The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris
Conditions: Stable Angina Pectoris, Acupoint Sensitization, Correlation Analysis, Diagnostic Value
Sponsor: West China Hospital

Official Title of the study：The diagnostic value of acupoint sensitization 
based on stable angina pectoris  
Date of the document：January，2018 
ClinicalTrials.gov identifier: NCT03341663 
Reasons for the updated protocol: In the detection of acupoint 
sensitization, due to the special spelling of 3 acupoints in the Traditional 
Chinese medicine, including Jueyinshu, Xinshu, Dushu. In our previous 
version protocol in October, 2017, we made some spelling mistakes about 
this very 3 acupoints, Now, we need to correct it. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
The diagnostic value of acupoint sensitization based on stable angina 
pectoris: a study protocol 
Abstract： 
Backgrounds: this study, as the second part, aims to detect the correlation between 
the coronary artery stenosis, Canadian Cardiovascular Society(CCS) angina pectoris 
classification and the differential functional status of acupoints in distinguishing the 
severity of chronic stable angina.  
Methods: We apply the cross-sectional study design to carry out the exemplary 
research in the aspects of disease diagnosis, in order to confirm the hypothesis 
"acupoint sensitization is associated with the severity of angina pectoris, and can 
contribute to the diagnosis of stable angina pectoris ".  
Discussion: This project will enrich the basic theory of TCM with a clear point of 
different functional acupoint status in the diagnosis of stable angina, which will offer 
important examples for the clinical application in disease diagnosis.                              
Keywords: Study protocol, diagnostic trial, stable angina pectoris 
1. Background 
Stable angina pectoris (AP) is the result of myocardial ischemia, typified by the 
clinical symptoms discomfort in the chest, jaw, shoulder, back, or arms, typically 
provoked by physical exertion or emotional stress and relieved by rest or 
nitroglycerin[1]. Despite the multiple medical and interventional technologies that 
have been developed to reduce myocardial ischemia, the ischemic heart disease was 
still be the top causes of death according to the released World Health Organization 
(WHO) report in 2004 and the updated data published in the New England journal 
medicine 2013[2-4].  
Compared to the traditional Chinese medicine (TCM) syndrome, the invasive 
coronary angiography(ICA) is considered the “gold standard” by providing a more 
accurate assessment of lesion severity than visual assessment in patients with 
suspected coronary artery disease (CAD), especially with high prevalent baseline 
cardiac risk factors[5]. A few studies have proved that there were relationships 
between TCM and coronary artery lesion. Historically, acupoint is described and 
understood with the state according to the core viewpoint and theory of The Inner 
Canon of Huangdi or Yellow Emperor's Inner Canon. When the human body has 
disease, acupoints on the body surface may be sensitized with various types of 
sensitization, and acupoint heat-sensitization is a type of acupoint sensitization. This 
sensitized acupoint can not only reflect the pathological phenomenon of the diseases 
but also can distinguish the severity of the disease effectively.  
But, there was no study to explore the correlation between the coronary artery 
stenosis and the acupoint sensitization. Thus, our study is designed to explore the 
correlation between the coronary artery lesions, Canadian Cardiovascular 

