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Article Traditional Medicine Research January 2019; 4(1): 33-41
Submit a manuscript: https://www.tmrjournals.com 33
TMR | January 2019 | vol. 4 | no. 1 |
A multi-center randomized controlled clinical trial of three-step acupuncture and
cupping therapy for cervicogenic headache
Kai Zhang1
*, Ge-Li Jiang2
, Lei Xiao3
, Li-Tai Chen4
1
Department of Acupuncture and Moxibustion, Tianjin Public Security Hospital, Tianjin, China. 2
Tianjin Ruhui Institute
of Humanities and Holistic Medicine, Tianjin, China. 3
The 254th Hospital of the Chinese People's Liberation Army,
Tianjin, China. 4
The 281th Hospital of the Chinese People's Liberation Army, Qinhuangdao, China.
*Correspondence to: Kai Zhang, Department of Acupuncture and Moxibustion, Tianjin Public Security Hospital, 6th
Floor, Public Security Hospital, 78 Nanjing Road, Heping District, Tianjin, China. E-mail: coolzhangkai@163.com.
Citation: Zhang K, Jiang GL, Xiao L, et al. A multi-center randomized controlled clinical trial of three-step acupuncture
and cupping therapy for cervicogenic headache. Traditional Medicine Research 2019, 4(1): 33-41.
DOI: 10.12032/TMR201915097
Submitted: 11 November 2018, Accepted: 21 December 2018, Online: 30 December 2018.
Highlights
The three-step acupuncture and cupping method has
a beneficial effect in the treatment of cervicogenic
headache, which provides rapid benefits, has better
short- and long-term efficacy.
Editor’s Summary
Acupuncture and cupping therapy is proven to be
effective as an alternative therapy in treating and
strengthening the therapeutic effect of other therapeutic
methods in the cervicogenic headache management.
Modernization of Traditional Medicine
Article Traditional Medicine Research January 2019; 4(1): 33-41
Submit a manuscript: https://www.tmrjournals.com 34
TMR | January 2019 | vol. 4 | no. 1 |
Abstract
Objective: To assess the clinical efficacy and safety of three-step acupuncture and cupping therapy for cervicogenic
headache (CEH). Methods: A randomized, single-blind, multi-center, parallel controlled clinical trial was performed,
including 63 patients with CEH who met the study criteria. They were randomly divided into treatment (n = 32) and
control groups (n = 31). The treatment group was treated with three-step acupuncture and cupping therapy, and the
control group was treated with sham acupuncture. The simplified McGill pain scores, comprising three parts: the pain
rating index, visual analogue scale score, and present pain intensity, alongside head and neck stiffness and cervical
vertebra range of motion, and a safety evaluation were recorded in the two groups before treatment, immediately after
the first treatment, after 10 days of treatment, after 20 days of treatment, and 3 months after the end of treatment. Results:
Compared with before treatment, the scores at each follow-up time point were significantly improved after treatment;
moreover, the treatment group was significantly better than the control group. When the scores at the 3 months follow-up
after the end of the treatment were compared with the scores after 20 days of treatment, there were no significant
differences in the treatment group while significant differences from the scores of the control group, suggesting that the
treatment group had better long-term benefits than the control group. Conclusion: Compared with the sham acupuncture
group, the three-step acupuncture and cupping method has a beneficial effect in the treatment of CEH. It provides rapid
benefits, has better short- and long-term efficacy than sham acupuncture, and is associated with a low recurrence rate.
Keywords: Acupuncture therapy, Cervical headache; Randomized controlled trial
Abbreviations: CEH, Cervicogenic headache;VAS, Visual analogue scale; SF-MPQ, McGill Pain Questionnaire; PRI,
Pain rating index; PPI, Present pain intensity; ROM, Range of motion; VEGF, Vascular endothelial growth factor; D114,
Delta-like ligand 4; TCM, Traditional Chinese medicine; CT, Compute tomography; MRI, Magnetic resonance imaging.
Competing interests: The authors report no conflicts of interest in this work.
Executive Editor: Cui-Hong Zhu.
摘要
目的:观察三步针罐疗法治疗颈源性头痛的临床有效性和安全性。
方法:采用随机、单盲、多中心平行对照临床试验方法,收集符合研究标准的颈源性头痛的患者 63 例,
随机分为治疗组 32 例和对照组 31 例,治疗组采用三步针罐疗法治疗,对照组采用假针刺治疗。分别于治
疗前、
首次治疗后即刻、
治疗 10 天后、
治疗 20 天后、
治疗结束 3 个月随访时观察两组患者的简化的 McGill
疼痛评分,包括三个部分:疼痛等级指数( PRI), 视觉模拟评定(VAS)和现有痛强度(PPI)和头颈部僵
硬感及颈椎活动度评定(ROM),并进行安全性评价。
结果:与治疗前比较,两组治疗后各个观察时间点各项评分均有显著改善,在观察时间点各项评分方面,
治疗组明显优于对照组;疗程结束后 3 个月随访时各项评分与治疗 20 天后评分比较,治疗组无显著性差
异,对照组各项评分均有显著性差异,提示治疗组与对照组相比有较好的远期疗法。
结论:三步针罐法与假针刺组比较,治疗颈源性头痛具有一定的近期疗效,见效快,近期疗效和远期疗效
上均优于假针刺组,复发率低。
关键词:针灸疗法;颈源性头痛;随机对照试验
Article Traditional Medicine Research January 2019; 4(1): 33-41
Submit a manuscript: https://www.tmrjournals.com 35
TMR | January 2019 | vol. 4 | no. 1 |
Background
Cervicogenic headache (CEH) is one of the most
common secondary headaches clinically, but current
clinical recognition efficiency is low and misdiagnosis is
simple [1, 2]. In 1983, Sjaastad [3] first proposed the
concept of CEH where the pain is in the head but the
pathology is in the cervical spine, at the World Headache
Conference. CEH refers to a group of syndromes with
ipsilateral headache caused by organic or functional
damage of the cervical spine or soft tissue, often
accompanied by neck tenderness, that is related to the
stimulation of the cervical nerve [4, 5]. Its pathogenesis
may be related to the convergence theory of pain afferents,
mechanical stimulation caused by intervertebral disc
degeneration, inflammatory edema, and muscle spasm [4,
5]. Therefore, the treatment of CEH should take
interventions for both pain relief and cervical spondylosis
into account.
Modern medical treatments for CEH include oral
medication, physical therapy, nerve block, and surgery,
among others. However, there is no evidence supporting
the effectiveness of oral medication for CEH [6]. In the
case of treatment with minimally invasive nerve block
injection, there is strong evidence supporting CEH treated
only by greater/lesser occipital nerve block injection
[7-9].
CEH falls in the category of Bizheng in the theory of
traditional Chinese medicine (TCM). Early in Qin and
Han Dynasties of China (the third century B.C.), Huangdi
Neijing recorded the principles and methods of
acupuncture in the treatment of Bizheng. That is to say,
according to the location of Bizheng, the corresponding
viscera acupoints are taken for acupuncture. Suwen·Bilun
(220–211 B.C., Han Dynasty of China) recorded that
Bizheng is caused by a combination of wind, cold, and
dampness. Li Shizhen described the application of
cupping therapy for Bizheng in the book Bencaogangmu
(1578 A.D., Ming Dynasty of China). In recent years, a
large number of clinical reports have confirmed the
efficacy of acupuncture and cupping in the treatment of
cervical spondyloses, including CEH [10-12]. A number
of meta-analyses have shown that [12-15] acupuncture is
safe and effective in the treatment of cervical spondylosis,
but there is a lack of high-quality clinical research
evidence to support it. At present, there are some
problems in the clinical research of acupuncture treatment
for CEH, such as unclear diagnostic criteria, inconsistent
criteria for the evaluation of curative effect, and
non-standard randomized controlled studies. The results
of the research are still controversial, which affects the
promotion and application of acupuncture and
moxibustion. Therefore, it is necessary to systematically
evaluate acupuncture treatment for CEH in order to better
guide clinical practice.
