The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: a Multicenter Randomized Controlled Trial
Phase: NA
Conditions: Postherpetic Neuralgia
Sponsor: Nanjing University of Traditional Chinese Medicine

Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia:  
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Jiangsu Province Hospital of Chinese Medicine 
Affiliated Hospital of Nanjing University of Chinese Medicine 
 
Clinical Study Protocol 
 
Analgesic Effect of Electroacupuncture on 
Postherpetic Neuralgia: a Multicenter Randomized 
Controlled Trial   
 
eTrack study number 2020NL-103-02 
Abbreviated Title AEEPN  
Principal Investigator Jianhua Sun, MD, PhD 
Telephone +86 25-86617141-31300 
Sponsor Department of Acupuncture and Rehabilitation, 
Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 
Jiangsu, China 
Trial registration Clinicaltrials.gov identifier: NCT04560361 
Version date Amendment 4.0 Final: April 15, 2021 

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PROTOCOL REVISION HISTORY 
Version Number 
Version Date 
Summary of Revisions Made 
Amendment 1.0 
June 16, 2020 
Draft version for GPC review 
Amendment 2.0 
July 3, 2020 
Draft version reviewed by Ethics 
Committee 
Amendment 3.0 
August 4, 2020 
Trial version after review (corrections 
and additions)  
Amendment 4.0 
April 15, 2021 
Final Version:  
Update clinical sub center information;  
add a secondary outcome (Zoster Brief 
Pain Inventory);  
correction of minor typos throughout 
 
ROLES AND RESPONSIBILITIS 
Department 
Name 
GCP 
training 
Roles and 
responsibilities 
Department of 
Acupuncture and 
Rehabilitation 
Jianhua Sun 
Yes 
Principal Investigator 
Qianyan Liu, Xiaoliang Wu, 
Jing Guo, Bingyang Liu 
Yes 
Clinical 
implementation 
group 
Jianhua Sun, Lixia Pei 
Yes 
Supervision 
Science and 
Technology 
Department 
Guirong Zhang, Qian Yu, 
Jin Zhu 
Yes 
Data management 
team 
Ethic Committee 
Mao Wang, Jingyong Zhou 
Yes 
Quality control team 
 
Clinical sites: 
Primary sponsor: 
1. Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu 210029, China 
Site Principal Investigators (PIs): Dr. Jianhua Sun, and Dr. Qianyan Liu 
Telephone: +86 25-86617141-31300, +86 18236918234 

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Secondary sponsors are as follows: 
2. Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese 
Medicine, Nanjing, Jiangsu 210001, China 
Site PIs: Dr. Jin Lu, Dr. Juanjuan Shi, and Dr. Lamei Tao 
Telephone: +86 17768101781, +86 13813897286, +86 15298384211 
3. Wuxi Hospital of Traditional Chinese Medicine, Wuxi, Jiangsu 214071, China 
Site PIs: Dr. Min Ding, Dr. Hua Feng, and Dr. Danni Gu 
Telephone: +86 15951839590, +86 13771521515, +86 0510-88859999-24300 
4. Nantong Hospital of Traditional Chinese Medicine, Nantong, Jiangsu 226001, 
China   
Site PIs: Dr. Rongrong Shen, Dr. Shuyu Xia, and Dr. Chunxia Lu 
Telephone: +86 0513-85126199, +86 0513-85126093 
5. Shuyang Hospital of Traditional Chinese Medicine, Suqian, Jiangsu 223600, 
China   
Site PIs: Dr. Min Chen, Dr. Yanfang Liu, and Dr. Rongli Zhang   
Telephone: +86 15950634875, +86 15850976735, +86 0527-87792339 
6. Huai'an Hospital of Traditional Chinese Medicine, Huai'an, Jiangsu 223001, 
China   
Site PIs: Dr. Yongtao Liu, Dr. Zhenan Li, and Dr. Chuqiong Zhang   
Telephone: +86 18305239793, +86 17388064576, +86 13952326701 
7. Lianyungang Hospital of Traditional Chinese Medicine, Lianyungang, Jiangsu 
222004, China   
Site PIs: Dr. Zhengming Yang, and Dr. Wenping Yao   
Telephone: +86 18061391788, +86 13092375519 
Declaration of Interests 
The study director of the AEEPN trial and the principal investigators of other 7 
clinical centers have no financial or other conflict of interest. The research results of 
this study are owned by primary sponsors, and all secondary sponsors will be signed 
in order of contribution. 
Confidentiality Statement 
The clinical scientific research data, technical information and other information 
provided in this document is strictly confidential and is available for review to the 
sponsor, researchers, Ethics Committees, investigators, investigation review 
committees, and other government regulatory agencies. Without the written 
authorization of the protocol developing investigator, no disclosure, notification, or 
transfer is allowed.  
 
 

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CONTENTS 
1. Background ................................................................................................................................... 6 
2. Study Objectives ........................................................................................................................... 8 
3. Methodology ................................................................................................................................. 8 
3.1 Trial design .......................................................................................................................... 8 
3.2 Randomization .................................................................................................................... 8 
3.3 Blinding ............................................................................................................................... 9 
3.4 Sample size ......................................................................................................................... 9 
4. Subjects ....................................................................................................................................... 10 
4.1 Diagnostic criteria ............................................................................................................. 10 
4.2 Eligibility criteria .............................................................................................................. 10 
4.3 Exclusion criteria .............................................................................................................. 11 
4.4 Subject termination ........................................................................................................... 12 
4.5 Subject dropping and handling .......................................................................................... 12 
4.6 Subject elimination ........................................................................................................... 13 
5. Interventions ............................................................................................................................... 13 
5.1 Lifestyle education ............................................................................................................ 13 
5.2 Electroacupuncture (EA) group ........................................................................................ 14 
5.3 Sham electroacupuncture (SEA) group ............................................................................. 14 
6. Concomitant Medications ........................................................................................................... 15 
6.1 Permitted concomitant medications .................................................................................. 15 
6.2 Prohibited concomitant medications ................................................................................. 16 
6.3 rescue medication .............................................................................................................. 17 
7. Outcomes measures..................................................................................................................... 17 
7.1 General record items ......................................................................................................... 17 
7.2.1 Biological information ................................................................................................... 17 
7.2.2 Outcomes ....................................................................................................................... 18 
7.2.2.1 primary outcome ................................................................................................. 18 
7.2.2.2 Secondary Outcomes ........................................................................................... 18 
8. Safety assessment standard ......................................................................................................... 22 
8.1 Observation of adverse events .......................................................................................... 22 
8.2 Standards for judging the severity of adverse events ........................................................ 23 
8.3 Treatment of adverse events .............................................................................................. 24 
8.3.1 Observe and record ................................................................................................ 24 
8.3.2 Medical treatment................................................................................................... 24 
8.3.3 Report ..................................................................................................................... 24 
9. Quality control and assurance of the study ................................................................................. 25 
9.1 Clinical quality control measures ...................................................................................... 25 
9.2 Pre-clinical trial training ................................................................................................... 25 
9.3 Measures to improve subject compliance ......................................................................... 26 
9.4 Quality control and quality assurance system ................................................................... 26 

