Effect of Acupuncture or Moxibustion at Acupoints Weizhong (BL40) and Chize (LU5) on the Change in Lumbar Temperature in Healthy People
Phase: NA
Conditions: Health
Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
 
 
 
 
 
A prospective, randomized, controlled clinical trial: 
The association between Weizhong point and waist 
based on infrared thermal imaging technology 
 
 
                 
 
 
 
 
Study type: Clinical study 
Study Center: The Third Affiliated Hospital of 
Zhejiang Chinese Medical 
University 
Department: Acupuncture department 
Signature: Yi Liang 
 
Date: 2022.10.10 
The study will be conducted in accordance with this clinical study protocol and GCP 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
CONTENTS 
I. RESEARCH BACKGROUND .............................................................................................. 6 
II. MAIN RESEARCH CONTENT, OBJECTIVES, PROGRAM AND PROGRESS, AND 
KEY PROBLEMS TO BE SOLVED: ....................................................................................... 7 
1. Research content ................................................................................................................ 7 
2. Objectives of the study ....................................................................................................... 8 
3. Study protocol .................................................................................................................... 8 
3.1. Study Protocol ............................................................................................................. 8 
3.1.1. Estimation of sample size ..................................................................................... 9 
3.1.2. Randomized control design and conduct ............................................................ 10 
3.1.3. Inclusion criteria ................................................................................................. 11 
3.1.4. Exclusion criteria ................................................................................................ 11 
3.1.5. Exclusion and drop-out criteria ........................................................................... 12 
3.1.6. Termination criteria ............................................................................................ 12 
3.1.7. Adverse events .................................................................................................... 13 
3.2. Interventions .............................................................................................................. 13 
3.2.1. Acupuncture at Weizhong Point Group: ............................................................. 13 
3.2.2. Acupuncture Chize acupoint group: ................................................................... 14 
3.2.3. Moxibustion at Weizhong Point Group: ............................................................. 14 
3.2.4. Moxibustion at Chize point group: ..................................................................... 15 
3.2.5. Therapeutic indexes and evaluation .................................................................... 15 
3.3. Emergency treatment ................................................................................................. 17 
3.4. Technical route .......................................................................................................... 19 
III. ADVERSE EVENTS (DESCRIBED ACCORDING TO THE SUBJECT) ..................... 19 
1. Definition of adverse events ............................................................................................. 20 
2. Obtain information on adverse events .............................................................................. 20 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
3. Observation and recording of adverse events .................................................................. 20 
4. Management of adverse events ........................................................................................ 20 
4. ETHICS AND QUALITY ................................................................................................... 21 
V. DATA MANAGEMENT .................................................................................................... 22 
6. STATISTICAL ANALYSIS ............................................................................................... 22 
1. Statistical software ........................................................................................................... 22 
2. Data description................................................................................................................ 22 
3. Data statistics.................................................................................................................... 23 
4. Statistical analysis plan .................................................................................................... 23 
VII. FINAL REPORT AND PUBLICATION......................................................................... 23 
VIII. QUALITY CONTROL ................................................................................................... 24 
IX. REFERENCES .................................................................................................................. 24 
  
