DOI QR코드

DOI QR Code

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

  • Shin, Jae-Young (Clinical Research Division, Korea Institute of Oriental Medicine) ;
  • Ku, Boncho (KM Fundamental Research Division, Korea Institute of Oriental Medicine) ;
  • Kim, Tae-Hun (Korean Medicine Clinical Trial Center, Kyung Hee University Oriental Medical Center) ;
  • Bae, Jang Han (KM Fundamental Research Division, Korea Institute of Oriental Medicine) ;
  • Jun, Min-Ho (KM Fundamental Research Division, Korea Institute of Oriental Medicine) ;
  • Lee, Jun-Hwan (Clinical Research Division, Korea Institute of Oriental Medicine) ;
  • Kim, Jaeuk U. (KM Fundamental Research Division, Korea Institute of Oriental Medicine)
  • Received : 2016.07.29
  • Accepted : 2016.08.24
  • Published : 2016.09.30

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 ($SE_{10-30Hz}$) 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.

Acknowledgement

Supported by : Korea Institute of Oriental Medicine

References

  1. Mayer DJ. Acupuncture: an evidence-based review of the clinical literature. Annu Rev Med 2000;51:49-63. https://doi.org/10.1146/annurev.med.51.1.49
  2. World Health Organization. WHO traditional medicine strategy: 2014-2023. Switzerland: WHO Library Cataloguing in Publication Data; 2013. 78 p.
  3. Lim DO, Jung MJ, Park JS. The survey of Korean medicine health care utilization and herbal medicine consumption. Cheongju: Korea Health Industry Development Istitute. 2014; 805 p.
  4. Kaptchuk TJ. Acupuncture: theory, efficacy and practice. Ann Intern Med. 2002;136(5):374-83. https://doi.org/10.7326/0003-4819-136-5-200203050-00010
  5. Chae YB, Kim YJ, Choe IH, Lim SB, Lee SJ, Lee HJ, et al. [A comparison study of acupuncture sensation scale between real acupuncture and sham needle]. Korean J Acupunct. 2006;23(4):85-99. Korean.
  6. B Wang. Huangdineijing suwen. Beijing: People's Medical Publishing House; 1963.
  7. Bae SC, Shin SH, Kim KW. [Pulse diagnosis procedure before and after the acupuncture in Hwangjenaekyung]. J Oriental Medical Classics. 2011;24(3):15-25. Korean.
  8. Lee BK, Park YB, Kim TH. [Diagnostics of Korean medicine]. Gyeonggi: Seongbosa; 2009. Korean.
  9. Boutouyrie P, Corvisier R, Azizi M, Lemoine D, Laloux B, Hallouin M, et al. Effects of acupuncture on radial artery hemodynamics: controlled trials in sensitized and naive subjects. Am J Physiol Heart Circ Physiol. 2001;280(2):628-33. https://doi.org/10.1152/ajpheart.2001.280.2.H628
  10. Sandberg M, Lundeberg T, Lindberg LG, Gerdle B. Effects of acupuncture on skin and muscle blood flow in healthy subjects. Eur J Appl Physiol. 2003;90(1-2):114-9. https://doi.org/10.1007/s00421-003-0825-3
  11. Takayama S, Seki T, Sugita N, Konno S, Arai H, Saijo Y, et al. Radial artery hemodynamic changes related to acupuncture. Explore. 2010;6(2):100-5. https://doi.org/10.1016/j.explore.2009.12.001
  12. Takayama S, Seki T, Watanabe M, Monma Y, Yang SY, Sugita N, et al. Brief effect of acupuncture on the peripheral arterial system of the upper limb and systemic hemodynamics in humans. J Altern Complement Med. 2010;16(7):707-13. https://doi.org/10.1089/acm.2009.0355
  13. Huang CM, Chang HC, Li TC, Chen CC, Liao YT, Kao ST. Acupuncture effects on the pulse spectrum of radial pressure pulse in dyspepsia. Am J Chin Med. 2012;40(3):443-54. https://doi.org/10.1142/S0192415X12500346
  14. Lee SH, Kim EJ, Park YC, Koh YJ, Nam DW. [Effect of acupuncture stimulation on heart rate variability in stroke patients]. The Acupuncture. 2006;23(1):135-43. Korean.
