambulatory
- Circadian Rhythm
- Clinical Protocols
- Feasibility Studies
- Female
- Humans
- Hypertension
(diagnosis, physiopathology, therapy)
- Male
- Middle Aged
- Pilot Projects
- Prehypertension
(diagnosis, physiopathology, therapy)
- Republic of Korea
- Research Design
- Risk Reduction Behavior
- Time Factors
- Treatment Outcome
- Young Adult
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