 
 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
I. Research Background 
As one of the components of traditional medicine, acupuncture and moxibustion is widely 
used at home and abroad due to its exact curative effect and no toxic side effects. It has been 
widely accepted and used in 183 countries and regions around the world. However, the 
biological basis and intrinsic mechanism of acupuncture and moxibustion have not been fully 
explained, although high-quality papers have been published in succession. With the 
continuous innovation of life science research technology and the deepening of modern 
research on acupuncture and moxibustion, the mysterious veil of the effect law and mechanism 
of acupuncture and moxibustion has been gradually unveiled. For example, academician Han 
Jisheng and his team have applied neurobiological techniques to prove that there are differences 
in the analgesic effect and onset time of different frequencies of electroacupuncture. The 
intrinsic biological basis may be related[1-3] to the release of different types of central opioid 
peptides at different times and different parts promoted by different frequencies of 
electroacupuncture. Recently, Professor Ma Qiufu's team at Harvard University revealed the 
regional specificity of electroacupuncture stimulation by using biological technologies such as 
lentivirus technology and gene mice, and found that there were different biological bases for 
the anti-inflammatory effects of electroacupuncture at different depths and intensities. The 
research results were published in Nature and Neuron[4,5]. The international academic status of 
acupuncture has also been further improved. Therefore, the biological basic research of 
acupuncture and moxibustion plays a pivotal role in both the explanation of the mechanism of 
traditional acupuncture and moxibustion and the promotion of its further development. 
The traditional theory of acupuncture and moxibustion is continuously summarized and 
refined based on the clinical practice experience of predecessors. Although the clinical efficacy 
is stable and widely used, there is still a lack of objective evidence and biological basic research. 
Therefore, on the basis of the summary of previous experience, it is particularly important to 
deeply reveal the intrinsic biological basis of the classic discussion of acupuncture and 
moxibustion through modern scientific research technology. In addition, although the human 
disease model is constructed through animal experiment simulation, a part of the therapeutic 
mechanism of acupuncture and moxibustion can be explained by comparing the physiological 
and biochemical indexes and functional indexes of the model animals in each group. However, 
the ideology and social attributes of human beings directly lead to insurable huge differences 
between human beings and animals. Therefore, clinical trials based on human beings are still 
an indispensable part. 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
It is mentioned in Neijing (The Classic of Internal Medicine) that Weizhong acupoint is 
used to treat waist diseases. It is recorded in Plain Questions: "The foot Taiyang pulse causes 
low back pain, citing the back of the neck ridge as the severe form, and needling it at 
Zhongtaiyang for severe bleeding". After the summary and summary of many doctors, the 
basic symptoms of Weizhong acupoint were refined as waist and leg[6] symptoms in the Song 
Dynasty, and then continued to summarize and summarize. Then, the "Wei zhong qiu" in the 
song of the four general acupoints in the Complete Compendium of Acupuncture and 
Moxibustion, which is still in use today. In clinical practice, bloodlet therapy[7], 
electroacupuncture[8], mo[9]xibustion and other methods are often applied at Weizhong point 
to treat various lumbar disorders, and good effects are obtained. The existing studies have 
preliminarily shown that there is some objective relationship between the waist and back and 
Weizhong point. For example, the stimulation of Weizhong point can observe the rich[10] 
local blood supply, the increase[11] of local temperature, and the improvement[12] of waist 
muscle fatigue resistance. When the waist and back lesions occur, acupoint sensi[13]tization 
phenomena such as force sensitivity, heat[14] sensitivity and local electrical resistance 
changes[15] can also be observed at Weizhong point. However, the specific association 
between Weizhong point and waist and back still needs to be further explored and improved. 
Therefore, this study intends to take the connotation study of "Weizhong acupoint on waist 
and back" as the entry point, to explore the correlation between the waist and Weizhong 
acupoint through infrared thermal imaging technology, and to explore the differences in the 
image of the waist observation area by different intervention methods, in order to provide 
some reference for the interpretation of its scientific connotation. 
Ii. Main research content, objectives, program and progress, and key 
problems to be solved: 
1. Research Content 
The healthy people were selected as subjects and treated with moxibustion. FLIR E53 
infrared thermal imager was used as the observation instrument to detect the dynamic changes 
of skin temperature in a specific area of the waist after different interventions (acupuncture 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
and moxibustion) at different acupoints (Weizhong point and Chize point), in order to further 
explore the relationship between the waist and Weizhong point. To provide an objective 
research basis for enriching the scientific connotation of "waist and back". 
2. Objectives of the study 
To explore the relationship between the waist and Weizhong points and whether 
acupuncture and moxibustion have different effects on the observation area of waist by 
observing the changes of local average temperature of waist in healthy subjects after applying 
acupuncture or moxibustion to different points. 
3. Study PROTOCOL 
The investigator clearly and orally explained the study and its potential risks and benefits 
to the subject before starting the study. After obtaining consent from the patient or his or her 
authorized person, the patient or his or her authorized person and the investigator signed and 
dated the informed consent form. Patients or their authorized persons could be screened for 