  15. Han CH, Song TW, Shin MS, Shin SH, Choi SM. [Gogoon acupuncture for hypertension]. Korean J Acupunct. 2007;24(1):27-41. Korean.
  16. Park EJ, Cho MR. [Experimental study of dadun (LR1)$\bullet$shaochung (HT9)$\bullet$shaofu (HT8) reinforcement in acupuncture on the improvement of cerebral hemodynamics. The Acupuncture. 2007;24(1):111-25. Korean.
  17. Yeo KC, Yoon IA, Kim JN, Bang SP, Moon SI. [Effects of acupuncture at Palsa (BaXie) evaluated by the second derivative of photoplethysmogram waveform in hemiparetic patients after stroke]. The Acupuncture. 2010;27(2):23-30. Korean.
  18. Kim NY, Kang JH, Lee H. [The effect of sa-am lung tonifying acupuncture on radial pulse in healthy humans Subjects]. The Acupuncture. 2012;29(5):17-29. Korean.
  19. Wei LY, Lee CT, Chow P. A new scientific method of pulse diagnosis. Am J Acupunct. 1984;12(3):205-18.
  20. Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:3115. https://doi.org/10.1136/bmj.a3115
  21. Linde K, Niemann K, Schneider A, Meissner K. How large are the nonspecific effects of acupuncture? a meta-analysis of randomized controlled trials. BMC Med. 2010;8:75. https://doi.org/10.1186/1741-7015-8-75
  22. Lima JW, Hentschke VS, Rossato DD, Quagliotto E, Pinheiro L, Almeida E Jr, et al. Chronic electroacupuncture of the ST36 point improves baroreflex function and haemodynamic parameters in heart failure rats. Auton Neurosci. 2015;193:31-7. https://doi.org/10.1016/j.autneu.2015.05.002
  23. Hyun SH, Im JW, Jung WS, Cho KH, Kim YS, Ko CN, et al. 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:ID574986.
  24. WHO Regional Office for the Western Pacific. WHO standard accupuncture point location in the Western pacific region. Switzerland: WHO Library Cataloguing in Publication; 2009. 249 p.
  25. Kim JU, Lee YJ, Lee J, Kim JY. 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:ID381634.
  26. Bae JH, Jeon YJ, Kim JY, Kim JU. New assessment model of pulse depth based on sensor displacement in pulse diagnostic devices. Evid Based Complement Alternat Med. 2013;2013:ID938641.
  27. Marek MJ, Thomas BA, John C. Heart rate variability: standards of measurement, physiological interpretation, and clinical use. Eur Heart J. 1996;17(3)354-81. https://doi.org/10.1093/oxfordjournals.eurheartj.a014868
  28. Yazdanian H, Mahnam A, Edrisi M, Esfahani MA. Design and implementation of a portable impedance cardiography system for noninvasive stroke volume monitoring. J Med Signals Sens. 2016;6(1):47-56.
  29. Global physical activity questionnaire (GPAQ) analysis guide [internet]. Switzerland: World Health Organization; Available from: http://www.who.int/chp/steps/resources/GPAQ_Analysis_Guide.pdf.
  30. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73-86. https://doi.org/10.1016/S0005-7916(00)00012-4
  31. Kim YJ. Development, validity and reliability testing of a Deqi sensation questionnaire by in-depth interview [master thesis]. Seoul: Kyung Hee University; 2006.
  32. World Health Organization. WHO draft guidelines for adverse event reporting and learning systems. Switzerland: WHO Document Production Services. 2005. 80 p.
  33. Spilker B. Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott Williams & Wilkins; 1996. 1312 p.
  34. International clinical trials registry platform (ICTRP) [internet]. Switzerland: World Health Organization; Available from: http://www.who.int/ictrp/network/en/.

Cited by

  1. Hemodynamic changes caused by acupuncture in healthy volunteers: a prospective, single-arm exploratory clinical study vol.17, pp.1, 2017, https://doi.org/10.1186/s12906-017-1787-z