In long-term clinical practice, Professor Jiang Geli
proposed a three-step acupuncture and cupping therapy
regimen. The main points were the Zhengji, Zhongping,
Houxi, and neck Jiaji points. The first step is to apply
balanced needling to the main points. The second step is
to acupuncture the neck Jiaji point using
electro-acupuncture. The third step is blood-letting
puncture and cupping. To further objectively evaluate the
clinical efficacy of three-step acupuncture and cupping
therapy, we conducted a multicenter, randomized,
controlled clinical trial. This research protocol was
approved by the Ethics Committee of Tianjin University
of Traditional Chinese Medicine (Approval No.:
TJUTCM-EC20130002), and has been registered with the
China Clinical Trial Registration Center of the World
Health Organization Level 1 Clinical Trial Registration
Office, registration number is ChiCTR-TRC-13003606.
The registration day is September 4, 2013, and the
registration is titled Three-Step Acupuncture and Cupping
Therapy for Multicenter Randomized Controlled Clinical
Study of Cervical Headache.
Clinical data
Diagnostic criteria
The diagnostic criteria developed by the International
Research Conference on Cervical Headaches [3] are as
follows:
(A) Neck symptoms and signs:
1. Headache is aggravated with neck movement and/or
the head is maintained in an abnormal posture. Headache
is aggravated when pressing the upper neck or occipital
region on the side of the headache.
2. The range of neck movement is limited.
3. Non-root pain in the neck, shoulder, or upper limb of
the ipsilateral side (unclear positioning), or occasional
root pain.
(B) Diagnostic nerve block clearly abolishes headache.
(C) Unilateral headache, generally not transferred to the
contralateral side.
In item (A), the diagnostic criteria are ranked from 1 to
3 according to their diagnostic importance, and one or
more of them must be present to diagnose CEH. The
presence of item 1 is sufficient for a diagnosis, while
meeting item 2 or 3 is not sufficient for a diagnosis. If the
three items are met at the same time, the diagnosis is
unambiguous. The presence of (A) is diagnostic; (B) and
(C) are additional criteria.
On the basis of this standard, diagnostic should be
combined with cervical imaging (X-ray, compute
tomography [CT], or magnetic resonance imaging [MRI]).
If necessary, head CT or MRI is used to exclude
intracranial organic lesions.
Inclusion criteria
Patients aged 18-65 years old diagnosed with CEH were
included. There was no limitation based on sex. Subject
voluntarily provided signed informed consent.
Exclusion criteria
The following patients were excluded: patients with
cerebrovascular and bone destruction; patients with other
organ tumors; patients with acute heart and brain disease
in the past 1 month; uncooperative patients; patients with
Article Traditional Medicine Research January 2019; 4(1): 33-41
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TMR | January 2019 | vol. 4 | no. 1 |
severe primary diseases such as heart, brain, liver, kidney
and hematopoietic system disease; mentally ill patients;
patients participating in other clinical trials; pregnant and
lactating women; patients who are unable to provide
visual analogue scale (VAS) scores due to visual
problems or cognitive dysfunction; and patients who did
not provide signed informed consent.
Patient elimination criteria
1. Those who did not meet the inclusion criteria.
2. Those who met the inclusion criteria but were included
post-treatment.
3. Patients who were not interviewed after treatment.
Patient shedding criteria
1. During the test, the patient’s compliance was poor,
affecting the validity and safety of the study findings.
2. Serious adverse events, complications, or special
physiological changes occur, making it inappropriate to
continue the test. Such cases are counted as adverse
reactions.
3. Withdrawal of consent during the study process.
4. Due to various reasons, the treatment was not
completed during the study and the patient was lost to
follow-up.
5. The patient used a drug that had a greater impact on the
test treatment, affecting the validity and safety of the
study findings.
6. Incomplete data, affecting the validity and safety of the
study findings.
7. The patient attended less than 80% or more than 120%
of the predefined number of treatment sessions.
General information
From October 2013 to April 2016, a total of 64 patients
with CEH in the 464th, 254th, and 281st hospitals of the
Chinese People's Liberation Army were selected. Patients
aged 18-65 years were randomized into a treatment or
control group using a random number table, with 32
patients in each group. Among them, 32 were treated in
the treatment group and none were shed; 31 patients were
in the control group after one patient was shed. There
were 20 males and 12 females in the treatment group,
with an average age of 46 years. The longest history of
CEH was 3 years and the shortest was 5 days. In the
control group, there were 19 males and 12 females; the
average age was 48 years, and the longest history of CEH
was 3 years and the shortest was 7 days. There were no
significant differences in sex, age, or duration of disease
between the two groups.
Research methods
Random grouping
In this study, a randomized digital table method was used
to randomly assign 64 patients with CEH who met the
inclusion criteria into the treatment or control group.
Hidden assignment
A third person was assigned to handle the random number
table and case allocation. The receiving and treating
physicians did not know the group that the patient would
enter before random allocation. The randomization
process was performed independently by a physician who
did not participate in the study using a random number
table; the grouper and the patient were only informed that
the study was to compare the therapeutic effects of two
different acupuncture treatments. Patients assigned an odd
random number were classified into group A, and those
who were assigned an even random number were
classified into group B. The specific treatment methods
for the two groups were three-step canister therapy group
for the treatment group and sham acupuncture for the
control group.
Application of blinding method
All patients were only told that they would receive
acupuncture treatment but were not aware of their
specific grouping. Acupuncture treatment was performed
by one to two acupuncturists in each center. The
researchers arranged patients to be treated in an
independent environment, such as a partitioned or
separate room. They were not allowed to communicate
with patients about the choice of acupuncture points.
Acupuncturist background
The acupuncturists participating in the study are
practicing physicians, attending physicians, deputy
directors, or chief physicians who have been engaged in
the acupuncture industry for 5 or more years.
Treatment methods
The needle was a Huaying acupuncture needle produced
by Suzhou Medical Products Co., Ltd. The model H
specification is 0.3 mm × 30 mm and 0.3 mm × 40 mm
needle.
Treatment group: three-step canister therapy was used.
In the first step, a balanced needle method was used. The
patient sat on the bed. After routine disinfection, filiform
needles were used to acupuncture at the main points
including the Zhengji points (the center point of the
Shenting and Yintang lines), Houxi points, and
Zhongping points. The needle was inserted
perpendicularly 20-30 mm at the Zhengji point; reducing
manipulation by lifting and thrusting was applied until a
feeling of numbness radiated to the base of the nose. The
reducing method was performed on the Houxi and
Zhongping points (singular points, the outer point of the
outer knee and the outer sac line) by both lifting and
thrusting, as well as twirling and rotating the needle. On
both sides of the Houxi point, acupuncture was applied
obliquely for 10-20mm towards the wrist and until the
needling sensation radiated to the forearm. Bilateral
Zhongping points were punctured perpendicularly for
20-30 mm until the needling sensation radiated to the foot.
The patient was required to move the affected part for 2
minutes without removing the needles. In the second step,
an electric needle punctured both sides of the neck Jiaji
points and a neutral reinforcing-reducing method was
applied. The needle was inserted 20-30 mm inch at the
Jiaji until a needling sensation radiated to the shoulder
Article Traditional Medicine Research January 2019; 4(1): 33-41
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TMR | January 2019 | vol. 4 | no. 1 |
after the arrival of Qi. The Jiaji points were then
stimulated with a bilateral symmetrical dense wave for 20
minutes using the KWD2-808 electro-acupuncture
instrument. In the third step, after removing the needle,
Dazhui and one or two Ashi points were chosen for the
release of blood and cupping. The points were sterilized
with 75% ethanol, and the points were penetrated with a
three-edged needle to a depth of 2-4 mm, after which the
needle was withdrawn immediately. The cupping method
was then applied to the points, leading to the discharge of
3-5 ml of blood. The cup was left in situ for 10-15
minutes. Acupuncture of the Zhengji, Houxi, and
Zhongping points was performed five times a week.
Pricking bloodletting was performed 1-2 times a week,
and cupping once every other day. Treatment for 10 days
was considered a course of treatment. Patients underwent
a total of two courses of treatment with a 2-day interval
between each treatment course.