participation in the study only if they had provided written informed consent. 
3.1. Study Protocol 
Subjects were screened strictly according to the diagnostic criteria, inclusion criteria and 
exclusion criteria. After confirmation of enrollment, they were randomly divided into groups 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
according to the random number table until the total number of observation was completed. 
Healthy subjects aged 18-40 years old from Zhejiang Chinese Medical University were 
included in this study. 
3.1.1. Estimation of sample size 
This project uses the sample size calculation method of 2×2 factorial design. Referring to the 
changes[10,16] of waist average temperature in previous similar experiments and the results of pre-
experiments, the following assumptions are made: 
⚫ 
Acupuncture × Weizhong acupoint (right) group > moxibustion × Weizhong acupoint (right) 
group > all other groups 
⚫ 
Acupuncture × Weizhong (right) group > acupuncture × Chize (right) group 
⚫ 
Moxibustion method × Weizhong point (right) group > Moxibustion method × Chize point 
(right) group 
Δ (℃) 
Different points 
Different interventions 
Acupuncture 
Moxibustion 
Weizhong acupoint (right) 
1.4 
0.7 
Chieze Cave (right) 
0.3 
0.2 
Two-sided test was used without considering the interaction effect, and the number of 
samples required for each combination was estimated by comparing the means of two samples 
(see Medical Statistics edited by Sun Zhenqiu). The specific calculation formula was as follows, 
and the maximum value was selected as the minimum number of samples in each group: 
𝑛= 2 [
(𝑢𝛼+ 𝑢𝛽) × 𝜎
𝛿
]
2
+ 1
4
𝑢𝛼
2 
𝑁= 𝑚𝑎𝑥{𝑛1 , 𝑛2, 𝑛3} 
Where N is the required amount of samples; n1 is the sample2 size required for comparison 
between the acupuncture and moxibustion at the Weizhong acupoint group, the acupuncture and 
moxibustion at the Chize acupoint group,3 the acupuncture and moxibustion at4 the Chize 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
acupoint group, and the acupuncture and moxibustion at the Chize acupoint group. Because n4 is 
not the key object of this study, it is not included in the calculation of sample size. δ=µ1−µ,2 is 
the difference between the two population means,σ is the population standard deviation 
(assuming the two population standard deviation is equal); uα and uβ are the values of u 
corresponding to the test level α and the type I error probability β, respectively. 
At the significance level of α=0.05 (two-sided), the test power (1−β) =80% was selected. 
According to the results of the preliminary experiment, we set σ=1.17, and the sample size was 
45 / group, with a total of 180 cases in four groups. 
3.1.2. A randomized controlled trial was designed and conducted 
(1) Healthy subjects were randomly assigned by SPSS 20.0 software program. The 180 
digits were randomly divided into a moxibustion group at Weizhong point, a moxibustion 
group at Chize point, an acupuncture group at Weizhong point and an acupuncture group at 
Chize point according to the ratio of 1:1:1:1. The grouping information was kept confidential 
by the project leader. 
(2) The random allocation card was prepared as follows: 
Association between Weizhong point and waist and back based on 
infrared thermal imaging technology 
No. : 
Groups: 
Methods of intervention: 
(3) The random assignment card is sealed in an envelope with the same number recorded 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
on the envelope as the card. 
(4) Arrange the envelopes containing the randomization cards in order of number 
(5) The randomization cards were made and kept by the investigators and distributed to 
the operators during the study. When eligible subjects entered the study, the operator 
opened the same numbered envelopes in the order in which they entered and grouped 
according to the rules of the cards inside the envelopes without making any changes. 
Participants in the group assignment did not participate in the statistical analysis of the 
data. Data extraction and statistics were collected and sorted by the personnel who did 
not know the grouping, and the researchers, operators, and statisticians were separated. 
3.1.3. Inclusion criteria 
① Age ≥18 years old, both sexes, 18.5≤BMI≤23.9 kg/m2; 
② Previous good health without organic diseases; 
③ Understand the study process voluntarily participated in the study and signed the 
informed consent form. 
3.1.4. Exclusion Criteria 
① Women who are menstruating, pregnant, or breastfeeding; 
② Unable to complete the filming in a prone position; 
③ Those with skin diseases or skin damage, sensory disorders, scars or vegetations at 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
the test points; 
④ Patients with serious systemic diseases, or those considered by the investigators to be 
unsuitable for the study; 
⑤ Patients with epilepsy, head injury or other related neurological diseases. 
3.1.5. Exclusion and expulsion criteria 
Exclusion criteria (those who have been enrolled but meet one of the following criteria 
should be excluded) : (1) Those who do not meet the inclusion and exclusion criteria are 
found in the trial; (2) obvious adverse reactions occurred during the treatment; (3) The 
subjects were not treated according to the treatment plan after enrollment. Note: The excluded 
cases should be explained, and the original medical records should be kept for future 
reference. No statistical analysis of efficacy will be performed, but those who have received 
at least one treatment and have records can participate in the analysis of adverse reactions. 
Drop-out criteria (patients who had been enrolled but had not completed the clinical 
protocol were considered drop-out in the following circumstances) : (1) patients withdrew or 
lost follow-up; (2) Serious adverse reactions or adverse events occurred during treatment. 
Note: The reasons for dropouts should be explained, and the study medical records 
should be kept for future reference. Data were not carried forward at follow-up. 
3.1.6. Termination criterion 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
(1) Specialists will be responsible for the evaluation of severe adverse reactions during 
the study to determine whether to continue or terminate the study; 
(2) if the subjects developed serious complications or other serious diseases during the 
study period and needed to take emergency measures; 
