Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062912) titled 'Effects of intermittent pinpoint thermal stimulation using electronic moxibustion on cardiovascular responses: a randomized crossover study' on Sept. 15.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Morinomiya University of Medical Sciences

Condition: Condition - Healthy adult. Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: 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 Size - 15

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072005

Disclaimer: Curated by HT Syndication.