Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
Phase: NA
Conditions: Neuromyelitis Optica Spectrum Disorders, Pain
Sponsor: Yuanqi Zhao,MD

1 
 
 
To explore the treatment of optic 
neuromyelitis with 
electroacupuncture(NMOSD)The efficacy and 
mechanism of pain in patients 
 
 
 
Project Source: Postgraduate Project 
 
Research Unit: Guangdong Provincial Hospital of 
Traditional Chinese Medicine 
 
Head of Research: Zhao Yuanqi, Li Xiaojun 
 
Version number:6.0 
Version date:2022.03.01 

2 
 
1. Program summary 
Research 
topic: 
To explore the treatment of optic neuromyelitis spectrum 
disease by electroacupuncture (NMOSD) Study on the efficacy 
and mechanism of pain in patients 
Purpose of 
the 
research 
Main purpose: to observe the electrical target NMOSD Secondary 
purpose of the curative effect of patient pain: Discussion 
NMOSD The mechanism of pain in patients and the mechanism of 
electroacupuncture in the treatment of pain in patients with 
optic neuromyelitis spectrum disease 
Research 
hypothesis 
Electroacupuncture can be treated effectively. NMOSD Pain in 
the patient 
Research 
design 
Randomized controlled trial 
Test group Electroneedle group 
Control 
group 
False needle group 
Sample 
size 
20 
Selection 
Criteria 
1Accord with 2021 Diagnostic criteria for optic poliomyelitis 
genealogical diseases in China's Guidelines for the Diagnosis 
and Treatment of optic Neurospinal Myelitis Gene Diseases; 
2NRS≥4 Score; 
3Patients use stable doses of biotherapy and/Or strong loose, 
before joining the group 30 There is no adjustment plan within 
the day; 
4Patients before joining the group 30 No standard drug 
combinations for pain treatment, including antiepileptic drugs, 
antidepressants or opioids, were adjusted within the day. 
5The patient or the patient's family sign informed consent. 
618-80 Year-year-old patient。 
Exclusion 
criteria 
1Patients participating in other clinical studies； 
2Patients with low cognitive or mental ability; 
3People who are pregnant, breastfeed or plan to get pregnant 
during the study; 
4People with serious diseases related to the heart, liver, 
kidneys or hematopoietic system; 
5Patients with diabetic peripheral neurosis. 
Test cycle Total test cycle30God, all8Visit twice a week. 
Outcome 
evaluation 
indicators 
Main indicators:NRS Mark 

3 
 
Secondary indicators:EDSS、MPQ Rating,SAS Anxiety Scale,SDS 
Depression Scale,SF-36 Quality of life scale,IL6、TNF-Α、fMRI 
Target 
Safety 
evaluation 
indicators 
Adverse reactions, blood routine, biochemistry, liver function 
 
 
2. Research background 
The pain is NMOSD A common symptom of the patient. Known as high as 
86%Taxi NMOSD Patients will be affected by pain.[3,13,14,15]. A survey on the 
quality of life and medical experience of Chinese patients shows that pain is 
the third concern of patients in addition to recurrence and drug side effects, 
and even more trouble the lives of patients than disability. Weigh 10%The 
patient believes that the severe pain caused by the disease greatly interferes 
with normal life. 6%Patients believe that physical pain seriously prevents them 
from enjoying life. 
NMOSD The pain of patients is mainly divided into neuropathological pain 
and spasm-related pain. Some 
clinical observations 
suggest 
clinical 
factors.(Such as poliomyelitis and emotions)And demographic factors(Such as 
age)Give NMOSD Pain-relatedness of patients[3,4,10,11]. At present NMOSD 
Possible mechanism of pain[32-36] ： 1In the physiological state,AQP4 With 
excitatory amino acid transporter 2 （ EAAT2) Common expression, so that 
astrocytes consume glutamate.AQP4-ab Positive patient's AQP4 In the absence, 
the intake of glutamate by astrocytes leads to the excessive accumulation of 
glutamate in the extracellular space, resulting in abnormal excitation of 
neurons and excitatory tissue damage.2The central nervous system regulates pain 
mainly from 2 Aspects: Increased excitement and reduction of inhibition. This 2 
Each aspect is affected by reactive astrocyte proliferation and its related 
inflammatory reactions.3Abnormal brain structure: Studies found that the 
posterior ventral nucleus(VPN) Volume is negatively correlated with a variety 
of pain intensity indicators. The volume of hippocampus and pale bules in 
patients with neurological pain is smaller than that of patients with non- 
nervous pain, and the pain intensity is negatively correlated with the nucleus 
and thalamus volume. 
At present, despite a variety of analgesic drugs and a variety of drug 
combinations for different pain mechanisms.[12], but there are still 60-80%Taxi 
NMOSD Patients with moderate and severe pain and completely get rid of pain 
are less than 10% [3,4]. At the same time, there are many large samples and 
multiple centers. RCT Research suggests that electroacupuncture is effective in 
treating pain.[25,26,41,42]. National Institutes of Health(National Institutes Of 
Health)Estimated, more than 1500 Ten thousand Americans use it.Acupuncture 

