Hindawi

Evidence-Based Complementary and Alternative Medicine

Volume 2020, Article ID 6531743, 7 pages
https://doi.org/10.1155/2020/6531743

Research Article
Efficacy of Manipulative Acupuncture Therapy Monitored by LSCI
Technology in Patients with Severe Bell’s Palsy: A Randomized
Controlled Trial

Weizheng Zhong,1 Haibo Yu,1 Xiaodan Rao,1 Jianhuang Wu,2 Yanhua Gou,1 Han Cui,1
Xingxian Huang,1 and Ling Wang 1
1
Shenzhen Traditional Chinese Medicine Hospital, Shenzhen 518033, Guangdong, China
2
Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen 518055, China

Correspondence should be addressed to Ling Wang; [email protected]

Received 19 June 2020; Revised 9 November 2020; Accepted 8 December 2020; Published 16 December 2020

Academic Editor: Gioacchino Calapai

Copyright © 2020 Weizheng Zhong et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is
properly cited.
To determine if the effect of manipulative acupuncture monitored by laser speckle contrast imaging (LSCI) can improve facial
blood perfusion in patients with severe Bell’s palsy. This randomized, single-blind, controlled trial included 120 newly diagnosed
patients (within 14 days) with severe Bell’s palsy (House–Brackmann grading system (HBGS) ≥ grade IV). The patients were
randomized (1 : 1) to receive either acupoints acupuncture combined with manipulations of twirling, lifting, and thrusting
treatments (manipulative acupuncture) or acupoints acupuncture therapy alone (simple acupuncture). These treatments con-
sisted of a total of 24 sessions, three times per week, and each treatment lasted for 30 min. Following 8 weeks of treatment and 6
months after the initial onset of facial palsy, facial nerve functioning was scored (HBGS) and clinical efficacy was measured. The
patients’ facial blood perfusion significantly improved following manipulative acupuncture assisted by LSCI compared with that at
baseline (P < 0.01). At the conclusion of the 8-week treatment, both groups showed improvement; however, the recovery rate was
significantly different (manipulative acupuncture 53.3% vs. simple acupuncture 33.9%, P < 0.05). Follow-up analysis at 6 months
after the onset of facial palsy revealed a significantly higher recovery rate (91.7% vs. 78.0%; P < 0.05). In addition, the number of
treatments in the observation group was less than that in the simple acupuncture therapy group (P < 0.05). Compared with simple
acupuncture therapy, manipulative acupuncture therapy led to a more significant recovery rate in the treatment of severe Bell’s
palsy and required a shorter course of treatment. This trial was registered with ChiCTR1800019463.

1. Introduction immunological reasons, trauma to the nerve, and idiopathic

reasons [3]. Bell’s palsy occurs due to inflammation of the
Bell’s palsy is an acute peripheral facial nerve palsy of un- facial nerve in the narrow fallopian canal. In patients with
known cause and accounts for 50% of all cases of facial nerve Bell’s palsy, facial nerve swelling was generally present and
palsy [1]. The annual incidence rate is between 13 and 34 was reported in decompression surgery [4, 5]. Edema sec-
cases per 100,000 individuals [2]. Bell’s palsy is more ondary to herpes simplex virus 1, such as inflammation or
prevalent in females than in males. Under natural conditions ischemia, generally resulted in elevated pressure, leading to
without any treatment, 94% of patients with incomplete further vascular damage. Additionally, continuous ischemia
lesions returned to normal, whereas only 60% of those with inhibits facial nerve regeneration, resulting in severe facial
clinically complete lesions exhibited complete recovery [1]. palsy and a low chance of recovery. Therefore, Bell’s palsy is
Although the etiology of Bell’s palsy remains unclear, the significantly affected by the microcirculation of tissues near
potential causes of Bell’s palsy include viral infections such the facial nerves. In our previous study, laser speckle contrast
as herpes simplex virus 1, rheumatic swelling, ischemia, imaging (LSCI) was able to detect the asymmetrical
2 Evidence-Based Complementary and Alternative Medicine

