UMIN-ICDS Clinical Trial

Public title

Effects of intermittent pinpoint thermal stimulation using electronic moxibustion on cardiovascular responses: a randomized crossover study.

Acronym

Effects of intermittent pinpoint thermal stimulation using electronic moxibustion on cardiovascular responses: a randomized crossover study.

Scientific Title

Quantitative analysis of cardiovascular responses to thermal and pressure stimulation.

Scientific Title:Acronym

Quantitative analysis of cardiovascular responses to thermal and pressure stimulation.

Region

Japan

Condition

Healthy adult.

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The present study focused on pinpoint thermal stimulation that mimics moxibustion and examined its effects on cardiovascular responses. The study was conducted in two stages. In Study 1, continuous stimulation was applied to characterize the basic response. In Study 2, the stimulation protocol was modified to an intermittent pattern by periodically moving the device vertically toward and away from the skin surface, with the aim of sustaining the response observed in Study 1. We hypothesized that intermittent stimulation would maintain the heart rate reduction observed during continuous stimulation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cardiovascular variables: Heart rate (HR), mean blood pressure (MBP) and skin temperature (SKT) were continuously recorded, and the mean values of each parameter were compared between the rest and intervention periods.

Key secondary outcomes

Heart rate variability (HRV): HRV was analyzed from ECG recordings in Study 2 only. High-frequency power in normalized units (HFnu) and the low frequency to high frequency (LF/HF) ratio were calculated.
Psychological indices: Immediately after the experimental, participants rated their subjective responses using a numerical rating scale in Study 2. Valence (0 = unpleasant, 9 =pleasant) and arousal (0 = relaxing, 9 = stimulating) were assessed.
Respiratory variables: In the subgroup analysis, respiratory rate (RR) and tidal volume (VT) were continuously recorded. Respiratory variables were averaged over the same periods as cardiovascular variables.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Upon arrival at the laboratory, participants rested quietly in the supine position for 10 min to achieve a stable baseline condition in Study 1. Participants underwent a single session consisting of 3-min resting baseline period (Pre) followed by a 3-min continuous thermal stimulation period (Stim). Continuous pinpoint thermal stimulation was applied by maintaining constant contact between the device and the skin surface throughout the stimulation period. The temperature was set to 49 degrees C. The stimulation site was the Zusanli acupoint (WHO; ST36) on the left leg.

Interventions/Control_2

Study 2 was a randomized crossover trial with two experimental conditions; a control condition (CL; no heating) and a thermal stimulation condition (TL). The order of the condition was randomized across participants. Each condition was performed on separate day (at least 1 week), and all experiments were conducted at the same time of the day for each participant to minimize circadian influences. Upon arrival at the laboratory, participants rested quietly in the supine position for 10 min prior to each experimental session. Each condition consisted of a 5-min resting baseline period (Pre) followed by a 5-min intervention period (Stim). Intermittent pinpoint thermal stimulation was applied by moving the device vertically away from and toward the skin surface within a range of 20 mm at 10-second intervals, thereby providing repeated thermal exposure. In the TL condition, the temperature was set to 49 degrees C; in the CL condition, the same procedure was performed with the heating function turned off. The stimulation site was the Zusanli acupoint (WHO; ST36) on the left leg.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy adults participated in the study.
Participants were instructed to abstain from caffein, alcohol, and strenuous physical activity for at least 12 hours prior to the experiment.
All participants had no history of cardiovascular, neurological, and respiratory disorders, and were not taking any medications known to affect autonomic or cardiovascular function.

Key exclusion criteria

The exclusion criteria were participants who had a history of cardiovascular, neurological, and respiratory disorders and taking any medications known to affect autonomic or cardiovascular function.

Target sample size

15

Name of lead principal investigator

1st name	Hidehiro
Middle name
Last name	Nakahara

Organization

Morinomiya University of Medical Sciences

Division name

Faculty of Medical Science Technology Department of Acupuncture

Zip code

559-8611

Address

1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka, Japan

TEL

06-6616-6911

Email

nakahara@morinomiya-u.ac.jp

Name of contact person

1st name	Kojiro
Middle name
Last name	Ito

Organization

Morinomiya University of Medical Sciences

Division name

Faculty of Medical Science Technology Department of Acupuncture

Zip code

559-8611

Address

1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka, Japan

TEL

06-6616-6911

Homepage URL

Email

kojiro_ito@morinomiya-u.ac.jp

Institute

Morinomiya University of Medical Sciences

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Morinomiya University of Medical Sciences

Address

1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka, 559-8611, Japan

Tel

06-6616-6911

Email

kenkyu@morinomiya-u.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

森ノ宮医療大学(大阪府)

Date of disclosure of the study information

2026

Year

09

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

29

Results

In Study 1, HR decreased during stimulation associated with increased SKT, but both returned toward baseline during continuous stimulation. In Study 2, HR decreased during stimulation in the TL condition accompanied by increased SKT, and was maintained throughout the intervention period. Significant Condition x Time interactions were observed for HR, SKT, high-frequency power in normalized units (HFnu), and low frequency/high frequency (LF/HF) ratio. No significant interaction was observed for MBP.