4 
 
therapy[27，28]. The use of electric needles is now recognized by the World Health 
Organization.[29-31]. 
The 
author 
expounds 
the 
analgesic 
effect 
of 
electroacupuncture from the aspects of traditional Chinese medicine and modern 
medicine.Among them, the design of fake acupuncture is mainly published in BMC 
Acupuncture study of the same type of disease with pain in the journal[47]。 
Based on the results of the literature, some progress has been made in the 
study of electroacupuncture in the treatment of pain, which can be used to 
regulate inflammatory factors. 
[16,17,21-23], release analgesic-related factors[19,20,37,39-41], regulate the 
corresponding brain area[45,46]Activities and other aspects play an analgesic 
effect. 
Therefore, this study hopes to explore the efficacy and related mechanism of 
electroacupuncture in the treatment of pain in patients with optic poliomyelitis 
spectrum diseases by comparing the efficacy of electroacupuncture group and the 
pseudo-acupuncture group. This study assumes that electricity has an effect on 
pain in patients with optic neuromyelitis spectrum disease, and then verifies 
the mechanism of electricity on the pain of patients with optic neuromyelitis 
genealogy diseases for clinical treatment options. 
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3. Objective: To observe the effect of electricity on pain in 
patients with optic neuromyelitis spectrum disease. 
Secondary Purpose: Discuss NMOSD The mechanism of pain in patients and the 
mechanism of electroacupuncture in the treatment of pain in patients with optic 
neuromyelitis spectrum disease 
4. Test design 
Randomized controlled study 
5. Case selection 
5.1 Selection Criteria 
1Accord with 2021 Diagnostic criteria for optic poliomyelitis genealogical 
diseases in China's Guidelines for the Diagnosis and Treatment of optic 
Neurospinal Myelitis Gene Diseases; 
2NRS≥4 Score; 
3Patients use stable doses of biotherapy and/Or strong loose, before joining 
the group 30 There is no adjustment plan within the day; 
4Patients before joining the group 30 No standard drug combinations for pain 
treatment, including antiepileptic drugs, antidepressants or opioids, were 
adjusted within the day. 
5The patient or the patient's family sign informed consent. 
618-80 Year-year-old patient。 
5.2 Exclusion criteria: 
1Patients participating in other clinical studies； 
2Patients with low cognitive or mental ability. 
3People who are pregnant, breastfeed or plan to get pregnant during the 
study; 
4People with serious diseases related to the heart, liver, kidney or 
hematopoietic system. 
5Patients with diabetic peripheral neurosis. 