distribution of facial skin perfusion in patients with Bell’s The inclusion criteria were as follows: (1) age 18–70
palsy [6]. Moreover, blood perfusion of acute facial palsy, years; (2) diagnosis of Bell’s palsy by a neurologist; (3) HBGS
metabolic activity of the affected facial tissues, and facial score ≥ grade IV; (4) newly diagnosed (disease duration ≤ 14
nerve function have been shown to be significantly improved days); and (5) willingness to participate in the study and
by acupuncture [7]. These findings suggest that acupuncture provide informed consent. The exclusion criteria were as
plays a beneficial role in Bell’s palsy. follows: (1) face paralysis caused by another disease; (2)
However, all these studies are observational; therefore, diagnosed for more than 14 days; and (3) presence of severe
the causal relationship has not yet been elucidated. This comorbidities that could impact the implementation of the
study was designed as a randomized, single-blind, controlled treatment and performance.
trial to evaluate whether the treatment of manipulative
acupuncture monitored by LSCI technology could improve
2.2. Randomization and Masking. Patients were randomly
blood perfusion, enhance the curative effect, and reduce the
assigned (1 : 1) to receive either manipulative acupuncture
recovery time of patients with severe Bell’s palsy.
under LSCI or simple acupuncture treatment via the use of a
randomization scheme. The randomization code was
2. Materials and Methods computer-generated at the Shenzhen Traditional Chinese
Medicine Hospital. The allocation was concealed until
2.1. Study Design and Participants. This was a single-centre,
shortly before treatment. All follow-up contact with patients,
randomized, single-blind, controlled, parallel assignment
families, and caregivers was performed by investigators who
study of manipulative acupuncture monitored via LSCI
were unaware of the patients’ random assignments and
technology versus simple acupuncture for the treatment of
medical treatment management. Outcome assessors and
patients with severe Bell’s palsy.
data analysts were also blinded to the treatment allocation
The study protocol was approved by the Medical Re-
until the study database was locked.
search Ethics Committee of Shenzhen Hospital of Tradi-
tional Chinese Medicine. Sample size calculation was
dependent on a randomized pilot study of 16 patients with 2.3. Treatments and Management. Study interventions were
severe facial paralysis before the trial. The pilot study found developed by a consensus of acupuncture experts and per the
that the cure rate of manipulative acupuncture under LSCI results of our pilot study [7]. Eligible patients received 24
was 87.5% and that of simple acupuncture treatment was sessions of acupuncture treatment, three times a week, with
62.5%. Then, we calculated the sample size of the two groups each treatment lasting 30 min. The treatment duration was 8
as 116, with an α of 0.05 and statistical power of 0.90. weeks. If an HBGS grade of I was attained before 8 weeks,
Considering a dropout rate of 10%, the sample size was treatment was ceased. The acupuncture protocol was stan-
