Clinical trial NCT05249010: The Effect of Moxibustion on the Meridian
Official title: The Effect of Moxibustion on the Meridian: A Prospective, Crossover Designed, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acupuncture
Moxibustion
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from those considered healthy and at least 20 years old who agreed to the informed consent. The exclusion criteria for this study were: those under 20 years old, pregnant or breast-feeding women, those with an empty stomach before the study, a tendency toward bleeding with thrombocytopenia or platelets \< 20000 or a user of an anti-platelet drug.

Brief summary: The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.

Detailed description: Moxibustion is a traditional Chinese medicine, which use the burned moxa to generate warmth on the human's local skin and then exerts a therapeutic effect. Research found that moxibustion has effect on analgesic and anti-inflammation, which can be applied on myofascial pain, insomnia, osteoarthritis, osteoporosis, cancer related fatigue, irritable bowel disease etc.. Although research reveal that moxibustion can treat these diseases probably by effect on analgesic and anti-inflammation, the mechanism of moxibustion is still not clear.

In modern study, the meridian has electric characteristic and the therapeutic effect of acupuncture may be related to the electricity resulting by acupuncture manipulation. However, there is no study to investigate the electric effect of moxibustion on the meridian. In our study, the investigators applied the semiconductor analyzer Agilent B1500A to investigate the electric characteristic of meridians and visual analogue scale (VAS) before and after moxibustion, which may provide another vision on moxibustion in the future.

The investigators intend to recruit 30 healthy participants with age more than 20 years old to participate this study. The participants receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A immediately(baseline data). The investigators add the burned moxa on the acupuncture as a method for moxibustion. After the moxa burned out, the investigators measure the VAS and electric characteristic immediately again(post moxibustion data). The investigators will use paired t test and repeated measure two ways ANOVA to compare the VAS and electricity of baseline data and post moxibustion data in each participant.

The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.

Eligibility criteria: Inclusion Criteria:

* at least 20 years old
* agree to the informed consent

Exclusion Criteria:

* under 20 years old
* pregnant or breast-feeding women
* those with an empty stomach before the study
* a tendency toward bleeding with thrombocytopenia or history of platelets \< 20000 or a user of an anti-platelet drug.

Primary outcomes:
measure: change of visual analogue scale (VAS), score from 0 to 10, the lower score means less pain while the higher score means more pain.
timeFrame: through study completion, an average of 90 minutes
measure: The change of electric current
timeFrame: through study completion, an average of 90 minutes
measure: The change of voltage
timeFrame: through study completion, an average of 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Sun Yat-Sen University
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Chiang Hung, Professor
role: STUDY_DIRECTOR
References:
citation: He XR, Wang Q, Li PP. Acupuncture and moxibustion for cancer-related fatigue: a systematic review and meta-analysis. Asian Pac J Cancer Prev. 2013;14(5):3067-74. doi: 10.7314/apjcp.2013.14.5.3067.
citation: Lim MY, Huang J, Zhao B. Standardisation of moxibustion: challenges and future development. Acupunct Med. 2015 Apr;33(2):142-7. doi: 10.1136/acupmed-2014-010688. Epub 2014 Dec 15.
citation: Hung YC, Chen WC, Chang TC, Zheng HX, Liu YW, Tan YF, Lin SK, Lu YH, Hu WL, Tsai TM. Meridian study on the response current affected by electrical pulse and acupuncture. Nanoscale Res Lett. 2020 Jul 10;15(1):146. doi: 10.1186/s11671-020-03373-2.