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10. Data collection, management, monitoring and auditing............................................................ 26 
11. Statistical Analysis .................................................................................................................... 28 
11.1 Choice of analysis data set .............................................................................................. 28 
11.2 statistical software ........................................................................................................... 28 
11.3 Content of statistical analysis .......................................................................................... 28 
11.4 Statistical analysis of population ..................................................................................... 28 
11.5 Statistical analysis method .............................................................................................. 29 
12. Ethical considerations ............................................................................................................... 29 
13. Abbreviations ............................................................................................................................ 31 
14. References ................................................................................................................................. 31 
Appendix 1 ...................................................................................................................................... 34 
Appendix 2 ...................................................................................................................................... 35 
Appendix 3 ...................................................................................................................................... 36 
 
 

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1. Background 
Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) 
and it is a kind of severe and intractable pain. According to meta-analysis data, the 
annual incidence of this disease is 3.9-42.0/100,000 people1. The annual incidence of 
HZ is 3‰-5‰, about 5%-30% of patients with HZ have PHN, and 30%-50% of PHN 
patients have experienced persistent pain for more than 1 year2, of which middle-aged 
and elderly people are the main population of PHN. Clinical manifestations of the 
disease for patients suffering from nerve distribution of sudden or persistent burning, 
tingling, jumping pain or knife cutting pain, many pain allergies or pain abnormalities, 
such as wind, light touch can produce severe pain, often affect diet and sleep.  
Due to prolonged severe pain, patients often have mental symptoms such as depression 
and irritability. In the area of skin damage, scars, pigmentation or pigment shedding left 
after the skin lesion can be seen. Although the occurrence and prognosis of this disease 
are related to many factors, the body's own immune function status has a direct impact. 
For patients with strong immunity, even without medicine, they can contain varicella-
zoster virus through their own strong immunity and heal themselves quickly. For people 
with low immunity, high work pressure, staying up late, sick, overworked, or older 
patients with basic systemic diseases, the incidence of PHN is extremely high, and 
severe cases often have recurring attacks. Even the pain lasts for months or years, which 
seriously affects the patient's quality of life, and even leads to depression of the patient, 
seriously affecting their living ability and social activities, and increasing the burden 
on individuals and society.  
For patients with PHN, antiviral and analgesic treatments are often used clinically to 
regulate immune function and nourish nerves. Because the varicella-zoster virus has 
considerable nerve and skin toxicity, when the subcutaneous nerves are destroyed by 
the virus for a long time, although some antiepileptic drugs (such as gabapentin, 
pregabalin), tricyclic antidepressants (such as nortriptyline), opioids, 5% lidocaine 

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patch, etc., as well as nerve block therapy can relieve the patient’s pain to a certain 
extent, but may cause serious side effects, and the treatment effect is not good. Pain is 
prone to recurrence after the drug is stopped, making PHN become a pain problem in 
the medical field and a potential killer of the health of middle-aged and elderly people. 
Therefore, finding a treatment method that can effectively relieve the pain of patients 
with PHN without pharmacological side effects has become the common demand of 
today's society and the majority of pain patients, and has strong clinical research 
significance. 
According to clinical experience and related literature reports, electroacupuncture has 
a certain analgesic effect on PHN. According to Chinese National Knowledge 
Infrastructure (CNKI) literature reports, Therapies such as blood pricking, cupping, 
ozone, acupoint embedding, moxibustion, acupuncture bloodletting, and fire needling 
have a certain therapeutic effect on PHN. There is no high-quality clinical randomized 
controlled study specifically aimed at the analgesic effect of electroacupuncture in the 
treatment of PHN. A correlation study retrieved in the National Center of 
Biotechnology Information (NCBI) in the United States reported that the effectiveness 
of electroacupuncture at Jiaji points combined with moxibustion and intermediate 
frequency treatment on PHN3, and Tongji Medical College of Huazhong University of 
Science and Technology reported that electroacupuncture can improve the heat 
sensitivity and mechanical sensitivity of rats with PHN4. However, there is no report 
on the clinical randomized controlled (RCT) study of the analgesic effect of 
electroacupuncture on PHN. 
In view of the high epidemiological incidence of PHN, the severity and stubbornness 
of pain, the disease is insensitive to many drugs, and the existence of drug resistance 
and many drug side effects, to bring great pain and distress to patients, so the treatment 
of PHN has become a world problem. However, the clinical randomized controlled 
study related to the analgesic effect of electroacupuncture on PHN has not been reported 
in the literature so far. Therefore, our research group initiated this clinical trial, mainly 

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on Ashi point, combined with the distal acupoints Zhigou and Yanglingquan, to evaluate 
whether electroacupuncture can effectively relieve the pain of patients with PHN, and 
to provide a strong basis for clarifying the treatment of PHN by electroacupuncture.  
2. Study Objectives 
The objective of this study is to examine the analgesic effect and safety of 
electroacupuncture and sham electroacupuncture for the treatment of PHN.  
3. Methodology 
3.1 Trial design 
The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia (AEEPN) study 
is a multicenter, prospective, parallel-arm, randomized, participant-blinded, sham 
electroacupuncture-controlled clinical trial of an estimated 448 patients with PHN, 
which follows the Declaration of Helsinki and the Quality Management Practices for 
Clinical Trials of Medical Devices. The study duration (as shown in Figure 1) is about 
10 weeks, which includes a washout period (7 days or more), a screening observation 
period (3 to 7 days), a treatment period (4 weeks), and a follow-up period (1 month). 
AEEPN is conducted at 7 hospitals in China and the ethics committee of each hospital 
approved the study protocol.  
3.2 Randomization 
Eligible patients are randomly allocated in a ratio of 1:1 to the EA or SEA group by a 
central randomization system (Clinical Research Data Collection and Management 
System of Jiangsu Province Hospital of Chinese Medicine). Multi-center stratified 
variable block randomization is used, and the block size of each center is randomly set 
to 4, 6, and 8. Considering that the number of patients in each stratum fluctuates due to 
block variation, 21 stratums are preset at random and take the first 7 groups with the 
number of patients equal to 64 as the final grouping. The randomization sequence is 

