A Randomized Controlled Trial of Auricular Thumbtack Needle Therapy Combined With Conventional Treatment and Median Nerve Electrical Stimulation on Consciousness Recovery Prognosis and Family Satisfaction in Craniocerebral Injury Patients With Consciousness Disorder
Phase: NA
Conditions: Traumatic Brain Injury, Cerebral Hemorrhage
Sponsor: Li Hai

The
First
Affiliated
Hospital
of
Gannan
Medical
University, Department of Rehabilitation Medicine
Efficacy Observation of Electrical Stimulation of the
Median Nerve Combined with Ear Acupressure on
Consciousness Disorders in Patients with Cranial Brain
Injury
Ethics Approval Number: LLSL-2022053105
Date: May 30, 2022

Efficacy Observation of Electrical Stimulation of the Median
Nerve Combined with Ear Acupressure on Consciousness Disorders
in Patients with Cranial Brain Injury
1.Subject content and significance
Consciousness disturbance after craniocerebral injury is a common
neurosurgical emergency, which to the category of "unconscious",
"unconscious of people" and "confused" in traditional Chinese medicine.
Patients
often
suffer
from
different
degrees
of
consciousness
disturbance due toonal injury of the reticular ascending activation
system of the brain stem. The high mortality rate, high disability rate and
high medical expenses of coma after craniocerebral injury brought great
economic burden to the country, society and families, and also brought
great life pressure and mental pressure to the family members.
Median nerve electrical stimulation (MNES) is a method of
stimulating the median nerve with low-frequency pulse current, which
stimulates the nervous system through the median nerve-spinal
nerve-cervical spinal cord-brainstem-thalamus-cortical functional area
conduction pathway. Electrical stimulation can relieve theition of nerve
cells, enhance the excitability of inhibited nerve cells, relieve the
inhibition of the ascending reticular activating system (ARAS) in the
brainstem shorten the coma time of patients, and restore function,
thereby promoting the recovery of consciousness.

Auricular acupressure is a new type of needle embedding method,
has a high degree of safety and is easy to operate, and has achieved
good clinical efficacy. And auricular acupuncture treatment, because of
its close relationship with the z-fu organs and meridians, can play a good
role in the "static and left" characteristics of the pressing needle, which
can produce a continuous and stable stimulation after the is inserted
under the skin, continuously promote the orderly circulation of qi and
blood in the meridians, and stimulate the healthy qi of the human body,
so as achieve the purpose of dispelling pathogenic factors. However,
there are few reports on the promotion of auricular acupressure in the
recovery of consciousness after craniocebral injury. The purpose of this
study was to apply median nerve electrical stimulation and auricular
pressing needle to the treatment of consciousness disorders after
craniocerebral injury, order to improve the effect of coma recovery in
patients with craniocerebral injury.
2.Objective
To investigate the effect of combined electroacupuncture of median
nerve
and
auricular
point
on
the
recovery
of
disturbance
of
consciousness in patients with crancerebral injury, in order to improve
the effect of coma recovery in patients.
3.Research idea (working hypothesis)
Modern rehabilitation theory shows that the functional system of

the central nervous system has the ability of plasticity and re after
craniocerebral injury, and appropriate stimulation is conducive to the
reinnervation of nerves. Median nerve electrical stimulation (MNES) is a
cutting- treatment modality clinically for the treatment of coma, and
gradually favored by experts at home and abroad, because of its
significant
advantages
such
as
simplicity,
effectiveness
and
non-invasiveness
promoting
awakening,
and
has
reached
rapid
development and popularization in recent years. Its mechanism is to act
on the reticular ascending activation system of the brainstem by
low-frequency pulse stimulation (usually twice a day of median nerve
electrical stimulation treatment, lasting for 60 minutes, lasting for about
8 weeks), to maintain the excited state of the cere cortex, stimulate
nerve cells in various parts of the cerebral cortex, promote the release of
acetylcholine, and maintain the state of awakening of the cerebral
cortex.
The treatment of diseases by auricular acupoints has been
documented in ancient Chinese literature. It is written in the "M
Question Chapter" of "Yellow Emperor's Inner Canon: Ling Shu" that "the
ear is the place where the main meridians gather" and "the meridians
connect to the ear." Stimulating auricular acupoints can regulate the
functions of the related meridians, playing a role in the circulation ofi
and blood, and regulating the yin and yang of the zang-fu organs. The