(3) the subjects could not continue the study for other reasons. 
3.1.7. Adverse events 
Adverse events and the reasons for dropouts were recorded in detail. 
3.2. Interventions 
In this study, the subjects were randomly divided into a moxibustion group at Weizhong 
point, a moxibustion group at Chize point, an acupuncture group at Weizhong point, and an 
acupuncture group at Chize point at a ratio of 1:1:1:1 for a randomized controlled trial to 
observe the relationship between waist and Weizhong point. Proposed research time: January 
1, 2023 to December 31, 2023. Specific treatments are as follows. 
3.2.1. Acupuncture at Weizhong acupoint group: 
① Acupoint selection: Bilateral Weizhong (BL40)  
② Location: Refer to the national standard of the People's Republic of China (GB/T 
12346-2006) "Acupoint Name and Location" 
③ Acupuncture operation: The acupuncture needles of φ25×40mm Huatuo brand were 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
selected and sterilized at Weizhong points with 75% alcohol. Acupuncture was 
performed avoiding the nerves and blood vessels. The depth of the needles was about 
1 cun (33mm). When the subject had deqi sensation such as acid, numbness, and 
swelling pain, the manipulation was stopped, and the needle was retained for 30 
minutes. No manipulation stimulation was given during the retention period. 
④ The intervention time was 30 min  
3.2.2. Acupuncture Chize acupoint group: 
① Acupoint selection: Bilateral Chize (LU5) 
② Location: Refer to the national standard of the People's Republic of China (GB/T 
12346-2006) "Acupoint Name and Location" 
③ Acupuncture operation: the same as Weizhong point operation. 
④ The intervention time was 30 minutes 
3.2.3. Moxibustion committee point group: 
① Acupoint selection: bilateral Weizhong (BL40) 
② Location: Refer to the national standard of the People's Republic of China (GB/T 
12346-2006) "Acupoint Name and Location" 
③ Moxibustion operation: the ambient temperature was controlled at 25-27℃, and the 
humidity was controlled at 40%-60%. The subjects were placed in the prone 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
position, with their right lower limb exposed, and intervention was applied to the 
Weizhong acupoint area with Fuyang moxibustion 
④ The intervention time was 30 min 
3.2.4. Moxibustion at Chize point group: 
① Acupoint selection: Bilateral Chize (LU5)  
② Location: Refer to the national standard of the People's Republic of China (GB/T 
12346-2006) "Acupoint Name and Location" in 2006. 
③ Moxibustion method operation: same as above 
④ The intervention time was 30 minutes 
3.2.5. Efficacy indicators and evaluation 
(1) Baseline MEASURES: Through interviews and questionnaires, the subjects' gender, 
age, weight, height, frequency (weekly) of waist discomfort (such as waist acid, 
etc.), and whether they had received acupuncture/moxibustion related treatment were 
collected. Before the intervention, the average temperature of waist observation area 
(the geometric figure surrounding the second lateral line of bilateral bladder and the 
horizontal lines of T12 and S1) was recorded by infrared thermal imaging 
instrument. 
(2) The main outcome measures were the average temperature changes in the waist 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
observation area (the geometric figure surrounded by the second lateral line of 
bilateral bladder and the horizontal lines T12 and S1) 30 minutes after the 
intervention and immediately after the intervention 
(3) Secondary outcome measures: 
① The highest temperature in the designated area of the waist 30min after applying 
the intervention; 
② The average temperature change value of the designated area of the waist was 
measured 5 min and 15 min after intervention. 
③ The average temperature of local acupoints (φ=2cm) at Weizhong and Chize 
before intervention and 30 min after intervention were recorded. 
④ Evaluation of waist warm sensation: Binary data (yes/no) and NRS score (0-10) 
were used to record the waist warm sensation and its intensity during the 
intervention. 
⑤ The differences of pain threshold before rest and immediately after the 
intervention were compared at Shen双shu (BL 23), Zhishi双 (BL 52), Mingmen 
(GV 4) and We双izhong (BL 40). 
(4) Safety evaluation: the adverse reactions and their manifestations, occurrence time, 
degree, treatment measures, process and outcome were recorded, and the correlation 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
between the adverse reactions and the treatment was judged. 
(5) Compliance evaluation: the drop-out situation and reasons were recorded and 
analyzed. 
3.3. Emergency response 
(1) Dizzy acupuncture/moxibustion: the intervention (acupuncture/moxibustion) should 
be stopped immediately, all the acupuncture needles should be removed, the patient should lie 
flat with the head slightly lower, unbutton his clothes, and pay attention to keep warm. If he 
lies still for a while, he can return to normal. On the basis of the above treatment, the severe 
cases can be treated with acupuncture at Shuigou (GV 26), Ciliao (BL 32), Neiguan (PC 6), 
Zusanli (ST 36), Yongquan (SP 9), etc., or moxibustion at Baihui (GV 20), Guanyuan (CV 4), 
Qihai (CV 6), etc. If the patient is still unconscious, breathing is weak, and the pulse is weak, 
first aid measures should be taken and emergency consultation should be requested. 
(2) Burn injury: the intervention was stopped immediately, and the patients were rinsed 
with running cold water or applied with ice packs locally. If there were no blisters or small 
blisters, topical scald ointment was applied after disinfection with iodophor. If the scope of 
blisters is large, after disinfection, the blisters are broken by sterile syringes, and the liquid 
inside the blisters is drained, and then the sterile dressing is applied. 
(3) Subcutaneous hemorrhage: if there is a small amount of subcutaneous hemorrhage 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
and local bleeding, no special treatment will be done. If the local swelling and pain is severe, 
the area of cyan is large and affects the activity function, cold compress is given within 24 
hours to stop bleeding, and hot compress or local moxibustion is given after 24 hours to 
promote the stasis to dissipate and absorb. 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
3.4. Technical route 
 