Results date posted

2026

Year

09

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

A total of 29 healthy adults participated in this study. Fourteen participants (7 males and 7 females; age: 19.8 +/- 1.6 years; height: 161.7 +/- 9.9 cm; body mass: 58.2 +/- 11.1 kg; BMI: 22.0 +/- 1.9 kg/m2) were included in Study 1, and 15 participants (8 males and 7 females; age: 20.1 +/- 1.5 years; height: 167.9 +/- 6.9 cm; body mass: 62.3 +/- 10.7 kg; BMI: 21.9 +/- 2.3 kg/m2) in Study 2.

Participant flow

Fourteen participants were enrolled in Study 1, and all participants completed the experimental and were included in the final analysis.
Fifteen participants were enrolled in Study 2, and all participants completed both the CL and TL conditions and were included in the final analysis.

Adverse events

No adverse events were observed in this study, despite local increase in skin temperature.

Outcome measures

In Study 1, a one-way repeated-measures ANOVA revealed a significant main effect of Time on HR [F (3, 39) = 11.9, p < 0.001, eta_p2 = 0.478] and SKT [F (3,39) = 474.00, p < 0.001, eta_p2 = 0.973]. Post hoc analysis revealed that HR was significantly lower during the first minute of stimulation (p < 0.001) and second minute of stimulation (p = 0.043) compared with the resting period. A one-way repeated-measures ANOVA revealed no main effect of Time [F (3, 39) = 2.09, p = 0.117, eta_p2 = 0.138] for MBP.
In Study 2, a two-way repeated-measures ANOVA (Condition x Time) revealed a significant interaction effect for HR [F (1,14) = 16.82, p = 0.001, eta_p2 = 0.546], with a significant main effect of Time [F (1,14) = 17.92, p < 0.001, eta_p2 = 0.561] but no significant main effect of Condition [F (1,14) = 0.05, p = 0.822, eta_p2 = 0.004]. Post hoc analysis showed that HR decreased significantly during the intervention period compared with the resting period in the TL condition (p < 0.001). A two-way repeated-measures ANOVA (Condition x Time) also revealed a significant interaction effect for SKT [F (1,14) = 454.00, p < 0.001, eta_p2 = 0.970]. For MBP, a two-way repeated-measures ANOVA revealed no significant interaction between Condition and Time [F (1,14) = 0.56, p = 0.465, eta_p2 = 0.039] and no significant main effect of Condition [F (1,14) = 0.08, p = 0.781, eta_p2 = 0.006] or Time [F (1,14) = 4.19, p = 0.060, eta_p2 = 0.230]. For heart rate variability (HRV), a two-way repeated-measures ANOVA revealed a significant interaction between Condition and Time for HFnu [F (1,14) = 6.97, p = 0.019, eta_p2 = 0.332], but no significant main effect of Condition [F (1,14) = 0.74, p = 0.403, eta_p2 = 0.050] or Time [F (1,14) = 0.07, p = 0.790, eta_p2 = 0.005]. For the LF/HF ratio, a significant interaction was observed [F (1,14) = 13.88, p = 0.002, eta_p2 = 0.498], with no significant main effect of Condition [F (1,14) = 2.01, p = 0.178, eta_p2 = 0.126] or Time [(F (1,14) = 0.16, p = 0.698, eta_p2 = 0.011]. A paired t-test revealed no significant difference in valence between the two conditions (p = 0.054). Similarly, no significant difference in arousal was found between conditions (p = 0.809).
In the subgroup analysis, a two-way repeated-measures ANOVA revealed no significant interaction between Condition and Time for respiratory rate (RR) [F (1,9) = 2.277, p = 0.166, eta_p2 = 0.202], with no significant main effect of Condition [F (1,9) = 0.695, p = 0.426, eta_p2 = 0.072] or Time [F (1,9) = 0.822, p = 0.388, eta_p2 = 0.084]. For tidal volume (VT), no significant interaction was observed [F (1,9) = 0.882, p = 0.372, eta_p2 = 0.089], and main effects of Condition [F (1,9) = 0.545, p = 0.479, eta_p2 = 0.057] and Time [F (1,9) = 2.971, p = 0.119, eta_p2 = 0.248] were not significant.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2022

Year

10

Month

14

Day

Date of IRB

2019

Year

08

Month

22

Day

Anticipated trial start date

2022

Year

10

Month

14

Day

Last follow-up date

2025

Year

11

Month

13

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2025

Year

11

Month

13

Day

Other related information

In Study 1, values averaged over the last 60 s of the Pre period were used as baseline values, and the stimulation period was divided into three 1-min segments for analysis. In Study 2, mean values were calculated over the entire 5-min Pre and Stim periods. All data were visually inspected for artifacts, and segments with excessive noise were exclude from analysis.
All statistical analyses were performed using Jamovi (version 2.3.28.0). Data are presented as mean +/- standard deviation (SD), and statistical significance was set at p < 0.05. In Study 1, changes over time was assessed using one-way repeated-measures analysis of variance (ANOVA). In Study 2, a two-way repeated -measures ANOVA was conducted with factors of Condition (CL vs. TL) and Time (Pre vs. Stim). The primary analysis focused on the interaction between Condition and Time. When significant main effects or interactions were observed, post hoc comparisons were performed using Bonferroni-correction. Psychological indices (valence and arousal) were compared using paired t-test. Effect sizes were reported as partial eta squared (eta_p2). Normality of the data was assessed using the Shapiro-Wilk test.

Registered date

2026

Year

09

Month

14

Day

Last modified on

2026

Year

09

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072005