UMIN-CTR Clinical Trial

Public title

The preventive effect of acupuncture stimulation on optokinetic motion sickness: Examination of optimal acupuncture stimulation conditions in a randomized controlled trial

Acronym

The preventive effect of acupuncture stimulation on optokinetic motion sickness

Scientific Title

The preventive effect of acupuncture stimulation on optokinetic motion sickness: Examination of optimal acupuncture stimulation conditions in a randomized controlled trial

Scientific Title:Acronym

The preventive effect of acupuncture stimulation on optokinetic motion sickness

Region

Japan

Condition

Optokinetic motion sickness
Nausea

Classification by specialty

Medicine in general	Gastroenterology	Neurology
Psychiatry	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aims of this study are to investigate the effect of acupuncture stimulation on optokinetic motion sickness had been induced by virtual reality (VR) system in healthy volunteers. We consider the preventive effect of acupuncture stimulation and optimal acupuncture stimulation conditions for various autonomic nervous symptoms such as nausea in a randomized controlled trial using sham needle.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The electrogastrogram (EGG) is measured using a portable EGG recorder (EGS2. Nipro Co., Japan). A disposable Ag-AgCl electrodes (Vitrode F, NIHON KODEN, Japan) are placed just under the left and right costal margin at the upper quarter level between the processus xiphoideus and the umbilicus. Moreover, the keratin is removed using tape to reduce the electrical resistance of the skin in before applying the electrodes. EGG data are transferred to a PC at a sampling rate of 1 Hz, then using a fast Fourie's transform (FFT), we compute an algorithm of a power spectra of every 256 sec. Each EGG recording divided into blocks of 60 sec without overlapping. On the power spectrum of each 60 sec, the dominant frequencies of EGG are defined under 0-9 cpm. The percentages of the normogastria range (2-4 cpm), the bradygastria range (0-2 cpm), and the tachygastria range (4-9 cpm) are calculated, respectively. EGG is measured for 20 minutes of 5 minutes at rest before acupuncture stimulation and 15 minutes during VR intervention.

Key secondary outcomes

For the electrocardiogram (ECG), a disposable Ag-AgCl electrodes (Vitrode Bs, NIHON KODEN, Japan) are attached to the chest and amplified using a bio-amplifier (ML132, AD instruments, Australia). The filter settings are high cut filter 60 Hz and the time constant is 0.03 sec. The ECG is taken into a PC at a sampling rate of 1 kHz via an A / D converter (Power Lab 8sp, AD Instruments, Australia), and HRV analysis is used the analysis software Chart5 (AD Instruments, Australia) and HRV module. In the power spectrum obtained by FFT, 0.05-0.15 Hz power is defined as the low-frequency (LF) component, and 0.15-0.4 Hz power is defined as the high-frequency (HF) component. The ratios of LF and HF to the total power values are defined as normalized units of LF (LFnu) and normalized units of HF (HFnu). Moreover, LF / HF is calculated which is the ratio of the LF component and the HF component. The HFnu is used as the index for vagal activity and the LFnu is used as the index of sympathetic activity and the LF/HF ratio is used as the index of sympatho-vagal balance. The measurement is performed for a total of 20 minutes of 5 minutes before acupuncture stimulation and 15 minutes during VR intervention.
The evaluation of nausea is performed with 0 points for no symptoms and 100 points for vomiting, and listen to 3 times of before acupuncture stimulation and before/after VR intervention.
The subjective symptom of motion sickness (SSMS) is used to evaluate motion sickness. SSMS consists of 7 items of dizziness, headaches, warmth, sweating, drowsiness, increasing salivation, and nausea in motion sickness. The degree of each symptom is rated on a scale of 4 and 6, and the minimum score is 0 and the maximum score is 49. This SSMS is listened to every 3 minutes for 15 minutes corresponding to VR intervention, and the transition of symptoms over time is confirmed.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Control group (sham acupuncture group): After 20 minutes of rest, including placement of the electrodes and the VR head set, the subjects are asked to sit on the chair for a total of 40 min: 5 min baseline period, 20 min acupuncture stimulation, and 15 min VR intervention. The VR intervention is created based on previous reports, and a cylindrical shape with a diameter of 75 cm become a virtual space. A cylindrical shape have alternating white 6.2 cm and black 3.8 cm vertical stripes inside, that is rotated clockwise at a speed of 60 degree per second for 15 minutes to induce optokinetic motion sickness. At this time, the subjects complain of autonomic nervous symptoms and are instructed to remove the VR head set if they could not tolerate it. In sham acupuncture group, we use custom-made (in-house) sham acupuncture needles with disinfected stainless acupuncture needles (0.80 mm diameter and 40 mm length; TAIHO Medical Products Co., Ltd., Hiroshima, Japan) inserted into a custom-made guide tube. The needling sites are performed on ST36 bilaterally located in the tibialis anterior muscle between the head of fibula and the lower end of the tibial tuberosity.