In the control group, a sham needle was used. The
eight selected acupoints were as follows: the two sides of
the midpoint of the connection of the Jiaosun and Suaigu
points, the two sides of the midpoint of the connection of
the Fengchi and Anmian points, the two sides of the
midpoint of the connection of the Qiuxu and Jiexi points,
the middle of the Shanjiao channel and small intestine
channel on the same horizontal line as the Waiguan point,
and the middle of the gallbladder channel and bladder
channel on the same horizontal line as the Yanglingquan
points. Using a shallow needling method, a shallow
puncture of 1-4 mm located at the above points was
performed without manipulation. After removing the
needle, cupping was applied at the Dazhui points and one
or two areas located at 45 degree below and 30-40 mm
from the Dazhui points. The cups were left in situ for
10-15 minutes, once every other day. Treatment for 10
days was considered a course of treatment. Patients
underwent a total of two courses of treatment, with a
2-day interval between each treatment course.
Combined administration during the study: As far as
possible, no other therapeutic drugs, such as analgesics,
sedatives, calcium ion antagonists, and ergotamine
preparations, were used. The basic medications must be
the same for both groups of patients.
Therapeutic observations
The simplified McGill Pain Questionnaire (SF-MPQ) [16]
consisting of three parts, pain rating index (PRI), visual
analogue scale (VAS), and present pain intensity (PPI),
was performed pre-treatment, immediately after the first
treatment, 10 days after treatment, 20 days after treatment,
and 3 months follow-up at the end of the treatment. The
first 11 items in the PRI are the patient's pain perception
scores, the last four items are the patient's emotional
scores, and the sum of the 15 items gives the total PRI
score. The VAS score was obtained using a 10cm long
straight line with the ends of the line representing either
pain-free or severe pain, with patient's selecting a location
to indicate their current degree of pain. The PPI scores are
divided into six levels of “no pain,” “mild,”
“discomforting,” “distressing,” “horrible,” and
“excruciating,” with each category scoring 0, 1, 2, 3, 4, or
5 points, respectively.
Neck stiffness and range of motion (ROM) in the neck
scoring criteria [17] were as follows: 1 point, no impact
on daily life, free movement; 2 points, there is a certain
influence, the degree and scope of activity is limited; 3
points, the impact is great, the activity is stiff and
laborious; and 4 points, basically cannot be active.
Safety evaluation
During the test, the adverse reactions of subjects, such as
hysteresis, fainting, subcutaneous hematoma,
pneumothorax, and neuralgia, were observed and
recorded.
Statistical analysis
The clinical data were analyzed using SPSS version 24.0.
The significance level was P < 0.05. The t-test was
used to compare the two groups of numerical variables. If
the overall distribution was skewed, the rank sum test was
used. Count data were analyzed using the χ2
test.
Results
The PRI, VAS, and PPI of the SF-MPQ were used to
compare scores between the two groups before and after
treatment. Neck stiffness and ROM between the two
groups before and after treatment were also compared.
Comparison of PRI scores before and after treatment
between the two groups of patients
Table 1 and Table 2 show that there was no significant
difference in total PRI scores, PRI sensory, or PRI
emotional scores between the two groups before
treatment. Total PRI scores after treatment in both groups
were lower than those before treatment. Compared with
those of the control group, total PRI scores after 10 days
of treatment, 20 days of treatment, and 3 months after the
end of treatment were all significantly lower in the
treatment group ( P = 0.001, P < 0.001, P < 0.001).
Compared with those of the control group, the PRI
feeling item scores and emotional item scores after 10
days of treatment, 20 days of treatment, and 3 months
after the end of the treatment were all significantly lower
in the treatment group (feeling item scores: P = 0.001, P
< 0.001, P < 0.001; emotional item scores: P = 0.032, P
= 0.035, P = 0.013.). The results indicate that both the
short-term and long-term effects in the treatment group
were significantly better than those in the control group.
There was no significant difference in total PRI scores
between 3 months after the end of the treatment and after
20 days of treatment in the treatment group.
Comparison of VAS between the two groups before
and after treatment
Table 3 suggests that there was no significant difference
in VAS score between the two groups before treatment.
Article Traditional Medicine Research January 2019; 4(1): 33-41
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TMR | January 2019 | vol. 4 | no. 1 |
After treatment, the VAS scores of the treatment and
control group were lower than prior to treatment. The
VAS scores of the two groups were significantly different
at different time points. Compared with those of the
control group, VAS scores after the first treatment, 10
days of treatment, 20 days of treatment, and 3 months
after the end of the treatment in the treatment group were
all significantly lower (P = 0.024, P = 0.001, P < 0.001, P
< 0.001.). It shows that the treatment group received
superior pain relief to the control group, and experienced
better long-term effects and a low recurrence rate.
Comparison of existing pain intensity between the two
groups before and after treatment
Table 4 suggests that the PPI scores of the treatment and
control groups after treatment were lower than after the
last treatment, showing a downward trend. After the first
treatment, the PPI score of the treatment group was
significantly lower than that of the control group (P =
0.043). It indicates that the treatment group received
excellent immediate pain relief. Compared with those of
control group, the PPI scores 3 months after the end of
the treatment in the treatment group were significantly
lower (P = 0.015). It shows that the long-term analgesic
effect of the treatment is good.
Comparison of cervical vertebrae activity ROM
before and after treatment in both groups
Table 5 suggests that the ROM scores of the treatment
and control groups were lower than those before
treatment, showing a decreasing trend. After the first
treatment, the ROM score of the treatment group was
significantly lower than that of the control group ( P =
0.033). This indicates that the treatment group
experienced an improvement in cervical ROM
immediately. Compared with those of the control group,
ROM scores after the first treatment, 10 days of treatment,
20 days of treatment, and 3 months after the end of
treatment in the treatment group were significantly lower
(P = 0.033, P = 0.020, P = 0.015, P = 0.002). There was
no significant difference in ROM scores between 3
months after the end of the treatment and after 20 days of
treatment in the treatment group. However, 3 months after
the end of the treatment in control group, the ROM score
was significantly higher than that of after 20 days of
treatment (P = 0.037). This shows that the long-term
analgesic effect in the treatment group is good.
Safety evaluation
Table 1 Comparison of the total PRI scores before and after treatment between the two groups (x ± s)
Group N Before
treatment
First
treatment
After 10 days
of treatment
After 20 days of
treatment
Follow-up 3 months after
the end of treatment
Treatment 32 23.34 ± 2.88 18.63 ± 4.22a
14.09 ± 5.22b, h
11.78 ± 5.90c, i
12.63 ± 6.14j
Control 31 22.71 ± 4.01 20.87 ± 4.43d
18.42 ± 4.19e
16.81 ± 4.46f
18.90 ± 6.02g
Comparison with before treatment: a, P < 0.001; d, P < 0.001. Comparison with last treatment: b, P < 0.001; c, P =
0.006; e, P = 0.001; f, P < 0.001; g, P = 0.031. Comparison with control group: h, P = 0.001; i, P < 0.001; j, P < 0.001.
Table 2 Comparison of PRI sensory and emotional scores before and after treatment between the two groups
(x ± s)
Time point Items Treatment Control t P
Before treatment Feeling item 18.03 ± 2.19 17.61 ± 3.08 0.622 0.536
Emotional item 5.31 ± 1.64 5.10 ± 1.40 0.562 0.576
Immediately after first treatment Feeling item 14.88 ± 3.08 16.52 ± 3.39 -2.015 0.048
Emotional item 3.75 ± 1.70 4.35 ± 1.43 -1.525 0.132
After 10 days of treatment Feeling item 11.63 ± 4.43 15.39 ± 3.70 -3.653 0.001
Emotional item 2.47 ± 1.24 3.03 ± 0.71 -2.201 0.032
After 20 days of treatment Feeling item 9.44 ± 4.98 13.87 ± 4.02 -3.878 < 0.001
Emotional item 2.34 ± 1.36 2.97 ± 0.88 -2.160 0.035
Follow-up 3 months after the end of
treatment
Feeling item 10.16 ± 5.32 15.61 ± 5.49 -4.007 < 0.001
Emotional item 2.47 ± 1.41 3.29 ± 1.10 -2.567 0.013
Article Traditional Medicine Research January 2019; 4(1): 33-41
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TMR | January 2019 | vol. 4 | no. 1 |
Adverse events. In the treatment group, there were 11
patients with acupuncture pain, four patients with
subcutaneous hematoma, one patient with stagnation, and
one patient with itching after acupuncture. In the control
group, there were nine patients with acupuncture pain and
three patients with subcutaneous hematoma. The
acupuncture pain was within a range that the patients
could tolerate. After acupuncture, the hematoma
disappeared after applying pressure for 1-5 minutes. The
patient with stagnation may have been related to the
movement of the body after acupuncture. The needle was
removed and itching of the skin was relieved half an hour
after the needle was taken. In the control group, one
34-year-old man fainted, and had dizziness, palpitations,
and sweating after the first treatment. Immediately after
the needle was removed, the symptoms were relieved
after 10 minutes of rest. The patient had no past history of
acupuncture, but he was on an empty stomach before
treatment. The patient was asked to have breakfast before
treatment next time and no fainting appeared after the
treatment.