calculated as 128. Considering the difficulty in enrolling dardized according to the following order of acupoints:
patients with severe paralysis, we finally set the sample size as Cuanzhu (BL 2), Yangbai (GB 14), Taiyang (EX-HN 5),
120 patients in two groups. Patients were recruited through Quanliao (SI 18), Dicang (ST 4), Yingxiang (LI 20), and
the Acupuncture Department and the Neurology Depart- Yifeng (TE 17) on the affected side and Chengjiang (RN 24)
ment of Shenzhen Traditional Chinese Medicine Hospital in and Hegu (LI 4) bilaterally.
Shenzhen, China, from August 2017 to January 2019. All Acupuncture was performed by three trained profes-
patients who consented to participate in the study provided sional acupuncturists. Disposable stainless-steel needles
informed consent. (Suzou Huanqiu Acupuncture and Moxibustion Appliance
Patients aged 18–70 years recently diagnosed (within 14 Co., Ltd.) that were 0.3 mm in diameter and 25 mm or
days) with Bell’s palsy were assessed by a single professional 40 mm in length were used. A standard protocol was fol-
neurologist for consideration of inclusion in this study at the lowed in the manipulative acupuncture group and simple
screening stage. Each patient was assessed via their acupuncture group. A standard protocol was followed for
House–Brackmann grading system (HBGS) score, and pa- each treatment by all neurologists: The protocol was as
tients who were rated IV–VI were considered for this study. follows: (1) inserting the needles subcutaneously downwards
Bell’s palsy was defined as a sudden occurrence of unilateral into Cuanzhu (BL 2) and Yangbai (GB 14) up to 12.5 mm;
paralysis caused by a lesion on the facial nerves. According (2) inserting the needle perpendicularly into Taiyang (EX-
to the definition of Bell’s facial palsy in the Clinical practice HN 5) and Quanliao (SI 18) up to 12.5 mm; (3) inserting the
guidelines (2013) [8], Bell’s palsy can be diagnosed if patients needle from Dicang (ST 4) toward Jiache (ST 6) up to
have the following characteristics and symptoms: (1) acute 35 mm; (4) inserting the needle obliquely into Yingxiang (LI
onset (maximum severity within 72 h); (2) the affected side 20) along the nasolabial fold up to 7.5 mm; (5) inserting the
of the face shows muscle stiffness, numbness, and paralysis; needle obliquely outward into Chengjiang (RN 24) up to
wrinkles on the forehead disappear, and the rima oculi 7.5 mm; and (6) inserting the needle perpendicularly into
enlarge, exposing the eyeball and increasing the secretion of Yifeng (TE 17) and Hegu (LI 4) up to 20 mm. In the ma-
tears; the nasolabial fold becomes shallower, and the corner nipulative acupuncture group, following the insertion of the
of the mouth droops and twists to the contralateral side; and needles, equal manipulations of twirling, lifting, and
(3) the affected side of the face cannot frown, knit brows, or thrusting were performed until the blood perfusion was left-
close the eye completely and cannot show teeth or cheek right balanced or stable blood flow was maintained, as
pouch or whistle properly. determined by LSCI. These manipulations were repeated
Evidence-Based Complementary and Alternative Medicine 3