8 
 
5.3 Exclusion criteria: 
 Incorrectly included in the case; 
 Subjects took drugs that affected the relevant indicators of this 
study without authorization; 
5.4 Fall off standard: 
 The subjects failed to complete the treatment as required by 
the researchers; 
 The subjects did not cooperate with the arrangement for 
personal reasons, and the researchers believed that the patient had 
poor compliance and was not suitable for research; 
  The subjects withdrew from the study on their own. 
6. Sampling estimation and grouping method 
6.1 Estimate of sample size 
The spectrum disease of optic neuromyelitis is a rare disease, and this 
study is an exploratory study. Referring to previous studies, the sample size of 
this topic is 20 Example. 
6.2 Random grouping method 
Use a simple randomization method to input the estimated sample 
content.SPSS V.25.0 Statistical software to obtain order numbers, random seed 
numbers and grouping results. Then make a random card and seal it in an opaque 
envelope. Before preparing to start the clinical trial, the serial number will 
be used according to the order in which the subjects were included in the study, 
the order number on the corresponding envelope will be opened, and then grouped 
according to the prompts on the random card. The whole process ensures 
randomness and secrecy and reduces the bias of researchers. 
6.3 Blind law 
The study includes the blind design of patients and evaluators. Only 
acupuncture operators know.Intervention to be used. The treatment was 
carried out according to the individual's schedule, so no patient had any 
contact with other patients in the study. In addition, all patients agree 
not to contact other participants and avoid talking about their treatment. 
7. Interventions 
This study is divided into 2 The group is the electric needle group and the 
false needle group respectively. The place of acupuncture treatment isDepartment 
of Neurology, Dade Road Hospital, Guangdong Provincial Hospital of Traditional 
Chinese Medicine. Every week 2 Times, every time 30 Minutes of electric needles 
(true or false), continuous 1 Months in total 8 Times (the course of treatment 
is 30 Oh, my God). 
1、Basic treatment and emergency plan 
Before starting the designated treatment plan, the patientAccepted NMOSD 
Guidelines for the remission period (hormonal combined immunosuppressants 
(immunosuppressants include thiopurine, medicophenol ester or rithitoximab)) 
and/Accepted NMOSD Guidelines for patients with pain (pribalin, barclofen or 

9 
 
gabapentine), basic treatment during the study and guidelines for patients 
before grouping.. In the next stage of the study, all patients will start their 
designated treatment plan.(Electric needle)This point in time is set to 1 Day, 
the treatment period is 30 Oh, my God. Patients record the daily intake and 
intensity of analgesic drugs required.(NRS)Standardized patient diary of pain 
parts. 
2、Test group: electric needle group 
Take acupuncture points: three miles of both feet (ST36), Sanyin sex (SP6), 
Hegu (LI4) and Quchi (LI11), insert the needle, insert the ninth needle into the 
seal hall (EX-HN3） 
Acupoint location reference 2006 National standards of the People's Republic 
of China (GB/T12346-2006Name and Positioning of Acupoints. 
Operation process: The patient's position is supine. For acupuncturists 
75%After disinfecting the acupoints on both sides of your hands and the subject, 
the double-sided acupuncture points will be covered with foam pads (1*1*1cm3). 
Acupuncture point adoption0.25 ×0.25mm The disposable sterile acupuncture 
needle passes through the hollow tube and punctures into the acupuncture point 
through the foam adhesive pad. Acupoints, insertion angle and insertion depth 
are based on the references in the classic literature of traditional Chinese 
medicine. After taking the needle, the subjects will feel sour, numb and swollen 
in the local place. Connect the two electrodes of the electroneedle to the 
needle handle of the same limb acupuncture point.,There is no positive or 
negative difference.,Note that the metal surfaces of the two electrodes cannot 
be leaning against each other. Needle parameters: select sparse waves,The 
frequency is set to 4HzThe stimulation intensity is based on the patient's 
tolerance, and the needle retention time is 30 Minutes. 
Control group: false needle group 
Acupuncture points: acupoints used in the electric needle groupHorizontal 
side 1cmPay attention to avoiding traditional Chinese medicine. 14 Any 
corresponding area in the meridian. 
Acupoint location reference 2006 National standards of the People's Republic 
of China (GenerationB/T12346-2006Name and Positioning of Acupoints. 
Operation process: The patient's position is supine. For acupuncturists75% 
After disinfecting the acupoints on both sides of your hands and the subject, 
the double-sided acupuncture points will be covered with foam pads (1*1*1cm3). 
All acupuncture points are used.0.25 ×0.25mm The disposable sterile acupuncture 
needle passes through the hollow tube and punctures into the acupuncture point 
through the foam adhesive pad. The insertion of the needle is shallower (less 
than 0.2cm), it has a similar pain when a normal needle pricks into the needle. 
Connect the two electrodes of the electroneedle to the needle handle of the 
same limb acupuncture point.,There is no positive or negative difference.,Note 
that the metal surfaces of the two electrodes cannot be leaning against each 