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generated and validated by an independent statistician using R software, and then 
imported into EDC's central randomization system and kept by an administrator who 
do not participate in this trial. The central randomization system has set strict personnel 
permissions, and no one has right to view the randomization scheme except the highest-
level system administrator. After participants meet all the inclusion criteria and 
complete the baseline assessment, an acupuncturist will log in to the central 
randomization system to apply for random numbers which will be displayed then, and 
the patients will receive the corresponding treatment. The Clinical Research 
Coordinators (CRCs) will be responsible for enrolling participants, obtaining informed 
consent, and CRF recording. 
3.3 Blinding 
Patients and CRCs (i.e., outcome assessors, data recorders, data entry clerks and 
statistical analysts) are blinded to the group assignment. Due to the nature of the 
intervention, acupuncturists are not be blinded to the treatment. 
3.4 Sample size 
According to previous studies, it is anticipated that a difference in primary outcome 
(NRS-11) between EA group and SEA group is 1.2 and the combined standard deviation 
of the two groups is 3.5. To achieve 90% statistical power and control the type I error 
rate below 0.05, we calculated by PASS 15 that a sample of 448 participants (224 
participants in each group) will be required to detect a two-sided significant difference 
between the two groups and compensate for a dropout rate of 20%. All participants are 
equally distributed among 7 clinical centers, and 64 participants per center will be 
recruited. 

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4. Subjects 
4.1 Diagnostic criteria 
Guidelines for the management of herpes zoster based on the European consensus Part 
1: diagnosis (under the guidance of the European Dermatology Forum (EDF) and the 
European Academy of Dermatology and Venereology (EADV), 2017)5, and the 2016 
edition of the guidelines and specifications of the Chinese expert consensus on the 
diagnosis and treatment of postherpetic neuralgia: have a clear history of acute HZ and 
the pain persists for more than 90 days after the onset of erythematous macules and 
rash.  
The auxiliary indications for PHN: 
 The lesions are usually accompanied by paroxysmal, persistent or evoked pain, 
sensory abnormalities and hyperalgesia, and have the characteristics of distribution 
according to innervation area;  
 The lesions may be accompanied by manifestations of autonomic nervous 
dysfunction such as hyperhidrosis;  
 Local skin can be seen with residual scars or pigmentation;  
 Patient’s ability of daily living changes, that may be accompanied by sleep 
disorders, anxiety, low mood and depression. 
4.2 Eligibility criteria 
 Meet the diagnostic criteria for PHN;  
 Men or women between 45 and 75 years; 
 Diagnosed with moderate or higher pain during the screening observation period 
(daily pain scores of 11-point numeric rating scale (NRS-11) were collected during 
the observation period, and the average pain score ≥4) ;  
 Did not participate in other ongoing clinical studies; 
 Volunteer to participate in the AEEPN trial and sign the informed consent form 

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(ICF). 
4.3 Exclusion criteria 
 patients who are currently receiving, or have received more than one “permitted 
concomitant medications” or any “prohibited concomitant medications and 
treatments” for the treatment of PHN at least 14 days before the screening 
observation period, and are unwilling to undergo a washout period (≥7 days), or 
patients with serious safety issues during the washout period or observation period;  
 Patients who are expected to receive any new prescription drug or other treatment 
for PHN after the start of the trial; 
 Patients with serious uncontrolled medical conditions, such as cardiovascular, lung, 
liver, kidney, gastrointestinal tract, metabolism, endocrine, nervous system, 
respiratory system, urogenital system and other serious diseases, or systemic organ 
dysfunction, malignant tumor, hematologic disease such as bleeding tendency or 
coagulation dysfunction, serious mental illness such as depression or schizophrenia 
Symptoms, hepatitis B antigen or hepatitis C antibody positive known state or 
history of immune dysfunction, history of HIV infection, etc.; 
 Patients with severe pain unrelated to PHN, such as after surgery for clinical major 
diseases; 
 Patients with PHN who have received nerve intervention or other neurosurgical 
treatment, such as selective nerve damage, percutaneous radiofrequency 
thermocoagulation or pulsed nerve modulation technology, etc.; 
 Patients with some special types of herpes zoster, such as those with meninges, 
cornea, conjunctiva, ear involvement, visceral herpes zoster, generalized herpes 
zoster; 
 Patients with skin ulceration, new herpes, or skin infection;  
 Patients with cardiac pacemaker, metal allergy or severe fear of needle;  
 Patients who are unable to give full informed consent or cannot cooperate with pain 

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scale assessment due to mental, mental, linguistic or behavioral disorders;  
 Patients who have poor compliance or are prone to fall off due to other reasons, 
such as the current residence is not in the city where the recruitment hospital is 
located, or the working environment changes frequently;  
 Pregnant and lactating women 
4.4 Subject termination 
 Those who cannot tolerate acupuncture, have serious adverse events during the 
treatment, and should stop the clinical trial of this case according to the doctor's 
judgment;  
 During the research period, the subject has serious complications or other serious 
diseases and needs emergency measures; or has other diseases that affect the 
observation of the test, and the clinical trial should be stopped according to the 
doctor's judgment;  
 During the clinical trial, the subject is unwilling to continue the clinical trial for 
various reasons, and actively asks the doctor in charge to withdraw from the clinical 
trial. 
4.5 Subject dropping and handling 
Criteria for Subject dropping: subjects who have received informed consent and 
screened qualified to enter the randomized trial, who fail to complete the course of 
treatment and observation period specified in this program for some reason, are 
regarded as dropped cases. 
Disposal of subjects dropping:  
 When the subject falls off, the person in charge of the project will contact the 
subject as much as possible, ask the reason, record the details, and complete the 
evaluation project as much as possible by means of door-to-door visits, follow-up 
appointments, telephone calls, and WeChat. 