Society(CCS) angina pectoris classification and the acupoint sensitization, which can 
ensure the degree of acupoint sensitization in distinguishing the severity of the 
disease.  
2. Methods 
This part adopts the "single entry" cross-sectional study design. After the eligible 
patients recruited in group, the coronary artery stenosis will be evaluated through 
coronary angiography and the Canadian Cardiovascular Society(CCS) angina pectoris 
classification will also be evaluated at the same time. The degree of acupoint 
sensitization will be tested by the electronic Von Frey instrument by one professional 
acupuncturist . 
2.1 Study population 
Eligible stable angina pectoris patients should match the inclusion criteria and 
the exclusion criteria. Inclusion criteria: participants will be included if they fulfill the 
following criteria:1)patients meet the diagnostic criteria of ACC/AHA angina pectoris 
of coronary heart disease ; 2)35≤age ≤80 years, male or female; 3) the onset of 
angina pectoris ≥3 months and the frequency of angina attack≥twice a week; 4) 
patients agree to do coronary angiography examination and signed the informed 
consent. Exclusion criteria: patients with any of the following conditions will be 
excluded:1)People with mental disabilities and intelligent obstacle;2) Patients who 
can’t accomplish the detection of acupoint sensitization;3)Patients with allergic 
condition, especially the contrast media;4) Patients with acute myocardial infarction, 
unstable angina, during arrhythmia and serious diseases which can affect the blood 
supply of myocardial;5) Skin or peripheral nerve paresthesia, pain or the detect area 
of skin ulcerate ;6) pregnant or lactating women;7) Patients who undergoing other 
clinical trials. 
2.2 Detection of acupoint sensitization 
Theoretically, the higher readings of the Von Frey electronic measuring 
instrument, the higher the degree of acupoint sensitization. First of all, in order to 
ensure the privacy of the participants, an independent sensitizing detection room will 
be set. Meanwhile, there must be a nurse or other medical staff when the female 
subjects in sensitization detection operation. Secondly, the participants pose the right 
position, double lower limbs stretch the knee, testers press each region with finger and 
proper 
strength 
in 
total 
12 
acupoints, 
including 
Shenmen,Yinxi, 
Shaohao,Jiquan,Neiguan, Ximen, Quze, Danzhong, Juque, Jueyinshu, Xinshu, Dushu. 
Researchers detect the sensitization of acupoints by using Von Frey electronic 
measuring pain instrument. Every acupoint will be tested for 2 times, and if the mean 
value is higher than 15, the third test will be conducted. 
All the collected data will be documented in the case report form(CRF). At the 
same time, the data will be saved in the computer folder which established 
beforehand.  
2.3 CCS angina pectoris classification 
Based on the following standard and combined with our concept of design, all 

the eligible patients will be evaluated referring to the following standards by two 
researchers. 
Classifications Detailed contents 
Class I: 
Ordinary physical activity does not cause angina, such as walking, climbing 
stairs. Angina (occurs) with strenuous, rapid or prolonged exertion at work 
or recreation 
Class II 
Slight limitation of ordinary activity. Angina occurs on walking or climbing 
stairs rapidly, walking uphill, walking or stair climbing after meals, or in 
cold, in wind, or under emotional stress, or only during the few hours after 
awakening. Angina occurs on walking more than 2 blocks on the level and 
climbing more than one flight of ordinary stairs at a normal pace and in 
normal condition. 
Class III 
Marked limitations of ordinary physical activity. Angina occurs on walking 
one to two blocks on the level and climbing one flight of stairs in normal 
condition and at a normal pace. 
Class IV 
Inability to carry on any physical activity without discomfort anginal 
symptoms may be present at rest 
 
2.4 Coronary angiography  
All the included patients will undergo the coronary angiography to observe and 
record stenosis in coronary artery branches, including left main artery, left anterior 
descending artery, diagonal branches, left circumflex artery, obtuse marginal branch, 
acute marginal artery, right coronary artery and posterior descending artery. 
All the collected data will be documented in the CRF. At the same time, the data 
will be saved in the computer folder which established beforehand. 
2.5 Recruitment procedures 
The following scheme will be used to recruit participants with angina pectoris. 
Patients visiting the outpatient clinics and inpatient department in the department of 
Cardiology of the West China Hospital in Sichuan university will be informed by the 
cardiologist of the present trial. Research assistants will continue the enrollment 
process by screening eligible participants according to the inclusion/exclusion criteria. 
Participants will be included only if they meet the inclusion criteria and provide 
written informed consent indicating that they agree to every procedure of the trial and 
join in the trial willingly.  
2.6 Sample size calculation  
According to the diagnostic test sample size, ensuring the accuracy in the 
prediction, sensitivity is set 80% and specificity is 60%, = 0.05,  the difference 
between the samples and the overall is  = 0.10. Considering a 15% dropout, 183 
participants will be included in this trial finally.  
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2.7 Practitioners training  
All researchers involved in this trial, all clinical physicians who enroll participants 