Discussion
CEH has been widely accepted by medical workers after
years of research and development. CEH can be classified
into neurogenic pain and myogenic pain depending on
which part of the nerve root is involved. The sensory root
fibers of the nerve root are stimulated to cause
neuropathic pain, while the ventral motor nerve roots are
stimulated to cause myogenic pain. The medial branch of
the second cervical nerve and fibers from the third
cervical nerve together form the occipital nerve. The
occipital nerve and auricular nerve are the main nerves
that conduct an otogenic headache. In addition, the first,
second, and third cervical nerves mostly pass through the
soft muscle tissue after leaving the spinal canal. When the
soft tissue is inflamed, ischemic, damaged, or stressed, it
will affect the function of the nerve and cause CEH.
Cervical intervertebral disc degeneration, protrusion, and
intervertebral disc material release can directly cause
aseptic inflammation and edema, produce
immunoreactive inflammation, and cause discogenic
Table 3 Comparison of VAS before and after treatment between the two groups (x ± s)
Group Before
treatment
Immediately after
first treatment
After 10 days of
treatment
After 20 days of
treatment
Follow-up 3 months
after the end of
treatment
Treatment 7.30 ± 1.14 5.58 ± 1.48a, g
4.14 ± 1.67b, h
3.48 ± 1.62c, i
3.74 ± 1.69j
Control 7.17 ± 0.96 6.35 ± 1.12d
5.45 ± 1.17e
5.13 ± 1.29 5.58 ± 1.46f
Comparison with before treatment: a, P < 0.001; d, P < 0.001. Comparison with last treatment: b, P < 0.001; c, P =
0.005; e, P < 0.001; f, P = 0.037. Comparison with control group: g, P = 0.024; h, P = 0.001; i, P < 0.001; j, P <
0.001.
Table 4 Comparison of PPI between the two groups before and after treatment (x ± s)
Group Before
treatment
Immediately
after first
treatment
After 10 days of
treatment
After 20 days of
treatment
Follow-up 3 months
after the end of
treatment
Treatment group 3.66 ± 0.65 2.63 ± 0.91a, g
2.00 ± 0.98b, h
1.75 ± 1.02c, i
2.03 ± 1.06j
Control group 3.45 ± 0.72 3.06 ± 0.77d
2.58 ± 0.67e
2.35 ± 0.80 2.65 ± 0.88f
Comparison with before treatment: a, P < 0.001; d, P < 0.001. Comparison with last treatment: b, P = 0.001; c, P =
0.048; e, P = 0.001; f, P = 0.012. Comparison with control group: g, P = 0.043; h, P = 0.008; i, P = 0.011; j, P =
0.015.
Table 5 Comparison of ROM before and after treatment in both groups (x ± s)
Group Before
treatment
Immediately
after first
treatment
After 10 days of
treatment
After 20 days of
treatment
Follow-up 3 months
after the end of
treatment
Treatment group 2.47 ± 0.76 1.75 ± 0.67a, d
1.44 ± 0.76b,e
1.34 ± 0.70f 1.56 ± 0.56g
Control group 2.29 ± 0.69 2.16 ± 0.82 1.87 ± 0.67 1.84 ± 0.86 2.16 ± 0.90c
Comparison with before treatment: a, P < 0.001. Comparison with last treatment: b, P = 0.010; c, P = 0.037.
Comparison between groups: d, P = 0.033; e, P = 0.020; f, P = 0.015; g, P = 0.002.
Article Traditional Medicine Research January 2019; 4(1): 33-41
Submit a manuscript: https://www.tmrjournals.com 40
TMR | January 2019 | vol. 4 | no. 1 |
radiculitis. In addition to direct root pain, the distal
release of inflammatory mediators, causing the
inflammation of the inner soft tissue, can also produce
pain. This is the mechanism by which some patients
develop refractory CEH [18, 19].
A number of studies [18-25] have confirmed that
acupuncture is safe and effective in treating CEH.
According to the pathogenesis of CEH, the possible
mechanisms of action of acupuncture treatment in CEH
may include improving local blood circulation, relieving
edema, loosening adhesions, and thus providing relief to
some extent from disc herniation, spinal stenosis, and
muscle spasm, among other pathologies. The pressure on
the vascular nerves makes the symptoms disappear. This
may be because it promotes the metabolism of
pain-causing substances. Acupuncture can reduce the
expression of FOS protein in the thalamic pain-sensing
area and cyclooxygenase-2 in the spinal dorsal horn and
can significantly inhibit the expression of pain-related
information. Acupuncture may also act via effects on pain
and protecting the nerve roots [26]. Treatment may
promote the production of biologically active substances
in the body, slowing the degeneration of cervical
intervertebral disc tissue, regulating the
microenvironmental changes in the cervical intervertebral
disc tissue, and thereby stimulating vascular endothelial
growth factor (VEGF) and the expression of delta-like
ligand 4 (D114), both of which can promote angiogenesis.
Acupuncture may lead to the upregulation of VEGF and
D114 protein and mRNA expression in the cervical
intervertebral disc tissue, and promote the production of
cervical intervertebral disc blood vessels, thus delaying
the degree of degeneration of the cervical disc and
restoring degenerated cervical intervertebral disc tissue
[27].
CEH belongs to the "Bizheng" category of TCM.
Chinese medicine believes that the pathogenesis of this
disease is Qi and blood blockage, and meridian
obstruction. The treatment principle of “promoting blood
circulation to remove meridian obstruction” was
established, and “three-step acupuncture and cupping
therapy” was invented [28]. The Zhengji points on the Du
meridian are the places where meridian-Qi of Taiyang is
concentrated [29]. The Du Meridian, the governor's Yang,
can smooth Taiyang meridian and Du meridian as well as
activate blood and relieve pain. The Houxi point, one of
Eight Confluent Points that is connected with the Du
Meridian, can arouse the brain, calm the nerves and
smooth pain. Zhongping acupoints, one of the Extra
Points, is located on the route of stomach meridian. The
stomach meridian is a multi-Qi and multi-blood meridian;
its branches intersect with the Du meridian at Dazhui
acupoint, so acupuncture at this point affects the Qi and
blood, smooth blood, and nourishes the brain, eliminating
headache. The cervical Jiaji points are located between
the Du meridian and the Taiyang bladder meridian, and
the internal organs are closely related to them. Then
stimulating the neck Jiaji points can directly clear the
local meridians, Qi, and blood. Local puncture cupping at
the Dazhui or Ashi points have the effect of promoting
blood circulation and relieving pain.
Zhang Kai, et al. [12] conducted a meta-analysis of the
efficacy of acupuncture and non-steroidal anti-
inflammatory drugs in the treatment of CEH,
demonstrating that acupuncture has better curative effect
than oral non-steroidal anti-inflammatory drugs, and,
furthermore, needle sting therapy does not increase the
incidence of adverse reactions [30, 31]. However, most of
the studies included had problems concerning factors
such as blinding, allocation concealment, and adverse
reaction analysis. This study confirmed the safety and
effectiveness of acupuncture treatment for CEH from the
perspective of evidence-based medicine. It shows that
three-step therapy is more effective than the sham
acupuncture, with good immediate analgesic effect, low
recurrence rate, and good long-term curative effect. The
shortcoming of this study is the small sample size, which
limits the strength of the evidence.