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 If the test case is withdrawn due to needle allergy or fainting or other adverse 
reactions, and treatment is ineffective, the person in charge of the project will take 
corresponding measures based on the actual conditions of the subjects. 
 Relevant test data are properly kept for the dropped cases and kept in files for 
subsequent statistics of the full analysis set. There is no need to re-recruit subjects 
to fill the number of dropped cases. 
4.6 Subject elimination 
 Due to the patient's concealment of the condition or other conditions, cases that did 
not meet the inclusion criteria and met the exclusion criteria were found after 
inclusion. 
 After being included, they refused to participate in the trial and have not yet 
recorded any clinical data. 
Before the statistical analysis of the data, the statistician and the main researcher shall 
discuss and judge whether the case should be eliminated. 
5. Interventions  
5.1 Lifestyle education 
All participants will receive lifestyle interventions as basic treatment: advocate 
reasonable diet for patients, promote healthy diet knowledge of low-salt, low-fat and 
low-sugar; identify patients' concerns, help patients relieve stress factors and reduce 
avoidance behavior, establish a positive doctor-patient relationship; review patients' 
drug dosage, quality of life, daily activity ability, anxiety and depression assessments, 
provide healthy lifestyle education.  
Electroacupuncture therapy program is developed by the consensus reached by 
acupuncture experts based on previous studies of electroacupuncture for PHN. This 
study will use Hwato brand disposable acupuncture needles (size: 0.30 × 40 mm), 
placebo blunt needles (size: 0.40×13 mm), insulating adhesive pads (Chinese patent 

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number: ZL 2020 2 1980069.2), and SDZ-V electroacupuncture apparatuses.  
5.2 Electroacupuncture (EA) group 
Points selection: ipsilateral Zhigou (SJ6), Yanglingquan (GB34), and Ashi points. 
Location: Refer to the National Standard of the People’s Republic of China "Acupoint 
Name and Location" (GB/T 12346-2006) for acupoint location. 
Operation method: Participants take the appropriate position on the treatment bed 
according to the location of PHN. After routine skin disinfection, the sterile insulating 
adhesive pads are placed on ipsilateral Zhigou, Yanglingquan and Ashi points. Then 
acupuncture needles are inserted vertically into the skin of Zhigou and Yanglingquan 
through the pads approximately 15 to 20 mm, and performs slight, equal manipulations 
of twirling and lifting to reach the sensation of deqi (known as soreness, numbness, 
distention, heaviness or other sensations, which is considered to indicate effective 
acupuncture). Besides, acupuncture needles are inserted obliquely (at an angle of 30 to 
45 degrees) into the skin of Ashi points through the pads approximately 10 mm, and 
point the needle towards the painful area of PHN. The paired poles of 
electroacupuncture apparatus are connected to the needle handles at ipsilateral Zhigou 
and Yanglingquan, and for Ashi points, the paired poles are connected to the head and 
tail acupoints of the long axis of the painful area. The waveform of electroacupuncture 
stimulation is a continuous wave with a frequency of 2 Hz and a current intensity of 1-
5 mA (causing mild tremor of the skin around the acupoints without pain), and continue 
the electroacupuncture treatment for 30 minutes.  
Frequency and duration of treatment: All patients will receive electroacupuncture 
treatment once per day, 5 times a week for 4 consecutive weeks (20 treatments in total). 
5.3 Sham electroacupuncture (SEA) group 
Participants randomly assigned to the SEA group will received sham 
electroacupuncture by using placebo blunt needles at the same acupoints. After 

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disinfecting the skin and placing the sterile insulating adhesive pads on ipsilateral 
Zhigou, Yanglingquan and Ashi points, placebo blunt needles are inserted through the 
pads and reach the insulating adhesive layer, causing the participants to feel the needle 
resistance (a sensation of needle insertion). Other procedures, electrode placements, 
parameter of electroacupuncture apparatus and treatment settings are the same as in the 
EA group, but with no skin penetration or electricity output.  
6. Concomitant Medications 
6.1 Permitted concomitant medications 
During the first visit, the medication usage of the participants in the last 2 weeks will 
be inquired in detail and recorded, including drug name (or other therapy name), 
indications, dosage unit, frequency of administration, route of administration, and start 
and end time of medication.  
Participants will be allowed to take only one of the following medications to treat PHN 
if they take a stable dose level for PHN at least 14 days before the screening period:  
 any anticonvulsant drugs (e.g., pregabalin, gabapentin, oxcarbazepine, 
carbamazepine); 
 any one of serotonin-norepinephrine reuptake inhibitors (SNRIs) (venlafaxine, 
duloxetine, milnacipran);  
 any TCAs (e.g., amitriptyline, nortriptyline, clomipramine, doxepin, desipramine);  
 any opioid analgesics (e.g., tramadol, codeine, morphine, oxycodone, methadone);  
 any one of oral Non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, 
aceclofenac, celecoxib, nimesulide, meloxicam, diclofenac, ketotifen, naproxen). 
Afterwards, the participants should maintain the medication regimen during the entire 
study period unless there are safety issues during the observation period. If the 
participant wants to adjust the medication regimen, he or she can apply to his or her 
doctor, who can adjust the medication plan after the specific condition has been 

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assessed.  
Participants will be allowed to take a stable dose of the following drugs for the treatment 
of underlying diseases throughout the study:  
 benzodiazepines, non-benzodiazepines (e.g., eszopiclone) or related drugs for 
insomnia; 
 stable dose of diuretics, calcium antagonists or related drugs for the treatment of 
hypertension;  
 the selected 5-serotonin reuptake inhibitor for depression (e.g., sertraline, 
fluoxetine); 
 β agonists or anticholinergic drugs for chronic obstructive pulmonary disease;  
 oral aspirin for cardioprotection;  
 hypolipidemic drugs;  
 vitamin D, calcium supplements, or related drugs for the prevention of osteoporosis;  
 other drugs not included above and not related to the treatment of PHN.  
6.2 Prohibited concomitant medications 
The prohibited concomitant medications for the AEEPN trial are as follows:  
 any topical medication for PHN, including 5% lidocaine patch, lidocaine ointment, 
capsaicin patch, NSAIDs and any other topical drug preparations for the treatment 
of PHN;  
 monoamine oxidase inhibitors or any other antidepressants not included in the 
permitted concomitant medications;  
 steroids;  
 mexiletine;  
 lamotrigine;  
 ibuprofen and codeine phosphate tablets;  
 alpha-lipoic acid;  
 evening primrose oil;  