therapy of pressing needle has been demonstrated in the book "Su Wen:
Hetong Zhen Ye Lun", which advocates the "static and long-term
retention" of pressing needle. Auricular pressing needle therapy is a
method of inserting and fixing specific type of small needle into the
auricular acupoints for a longer period. By applying a steady and stable
stimulus to the auricular acupoints with needles, it can achieve the effect
of smoothing the meridians and collaterals, and regulating the yin and
yang of the zang-fu organs. It has advantages in improving the function
of consciousness. The long-term feature of auricular pressing needle
treatment makes up for the shortcomings of the short action time and
long cycle of median electrical stimulation, making the stimulation
continuous and stable, which can greatly reduce the treatment cycle and
is more conducive to improving the disturbance of consciousness in
patients.
This study aims the common disturbance of consciousness in
patients with head injury, combined with the application of median
nerve electrical stimulation and auricular pressing needle therapy, to
observe and analyze the efficacy difference between control group and
the experimental group, with the purpose of accelerating the recovery of
patients' consciousness, shortening the awakening time, and improving
the effect of coma recovery in patients with injury, and to alleviate the
economic pressure of society and families to the maximum extent.

Ethics Batch Number (NTC): LLSL-2022053105
4. Research Methods and Design
1. Subjects
Sixty patients with head injury treated in our hospital were selected
as subjects, randomly divided into control group and experimental, with
30 cases in each group.
1.1 Inclusion criteria
①All patients with disturbance of consciousness after brain injury；
②Stable vital signs no obvious bleeding, GCS score of 4-8 points;
③No severe organ failure, normal heart function；
④Course of disease within 10 days
⑤No history of head injury, no history of pregnancy and epilepsy.
1.2 Exclusion criteria
①Patients with other types of critical illnesses, such as severe diseases,
etc.；
②Allergic reactions to the electrodes and patches used in the
treatment；
③Relatives of patients do not cooperate and reject treatment.
1.3 Termination and handling of the trial
In the course of the trial, those who have serious adverse events, or
serious complications or worsening of the condition should be
immediately from the clinical trial by the doctor. When the case is

stopped, the doctor should immediately give symptomatic clinical
treatment. After the case is stopped, the doctor should investigate and
record cause, retain the case observation data, and take the last
detection result as the final result, and conduct data analysis on the
efficacy and adverse reactions.
2. Intervention measures
2.1 Control group: Conventional treatment methods were adopted,
including surgery, drug therapy, nutritional support, Chinese medicine,
and acupuncture, as well as prevention of complications. Meanwhile,
median nerve electrostimulation (Shenzhen Dongdi Xin Technology Co.,
Ltd, MT1023 multifunctional electrotherapy comprehensive treatment
instrument) was combined, with two treatments per day (skin electrodes
were placed 2cm above the wrist transversease on the anterior aspect of
the right forearm, using direct current asymmetric rectangular wave,
stimulation intensity of 20mA, pulse width of 300ms, frequency 40Hz,
working for 20 seconds per minute, resting for 40 seconds, generally
lasting for 60 minutes, and lasting for about 8 weeks.
2.2 Experimental group: In addition to conventional rehabilitation
treatment methods and median nerve electrostimulation, auricular
acupuncture was combined, with acupuncture at heart, Shenmen,
sympathetic, and subcortical points (Suzhou Medical Supplies Co., Ltd.,
Hua Tuo brand disposable sterile push acupuncture model 0.20×0.8mm).