and all assessors who collect data must attend training classes to make sure all 
practices in the hospital are generalized and standardized.  
2.8 Benefits and risks 
This study is a single entry, cross-sectional and diagnostic studies. During this 
research, patients did not receive any therapeutic interventions, but stick to the 
original angina treatment plan. The main detection of acupoint sensitization 
concerned with stable angina pectoris by the VonFrey electronic measuring 
instrument: just put the instrument probe at the acupoint sensitization on the surface 
of the skin and record the data displayed in the instrument. In the process of operation, 
the sponsor will shoulder the economic burden caused by the occurrence of adverse 
events related to this study. Besides, the cost in the following examination may reduce 
considerably. In order to protect patient privacy, all the data are shrouded in secrecy, 
all relevant researchers must sign a confidentiality agreement before access to the 
data.  
2.9 Safety and adverse event 
For the sake of patient safety, prevention measures and emergency medical plans 
will include well-equipped treatment rooms, emergency department, cardiovascular 
specialist and first-line clinical physicians. All adverse events(AEs) associated with 
detection would be recorded in detail; these AEs concerning the short transient local 
skin discomfort include redness, itching and subcutaneous bleeding. On the other 
hand, the anti-anginal drugs (basic therapy) will be documented as well. Serious 
adverse events (SAE) are defined as death or life threatening events, which may 
require inpatient hospitalization, cause prolongation of existing hospitalization, or 
even result in persistent or significant disability/incapacity and need intervention to 
prevent permanent impairment or damage. If participants suffer any AE/SAE, 
researchers must immediately take measures to protect the safety of the patients, all 
details will be documented, and then report to the principal investigator and the ethics 
committee within 24 hours so that they can decide whether the patient should 
withdraw from the trial. The sponsor will ensure that meet the requirements of all 
laws and regulations of reporting procedures. 
3. Statistical analysis 
Analysis were conducted to explore relationships between the degree of acupoint 
sensitization, the degree of coronary artery stenosis and CCS angina pectoris 
classification by SPSS20.0 software. For the collected data, the mechanical pain 
threshold of acupoint sensitization collected by Von Frey electronic measuring 
instrument and the degree of coronary angiography are continuous quantitative data. 
The grade of Canadian angina is qualitative data and specific correlation analysis 
method will be choose based on the type and distribution of collected data. Diagnostic 
value will be further analyzed in the final step. 
Trial status 
This trial hasn’t recruited any patients yet. 
Acknowledgments: We acknowledge the West China Hospital of Sichuan university 
and Chengdu University of Traditional Chinese Medicine for their full support in 
facilities, recruiting and detecting. We also appreciate the help and efforts for all 

research staffs participating in this trial. 
Financial support This trial was supported financially by the Natural Science 
Foundation of China with No. 81590955. 
 
References 
1. 
Task Force, M., et al., 2013 ESC guidelines on the management of stable coronary artery 
disease: the Task Force on the management of stable coronary artery disease of the European 
Society of Cardiology. Eur Heart J, 2013. 34(38): p. 2949-3003. 
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Murray, C.J. and A.D. Lopez, Measuring the global burden of disease. N Engl J Med, 2013. 
369(5): p. 448-57. 
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Adelborg, K., et al., Open retromuscular mesh repair versus onlay technique of incisional 
hernia: A randomized controlled trial. BMJ Open., 2016. 6(12): p. e012817. doi: 
10.1136/bmjopen-2016-012817. 
4. 
World 
Health 
Organization: 
Global 
Burden 
of 
Disease 
2004 
[http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_part2.pdf]. 
2004. 
5. 
ACC/AHA Guidelines for Coronary Angiography-A Report of the American College of 
Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on 
Coronary Angiography). Journal of the American College of Cardiology, 1999.