Interventions/Control_2

Manual acupuncture group: After 20 minutes of rest, including placement of the electrodes and the VR head set, the subjects are asked to sit on the chair for a total of 40 min: 5 min baseline period, 20 min acupuncture stimulation, and 15 min VR intervention. The VR intervention is created based on previous reports, and a cylindrical shape with a diameter of 75 cm become a virtual space. A cylindrical shape have alternating white 6.2 cm and black 3.8 cm vertical stripes inside, that is rotated clockwise at a speed of 60 degree per second for 15 minutes to induce optokinetic motion sickness. At this time, the subjects complain of autonomic nervous symptoms and are instructed to remove the VR head set if they could not tolerate it. In manual acupuncture group, we use a sterile stainless acupuncture needle (diameter, 0.20 mm; length, 40 mm; SEIRIN Co., Shizuoka, Japan) and is inserted perpendicularly to a depth of 15~20 mm under the skin, and the manual acupuncture (insert a needle into the body and remain it for a while) is performed for 20 minutes in before VR intervention. The needling sites are performed on ST36 bilaterally located in the tibialis anterior muscle between the head of fibula and the lower end of the tibial tuberosity.

Interventions/Control_3

Electroacupuncture group: After 20 minutes of rest, including placement of the electrodes and the VR head set, the subjects are asked to sit on the chair for a total of 40 min: 5 min baseline period, 20 min acupuncture stimulation, and 15 min VR intervention. The VR intervention is created based on previous reports, and a cylindrical shape with a diameter of 75 cm become a virtual space. A cylindrical shape have alternating white 6.2 cm and black 3.8 cm vertical stripes inside, that is rotated clockwise at a speed of 60 degree per second for 15 minutes to induce optokinetic motion sickness. At this time, the subjects complain of autonomic nervous symptoms and are instructed to remove the VR head set if they could not tolerate it. In electroacupuncture group, we use a sterile stainless acupuncture needle similar to the manual acupuncture group and is inserted perpendicularly to a depth of 15~20 mm under the skin, and Ohm Pulser LFP-2000e (Zen Iryoki Co., Tokyo, Japan) is used to electroacupuncture at 10 Hz for 20 minutes in before VR intervention. The needling sites are performed on ST36 bilaterally located in the tibialis anterior muscle between the head of fibula and the lower end of the tibial tuberosity.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

30

years-old

>

Gender

Male

Key inclusion criteria

The eligibility criteria for subjects are healthy male volunteers between the ages of 18 and 30.

Key exclusion criteria

The exclusion criteria are: (1) those who were to the hospital and on medication due to underlying medical conditions, (2) those who were unwell due to sleep disorders, (3) those with a history of gastrointestinal disorders and inner ear disorders, central nervous disorders.

Target sample size

28

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

Name of contact person

1st name	Daiyu
Middle name
Last name	Shinohara

Organization

Teikyo Heisei University

Division name

Graduate School of Health Sciences

Zip code

170-8445

Address

2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo

TEL

080-5521-6516

Homepage URL

Email

d.shinohara1@gmail.com

Institute

Teikyo Heisei University

Institute

Department

Personal name

Organization

Teikyo Heisei University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

07

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2022

Year

04

Month

15

Day

Date of IRB

2022

Year

07

Month

25

Day

Anticipated trial start date

2022

Year

07

Month

29

Day

Last follow-up date

2022

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

07

Month

26

Day

Last modified on

2022

Year

09

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055237