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 any skeletal muscle relaxant (e.g., botulinum toxin, baclofen);  
 any antipsychotics or neuroleptic medications;  
 any other medication for pain relief not included above.  
 during the study period, any neuromodulation techniques (e.g., nerve pulse 
radiofrequency, nerve electrical stimulation), nerve block, and other forms of 
analgesic therapy that may confuse the evaluation of PHN is prohibited.  
6.3 Rescue medication 
Participants will be allowed to take oral paracetamol/acetaminophen (up to 2 grams per 
day, as needed) as rescue medication for unacceptable pain. The use of rescue 
medication must be promptly recorded in the CRF and entered into the EDC system, 
and all participants are discouraged from receiving any prohibited medications or 
treatments throughout the trial, if received, they are asked to document all. 
7. Outcomes measures 
7.1 General record items 
Hospital code, case random number, abbreviation of subject's name, start date of trial. 
7.2.1 Biological information 
Demographic characteristics: gender, age, height, weight, medical history, marriage, 
education 
History of PHN: course of disease, location of onset, TCM syndrome, medication and 
treatment for PHN in the past 14 days   
Basic diseases: medication and treatment for basic diseases in the past 14 days  
Observation time point: Collect the above data before enrollment 

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7.2.2 Outcomes 
7.2.2.1 primary outcome 
11-point numeric rating scale (NRS-11)6-8: Use a scale of 0-10 to represent different 
degrees of pain: 0 means no pain; 10 means severe pain.  
The grading standard of pain degree is: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 
7-10: severe pain. 
 
Time Frame: Change from Baseline at 4 weeks 
7.2.2.2 Secondary Outcomes 
7.2.2.2.1 11-point numeric rating scale (NRS-11) 
Time Frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 
weeks, one-month follow-up after treatment 
7.2.2.2.2 Visual analogue scale (VAS)8,9 
 A horizontal line 10cm long (or 100mm), one end of the horizontal line indicates no 
pain (0); the other end indicates the most severe pain imaginable (10); the middle part 
indicates different degrees of pain. Ask the subjects to draw a vertical line mark at the 
place closest to their pain level to quantify the intensity of their pain. 
 
Time Frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 
weeks, one-month follow-up after treatment 
7.2.2.2.3 Verbal rating scale (VRS)7  
According to the grading method used to assess the degree of pain in the subject, the 
evaluator divided the degree of pain in the subject from no pain to severe pain, which 

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is relatively simple and has a good correlation with NRS. VRS was scored with "no 
pain" = 0, "mild pain" = 1, "moderate pain" = 2, and "severe pain" = 3. 
 Level 0: No pain.  
 Level I (mild): Pain, but tolerable, can live a normal life, sleep is not disturbed. 
 Level II (moderate): Pain is obvious, intolerable, painkillers are required, and sleep 
is disturbed. 
 Level III (severe): The pain is severe and unbearable, analgesics must be used, 
sleep is severely disturbed, and it may be accompanied by autonomic disorders or 
passive posture. 
Time Frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 
weeks, one-month follow-up after treatment 
7.2.2.2.4 Mechanical pain threshold (MPT)10-13 
In order for the subject to focus on the sensory test, the test should be in a quiet room. 
After exposing the test site (select the middle position of the PHN, try to ensure that the 
test position is basically unchanged at subsequent time points; avoid scars and injury 
sites), the researcher should ask the subject to close their eyes or look away, using 20 
hand-helds The Von frey filament (starting from the 2.83 specification) is applied 
vertically on the skin surface until the filament is bent into a 90 degree or "C" shape 
and remains in place for about 1.5 s. The subject indicated whether the Von frey 
filament caused pain by answering "yes" or "no". If the subject answers "No", use a 
larger diameter filament to increase the intensity application until the subject responds. 
After the subject answered "yes", the descending stimulus sequence was used, and the 
smaller diameter filament was used to reduce the intensity of the stimulation until the 
subject answered "no". Alternate between ascending and descending order until 5 
deflection points are recorded. The final mechanical pain threshold is the geometric 
mean of these 5 points. 
Time Frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 
weeks, one-month follow-up after treatment 

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7.2.2.2.5 Pain area of PHN (PAP)14,15 
Refer to the scoring method of the 45 body areas rating scale.  
PHN pain area = the patient’s body surface area (BSA, m2) * "pain area code" as a 
percentage of body surface * "PHN area" as a percentage of pain area (assessed by the 
investigator) 
 
Time Frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 
weeks, one-month follow-up after treatment 
7.2.2.2.6 Average number of pain episodes (ANPE)16 (Within 24 hours) 
 Painless: 0 times 
 Intermittent pain: 1-50 times (optional 1-2, 3-5, 6-10, 11-50) 
 Persistent pain: >50 times 
Time Frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 
weeks, one-month follow-up after treatment 
7.2.2.2.7 Average duration of each pain episode (ADEPE) 
Duration range: 0 minutes (no pain) -24 hours (persistent pain) 
Time Frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 
weeks, one-month follow-up after treatment 

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7.2.2.2.8 Short form of McGill pain questionnaire 2 (SF-MPQ-2)17-21 
It includes four dimensions: persistent pain, paroxysmal pain, neuropathic pain, and the 
influence on mood, with a total of 22 items (See appendix 1). 
Time Frame: Change from Baseline at 4 weeks, one-month follow-up after treatment 
7.2.2.2.9 Zoster brief pain inventory (ZBPI)22 (See appendix 2) 
Time Frame: Change from Baseline at 4 weeks, one-month follow-up after treatment 
7.2.2.2.10 Depression, anxiety and positive outlook scale (DAPOS)23 (See appendix 
3) 
A reliable and brief scale that specifically evaluates the mood of patients with pain, 
including depression, anxiety, and positive influence, with a total of 11 items. Each item 
is scored 1-5, 1 point means never happening, 5 points means always happening. 
Time Frame: Change from Baseline at 4 weeks, one-month follow-up after treatment 
7.2.2.2.11 Patient global impression of change (PGIC)24 
Clinical overall impression scale, to assess whether the patient's clinical condition has 
improved or declined. Score 1-5, in order of obvious improvement, slight improvement, 
no change, slight aggravation, and obvious aggravation. 
Time Frame: Change from Baseline at 4 weeks, one-month follow-up after treatment 
7.2.2.2.12 Safety of electroacupuncture (SEA) 
Evaluation is performed before and after each treatment. Contents include broken 
needles, fainting needles, unbearable acupuncture pain (VAS ≥ 8 points), local 
hematomas, infections and abscesses; other discomforts after acupuncture (after 
acupuncture with a duration of 1 hour or more after the needle stick) Pain, nausea, 
vomiting, palpitations, dizziness, headache, anorexia and insomnia) symptoms, average 
severity and average duration; and other unforeseen adverse events. 
This study requires patients to report adverse reactions at any time, and doctors timely 
record the name, frequency and duration of adverse reactions. 
7.2.2.2.13 Use of concomitant medications 
The percentage of patients using concomitant medications and the changes in dosage 