Conclusion
In summary, in the treatment of CEH, the three-step
canister therapy group is significantly better than the
control treatment in improving PRI, VAS, PPI, and ROM
scores. The three-step canister therapy has an immediate
analgesic effect. It can also quickly improve cervical
vertebra ROM and has good short-term and long-term
effects.
References
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Cervicogenic headache: too important to be left
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Jiaji points for cervical vertigo. Shandong Univ
Tradit Chin Med 2013, 12: 153-157.
14. Wang YX. Meta-analysis of electroacupuncture for
cervical spondylosis. Shandong Univ Tradit Chin
Med 2013, 16: 251-255.
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evaluation of the effectiveness of abdominal
acupuncture in the treatment of cervical spondylosis.
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occipital neuralgia with acupuncture combined with
acupuncture. Changchun: Changchun University of
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A multi-center randomized controlled clinical trial of three-step acupuncture and cupping therapy for cervicogenic headache

  • 1. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 33 TMR | January 2019 | vol. 4 | no. 1 | A multi-center randomized controlled clinical trial of three-step acupuncture and cupping therapy for cervicogenic headache Kai Zhang1 *, Ge-Li Jiang2 , Lei Xiao3 , Li-Tai Chen4 1 Department of Acupuncture and Moxibustion, Tianjin Public Security Hospital, Tianjin, China. 2 Tianjin Ruhui Institute of Humanities and Holistic Medicine, Tianjin, China. 3 The 254th Hospital of the Chinese People's Liberation Army, Tianjin, China. 4 The 281th Hospital of the Chinese People's Liberation Army, Qinhuangdao, China. *Correspondence to: Kai Zhang, Department of Acupuncture and Moxibustion, Tianjin Public Security Hospital, 6th Floor, Public Security Hospital, 78 Nanjing Road, Heping District, Tianjin, China. E-mail: coolzhangkai@163.com. Citation: Zhang K, Jiang GL, Xiao L, et al. A multi-center randomized controlled clinical trial of three-step acupuncture and cupping therapy for cervicogenic headache. Traditional Medicine Research 2019, 4(1): 33-41. DOI: 10.12032/TMR201915097 Submitted: 11 November 2018, Accepted: 21 December 2018, Online: 30 December 2018. Highlights The three-step acupuncture and cupping method has a beneficial effect in the treatment of cervicogenic headache, which provides rapid benefits, has better short- and long-term efficacy. Editor’s Summary Acupuncture and cupping therapy is proven to be effective as an alternative therapy in treating and strengthening the therapeutic effect of other therapeutic methods in the cervicogenic headache management. Modernization of Traditional Medicine
  • 2. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 34 TMR | January 2019 | vol. 4 | no. 1 | Abstract Objective: To assess the clinical efficacy and safety of three-step acupuncture and cupping therapy for cervicogenic headache (CEH). Methods: A randomized, single-blind, multi-center, parallel controlled clinical trial was performed, including 63 patients with CEH who met the study criteria. They were randomly divided into treatment (n = 32) and control groups (n = 31). The treatment group was treated with three-step acupuncture and cupping therapy, and the control group was treated with sham acupuncture. The simplified McGill pain scores, comprising three parts: the pain rating index, visual analogue scale score, and present pain intensity, alongside head and neck stiffness and cervical vertebra range of motion, and a safety evaluation were recorded in the two groups before treatment, immediately after the first treatment, after 10 days of treatment, after 20 days of treatment, and 3 months after the end of treatment. Results: Compared with before treatment, the scores at each follow-up time point were significantly improved after treatment; moreover, the treatment group was significantly better than the control group. When the scores at the 3 months follow-up after the end of the treatment were compared with the scores after 20 days of treatment, there were no significant differences in the treatment group while significant differences from the scores of the control group, suggesting that the treatment group had better long-term benefits than the control group. Conclusion: Compared with the sham acupuncture group, the three-step acupuncture and cupping method has a beneficial effect in the treatment of CEH. It provides rapid benefits, has better short- and long-term efficacy than sham acupuncture, and is associated with a low recurrence rate. Keywords: Acupuncture therapy, Cervical headache; Randomized controlled trial Abbreviations: CEH, Cervicogenic headache;VAS, Visual analogue scale; SF-MPQ, McGill Pain Questionnaire; PRI, Pain rating index; PPI, Present pain intensity; ROM, Range of motion; VEGF, Vascular endothelial growth factor; D114, Delta-like ligand 4; TCM, Traditional Chinese medicine; CT, Compute tomography; MRI, Magnetic resonance imaging. Competing interests: The authors report no conflicts of interest in this work. Executive Editor: Cui-Hong Zhu. 摘要 目的:观察三步针罐疗法治疗颈源性头痛的临床有效性和安全性。 方法:采用随机、单盲、多中心平行对照临床试验方法,收集符合研究标准的颈源性头痛的患者 63 例, 随机分为治疗组 32 例和对照组 31 例,治疗组采用三步针罐疗法治疗,对照组采用假针刺治疗。分别于治 疗前、 首次治疗后即刻、 治疗 10 天后、 治疗 20 天后、 治疗结束 3 个月随访时观察两组患者的简化的 McGill 疼痛评分,包括三个部分:疼痛等级指数( PRI), 视觉模拟评定(VAS)和现有痛强度(PPI)和头颈部僵 硬感及颈椎活动度评定(ROM),并进行安全性评价。 结果:与治疗前比较,两组治疗后各个观察时间点各项评分均有显著改善,在观察时间点各项评分方面, 治疗组明显优于对照组;疗程结束后 3 个月随访时各项评分与治疗 20 天后评分比较,治疗组无显著性差 异,对照组各项评分均有显著性差异,提示治疗组与对照组相比有较好的远期疗法。 结论:三步针罐法与假针刺组比较,治疗颈源性头痛具有一定的近期疗效,见效快,近期疗效和远期疗效 上均优于假针刺组,复发率低。 关键词:针灸疗法;颈源性头痛;随机对照试验
  • 3. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 35 TMR | January 2019 | vol. 4 | no. 1 | Background Cervicogenic headache (CEH) is one of the most common secondary headaches clinically, but current clinical recognition efficiency is low and misdiagnosis is simple [1, 2]. In 1983, Sjaastad [3] first proposed the concept of CEH where the pain is in the head but the pathology is in the cervical spine, at the World Headache Conference. CEH refers to a group of syndromes with ipsilateral headache caused by organic or functional damage of the cervical spine or soft tissue, often accompanied by neck tenderness, that is related to the stimulation of the cervical nerve [4, 5]. Its pathogenesis may be related to the convergence theory of pain afferents, mechanical stimulation caused by intervertebral disc degeneration, inflammatory edema, and muscle spasm [4, 5]. Therefore, the treatment of CEH should take interventions for both pain relief and cervical spondylosis into account. Modern medical treatments for CEH include oral medication, physical therapy, nerve block, and surgery, among others. However, there is no evidence supporting the effectiveness of oral medication for CEH [6]. In the case of treatment with minimally invasive nerve block injection, there is strong evidence supporting CEH treated only by greater/lesser occipital nerve block injection [7-9]. CEH falls in the category of Bizheng in the theory of traditional Chinese medicine (TCM). Early in Qin and Han Dynasties of China (the third century B.C.), Huangdi Neijing recorded the principles and methods of acupuncture in the treatment of Bizheng. That is to say, according to the location of Bizheng, the corresponding viscera acupoints are taken for acupuncture. Suwen·Bilun (220–211 B.C., Han Dynasty of China) recorded that Bizheng is caused by a combination of wind, cold, and dampness. Li Shizhen described the application of cupping therapy for Bizheng in the book Bencaogangmu (1578 A.D., Ming Dynasty of China). In recent years, a large number of clinical reports have confirmed the efficacy of acupuncture and cupping in the treatment of cervical spondyloses, including CEH [10-12]. A number of meta-analyses have shown that [12-15] acupuncture is safe and effective in the treatment of cervical spondylosis, but there is a lack of high-quality clinical research evidence to support it. At present, there are some problems in the clinical research of acupuncture treatment for CEH, such as unclear diagnostic criteria, inconsistent criteria for the evaluation of curative effect, and non-standard randomized controlled studies. The results of the research are still controversial, which affects the promotion and application of acupuncture and moxibustion. Therefore, it is necessary to systematically evaluate acupuncture treatment for CEH in order to better guide clinical practice. In long-term clinical practice, Professor Jiang Geli proposed a three-step acupuncture and cupping therapy regimen. The main points were the Zhengji, Zhongping, Houxi, and neck Jiaji points. The first step is to apply balanced needling to the main points. The second step is to acupuncture the neck Jiaji point using electro-acupuncture. The third step is blood-letting puncture and cupping. To further objectively evaluate the clinical efficacy of three-step acupuncture and cupping therapy, we conducted a multicenter, randomized, controlled clinical trial. This research protocol was approved by the Ethics Committee of Tianjin University of Traditional Chinese Medicine (Approval No.: TJUTCM-EC20130002), and has been registered with the China Clinical Trial Registration Center of the World Health Organization Level 1 Clinical Trial Registration Office, registration number is ChiCTR-TRC-13003606. The registration day is September 4, 2013, and the registration is titled Three-Step Acupuncture and Cupping Therapy for Multicenter Randomized Controlled Clinical Study of Cervical Headache. Clinical data Diagnostic criteria The diagnostic criteria developed by the International Research Conference on Cervical Headaches [3] are as follows: (A) Neck symptoms and signs: 1. Headache is aggravated with neck movement and/or the head is maintained in an abnormal posture. Headache is aggravated when pressing the upper neck or occipital region on the side of the headache. 