Effects of Acupuncture Stimulation on the Radial artery’s Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single- arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30 Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University’s Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization’s (WHO’s) Registry Network.
Abstract
Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single- arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30 Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University’s Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization’s (WHO’s) Registry Network.
참고문헌 (34)
- Mayer DJ, "Acupuncture: an evidence-based review of the clinical literature", Annu Rev Med, 51, pp.49~63 (2000)
- World Health Organization, "WHO traditional medicine strategy: 2014-2023", pp.78~ (2013), WHO Library Cataloguing in Publication Data
- Lim DO, "The survey of Korean medicine health care utilization and herbal medicine consumption", pp.805~ (2014), Korea Health Industry Development Istitute
- Kaptchuk TJ, "Acupuncture : theory, efficacy and practice", Ann Intern Med, 136(5), pp.374~383 (2002)
- 채윤병, "거짓침 피부접촉부 형태에 따른 침감 차이 연구", Korean Journal of Acupuncture, 23(4), pp.85~99 (2006), 경락경혈학회
- B Wang, "Huangdineijing suwen" (1963), People’s Medical Publishing House
- 배성철, "『황제내경』에 나타난 침자 전후의 맥진", 대한한의학원전학회지, 24(3), pp.15~25 (2011), 대한한의학원전학회
- Lee BK, "Diagnostics of Korean medicine" (2009), Seongbosa
- Boutouyrie P, "Effects of acupuncture on radial artery hemodynamics: controlled trials in sensitized and naive subjects", Am J Physiol Heart Circ Physiol, 280(2), pp.628~633 (2001)
- Sandberg M, "Effects of acupuncture on skin and muscle blood flow in healthy subjects", Eur J Appl Physiol, 90(1-2), pp.114~119 (2003)
- Takayama S, "Radial artery hemodynamic changes related to acupuncture", Explore, 6(2), pp.100~105 (2010)
- Takayama S, "Brief effect of acupuncture on the peripheral arterial system of the upper limb and systemic hemodynamics in humans", J Altern Complement Med, 16(7), pp.707~713 (2010)
- Huang CM, "Acupuncture effects on the pulse spectrum of radial pressure pulse in dyspepsia", Am J Chin Med, 40(3), pp.443~454 (2012)
- 이상훈, "침자극이 뇌졸중 환자의 심박변이도에 미치는 영향", 대한침구의학회지, 23(1), pp.135~143 (2006), 대한침구의학회
- 한창현, "고혈압 환자에서 곡운침법의 혈압강하 효과", Korean Journal of Acupuncture, 24(1), pp.27~41 (2007), 경락경혈학회
- 박은주, "大敦？少衝？少府 刺鍼이 腦血流力學에 미치는 영향", 대한침구의학회지, 24(1), pp.111~125 (2007), 대한침구의학회
- 여경찬, "편마비 환자에서 八邪穴 刺鍼이 가속도맥파에 미치는 영향", 대한침구의학회지, 27(2), pp.23~30 (2010), 대한침구의학회
- 김나연, "肺正格 자침이 寸關尺 맥파 변화에 미치는 영향", 대한침구의학회지, 29(5), pp.17~29 (2012), 대한침구의학회
- Wei LY, "A new scientific method of pulse diagnosis", Am J Acupunct, 12(3), pp.205~218 (1984)
- Madsen MV, "Acupuncture treatment for pain : systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups", BMJ, 338, pp.3115~ (2009)
- Linde K, "How large are the nonspecific effects of acupuncture? a meta- analysis of randomized controlled trials", BMC Med, 8, pp.75~ (2010)
- Lima JW, "Chronic electroacupuncture of the ST36 point improves baroreflex function and haemodynamic parameters in heart failure rats", Auton Neurosci, 193, pp.31~37 (2015)
- Hyun SH, "Effect of ST36 acupuncture on hyperventilation- induced CO2 reactivity of the basilar and middle cerebral arteries and heart rate variability in normal subjects", Evid Based Complement Alternat Med, 2014 (2014)
- WHO Regional Office for the Western Pacific, "WHO standard accupuncture point location in the Western pacific region", pp.249~ (2009), WHO Library Cataloguing in Publication
- Kim JU, "Differences in the properties of radial artery between Cun, Guan, Chi and nearby segments using ultrasonographic imaging: a pilot study on arterial eepth, diameter, and blood flow", Evid Based Complement Alternat Med, 2015 (2015)
- Bae JH, "New assessment model of pulse depth based on sensor displacement in pulse diagnostic devices", Evid Based Complement Alternat Med, 2013 (2013)
- Marek MJ, "Heart rate variability: standards of measurement, physiological interpretation, and clinical use", Eur Heart J, 17(3), pp.354~381 (1996)
- Yazdanian H, "Design and implementation of a portable impedance cardiography system for noninvasive stroke volume monitoring", J Med Signals Sens, 6(1), pp.47~56 (2016)
- "Global physical activity questionnaire (GPAQ) analysis guide"[URL]
- Devilly GJ, "Psychometric properties of the credibility", expectancy questionnaire, 2000, pp.31(2), 73~86
- Kim YJ, "Development, validity and reliability testing of a Deqi sensation questionnaire by in-depth interview", master, pp.2006
- World Health Organization, "WHO draft guidelines for adverse event reporting and learning systems", pp.80~ (2005), WHO Document Production Services
- Spilker B, "Quality of life and pharmacoeconomics in clinical trials", pp.1312~ (1996), Lippincott Williams & Wilkins
- "International clinical trials registry platform (ICTRP)"[URL]