10 
 
other. Needle parameters: select sparse waves,The frequency is set to 4Hz, the 
stimulation intensity is 0mA, the retention time is 30 Minutes. 
8. Research steps 
1. Screening period: 
（1） 
The doctor will ask, record the medical history and the results of 
previous examinations, conduct a comprehensive physical examination of you, and 
the nurse will collect the patient. 3ml Blood routine, biochemical, liver 
function,IL6、TNF-ΑExamine and take blood samples, tongue coating samples and 
feces samples, and collect demographic information of subjects through the 
inpatient medical record system. 
（2） 
Perfect EDSS、NRS Scales,MPQ Pain scale,SDS Depression Scale,SAS 
Anxiety Scale,SF-36 Quality of life scale. 
（3） 
Perfect and collect head, neck and chest MR Scan and enhance 
relevant data to improve fMRI Check and collect relevant data. 
2. Treatment period: 
The electroacupuncture group will be treated with electroacupuncture on the 
basis of immunotherapy and basic analgesia, and the control group will receive 
false acupuncture treatment on the basis of immunotherapy and basic analgesia. 
Every week 2 Times, every time 30 Minutes of electric needles (true or false), 
continuous 1 Months in total 8 Times (the course of treatment is 30 Oh, my God). 
Patients fill in a pain diary every day, and the treatment is carried out by the 
same acupuncturist. The manufacturer and use of acupuncture acupuncture needles, 
fake acupuncture and electroacupuncture instruments are consistent. 
3. Eighth post-treatment visit (group No. 28±3 Day: 
（1） 
Patients collected by nurses 3ml The blood is routinely tested for 
blood, biochemical and liver function, and blood samples, tongue coating samples 
and feces samples are retained. 
（2） 
Perfect EDSS、NRS Scales,MPQ Pain scale,SDS DepressionTable,SAS 
Anxiety Scale,SF-36 Quality of life scale. 
（3） 
Perfect fMRI Check and collect relevant data. 
In this study, blood samples, tongue coating specimens and fecal samples 
were used to explore. NMOSD The relevant mechanism of pain in patients and 
the mechanism of electroacupuncture in the treatment of pain in patients with 
optic neuromyelitis spectrum diseases, all samples will be frozen in the 
Biological Resources Center of Guangdong Provincial Hospital of Traditional 
Chinese Medicine and preserved. 3 The sample was destroyed after the study. All 
samples are only used for this study, and your relevant personal information 
will not be made public. Researchers, personnel of the Bioresource Center and 
the Ethics Committee will be allowed to have access to these samples, and 

11 
 
subjects can request withdrawal from the reservation or research of the sample 
at any time. 
9. Outcome evaluation indicators 
Main evaluation indicators:NRS 
Pain sheet rating 
Secondary evaluation indicators:EDSS、MPQ Rating,SAS Anxiety Scale,SDS 
Depression Scale,SF-36 Quality of life scale,IL6、TNF-α、fMRI Indicators. 
10. Technology roadmap 
 
 
 
11. Safety evaluation 
11.1 Laboratory inspection 
Blood routine, liver function, biochemical and other tests. 
11.2 Bad Events/React 

12 
 
11.2.1 Common adverse acupuncture events/Reaction and treatment: Acupuncture 
has adverse reactions such as hematoma, stagnation needle, halo 
needle, etc. 
1） Spend money/Hematoma: During acupuncture and acupuncture, 
local bleeding caused by puncture of blood vessels./Hematoma. Mild 
bleedingOf Patients with hematoma can use disinfectant cotton swabs 
or cotton balls for local compression to stop the bleeding without 
special treatment. Moderate and severe bleeding/Patients with 
hematoma should be based on their bleeding./Take corresponding 
measures to the degree of hematoma, first stop the bleeding to 
prevent the increase of local swelling, carry out local anti- 
inflammatory treatment, and ask a surgeon to assist in dealing with 
it. 
2） Stagnation needle: When acupuncture the stagnation needle, 
you should first relax the local tense muscles, and gently take the 
needle. Do not pull it hard. It can be opened next to the stagnant 
needle. 2 Enter the needle inch by inch, and then take out the 
stranded acupuncture needle. Severe needle stagnation should be 
assisted by a surgeon. 
3） Needle halo: When the patient pricks the needle with 
acupuncture, he should quickly take out the needle and let the 
patient lie flat, lower his head, cushion his footsteps, and 
moxibustion his Baihui acupuncture point. After the patient's halo 
needle situation is slightly relieved, he can be ordered to drink a 
little warm boiled water. If the patient's needle is serious and he 
or she can't wake up, it should be treated according to syncope. 
4） Infection: When there is redness, swelling and heat pain in 
the acupuncture area, the patient's affected part is told to rest 
and move less to reduce the spread of pain and inflammation, raise 
the limbs, promote reflux, reduce swelling, do not squeeze the 
affected part, and carry out local anti-inflammatory treatment. If 
necessary, you should ask a surgeon to assist in dealing with it. 
11.2.2 Observation, recording and handling of adverse events 
If the researchers found that the patient had adverse events caused by 
acupuncture/The reaction should be recorded inCRF Centre“Bad Events /Reaction 
record form”And for adverse events caused by acupuncture./Responding patients 
give enough comfort and treatment to make them have adverse events./The reaction 
should be eliminated as soon as possible. If there is a serious adverse event/In 
addition to the above treatment, the reaction should also be immediately 
reported to the Second Affiliated Hospital of Guangzhou University of 
Traditional Chinese Medicine. There are adverse events in patients./Whether to 
continue the research after the reaction, first 
The patient's own will should be respected first, and the researchers who report 
adverse reactions should judge according to their professional knowledge. 