2. The range of neck movement is limited. 3. Non-root pain in the neck, shoulder, or upper limb of the ipsilateral side (unclear positioning), or occasional root pain. (B) Diagnostic nerve block clearly abolishes headache. (C) Unilateral headache, generally not transferred to the contralateral side. In item (A), the diagnostic criteria are ranked from 1 to 3 according to their diagnostic importance, and one or more of them must be present to diagnose CEH. The presence of item 1 is sufficient for a diagnosis, while meeting item 2 or 3 is not sufficient for a diagnosis. If the three items are met at the same time, the diagnosis is unambiguous. The presence of (A) is diagnostic; (B) and (C) are additional criteria. On the basis of this standard, diagnostic should be combined with cervical imaging (X-ray, compute tomography [CT], or magnetic resonance imaging [MRI]). If necessary, head CT or MRI is used to exclude intracranial organic lesions. Inclusion criteria Patients aged 18-65 years old diagnosed with CEH were included. There was no limitation based on sex. Subject voluntarily provided signed informed consent. Exclusion criteria The following patients were excluded: patients with cerebrovascular and bone destruction; patients with other organ tumors; patients with acute heart and brain disease in the past 1 month; uncooperative patients; patients with
  • 4. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 36 TMR | January 2019 | vol. 4 | no. 1 | severe primary diseases such as heart, brain, liver, kidney and hematopoietic system disease; mentally ill patients; patients participating in other clinical trials; pregnant and lactating women; patients who are unable to provide visual analogue scale (VAS) scores due to visual problems or cognitive dysfunction; and patients who did not provide signed informed consent. Patient elimination criteria 1. Those who did not meet the inclusion criteria. 2. Those who met the inclusion criteria but were included post-treatment. 3. Patients who were not interviewed after treatment. Patient shedding criteria 1. During the test, the patient’s compliance was poor, affecting the validity and safety of the study findings. 2. Serious adverse events, complications, or special physiological changes occur, making it inappropriate to continue the test. Such cases are counted as adverse reactions. 3. Withdrawal of consent during the study process. 4. Due to various reasons, the treatment was not completed during the study and the patient was lost to follow-up. 5. The patient used a drug that had a greater impact on the test treatment, affecting the validity and safety of the study findings. 6. Incomplete data, affecting the validity and safety of the study findings. 7. The patient attended less than 80% or more than 120% of the predefined number of treatment sessions. General information From October 2013 to April 2016, a total of 64 patients with CEH in the 464th, 254th, and 281st hospitals of the Chinese People's Liberation Army were selected. Patients aged 18-65 years were randomized into a treatment or control group using a random number table, with 32 patients in each group. Among them, 32 were treated in the treatment group and none were shed; 31 patients were in the control group after one patient was shed. There were 20 males and 12 females in the treatment group, with an average age of 46 years. The longest history of CEH was 3 years and the shortest was 5 days. In the control group, there were 19 males and 12 females; the average age was 48 years, and the longest history of CEH was 3 years and the shortest was 7 days. There were no significant differences in sex, age, or duration of disease between the two groups. Research methods Random grouping In this study, a randomized digital table method was used to randomly assign 64 patients with CEH who met the inclusion criteria into the treatment or control group. Hidden assignment A third person was assigned to handle the random number table and case allocation. The receiving and treating physicians did not know the group that the patient would enter before random allocation. The randomization process was performed independently by a physician who did not participate in the study using a random number table; the grouper and the patient were only informed that the study was to compare the therapeutic effects of two different acupuncture treatments. Patients assigned an odd random number were classified into group A, and those who were assigned an even random number were classified into group B. The specific treatment methods for the two groups were three-step canister therapy group for the treatment group and sham acupuncture for the control group. Application of blinding method All patients were only told that they would receive acupuncture treatment but were not aware of their specific grouping. Acupuncture treatment was performed by one to two acupuncturists in each center. The researchers arranged patients to be treated in an independent environment, such as a partitioned or separate room. They were not allowed to communicate with patients about the choice of acupuncture points. Acupuncturist background The acupuncturists participating in the study are practicing physicians, attending physicians, deputy directors, or chief physicians who have been engaged in the acupuncture industry for 5 or more years. Treatment methods The needle was a Huaying acupuncture needle produced by Suzhou Medical Products Co., Ltd. The model H specification is 0.3 mm × 30 mm and 0.3 mm × 40 mm needle. Treatment group: three-step canister therapy was used. In the first step, a balanced needle method was used. The patient sat on the bed. After routine disinfection, filiform needles were used to acupuncture at the main points including the Zhengji points (the center point of the Shenting and Yintang lines), Houxi points, and Zhongping points. The needle was inserted perpendicularly 20-30 mm at the Zhengji point; reducing manipulation by lifting and thrusting was applied until a feeling of numbness radiated to the base of the nose. The reducing method was performed on the Houxi and Zhongping points (singular points, the outer point of the outer knee and the outer sac line) by both lifting and thrusting, as well as twirling and rotating the needle. On both sides of the Houxi point, acupuncture was applied obliquely for 10-20mm towards the wrist and until the needling sensation radiated to the forearm. Bilateral Zhongping points were punctured perpendicularly for 20-30 mm until the needling sensation radiated to the foot. The patient was required to move the affected part for 2 minutes without removing the needles. In the second step, an electric needle punctured both sides of the neck Jiaji points and a neutral reinforcing-reducing method was applied. The needle was inserted 20-30 mm inch at the Jiaji until a needling sensation radiated to the shoulder