every 10 min, and the needles were removed after 30 min. side over the impaired side was calculated to reduce the
However, the simple acupuncture group only included potential residual confounders irrelevant to blood perfusion.
acupuncture with no manipulations, and similarly, the
retained needles were removed after 30 min.
2.5. Outcomes. The primary outcome of this study was that
Trained doctors performed the clinical assessments at
the clinical recovery rate was defined based on HBGS after 8
baseline, following the 8-week treatment period, and 6
weeks of treatment and 6 months after the onset of facial
months following the onset of facial palsy. The trained
palsy. The HBGS grade was assessed by two independent
doctors measured and recorded the activity of the facial
professional neurologists who observed facial movement at
muscles, H-B degree, and the patients’ general neurosensory
rest, with a forced smile, with raised eyebrows, and with eyes
symptoms, including pain, taste, hearing, tear secretion, and
tightly closed. According to the House–Brackmann facial
adverse events, which were recorded at every visit and before
nerve grading system published in 2013, the sum of the score
and after treatment. The information on the most commonly
at the 4th position was divided into six grades, with grade I
reported adverse events, including pain, fainting, and
indicating normal and grade VI indicating total paralysis [8].
bruising, was carefully recorded. In terms of pain, we
The recovery rate was defined as patients with HBGS grade I,
established three categories: light (experienced obvious pain
and the recovery rate was then calculated. The secondary
during acupuncture but within the tolerable range and
outcome was the number of treatments required to recover
without causing continuous discomfort), moderate (expe-
from impaired facial nerve function to grade I.
rienced obvious and continuous pain during acupuncture
that did not persist for more than 1 h and without any
influence on follow-up acupuncture treatment), and severe 2.6. Statistical Analysis. All participants completed the en-
pain (persistent pain for more than 1 h, leading to with- tire treatment and were included in the analyses of primary
drawal from acupuncture treatment). and secondary outcomes. Means and standard deviations
(±SD) were calculated for continuous variables. We used the
t-test to compare differences in age and course of disease
2.4. Blood Perfusion Measurement Using LSCI. Blood per- between the treatment groups. The Wilcoxon test was used
fusion of patients in the manipulative acupuncture group to compare the grading of the facial nerve function between
was monitored using an LSCI device (SIM BFI-WF System, patients who underwent manipulative acupuncture under
Wuhan SIM Opto-Technology Co. Ltd., China). The stan- LSCI and those who underwent simple acupuncture because
dard operation procedure was used for each measurement, of the unevenness of the variances between the two groups.
and all the operators were trained. When using this device, The paired samples t-test was used to compare HBGS
the skin of the patients was illuminated by a laser light changes over time in each group and changes in blood
emitted by the LSCI device. The ratio of blood perfusion at perfusion before and after acupuncture in the manipulative
the affected area to that at the normal facial area was cal- acupuncture group. The chi-square test was used to analyse
culated; the lower the ratio, the poorer was the blood flow categorical variables.
recovery. The central wavelength was 785 nm. The reflected All analyses in this study were conducted using SPSS
laser light was collected by the lens and imaged on a high- version 16.0 statistical software (SPSS Inc., Chicago, Illinois,
resolution camera, which could be translated to a quanti- USA). A (two-side) P value of <0.05 was considered sta-
tative measurement of blood flow according to the image tistically significant.
analysis [9, 10]. Then, a color-coded image showing the
distribution of blood perfusion was generated. Red signified 3. Results and Discussion
a high level of blood perfusion, and blue represented a low
level of blood perfusion. The monitor detector was set From August 2017 to January 2019, 125 eligible patients with
25–30 cm above the patients’ face, with a maximum field of Bell’s palsy were screened for enrolment at Shenzhen Tra-
view of 14.8 × 14.8 cm so that the entire facial area could be ditional Chinese Medicine Hospital. A total of 120 patients
illuminated. The frequency used for the blood perfusion were willing and eligible to attend this study. Among the five
image was 1 s, and the size of the image was 512 × 512 pixels. excluded patients, two were sensitive to acupuncture pain
Regions with rich blood flow, including the eyelids and and were unable to undergo acupuncture treatment and
cheeks, were selected as regions of interest used to reflect the three were unwilling to participate in the study. Overall, 120
facial blood perfusion. The lens was placed directly above the patients completed randomization; 60 patients aged 20–69
patients’ face after they had been lying for 5 min with their years (males, 55.0%) underwent manipulative acupuncture
eyes closed and with the same head posture on a pillow, and treatment (acupoints acupuncture combined with manip-
then acupuncture was performed. Blood perfusion images of ulations of twirling, lifting, and thrusting treatments), and 60
the facial skin were taken and numbered before acupunc- patients aged 19–69 years (males, 50.85%) underwent simple
ture, following acupuncture with manipulation, and after acupoints acupuncture treatment (Figure 1). Among them,
removal of the needles. The duration of the manipulative 43 (72.9%) in the simple acupuncture group and 45 (75.0%)
acupuncture was recorded. in the manipulative acupuncture under the LSCI group were
The mean blood perfusion in both sides of the eyelids in the acute stage of facial palsy (P � 0.904). All participants
and cheeks at each week of the study and after 6 months was adhered to the study intervention during the 6-month
recorded. The relative blood perfusion rate for the normal follow-up. Only one patient withdrew after 2 weeks of
4 Evidence-Based Complementary and Alternative Medicine