Iii. Adverse events (described according to the subject) 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
1. Definition of adverse events 
From the time the subject signed the informed consent to the end of the intervention, 
events closely related to the intervention occurred, including the following:  
-- Acupuncture/dizzy moxibustion  
-- Burn and scald  
-- Subcutaneous bleeding  
2. Information on adverse events was obtained  
The basic information of the acupoint area and all adverse events reported by the 
subjects during and after the intervention were observed by the research doctors. 
3. Adverse events were observed and recorded  
Any symptoms and signs that occurred from the beginning of the intervention to the end 
of the intervention were closely related to the intervention method, such as dizzy/dizzy 
moxibustion, burn and scald, subcutaneous hemorrhage, etc.  
4. Management of adverse EVENTS  
 (1) Dizzy acupuncture/dizzy moxibustion: stop the intervention 
(acupuncture/moxibustion) immediately, and remove all the acupuncture needles, make the 
patient lie flat with the head slightly lower, unbutton his clothes, and pay attention to keep 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
warm. If he lies still for a while, he can return to normal. On the basis of the above treatment, 
the severe cases can be treated with acupuncture at Shuigou (GV 26), Ciliao (BL 32), 
Neiguan (PC 6), Zusanli (ST 36), Yongquan (SP 9), etc., or moxibustion at Baihui (GV 20), 
Guanyuan (CV 4), Qihai (CV 6), etc. If the patient is still unconscious, breathing is weak, and 
the pulse is weak, first aid measures should be taken and emergency consultation should be 
requested. 
(2) Burn injury: the intervention was stopped immediately, and the patients were rinsed 
with running cold water or applied with ice packs locally. If there were no blisters or small 
blisters, the patients were locally sterilized with iodarone and then broke through the burn 
ointment. If the range of blisters was large, sterile syringes were used to break the blisters 
after disinfection, and sterile dressings were used to bandage the blisters after removing the 
liquid in the blisters. 
(3) Subcutaneous hemorrhage: if there is a small amount of subcutaneous hemorrhage 
and local bleeding, no special treatment will be done. If the local swelling and pain is severe, 
the area of cyan is large and affects the activity function, cold compress is given within 24 
hours to stop bleeding, and hot compress or local moxibustion is given after 24 hours to 
promote the stasis to dissipate and absorb. 
4. Ethics and quality  
Prior ethics committee approval will be obtained before the start of this study. 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
It was important to obtain authorization for the use of the data before enrollment. To 
protect patient privacy, patient initials will be recorded on the CRF. 
5. Data management 
Investigators were required to fill in the collected data into the case report form and 
collect or record the data in EXCEL according to the requirements of the study protocol. 
Zheng Siyi was responsible for data management to ensure the authenticity, completeness and 
accuracy of the clinical trial data. At the end of the study, case report forms of all enrolled 
patients will be submitted to the data management center by the investigator. These case 
report forms should be completed and signed. Case-report form data collected from the sites 
will be checked for consistency, and question forms will be issued for inconsistent data, 
requiring investigator clarification. 
6. Statistical analysis 
1. Statistical software 
The data were analyzed by a third party statistician who was not involved in the 
preliminary study. Statistical software (SPSS 26.0) was used for statistical analysis. 
2. Description of data 
Measurement data were described by mean ± standard deviation (), median, maximum, 
minimum and quartile, and enumeration data were described by percentage (%).
s
x  

