UMIN-CTR Clinical Trial

Basic information
Public title	Autonomic responses of human organs induced by acupuncture and thermal stimulation: Randomized controlled trial evaluating electrocardiogram, finger plethysmogram, and local skin blood flow
Acronym	Autonomic responses of human organs induced by acupuncture and thermal stimulation
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
Scientific Title:Acronym	Autonomic responses of human organs induced by acupuncture and thermal stimulation
Region	Japan

Condition
Condition	Healthy condition
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	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.
Interventions/Control_2	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).
Interventions/Control_3	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.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	30 years-old >
Gender	Male
Key inclusion criteria	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
Key exclusion criteria	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.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Imai
Organization	Teikyo Heisei University
Division name	Graduate School of Health Sciences
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL	080-1527-1617
Email	k.imai@thu.ac.jp

Public contact
Name of contact person	1st name Namiki Middle name Last name Shinozaki
Organization	Teikyo Heisei University
Division name	Department of Acupuncture and Moxibustion, Graduate School of Health Sciences
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL	080-7698-1412
Homepage URL
Email	n.shinozaki1@gmail.com

Sponsor
Institute	Teikyo Heisei University
Institute
Department

Funding Source
Organization	Teikyo Heisei University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	ethical commitie, Teikyo Heisei University
Address	2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
Tel	03-5843-3111
Email	rec@thu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 04 Month 20 Day
Date of IRB	2022 Year 09 Month 05 Day
Anticipated trial start date	2022 Year 09 Month 16 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 13 Day
Last modified on	2022 Year 09 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055743