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and frequency of concomitant medications (including rescue medication) is analyzed 
after the completion of the trial. 
8. Safety assessment standard 
8.1 Observation of adverse events 
Adverse events are any unexpected symptoms, signs, or health conditions during the 
entire clinical study period (including washout period, observation period, routine 
treatment period, follow-up period, a total of 10 weeks), and may not have a causal 
relationship with the treatment in this study. Health conditions or diseases that existed 
before the start of this study can only be considered as an adverse event if they 
deteriorate further after starting the treatment of this study. Abnormal laboratory test 
values or test results can only be considered adverse events (AE) when they cause 
clinical symptoms or signs, are considered clinically significant or require treatment. 
Use non-inductive questions at each visit during the study period to discover adverse 
events from patients. Adverse events may also be reported by the patient during or 
between visits or discovered through physical examination, laboratory examination or 
other methods. All adverse events must be recorded on the adverse events page of the 
CRF, and the following information about the adverse events must be provided at the 
same time: 
 Severity (mild, moderate, severe). 
 The relationship with the research treatment (definitely related, very likely related, 
possibly related, possibly unrelated, definitely unrelated). 
 Duration (start and end dates or whether they still exist at the time of the last 
inspection). 
 Whether it is a serious adverse event (SAE). A serious adverse event (SAE) is 
defined as an adverse event leading to any of the following outcomes: 1) leading 
to death. 2) Fatal or life-threatening. 3) Lead to permanent or significant loss of 

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function or disability. 4) The patient needs to be hospitalized or the existing 
hospitalization time is extended, unless the hospitalization is due to: ①
Conventional treatment or monitoring of research indications has nothing to do 
with any deterioration of physical condition; The disease undergoes elective or pre-
planned treatment, and the disease has not deteriorated after the application of the 
research treatment; ③In the outpatient and emergency department, the event did 
not meet the criteria for serious adverse events mentioned above, and did not lead 
to hospitalization; ④Social reasons And containment, and the patient’s general 
condition has not deteriorated. 5) Lead to congenital malformations or birth defects. 
6) Other important medical events, that is, the event causes harm to the patient or 
may require medical or surgical intervention to prevent the occurrence of any one 
of the results listed in the above definition. Unlike conventional safety assessments, 
SAE requires continuous monitoring and special reporting requirements. 
 All adverse events need to be dealt with correctly. Treatment methods may include 
one or more of the following methods: no measures are taken (that is, only further 
observation); study treatment adjustment/temporary interruption; permanent 
suspension of study treatment due to the adverse event; addition of combined drug 
treatment; non-drug treatment ; Allow the patient to be hospitalized or extend the 
patient's hospital stay. The measures taken to deal with adverse events shall be 
recorded on the adverse events page of CRF. Once an adverse event is found, 
follow-up until it is resolved or until it is determined that it is permanent, and at 
each follow-up (if necessary, the frequency of follow-up can be increased) changes 
in the severity of the adverse event, suspicious relationship with the treatment of 
this study, and the need The intervention means and results are evaluated. 
8.2 Standards for judging the severity of adverse events 
 Mild: The subject can tolerate it, does not affect the treatment, does not require 
special treatment, and has no effect on the subject's recovery. 

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 Moderate: The subjects are unbearable and need to withdraw the drug to suspend 
the test or do special treatment, which has a direct impact on the subjects' recovery. 
 Severe: Endangering the life of the subject, causing death or disability, requiring 
immediate withdrawal or emergency treatment. 
8.3 Treatment of adverse events 
8.3.1 Observe and record 
Researchers should ask patients to truthfully report the changes in their condition after 
acupuncture and avoid induced questions. 
Any adverse reaction during the test should be filled in the "Adverse Event Form", 
followed up and investigated, and the treatment process and results should be recorded 
in detail until the laboratory examination returns to normal and the symptoms and signs 
disappear. Follow-up and follow-up methods can choose hospitalization, outpatient 
clinic, home visit, telephone, communication, etc. according to the severity of adverse 
reactions. 
8.3.2 Medical treatment 
When an adverse reaction is discovered, the researcher decides on diagnosis and 
treatment measures based on the condition and decides whether to suspend the 
observation. In the event of a serious adverse event, the study immediately took 
necessary measures to protect the safety of the subjects. 
8.3.3 Report 
For all adverse events that occurred during the clinical study period (including washout 
period, observation period, routine treatment period, and follow-up period, a total of at 
least 10 weeks), the investigator must truthfully fill in the "Adverse Events/Adverse 
Reaction Record Form" and include it on the report Sign and date. If a serious adverse 
event (SAE) occurs, it will be handled as usual, regardless of whether it is related to the 
treatment of this study, it must be reported to the head of the PHN clinical trial group 

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of Jiangsu Provincial Hospital of Traditional Chinese Medicine within 24 hours of the 
investigator’s 
knowledge 
(contact/Tel: 
Jianhua 
Sun 
/13914722816, 
Email: 
377201634@qq.com), and report to the ethics committee; if the enrolled patient is 
pregnant, it is also regarded as a major event, and the adverse event/adverse reaction 
record form must be filled in, and the investigator is informed Report to the person in 
charge of the PHN clinical trial group of Jiangsu Provincial Hospital of Traditional 
Chinese Medicine within hours (contact person/telephone: Jianhua Sun/13914722816, 
email: 377201634@qq.com), and report to the ethics committee at the same time. 
9. Quality control and assurance of the study 
9.1 Clinical quality control measures 
Establish standard operating procedures and quality control procedures for 
experimental observation indicators. The test results must be printed on a computer, 
and the data should be traceable. 
9.2 Pre-clinical trial training 
In order to ensure the smooth progress of the research, the research team must hold a 
special clinical training meeting to conduct unified training for clinical researchers 
before the official launch of the clinical trial. 
Carry out key training on the project implementation plan and various standard 
operation procedures (Standard Operation Procedure, SOP), so that each clinical 
researcher (including acupuncture operators, scale evaluators, research nurses, quality 
controllers and other related research Personnel) To be familiar with the research 
process and specific test implementation rules to improve the consistency of internal 
observations by researchers and the consistency between observers, and to ensure the 
reliability of clinical research conclusions. 
Sign the investigator's statement and establish indicator observation and quality control 
SOPs in the participating hospitals. 