Enrollment
Assessed for eligibility (n = 125)

Excluded (n = 5)
(i) Deemed unable to perform
by acupuncture (n = 2)
(ii) Declined to participate after
first visit (n = 3)

Single blind Single-blind randomization of

allocation study (n = 120)

Allocated to exercise therapy (n = 60) Allocated to education therapy (n = 60)

Allocation
(i) Received allocated intervention (n = 60) (i) Received allocated intervention (n = 59)

Lost to follow-up (n = 0) Lost to follow-up (n = 1)

Discontinued intervention (n = 0) Follow-up
Discontinued intervention (n = 0)

Analysed (n = 60) Analysed (n = 59)

Intention to
(i) Excluded from analysis (n = 0) treat analysis (i) Excluded from analysis (n = 0)

Figure 1: Flow chart for patients’ selection.

treatment in the simple acupuncture treatment group due to the recovery rate at 8 weeks for manipulative acupuncture was
personal reasons. 53.3%, which was 20% higher than that for simple acupuncture
The baseline characteristics of the patients, including sex, (33.9%), and the P value was 0.037 (Table 3 and Figure 4).
age, duration of disease, and HBGS grade, were similar between The number of treatments required to recover from
the two groups (all P values >0.05; Table 1). Blood perfusion at impaired facial nerve function to HBGS grade I was
both eyelids and cheeks in the manipulative acupuncture group 16.75 ± 4.09 in the manipulative acupuncture group,
was significantly increased (all P values <0.01), the ratio of the which was significantly less than that in in the simple
affected area to normal face area decreased from 1.35 ± 0.14 to acupuncture group (19.65 ± 2.96) (P � 0.008, Table 3).
1.15 ± 0.09 at the eyelids and from 1.29 ± 0.11 to 1.07 ± 0.08 at Bruising was a unique adverse event reported in the
the cheeks (Table 2 and Figure 2). Manipulative acupuncture study; 18.33% of patients in the manipulative acupuncture
significantly improved the facial nerve function HBGS grade of group and only 13.56% of patients in the simple acupuncture
60 patients. HBGS grades higher than IV at baseline to 5 (8.33%) group reported grade I bruising (P � 0.477) (Table 4). In
at 8 weeks and 0 at 6 months were compared with those in the addition, 12 patients (20%) in the manipulative acupuncture
simple acupoints acupuncture group with 11 patients with group and 10 (16.95%) in the simple acupuncture group
HBGS grades higher than IV at 8 weeks and 1 at 6 months (all P reported experiencing light pain, and 5 (8.33%) in the
values <0.05, Table 3 and Figure 3). Five patients each in the manipulative acupuncture group and 3 (5.08%) in the simple
simple acupuncture and manipulative acupuncture groups acupuncture group experienced moderate pain. No other
presented acute exacerbation during the follow-up period adverse events were noted in both groups.
(P � 0.48).
Following the 8-week treatment, the recovery rate at 6 4. Discussion
months was 91.7% in the manipulative acupuncture group,
which was nearly 10% higher than that in the simple acu- This study found that using simple acupoints for both
puncture group (81.4%), and the P value was 0.033. In addition, acupuncture and manipulative acupuncture significantly
Evidence-Based Complementary and Alternative Medicine 5

Table 1: Patients’ characteristics at baseline.

Characteristics Acupuncture group (n � 59) Manipulative acupuncture under LSCI group (n � 60) P value
Age (years) 19–59 20–69
Males, n (%) 38.47 ± 13.33 42.52 ± 13.47 0.103
Duration of disease (days) 1–13 1–14 0.670
HBGS (n)
IV 51 52
V 7 6
VI 1 2
Acute stage 43 (72.9) 45 (75.0%) 0.904

Table 2: Comparison of blood perfusion between before acupuncture and after needle removal in the observation group.
Blood perfusion Before acupuncture After acupuncture P value
Blood perfusion ratio at eyelids 1.35 ± 0.14 1.15 ± 0.09 <0.01
Blood perfusion ratio at cheeks 1.29 ± 0.11 1.07 ± 0.08 <0.01
Blood perfusion ratio: blood perfusion at the affected area to that at the normal facial area.

(a) (b) (c)

Figure 2: Blood perfusion monitored using LSCI technology in a patient with severe Bell’s palsy. (a) Before acupuncture. (b) Acupuncture
with manipulation. (c) After removing the needles.

Table 3: Primary and secondary outcomes after 8 weeks of treatment and after 6 months after the onset of facial paralysis.
Characteristics Acupuncture group (n � 20) Manipulative acupuncture under LSCI group (n � 32) P value
Recovery rate at 8 weeks (%) 33.9 53.3 0.033
Recovery rate at 6 months (%) 78.0 91.7 0.037
HBGS grade at 8 weeks (n) 11 5 0.018
IV 10 3
V 1 2
VI 0 0
HBGS grade at 6 months (n) 1 0 0.038
IV 1 0
V 0 0
VI 0 0
Number of treatments at 6 months 19.65 ± 2.96 16.75 ± 4.09 0.008
Acute exacerbation 5 (25.0%) 5 (15.6) 0.48

improved the HBGS grade of severe Bell’s palsy, resulting in environmental factors. Although the underlying mechanism
a higher recovery rate at 8 weeks after treatment and at 6 is uncertain, evidence suggests that herpes simplex virus
months after the onset of facial palsy. Moreover, fewer activation might be a likely cause of Bell’s palsy. Never-
treatments were required to recover the impaired facial theless, it is difficult to identify whether Bell’s palsy is caused
nerve function to grade I. by herpes simplex virus as there are no established or widely
A peripheral facial palsy is a common clinical syndrome available methods to confirm the activity of the herpes
due to complex causes, including disease, gene, and simplex virus. The pathological changes that occurred in
6 Evidence-Based Complementary and Alternative Medicine

