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.
BACKGROUND
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
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 (SE10-30Hz) 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.


CONCLUSIONS
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.


BACKGROUND
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.


BACKGROUND
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.
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.
Jae-Young
JY
Shin
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea; Korean Medicine Life Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Korea.
Jun-Hwan
JH
Lee
KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.
Boncho
B
Ku
KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.
Jang Han
JH
Bae
KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.
Min-Ho
MH
Un
KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea; Korean Medicine Life Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Korea.
Jaeuk U
JU
Kim
Korean Medicine Clinical Trial Center, Kyung Hee University Oriental Medical Center, Seoul, Korea.
Tae-Hun
TH
Kim
 protocol;  radial artery’s pressure pulse wave; acupuncture
Eur Heart J. 1996 Mar;17(3):354-81
8737210
Eur J Appl Physiol. 2003 Sep;90(1-2):114-9
12827364
Auton Neurosci. 2015 Dec;193:31-7
26032957
Annu Rev Med. 2000;51:49-63
10774452
Am J Physiol Heart Circ Physiol. 2001 Feb;280(2):H628-33
11158960
J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86
11132119
Evid Based Complement Alternat Med. 2015;2015:381634
25763090
BMC Med. 2010 Nov 23;8:75
21092261
BMJ. 2009 Jan 27;338:a3115
19174438
Explore (NY). 2010 Mar-Apr;6(2):100-5
20362267
Am J Chin Med. 2012;40(3):443-54
22745062
J Med Signals Sens. 2016 Jan-Mar;6(1):47-56
27014612
Evid Based Complement Alternat Med. 2013;2013:938641
24191173
J Altern Complement Med. 2010 Jul;16(7):707-13
20615147
Ann Intern Med. 2002 Mar 5;136(5):374-83
11874310
Evid Based Complement Alternat Med. 2014;2014:574986
25132861