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9.3 Measures to improve subject compliance 
In order to obtain better compliance, make the final summary analysis not less than 80% 
of the total number of cases entered into the trial, adopt the following measures to 
improve patient compliance: adhere to the principle of voluntariness, sign patient 
informed consent; from medical treatment Improve and maintain good patient 
compliance in terms of quality, treatment environment, medical expenses, etc., to 
encourage patients to adhere to treatment as much as possible during the study period; 
pay attention to establishing a good doctor-patient relationship, and explain in detail 
various examinations, treatments and re-examinations for included cases To obtain the 
patient’s consent and cooperation for the purpose and necessity; record their contact 
information in detail for follow-up. 
9.4 Quality control and quality assurance system 
Operators in charge of acupuncture treatment in each center must have an acupuncturist 
qualification certificate and independently undertake clinical treatment for more than 2 
years. Scale assessors and other investigators participating in the trial should perform 
their respective duties, strictly follow the clinical trial protocol, and adopt standard 
operating procedures to ensure the implementation of the clinical trial quality control 
and quality assurance system. 
10. Data collection, management, monitoring and auditing 
The data collection and analysis, quality assurance, trial conduct and implementation 
for this study will follow Good Clinical Practice (GCP) guidelines43. Before the 
AEEPN trial is officially initiated, the research group will hold a specialized clinical 
training meeting to conduct unified interpretation and training of all clinical researchers 
on the study implementation scheme, standard operation procedure (SOP), CRF filling, 
EDC system use and electronic data entry, so that researchers in each clinical center 
(including acupuncturists, outcome assessors, data recorders, data entry clerks, research 

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nurses, quality controllers and other related researchers) will be familiar with the study 
protocol and SOP, thereby the internal observation consistency of researchers will be 
improved. 
All CRFs for each participant will be filled in timely by researchers in each clinical 
center, including assessment scales, questionnaires, treatment compliance, concomitant 
medication and rescue medication use, AE, etc.. Any evidence-based correction of CRF, 
only lines can be drawn. The marginal note modified data will be signed and dated by 
the researcher, and the original records shall not be erased or overwritten. All original 
documents and CRFs will be stored in the clinical study office. Besides, all data will be 
accurately double-entered into EDC system and the electronic CRF are identical to 
paper CRF. Once the data entry is completed, the database will automatically perform 
consistency checks, missing value checks, value range and logic checks. If any 
inconsistencies or missing data are found, the data will be re-checked and corrected 
based on the original documents and CRFs. And the contents, time and operators of all 
operations will be recorded by the EDC system to ensure the accuracy, completeness 
and traceability of the research data entry. When 50% of the participants’ data is entered 
into the EDC system, we will perform an interim analysis on the primary outcome, 
whichever comes first. This will be performed by an independent statistician and will 
inform us whether the intervention has been proved to be effective (beyond reasonable 
doubt). Subsequently, we will decide whether (if necessary) to modify the study or 
terminate it prematurely. When all data is entered in the EDC system, 10% of the eCRF 
will be randomly selected for manual inspection, and the database will be locked and 
sent to the statisticians for further statistical analysis after all data inspection is 
completed and updated. Finally, we will submit the end of trial notification and final 
report to the Ethics Committees of 7 clinical centers, the Sponsor and ClinicalTrials.gov. 

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11. Statistical Analysis 
11.1 Choice of analysis data set 
Full analysis set: refers to the ideal subject set that is as close as possible to the 
principle of intentional analysis (the main analysis should include all randomized 
subjects). This data set is composed of all randomized subjects with the smallest sum 
It is obtained after a reasonable method is eliminated. Missing data of withdrawn 
participants is imputed using the multiple imputation method. The number of subjects 
who evaluated the efficacy at the end point of each group remained the same as that at 
the beginning of the trial. 
Per Protocol Set: In line with the experimental treatment plan, the main variables can 
be measured, the baseline variables are not missing, and there is no major violation of 
the experimental plan. 
Security set: All subjects who received at least one treatment after randomization. 
The main variables were analyzed using the full analysis set and the conforming plan 
set; the demographics, other baseline characteristics, and other curative effect index 
analysis were all using the conforming plan set. 
11.2 statistical software 
SAS 9.4 and graphpad were used for statistical analysis 
11.3 Content of statistical analysis 
The actual number of subjects in the two groups, shedding and elimination cases, 
demographic and other baseline characteristics, compliance, observation index analysis 
and safety analysis. 
11.4 Statistical analysis of population 
Randomized population: all randomized subjects constitute a randomized population. 

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According to the ITT principle, all randomized subjects will be statistically analyzed. 
11.5 Statistical analysis method 
The description of the enumeration data will use the number of cases and percentages, 
and the comparison between groups will use chi-square test, Fisher's exact probability 
method, Wilcoxon rank sum test, CMH χ2 test, and WLS covariance. The description 
of the measurement data will be carried out using the mean ± standard deviation, 
median, maximum, and minimum value. Quantitative data conform to a normal 
distribution with t test (test for homogeneity of variance between groups, with 0.05 as 
the test level, uneven variance The Satterthwaite method was used for the corrected t 
test), the Wilcoxon rank sum test and the Wilcoxon signed rank sum test were used for 
non-normal distribution. The hypothesis test uses a two-sided test uniformly, and the 
test statistics and the corresponding P value are given. P<0.05 is considered statistically 
significant, and P<0.01 is considered highly statistically significant. 
12. Ethical considerations 
Ethical review: This study will follow the relevant regulations of the World Medical 
Congress "Declaration of Helsinki". Before the start of the study, the clinical study was 
carried out after the ethics committee approved the trial protocol. If this protocol is 
revised during the implementation of the clinical trial, it will be submitted to the ethics 
committee for approval before implementation. 
Benefits and risks: The subjects and the society will benefit from this research, 
including the pain of the subjects will be improved, and the subjects can get the 
research-related inspection fees and registration fees for free during the research period. 
Obtain good medical services during the period. At the same time, this study may help 
more patients in the international community recognize the analgesic effect of 
electroacupuncture on PHN patients, so as to help other patients with the same disease 
get rid of pain as soon as possible. Subjects are at risk of possible adverse events due 