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
3. Statistics of data 
All the results were analyzed with the use of SPSS, version 23.0. All statistical tests 
were two-sided, and a P value of less than 0.05 was considered to indicate statistical 
significance. Normally distributed continuous variables were compared among the four 
groups using analysis of variance (ANOVA), and non-normally distributed variables were 
compared using the Kruskal-Wallis H test. If normal transformation could not be performed, 
the rank-sum test was used for comparison. Count data were compared using the chi-square 
test. Pearson correlation analysis was used for correlation analysis. Ordered logistics 
regression analysis was used to analyze the influence of general data on the final data. The 
factorial test focused on the main effects of the two treatments and their interaction. 
Therefore, repeated measures ANOVA with factorial design was used to analyze the 
differences in the effects of different treatments and different intervention acupoint areas on 
the observation area, and Sidak test was used for comparison between groups. 
4. Statistical Analysis Plan 
Done by professional statisticians. After all data entry and review, the statistician should 
complete the statistical analysis work in time and issue a written statistical analysis report. 
Vii. Final report and publication 
After the study, the study report will include a description of the study objectives, the 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
methods used in the study, and the results and conclusions.  
Viii. Quality control 
(1) The test SOP should be formulated by the research group. 
(2) A special training meeting was held one month before the official start of the clinical 
trial, and unified training was conducted for all investigators. The implementation plan and 
standard operating procedures (Sops) were mainly trained to make every clinical researcher 
familiar with the research process and specific implementation rules, and to ensure the 
reliability of clinical research conclusions. 
(3) All observations in clinical research should be verified and repeatedly confirmed to 
ensure the reliability and originality of the data, and to ensure that the results and conclusions 
in clinical research are derived from the original data. 
(4) To control the bias of the trial, special personnel should be employed to collect and 
count the trial data. A professional data management company was commissioned for clinical 
data management. 
(5) The quality inspection of clinical research should be strictly carried out once a 
month. 
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vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
electrical acupoint stimulation induces different effects on cerebral μ-opioid receptor 
availability in rhesus monkeys[J]. J Neurosci Res, 2014, 92(5): 555-63. 
[3] Huo R, Han S P, Liu F Y, et al. Responses of Primary Afferent Fibers to Acupuncture-
Like Peripheral Stimulation at Different Frequencies: Characterization by Single-Unit 
Recording in Rats[J]. Neurosci Bull, 2020, 36(8): 907-918. 
[4] Liu S, Wang Z, Su Y, A neuroanatomical basis for electroacupuncture to drive the vagal 
adrenal axis[J]. Nature, 2021, 598(7882): 641-645. 
[5] Liu S, Wang Z F, Su Y S, et al. Somatotopic Organization and Intensity Dependence in 
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[7] ZHOU Na. Clinical observation of Weizhong point bloodletting intervention on different 
syndrome types of low back pain [D]. Jiangxi University of Traditional Chinese Medicine, 
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[8] SHI Jing. Effect of electroacupuncture at Weizhong point on surface electromyography 
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[9] Tan S Y, Jiao L, Cheng P, et al. Analysis of clinical application rules of moxibustion in 
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[10] Fan Yifan. Effect of acupuncture on temperature change of lumbosacral region in normal 
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vision：1.0                            proposer：Yi LIANG                          date：2022.10.10 
 

vision：1.0                            proposer：Yi LIANG                          date：2022.10.10