  • 5. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 37 TMR | January 2019 | vol. 4 | no. 1 | after the arrival of Qi. The Jiaji points were then stimulated with a bilateral symmetrical dense wave for 20 minutes using the KWD2-808 electro-acupuncture instrument. In the third step, after removing the needle, Dazhui and one or two Ashi points were chosen for the release of blood and cupping. The points were sterilized with 75% ethanol, and the points were penetrated with a three-edged needle to a depth of 2-4 mm, after which the needle was withdrawn immediately. The cupping method was then applied to the points, leading to the discharge of 3-5 ml of blood. The cup was left in situ for 10-15 minutes. Acupuncture of the Zhengji, Houxi, and Zhongping points was performed five times a week. Pricking bloodletting was performed 1-2 times a week, and cupping once every other day. Treatment for 10 days was considered a course of treatment. Patients underwent a total of two courses of treatment with a 2-day interval between each treatment course. In the control group, a sham needle was used. The eight selected acupoints were as follows: the two sides of the midpoint of the connection of the Jiaosun and Suaigu points, the two sides of the midpoint of the connection of the Fengchi and Anmian points, the two sides of the midpoint of the connection of the Qiuxu and Jiexi points, the middle of the Shanjiao channel and small intestine channel on the same horizontal line as the Waiguan point, and the middle of the gallbladder channel and bladder channel on the same horizontal line as the Yanglingquan points. Using a shallow needling method, a shallow puncture of 1-4 mm located at the above points was performed without manipulation. After removing the needle, cupping was applied at the Dazhui points and one or two areas located at 45 degree below and 30-40 mm from the Dazhui points. The cups were left in situ for 10-15 minutes, once every other day. Treatment for 10 days was considered a course of treatment. Patients underwent a total of two courses of treatment, with a 2-day interval between each treatment course. Combined administration during the study: As far as possible, no other therapeutic drugs, such as analgesics, sedatives, calcium ion antagonists, and ergotamine preparations, were used. The basic medications must be the same for both groups of patients. Therapeutic observations The simplified McGill Pain Questionnaire (SF-MPQ) [16] consisting of three parts, pain rating index (PRI), visual analogue scale (VAS), and present pain intensity (PPI), was performed pre-treatment, immediately after the first treatment, 10 days after treatment, 20 days after treatment, and 3 months follow-up at the end of the treatment. The first 11 items in the PRI are the patient's pain perception scores, the last four items are the patient's emotional scores, and the sum of the 15 items gives the total PRI score. The VAS score was obtained using a 10cm long straight line with the ends of the line representing either pain-free or severe pain, with patient's selecting a location to indicate their current degree of pain. The PPI scores are divided into six levels of “no pain,” “mild,” “discomforting,” “distressing,” “horrible,” and “excruciating,” with each category scoring 0, 1, 2, 3, 4, or 5 points, respectively. Neck stiffness and range of motion (ROM) in the neck scoring criteria [17] were as follows: 1 point, no impact on daily life, free movement; 2 points, there is a certain influence, the degree and scope of activity is limited; 3 points, the impact is great, the activity is stiff and laborious; and 4 points, basically cannot be active. Safety evaluation During the test, the adverse reactions of subjects, such as hysteresis, fainting, subcutaneous hematoma, pneumothorax, and neuralgia, were observed and recorded. Statistical analysis The clinical data were analyzed using SPSS version 24.0. The significance level was P < 0.05. The t-test was used to compare the two groups of numerical variables. If the overall distribution was skewed, the rank sum test was used. Count data were analyzed using the χ2 test. Results The PRI, VAS, and PPI of the SF-MPQ were used to compare scores between the two groups before and after treatment. Neck stiffness and ROM between the two groups before and after treatment were also compared. Comparison of PRI scores before and after treatment between the two groups of patients Table 1 and Table 2 show that there was no significant difference in total PRI scores, PRI sensory, or PRI emotional scores between the two groups before treatment. Total PRI scores after treatment in both groups were lower than those before treatment. Compared with those of the control group, total PRI scores after 10 days of treatment, 20 days of treatment, and 3 months after the end of treatment were all significantly lower in the treatment group ( P = 0.001, P < 0.001, P < 0.001). Compared with those of the control group, the PRI feeling item scores and emotional item scores after 10 days of treatment, 20 days of treatment, and 3 months after the end of the treatment were all significantly lower in the treatment group (feeling item scores: P = 0.001, P < 0.001, P < 0.001; emotional item scores: P = 0.032, P = 0.035, P = 0.013.). The results indicate that both the short-term and long-term effects in the treatment group were significantly better than those in the control group. There was no significant difference in total PRI scores between 3 months after the end of the treatment and after 20 days of treatment in the treatment group. Comparison of VAS between the two groups before and after treatment Table 3 suggests that there was no significant difference in VAS score between the two groups before treatment.
  • 6. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 38 TMR | January 2019 | vol. 4 | no. 1 | After treatment, the VAS scores of the treatment and control group were lower than prior to treatment. The VAS scores of the two groups were significantly different at different time points. Compared with those of the control group, VAS scores after the first treatment, 10 days of treatment, 20 days of treatment, and 3 months after the end of the treatment in the treatment group were all significantly lower (P = 0.024, P = 0.001, P < 0.001, P < 0.001.). It shows that the treatment group received superior pain relief to the control group, and experienced better long-term effects and a low recurrence rate. Comparison of existing pain intensity between the two groups before and after treatment Table 4 suggests that the PPI scores of the treatment and control groups after treatment were lower than after the last treatment, showing a downward trend. After the first treatment, the PPI score of the treatment group was significantly lower than that of the control group (P = 0.043). It indicates that the treatment group received excellent immediate pain relief. Compared with those of control group, the PPI scores 3 months after the end of the treatment in the treatment group were significantly lower (P = 0.015). It shows that the long-term analgesic effect of the treatment is good. Comparison of cervical vertebrae activity ROM before and after treatment in both groups Table 5 suggests that the ROM scores of the treatment and control groups were lower than those before treatment, showing a decreasing trend. After the first treatment, the ROM score of the treatment group was significantly lower than that of the control group ( P = 0.033). This indicates that the treatment group experienced an improvement in cervical ROM immediately. Compared with those of the control group, ROM scores after the first treatment, 10 days of treatment, 20 days of treatment, and 3 months after the end of treatment in the treatment group were significantly lower (P = 0.033, P = 0.020, P = 0.015, P = 0.002). There was no significant difference in ROM scores between 3 months after the end of the treatment and after 20 days of treatment in the treatment group. However, 3 months after the end of the treatment in control group, the ROM score was significantly higher than that of after 20 days of treatment (P = 0.037). This shows that the long-term analgesic effect in the treatment group is good. Safety evaluation Table 1 Comparison of the total PRI scores before and after treatment between the two groups (x ± s) Group N Before treatment First treatment After 10 days of treatment After 20 days of treatment Follow-up 3 months after the end of treatment Treatment 32 23.34 ± 2.88 18.63 ± 4.22a 14.09 ± 5.22b, h 11.78 ± 5.90c, i 12.63 ± 6.14j Control 31 22.71 ± 4.01 20.87 ± 4.43d 18.42 ± 4.19e 16.81 ± 4.46f 18.90 ± 6.02g Comparison with before treatment: a, P < 0.001; d, P < 0.001. Comparison with last treatment: b, P < 0.001; c, P = 0.006; e, P = 0.001; f, P < 0.001; g, P = 0.031. Comparison with control group: h, P = 0.001; i, P < 0.001; j, P < 0.001. Table 2 Comparison of PRI sensory and emotional scores before and after treatment between the two groups (x ± s) Time point Items Treatment Control t P Before treatment Feeling item 18.03 ± 2.19 17.61 ± 3.08 0.622 0.536 Emotional item 5.31 ± 1.64 5.10 ± 1.40 0.562 0.576 Immediately after first treatment Feeling item 14.88 ± 3.08 16.52 ± 3.39 -2.015 0.048 Emotional item 3.75 ± 1.70 4.35 ± 1.43 -1.525 0.132 After 10 days of treatment Feeling item 11.63 ± 4.43 15.39 ± 3.70 -3.653 0.001 Emotional item 2.47 ± 1.24 3.03 ± 0.71 -2.201 0.032 After 20 days of treatment Feeling item 9.44 ± 4.98 13.87 ± 4.02 -3.878 < 0.001 Emotional item 2.34 ± 1.36 2.97 ± 0.88 -2.160 0.035 Follow-up 3 months after the end of treatment Feeling item 10.16 ± 5.32 15.61 ± 5.49 -4.007 < 0.001 Emotional item 2.47 ± 1.41 3.29 ± 1.10 -2.567 0.013