The family members were instructed to massage each acupoint three
times a day, each time for 10 minutes with moderate pressure, each
treatment for 3 days, rest for 1 day, repeat three times, a total of 11 days
in one course of treatment.
3. Observation indicators
After 4, 6, and 8 weeks of continuous intervention, the awakening
conditions, including GCS, GOS outcome evaluation, CRS-R scores, and
family satisfaction, were compared.
3.1 Awakening conditions: The time of patient awakening and the
awakening at 4, 6, and 8 weeks after intervention were recorded.
3.2 The GCS scale (Glasgow Coma Scale) includes three dimensions:
opening, language, and motor, with a full score of 15 points. The lower
the score, the worse the patient's neurological function recovery.
3.3 CRS-R (Coma Recovery Scale-Revised): It adds evaluation
content such as arousal response, communication ability, and auditory
level compared to the GCS scale. lowest score is 0, and the highest score
is 23. The higher the score, the higher the level of consciousness.
3.4 Prognosis evaluation was at 1 month after treatment based on
the Glasgow Outcome Scale (GOS). A score of 5 indicates good recovery,
4 indicates moderate disability, 3 indicates disability, 2 indicates a
vegetative state, and 1 indicates death.
3.5 Family satisfaction evaluation: It was divided into 5 levels

according to the Likert method, with 1 indicating very dissatisfied and 5
indicating very satisfied.
4.Statistical treatment
SPSS27.0 statistical software was used for analysis, and the count
data of each group was expressed as percentage or composition ratio.
The X2 test was used for the percentage or composition ratio between
groups. The measurement data of each group was expressed as mean ±
standard deviation (x⁻s). Comparison within the group before and after
treatment and comparison between the two groups were performed by
t-test. P<0.05 was considered statistically significant.
5.The characteristics or innovations of this topic
The research is based on evidence-based medicine and uses the
median nerve electrical stimulation therapy which is widely used in clinic
to increase cerebral blood flow of patients with craniocerebral injury,
directly excite the cerebral cortex and the reticular structure of the
brainstem, enhance the electroencephal activity, and improve the
neuroelectrophysiological activity. In clinical treatment, median nerve
electrical stimulation has the advantages of non-trauma, simple
operation, low cost, and and effective treatment. At the same time,
combined with the treatment mode of ear acupressure under the
guidance of traditional Chinese medicine meridian acupoint and
acupuncture, it can continuously and effectively stimulate the ear

acupoint, improve the excitement and conductivity of acupoint, and
achieve the effect of benign and bidirectional regulation. Moreover, can
make up for the lack of median nerve electrical stimulation time to the
greatest extent, optimize clinical efficacy, further improve the prognosis
of patients, and improve the quality of life. to the literature retrieval,
there is no literature reporting the same research as this topic in our
province, and this topic has a certain degree of innovation. At the same
time, the treatment of traditional Chinese and Western medicine is the
feature of this project, which can further promote the application of
traditional Chinese medicine in clinic.
6.Application Prospect
Disorders of are
one
of
the
most common symptoms
of
craniocerebral injury, with a broad market application and good
application prospects. Median nerve electrical stimulation has obvious
advantages in promoting awakening the technology is relatively mature,
and this treatment method is non-injurious, painless, and less expensive
during treatment, and the curative effect is widely recognized by
international evidencebased medicine, and it has been widely used in
clinical treatment at home and abroad, and the effect of promoting
awakening can be guaranteed; ear acupressure has grasped the of
traditional Chinese medicine implantation acupuncture of "static and
left", which can do a good job of continuous stimulation, and it is safe,

simple to operate, and be applied in community health service centers
with poor conditions, and it is easy to replicate and promote.
7.The background material of domestic and foreign
research progress related to this project
Although the history of the application of nerve electrical
stimulation (MNS) in coma arousal is not long, because of its significant
advantages in arousal, MNS has been widely used internationally to treat
coma Cooper [1] et al. were the first to use the right MN to treat patients
with closed head injury and coma and achieved certain results. Through
several clinical studies, they that MNS could increase the level of
consciousness in patients with TBI and coma, shorten the time of ICU
stay (about 10 days), and to some, it could also restore the language
function of patients; PeriCV [2] also studied the effect of MNS in treating
patients with TBI and coma. After analyzing data, they found that the
awakening rate of the stimulation group could reach 60%, while the
control group only had 40%, and the stimulation group had higher on the
Functional Independence Measure (FIM) scale and more significant
improvement in the quality of life. Their research results show that MNS
can be used for the arousal ofBI coma and is safe and effective in
treatment.
At present, there are few reports on ear acupressure therapy
abroad, and in China, it is mostly based different acupoints, which can