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to acupuncture during the experiment, such as fainting needles, broken needles, local 
infections or subcutaneous hematomas, etc. Researchers will take corresponding 
diagnosis and treatment measures according to the condition, and suspend observation 
when necessary to protect Subject safety. 
Recruitment of subjects: Recruiting subjects announcements, WeChat public account 
tweets, etc., release relevant information → sign up for interested persons → read 
research introduction → subject screening → selection of qualified persons → sign 
informed consent → random subjects Grouping →baseline evaluation →
electroacupuncture intervention→collecting observation indicators. Please refer to the 
attachment for the recruitment notice and research brief, and submit it to the ethics 
committee for review. 
Medical treatment and protection of subjects: The investigator is responsible for the 
medical treatment of the subjects, ensuring that the subjects receive appropriate 
treatment in the event of adverse events during the trial. 
Subject’s privacy protection: The subject’s personal privacy and data will be 
protected during the research process, and the subject’s personal information will not 
be disclosed. Only the researchers participating in the clinical trial may have access to 
the subject’s personal medical records. Data processing will adopt the method of "data 
anonymity", omit the information that can identify the individual of the subject, and 
will publish it publicly regardless of whether the research results are positive or 
negative. 
Informed consent process: Before each subject is selected for this study, the 
investigator will give the subject or his agent a complete and comprehensive 
introduction to the details of the study, including the purpose of the trial, trial 
procedures, possible benefits and Risks, subjects’ rights and obligations, etc., to enable 
subjects to fully understand and have sufficient time to consider, and to give their 
consent after satisfactory answers to all questions raised, and to sign written informed 
consent, and let subjects know that they have The right to withdraw from this study at 

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any time, and the informed consent will be retained as a clinical study document for 
future reference. When each patient signs the informed consent form, the doctor will 
leave his contact number to the patient so that the patient can contact the doctor at any 
time when his condition changes. 
13. Abbreviations 
AEEPN: Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia; PHN: 
Postherpetic Neuralgia; HZ: Herpes Zoster; Chinese National Knowledge 
Infrastructure: CNKI; National Center of Biotechnology Information: NCBI; RCT: 
Randomized Controlled Trials; European Dermatology Forum: EDF; European 
Academy of Dermatology and Venereology: EADV; CRF: Case Report Form; EDC: 
Electronic Data Capture; NRS-11: 11-point Numeric Rating Scale; ICF: Informed 
Consent Form; EA: Electroacupuncture; SEA: Sham electroacupuncture acupuncture; 
VAS: Visual Analogue Scale; VRS: Verbal Rating Scale; MPT: Mechanical Pain 
Threshold; PAP: Pain Area of PHN; ANPE: Average Number of Pain Episodes; ADEPE: 
Average Duration of Each Pain Episode; SF-MPQ-2: Short Form of McGill Pain 
Questionnaire 2; ZBPI: Zoster Brief Pain Inventory; DAPOS: Depression, Anxiety and 
Positive Outlook Scale; PGIC: Patient Global Impression of Change; SEA: Safety of 
Electroacupuncture; AE: Adverse Events; CRCs: Clinical Research Coordinators; GCP: 
Good Clinical Practice; SOP: Standard Operation Procedure; ITT: Intention-To-Treat.  
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to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain 
inventory. J Pain. 2004;5(6):344-356. 
23. 
Pincus T, Williams AC, Vogel S, Field A. The development and testing of the depression, anxiety, 
and positive outlook scale (DAPOS). Pain. 2004;109(1-2):181-188. 
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Shkirkova K, Schuberg S, Balouzian E, et al. Paramedic Global Impression of Change During 
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Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia:  
A Multicenter Randomized Controlled Trial 
Amendment 4.0 Final 
 
34 
 
Appendix 1 
 
 
 
 

Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia:  
A Multicenter Randomized Controlled Trial 
Amendment 4.0 Final 
 
35 
 
Appendix 2 
Zoster brief pain inventory (ZBPI) 
Pain Items 
Interference Items 
Worst pain in last 24 hours 
General activity 
Least pain in last 24 hours 
Mood 
Pain on average  
Walking ability 
Pain right now 
Normal work (including housework) 
  
Relations with other people 
  
Sleep 
  
Enjoyment of life 
Are you receiving any treatments or medications for your shingles pain? 
1.Yes   2.No 
In the last 24 hours, how much relief have these treatments or medications provided 
for your shingles pain? Please circle the one percentage that most shows how much 
relief you have received. 
0%   10%   20%   30%   40%   50%   60%   70%   80%    90%   100% 
No Relief                                                        Complete Relief 
 
 
 

Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia:  
A Multicenter Randomized Controlled Trial 
Amendment 4.0 Final 
 
36 
 
Appendix 3 
The Depression, Anxiety and Positive Outlook Scale (DAPOS) 
We would like to know how you have been feeling in the last few weeks. Please circle 
a number for each statement indicating how often you feel that way, where 1, almost 
never and 5, almost all the time 
 
Almost never            Almost all the time 
1 
I feel like a failure 
1 
2 
3 
4 
5 
2 
I get a frightened feeling, as if something 
awful is about to happen 
1 
2 
3 
4 
5 
3 
I feel guilty 
1 
2 
3 
4 
5 
4 
I can laugh and see the funny side of things 
1 
2 
3 
4 
5 
5 
I am disappointed in myself 
1 
2 
3 
4 
5 
6 
I get a frightened feeling, like butterflies in 
the stomach 
1 
2 
3 
4 
5 
7 
I feel cheerful 
1 
2 
3 
4 
5 
8 
I blame myself constantly 
1 
2 
3 
4 
5 
9 
I get a sudden feeling of panic 
1 
2 
3 
4 
5 
10 I look forward with enjoyment to things 
1 
2 
3 
4 
5 
11 I think about harming myself 
1 
2 
3 
4 
5