  • 7. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 39 TMR | January 2019 | vol. 4 | no. 1 | Adverse events. In the treatment group, there were 11 patients with acupuncture pain, four patients with subcutaneous hematoma, one patient with stagnation, and one patient with itching after acupuncture. In the control group, there were nine patients with acupuncture pain and three patients with subcutaneous hematoma. The acupuncture pain was within a range that the patients could tolerate. After acupuncture, the hematoma disappeared after applying pressure for 1-5 minutes. The patient with stagnation may have been related to the movement of the body after acupuncture. The needle was removed and itching of the skin was relieved half an hour after the needle was taken. In the control group, one 34-year-old man fainted, and had dizziness, palpitations, and sweating after the first treatment. Immediately after the needle was removed, the symptoms were relieved after 10 minutes of rest. The patient had no past history of acupuncture, but he was on an empty stomach before treatment. The patient was asked to have breakfast before treatment next time and no fainting appeared after the treatment. Discussion CEH has been widely accepted by medical workers after years of research and development. CEH can be classified into neurogenic pain and myogenic pain depending on which part of the nerve root is involved. The sensory root fibers of the nerve root are stimulated to cause neuropathic pain, while the ventral motor nerve roots are stimulated to cause myogenic pain. The medial branch of the second cervical nerve and fibers from the third cervical nerve together form the occipital nerve. The occipital nerve and auricular nerve are the main nerves that conduct an otogenic headache. In addition, the first, second, and third cervical nerves mostly pass through the soft muscle tissue after leaving the spinal canal. When the soft tissue is inflamed, ischemic, damaged, or stressed, it will affect the function of the nerve and cause CEH. Cervical intervertebral disc degeneration, protrusion, and intervertebral disc material release can directly cause aseptic inflammation and edema, produce immunoreactive inflammation, and cause discogenic Table 3 Comparison of VAS before and after treatment between the two groups (x ± s) Group Before treatment Immediately after first treatment After 10 days of treatment After 20 days of treatment Follow-up 3 months after the end of treatment Treatment 7.30 ± 1.14 5.58 ± 1.48a, g 4.14 ± 1.67b, h 3.48 ± 1.62c, i 3.74 ± 1.69j Control 7.17 ± 0.96 6.35 ± 1.12d 5.45 ± 1.17e 5.13 ± 1.29 5.58 ± 1.46f Comparison with before treatment: a, P < 0.001; d, P < 0.001. Comparison with last treatment: b, P < 0.001; c, P = 0.005; e, P < 0.001; f, P = 0.037. Comparison with control group: g, P = 0.024; h, P = 0.001; i, P < 0.001; j, P < 0.001. Table 4 Comparison of PPI between the two groups before and after treatment (x ± s) Group Before treatment Immediately after first treatment After 10 days of treatment After 20 days of treatment Follow-up 3 months after the end of treatment Treatment group 3.66 ± 0.65 2.63 ± 0.91a, g 2.00 ± 0.98b, h 1.75 ± 1.02c, i 2.03 ± 1.06j Control group 3.45 ± 0.72 3.06 ± 0.77d 2.58 ± 0.67e 2.35 ± 0.80 2.65 ± 0.88f Comparison with before treatment: a, P < 0.001; d, P < 0.001. Comparison with last treatment: b, P = 0.001; c, P = 0.048; e, P = 0.001; f, P = 0.012. Comparison with control group: g, P = 0.043; h, P = 0.008; i, P = 0.011; j, P = 0.015. Table 5 Comparison of ROM before and after treatment in both groups (x ± s) Group Before treatment Immediately after first treatment After 10 days of treatment After 20 days of treatment Follow-up 3 months after the end of treatment Treatment group 2.47 ± 0.76 1.75 ± 0.67a, d 1.44 ± 0.76b,e 1.34 ± 0.70f 1.56 ± 0.56g Control group 2.29 ± 0.69 2.16 ± 0.82 1.87 ± 0.67 1.84 ± 0.86 2.16 ± 0.90c Comparison with before treatment: a, P < 0.001. Comparison with last treatment: b, P = 0.010; c, P = 0.037. Comparison between groups: d, P = 0.033; e, P = 0.020; f, P = 0.015; g, P = 0.002.
  • 8. Article Traditional Medicine Research January 2019; 4(1): 33-41 Submit a manuscript: https://www.tmrjournals.com 40 TMR | January 2019 | vol. 4 | no. 1 | radiculitis. In addition to direct root pain, the distal release of inflammatory mediators, causing the inflammation of the inner soft tissue, can also produce pain. This is the mechanism by which some patients develop refractory CEH [18, 19]. A number of studies [18-25] have confirmed that acupuncture is safe and effective in treating CEH. According to the pathogenesis of CEH, the possible mechanisms of action of acupuncture treatment in CEH may include improving local blood circulation, relieving edema, loosening adhesions, and thus providing relief to some extent from disc herniation, spinal stenosis, and muscle spasm, among other pathologies. The pressure on the vascular nerves makes the symptoms disappear. This may be because it promotes the metabolism of pain-causing substances. Acupuncture can reduce the expression of FOS protein in the thalamic pain-sensing area and cyclooxygenase-2 in the spinal dorsal horn and can significantly inhibit the expression of pain-related information. Acupuncture may also act via effects on pain and protecting the nerve roots [26]. Treatment may promote the production of biologically active substances in the body, slowing the degeneration of cervical intervertebral disc tissue, regulating the microenvironmental changes in the cervical intervertebral disc tissue, and thereby stimulating vascular endothelial growth factor (VEGF) and the expression of delta-like ligand 4 (D114), both of which can promote angiogenesis. Acupuncture may lead to the upregulation of VEGF and D114 protein and mRNA expression in the cervical intervertebral disc tissue, and promote the production of cervical intervertebral disc blood vessels, thus delaying the degree of degeneration of the cervical disc and restoring degenerated cervical intervertebral disc tissue [27]. CEH belongs to the "Bizheng" category of TCM. Chinese medicine believes that the pathogenesis of this disease is Qi and blood blockage, and meridian obstruction. The treatment principle of “promoting blood circulation to remove meridian obstruction” was established, and “three-step acupuncture and cupping therapy” was invented [28]. The Zhengji points on the Du meridian are the places where meridian-Qi of Taiyang is concentrated [29]. The Du Meridian, the governor's Yang, can smooth Taiyang meridian and Du meridian as well as activate blood and relieve pain. The Houxi point, one of Eight Confluent Points that is connected with the Du Meridian, can arouse the brain, calm the nerves and smooth pain. Zhongping acupoints, one of the Extra Points, is located on the route of stomach meridian. The stomach meridian is a multi-Qi and multi-blood meridian; its branches intersect with the Du meridian at Dazhui acupoint, so acupuncture at this point affects the Qi and blood, smooth blood, and nourishes the brain, eliminating headache. The cervical Jiaji points are located between the Du meridian and the Taiyang bladder meridian, and the internal organs are closely related to them. Then stimulating the neck Jiaji points can directly clear the local meridians, Qi, and blood. Local puncture cupping at the Dazhui or Ashi points have the effect of promoting blood circulation and relieving pain. Zhang Kai, et al. [12] conducted a meta-analysis of the efficacy of acupuncture and non-steroidal anti- inflammatory drugs in the treatment of CEH, demonstrating that acupuncture has better curative effect than oral non-steroidal anti-inflammatory drugs, and, furthermore, needle sting therapy does not increase the incidence of adverse reactions [30, 31]. However, most of the studies included had problems concerning factors such as blinding, allocation concealment, and adverse reaction analysis. This study confirmed the safety and effectiveness of acupuncture treatment for CEH from the perspective of evidence-based medicine. It shows that three-step therapy is more effective than the sham acupuncture, with good immediate analgesic effect, low recurrence rate, and good long-term curative effect. The shortcoming of this study is the small sample size, which limits the strength of the evidence. Conclusion In summary, in the treatment of CEH, the three-step canister therapy group is significantly better than the control treatment in improving PRI, VAS, PPI, and ROM scores. The three-step canister therapy has an immediate analgesic effect. It can also quickly improve cervical vertebra ROM and has good short-term and long-term effects. References 1. Fredriksen TA, Antonaci F, Sjaastad O. Cervicogenic headache: too important to be left un-diagnosed. J Headache Pain 2015, 16: 6. 2. Jin JH, Fan YY, Liu YQ. Analysis of misdiagnosed cases of cervicogenic headache. Chin J Pain Med 2016, 22: 874-875. 3. Sjaastad O, Saunte C, Hovdahl H, et al. Cervicogenic headache. An hypothesis. Cephalalgia 1983, 3: 249-256. 4. Vincent MB. Cervicogenic headache: the neck is a generator: con. Headache 2010, 50: 706-709. 5. Becker WJ. Cervicogenic headache: evidence that the neck is a pain generator. Headache 2010, 50: 699-705. 6. Persson LC, Carlsson JY, Anderberg L. 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