Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick

Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick: A Pilot Study

Moxibustion plays an important role in Traditional Medicine treatments, which treats and prevents diseases by burning a herb preparation containing Moxa (Artemisia vulgaris, Mugwort) to stimulate the meridians of human body. Moxibustion is considered a safe and effective traditional therapy. Mild moxibustion is a kind of therapeutic method which characterized by wide indications, simple manipulation and comfortable feeling, is commonly used in clinical treatment. Mingmen acupoint located on the midline of the lower back, in the depression below the spinous process of the 2nd lumbar vertebra (L2). Its indications include Yang-deficiency syndrome, Cold-Stagnation syndrome, Cold Excessive syndrome,... and it is closely related to the knee area through the path of Thoroughfare Vessel (one of the Eight Extraordinary Vessels). In our study, we investigate the change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint with moxa stick in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Procedure: Mild moxibustion with moxa stick

Detailed Description

Participants and Methods: A randomized controlled trial is conducted by comparing the change in skin surface temperature before and after using mild moxibustion manipulation at the research acupoint (Mingmen (GV-4) acupoint) or the control acupoint (the left side Pishu (BL-20) acupoint) in healthy volunteers. A total of 38 participants will undergo 2 trial phases, corresponding to 2 times of moxibustion in 8 days, each time is 7 days apart. In the first trial phase: participants received moxibustion at left side Pishu (BL-20) acupoint. In the second trial phase: participants received moxibustion at Mingmen (GV-4) acupoint. The primary outcome was the change in skin surface temperature at the local stimulated area and the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint. This trial will be performed as a pilot study.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy males and females were individual age between enough 18 and 30 years old.
• BMI: 18.5 - 23 kg/m2
• Mental alertness, good contact, cooperation with researchers.
• Had no psychiatric stress problem during moxibustion day (confirmed by answering the DASS 21 questionaire with stress point less than 15 points).
• Had no history of cardio-vascular disease, diabetes, hyperthyroidism, hypothyroidism.

• Vital sign within normal limits:

  • Heart rates from from 60 to 99 beats/minute.
  • Systolic blood pressure between 90 and 139 mmHg.
  • Diastolic blood pressure between 60 and 89 mmHg.
  • Breathing rate: 16 ± 3 times/minute.
  • Body temperature: 36.59 ± 0.43 ℃.
  • SpO2 from 95 to 100%.
• Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
• Not currently participating in other intervention studies.

Exclusion Criteria:

• Having an inflammatory injury in the site of the skin to be investigated.
• Medical history of asthma or allergy with moxa smoke.
• Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24 hours.
• Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
• Other diseases that could affect or interfere with outcomes, including common cold or flu.
• Playing sport 2 hours before the study.
• Taking stimulants such as beer, alcohol, coffee and tobacco within 24 hours before conducting the study.
• Skin surface temperature disorders or sensation disorders at lower-back or knee area.
• Staying up at night or having insomnia before moxibustion day.
• Women during menstruation period, pregnancy, or breastfeeding.
• Currently using certain drugs which dilate blood vessels and drop in blood pressure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: P1M2; 19 participants received mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) and the research acupoint (Mingmen) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded.	Procedure: Mild moxibustion with moxa stick; To conduct this intervention, we used moxa sticks which were 1.5 cm in diameter, 13 cm long, and weighed 12 gram to perform mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) or Mingmen acupoint in 2 trial phases. The main ingredient of the moxa was dried mugwort leaf, produced in Vietnam. All moxa materials were obtained from the Sai Gon TCS Co., Ho Chi Minh City, Vietnam.
Experimental: Group B: M1P2; 19 participants received mild moxibustion manipulation at the research acupoint (Mingmen) and the control acupoint (the left side Pishu acupoint) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded.	Procedure: Mild moxibustion with moxa stick; To conduct this intervention, we used moxa sticks which were 1.5 cm in diameter, 13 cm long, and weighed 12 gram to perform mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) or Mingmen acupoint in 2 trial phases. The main ingredient of the moxa was dried mugwort leaf, produced in Vietnam. All moxa materials were obtained from the Sai Gon TCS Co., Ho Chi Minh City, Vietnam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint	During procedure
Change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint	During procedure

Collaborators and Investigators

• Sponsor: Bui Pham Minh Man

Publications and helpful links

Helpful Links

• Deng H, Shen X. The mechanism of moxibustion: ancient theory and modern research. Journal of Evidence-Based Complementary and Alternative Medicine. 2013;2013
• Kim SY, Chae Y, Lee SM, Lee H, Park HJ. The effectiveness of moxibustion: an overview during 10 years. Evid Based Complement Alternat Med. 2011;2011:306515. doi:10.1093/ecam/nep163
• Sun C, Li Y, Kuang J, Liang X, Wu J, Ji C. The thermal performance of biological tissue under moxibustion therapy. Journal of thermal biology. 2019;83:103-111.
• Coiffard B, Diallo AB, Mezouar S, Leone M, Mege JL. A Tangled Threesome: Circadian Rhythm, Body Temperature Variations, and the Immune System. Biology (Basel). Jan 18 2021;10(1)doi:10.3390/biology10010065
• Yang Y, Ji L, Li G, Deng X, Cai P, Guan LJJoTCM. Differences in thermal effects of moxibustion at Zusanli (ST 36) and Hegu (LI 4) on various facial areas in healthy people. 2012;32(3):397-403.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Moxibustion; Skin surface temperature
• Other Study ID Numbers: 677/HDDD-DHYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic characteristic and outcome data will be shared
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No