play a very good continuous stimulation effect, thus treating various
intractable diseases or pain diseases that often occur. Its application
range is wide, and can be used in various departments such as internal
medicine, surgery, gynecology, and pediatrics. Domestic literature
related to ear acupoint treatment is mainly concentrated in earupoint
paste, acupressure and other therapies, mostly using round substances
such as Semen Vaccariae and magnetic beads to paste on the ear
acupoints Jia Jie and Li Xiu Yun [3] used acupoint acupressure combined
with ear acupoint paste to assist in the treatment of cerebralorrhage
disturbance of consciousness and observed that it was effective and easy
to operate. He Qing Ming [4] et al. explored the role of ear acupress in
the arousal after total anesthesia for craniotomy, and found that it had
an exciting effect on the cerebral cortex, could accelerate the arousal,
and had the of low cost, few complications, simple operation, and safety.
However, at present, there are few studies on ear acupressure therapy at
home and abroad, mostly focusing the treatment of insomnia and
cognitive dysfunction, and there is still a large blank in the aspect of ear
acupressure arousal. Lin Juan [5] et al. ear acupoint embedding therapy
combined with electroencephalography to treat insomnia, and found
that its curative effect had obvious advantages, and it was found that its
treatment method simple and easy to operate, and suitable for
popularization and application. Jiao Nini [6] et al. used ear acupressure

to treat cognitive dysfunction after laposcopic hysterectomy, and found
that it could regulate autonomic nervous function disorders, relieve
neurasthenia, and improve cognitive function by stimulating the heart
acupoint
kidney
acupoint,
Shenmen
acupoint,
sympathetic,
and
subcortical acupoint, further proving the feasibility of ear acupressure
therapy. Li Jun7] et al. used acupuncture combined with ear acupressure
to treat insomnia, taking Shenmen, sympathetic, heart, brain, and
endocrine acoints, and achieved good curative effect, and found that ear
acupressure was more green in treatment, without obvious side effects,
and relieved and improved the insomnia of patients, which was worth
clinical promotion and application.
References:
[1] Cooper JB, Jane JA, Alves WMs et al. Right median nerve
electrical stimulation toen awakening from coma [J]. Brain Injury, 1999,
13(4): 261—267.
[2] Peri CV, Shaffrey ME, Farace E, et al. Pilot study of electrical
stimulation on median nerve in comatose severe brain injured patients:
3- outcome [J]. Brainlnj, 2001, 15(10): 903—910 mnoin.
[3] Jia Jie, Li Xiu Yun. Clinical observation of 40 cases of
pressotherapy combined with auricular acupressure to treat disturbance
of consciousness afterbral hemorrhage [J]. Sichuan Journal of Traditional
Chinese Medicine, 2013, 31(09): 136-13.4.

[4] He Qing Ming, Yan Yun Yun, Zheng Zhi Qiang, The role of
auricular acupressure in recovery of general anesthesia after craniotomy
[J] Chinese Journal of Practical Neurology, 2013, 16(14): 3-41.5.
[5] Lin Juan, Chai Wei Han, Lu Hong, Wang Ting Ting. Clinical
observation of insomnia treated with auricularupuncture combined with
electroencephalography [J] Journal of Clinical Traditional Chinese
Medicine, 2019, (115): 80-826.
[6] Ji Ni, Peng Sheng, Liu Ji 8 Rong, Zhang Chang Yu, Liu Chun Liang,
Liu Sha Sha, Wang Pin The effect of auricular acupressure on
postoperative cognitive dysfunction after laparoscopic hysterectomy [J].
Shanghai
Journal
of
Acupuncture
and
Moxustion,
2020,
39(8);
1022-10267.
[7] Li Jun, Fan Su, Wangng Yuan, Wei Jun, Zheng Yan, Si Jiang Tao
Clinical observation of treating insomnia with acupuncture combined
with auricular acupressureJ] Chinese Journal of Basic Medicine of
Traditional Chinese Medicine.
Date: May 30, 2022