13 
 
11.3 Serious adverse events 
11.3.1 Definition: Events that require hospitalization, prolonged 
hospitalization, disability, affecting working ability, endanger life 
or death, and leading to congenital malformations occur during 
clinical trials. 
11.3.2 Report of serious adverse events 
When there is a serious adverse reaction, it should be 24 Report to 
Guangzhou University of Traditional Chinese Medicine within hoursThe second 
affiliated hospital and fill in the form of serious adverse events. 
12. Data management and statistical analysis 
Measurement data use: average±Standard deviation, median(M), maximum value, 
Minimum value, matching is used for comparison in the counting data group.T 
Test(Or pairing symbol rank sum test), variance analysis is used for inter-group 
comparison (non-normal distribution and variance irregularity are tested by rank 
sum (Kruskal-Wallis)) and two comparison and calculation95% CI, The quantitative 
main outcome indicators of multiple observation time points are analyzed by 
repeated measurement. Rank sum test is used for comparison between hierarchical 
data groups (Kruskal-Wallis). The counting data is expressed by composition ratio 
and rate, and the comparison of total efficiency groups is expressed by cal- 
square test (orFisher Accurate probability method). Intergroup 
compositionCompared with comparison2 ×C Table or3 ×C Table cal-square 
inspection. 
13. Confidentiality 
The results of the research through this project may be published in medical 
journals, but we will keep the patient's information confidential in accordance 
with the requirements of the law. Unless required by relevant laws, the 
patient's personal information will not be disclosed. If necessary, government 
administrations and hospital ethics committees and their relevant personnel can 
consult patients' information as required. 
14. Ethical standards 
The program of this experiment,Case report form, The informed consent form 
should be approved in writing by the Ethics Committee of Guangdong Provincial 
Hospital of Traditional Chinese Medicine before it can be carried out. 
The researcher or person authorized by the researcher will be responsible 
for explaining the benefits and risks of participating in the trial to each 
patient, the legal representative of the patient or notary witness, and shall 
obtain the patient's written informed consent during the screening examination. 
All original informed consent co-signed and signed by the subjects or their 
legal representatives and the person presiding over the PIC process shall be 
kept by the researcher. 
15. Study schedules 
 
Starting and ending date 
Main research content 
Expected results 

14 
 
2021Year11Moon-- 
2022Year01Moon 
Consult domestic and foreign 
literature, sort out relevant 
data on electroacupuncture for 
pain treatment, establish 
diagnostic criteria, 
inclusion, exclusion and fall 
off of the topic, and make 
observation scales. 
Carry out a literature review, 
establish a medical record 
report form and an opening 
report. Unify the clinical 
trial method and filling in 
the medical record report 
form. 
2022Year02Moon-- 
2022Year12Moon 
Apply for ethical approval and 
register for clinical 
research, conduct clinical 
research, establish a 
database, manage various 
materials, and enter data. 
Complete the clinical trial 
registration. Complete the 
medical record report form. 
Scientifically analyze the 
data and write statistical 
reports. 
 
Clinical summary, statistical 
analysis. 
2022Year12Moon-- 
2023Year01Moon 
Write a closing report and a 
paper. 
Apply to close the topic and 
publish a paper.