Unique ID issued by UMIN | UMIN000048922 |
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Receipt number | R000055743 |
Scientific Title | Autonomic responses of human organs induced by acupuncture and thermal stimulation: Randomized controlled trial evaluating electrocardiogram, finger plethysmogram, and local skin blood flow |
Date of disclosure of the study information | 2022/09/15 |
Last modified on | 2022/09/13 15:03:29 |
Autonomic responses of human organs induced by acupuncture and thermal stimulation:
Randomized controlled trial evaluating electrocardiogram, finger plethysmogram, and local skin blood flow
Autonomic responses of human organs induced by acupuncture and thermal stimulation
Autonomic responses of human organs induced by acupuncture and thermal stimulation:
Randomized controlled trial evaluating electrocardiogram, finger plethysmogram, and local skin blood flow
Autonomic responses of human organs induced by acupuncture and thermal stimulation
Japan |
Healthy condition
Not applicable | Adult |
Others
NO
This study will examine the effects of acupuncture and thermal stimulation on haemodynamics using electrocardiogram, finger plethysmogram, and local skin blood flow. The differences in response by acupuncture and thermal stimulation will also be examined.
Safety,Efficacy
Measurement of the electrocardiogram (ECG): Electrodes are placed on the chest induction I and recordings are made. The instantaneous heart rate, QT interval, QTc interval are calculated from the recorded ECG. In addition, HRV analysis is performed as an indicator of cardiac autonomic function.
The ECG is measured for 10 minutes before stimulation, 2 minutes during stimulation, and 15 minutes after stimulation, for a total of 27 minutes.
Measurement of the finger plethysmogram: A pulse transducer (MP100, AD Instruments) is attached to the tip of the right index finger to record and calculate wave height values.
Measurement of the local skin blood flow: A laser Doppler skin blood flow meter (ALF-21, Advance) is used to fix the probe near the stimulation site and record the results.
The finger plethysmogram and the local skin blood flow are measured for 10 minutes before stimulation, 2 minutes during stimulation, and 15 minutes after stimulation, for a total of 27 minutes.
Assessment of the type of pain: The presence or absence of "pain" or "de qi" during the stimulation will be assessed after the end of the experiment.
Evaluation of the degree of pain: The intensity of the "pain" or "de qi" is assessed using a visual analogue scale (VAS) of 10 cm in width, respectively, with 100 points as the most intense pain on a scale of every 1 mm, and 0 as the scale indicating no pain.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
No treatment
3
Treatment
Maneuver |
The acupuncture stimulation group: The experiment will begin after 20 minutes of rest, with 10 minutes of rest before stimulation, 2 minutes during stimulation, and 15 minutes of rest after stimulation, for a total of 27 minutes. The acupuncture stimulation is applied by the sparrow pecking method; that is, the acupuncture needle is inserted and move vertically at the frequency of 1 Hz at a depth of 15-20 mm for 2 minutes. The site of acupuncture stimulation is the LI10 point on the right forearm (between the extensor carpi radialis longus and the extensor carpi radialis brevis on the radial side). Disposable stainless steel needles (40 mm,0.20 mm) are used.
The thermal stimulation group: The experiment will begin after 20 minutes of rest, with 10 minutes of rest before stimulation, 2 minutes during stimulation, and 15 minutes of rest after stimulation, for a total of 27 minutes. The thermal stimulation is performed using a Pain thermometer (UDH-105, UNIQUE MEDICAL) by applying the attached probe to the stimulation site. The site of thermal stimulation is the LI10 point on the right forearm (between the extensor carpi radialis longus and the extensor carpi radialis brevis on the radial side).
The control group: The experiment will begin after 20 minutes of rest, with 10 minutes of rest before stimulation, 2 minutes during stimulation, and 15 minutes of rest after stimulation, for a total of 27 minutes.
Nothing is done during stimulation.
18 | years-old | <= |
30 | years-old | > |
Male
1) Healthy person aged 18 and under 30
2) Those who can attend the study site within the study period
3) Persons who can get written consent for participation in this study
1) Persons who go to the hospital or take medication for basic diseases (chronic respiratory diseases, heart diseases, kidney diseases, liver diseases, diabetes, blood diseases (hyponatremia, difficult-to-treat high blood pressure, etc.), immune function Decreasing illnesses (including malignant tumors), neurological disorders, neuromuscular disorders and severe mental illnesses)
2) Persons who complain of poor physical condition due to sleep disorders
3) Persons who have a habit of excessive smoking * 1 and excessive alcohol intake * 2, and those who have an extremely irregular diet * 3
4) Those who donated 400 ml of blood within 12 weeks, 200 ml of blood within 4 weeks, and component blood within 2 weeks before the start of the experiment
5) Persons participating in other clinical trials
<Notes>
* 1 Excessive smoking generally means smoking 21 or more cigarettes a day.
* 2 Excessive alcohol intake is roughly equivalent to 2 cups of sake per day (500 ml of beer bottle x 2 bottles, whiskey double 60 ml x 2 cups, 1 go of shochu 180 ml, 1 cup of red wine glass 60 ml x 7 cups) or more. Refers to drinking.
* 3 Refers to a state in which one or more meals a day are one or more meals, and the meal time is constantly irregular.
18
1st name | Kenji |
Middle name | |
Last name | Imai |
Teikyo Heisei University
Graduate School of Health Sciences
170-8445
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
080-1527-1617
k.imai@thu.ac.jp
1st name | Namiki |
Middle name | |
Last name | Shinozaki |
Teikyo Heisei University
Department of Acupuncture and Moxibustion, Graduate School of Health Sciences
170-8445
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
080-7698-1412
n.shinozaki1@gmail.com
Teikyo Heisei University
Teikyo Heisei University
Other
ethical commitie, Teikyo Heisei University
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
03-5843-3111
rec@thu.ac.jp
NO
2022 | Year | 09 | Month | 15 | Day |
Unpublished
Preinitiation
2022 | Year | 04 | Month | 20 | Day |
2022 | Year | 09 | Month | 05 | Day |
2022 | Year | 09 | Month | 16 | Day |
2023 | Year | 03 | Month | 31 | Day |
2022 | Year | 09 | Month | 13 | Day |
2022 | Year | 09 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055743
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