35 60
30

Number of participants

Number of participants
50
25
40
20
30
15 32 55
20 46
10 20
16
5 1212 11 10 10
3 2 1 0 0 3 8 2 4 0 1 0 0 0 0
0 0
I II III IV V VI I II III IV V VI
HGBS after 8 weeks of treatment HGBS at 6 months after onset

Manipulative acupuncture group Manipulative acupuncture group

Simple acupuncture group Simple acupuncture group
(a) (b)

Figure 3: HBGS grade of participants in the two groups after 8 weeks of treatment and at 6 months after onset.

70 100.00
90.00
60
80.00
Number of subjects (n)

50 70.00 91.70%
Percentage (%)

40 60.00 78.00%
50.00
30 60 59 40.00 53.30%
20 30.00
32 20.00 33.90%
10 20
12 12 11
16 10.00
5 11
0 0.00
Cured Markedly Effective Ineffective Total Recovery rate at 8 weeks Recovery rate at 6 months
effective number (P = 0.033) (P = 0.037)
Manipulative acupuncture group
Manipulative acupuncture group
Simple acupuncture group
Simple acupuncture group
(a) (b)

Figure 4: Clinical efficacy (number of participants and recovery rate) of participants in the two treatment groups after treatment.

Table 4: Summary of adverse events in the manipulative acupuncture vs. simple acupuncture groups.
Treatment group Bruising Light pain Moderate pain Severe pain Fainting
Manipulative acupuncture (n � 60) 11 (18.33%) 12 (20%) 5 (8.33%) 0 0
Simple acupuncture (n � 59) 8 (13.56%) 10 (16.95%) 3 (5.08%) 0 0

patients with Bell’s palsy were primarily facial nerve edema technology to monitor the blood perfusion of the facial palsy
and degeneration caused by compression of the myelin patients and evaluated whether manipulative acupuncture
sheath or axon. Glucocorticoids were generally recom- could significantly improve the blood supply of the facial
mended for early and short-term use to eliminate inflam- paralysis side compared with simple acupuncture. The re-
matory edema. However, recently, some researchers have sults of this study showed efficacy for manipulative acu-
reported that facial neuritis could lead to various blood puncture as a new treatment method for Bell’s palsy,
circulation disorders. Moreover, the recovery of facial nerve particularly for severe cases. Manipulative acupuncture had
function depended on an appropriate blood supply to significantly improved the facial nerve function and recovery
maintain the nerve environment and nutrition supply [11]. rate at 8 weeks of treatment and at 6 months following the
Thus, increasing this blood supply might benefit the facial onset of the palsy. Moreover, this study also confirmed the
nerve of patients with facial palsy. However, currently, there hypothesis that the blood supply might play a critical role in
is a lack of effective drugs or treatments designed to spe- the prognosis of facial palsy.
cifically improve the blood supply of the facial nerve for Acupuncture has been widely used in the treatment of
these patients. Therefore, in this study, we used LSCI facial paralysis in China and has shown remarkable efficacy
Evidence-Based Complementary and Alternative Medicine 7

for various conditions. However, the underlying mechanism Conflicts of Interest

of acupuncture treatment has not yet been explicated.
Traditional Chinese medicine believes that acupuncture The authors declare that there are no conflicts of interest
treatment regulates and maintains the Yin-Yang balance. regarding the publication of this paper.
One of the theoretical functions of Yin and Yang is blood
flow. Acupuncture into acupoints did not puncture the facial Acknowledgments
nerve or the blood vessels; however, it promoted blood
circulation. Therefore, the manifestation of needling Deqi is This study was supported by Shenzhen Science and Tech-
described as the physician’s sense of compactness and the nology Research Program (nos. JCYJ20170412174037594
patient’s sense of soreness, heaviness, and distension during and JCYJ20170307155203481) and San Ming Project of
needling. However, these are subjective sensations, which Medicine in Shenzhen (no. SZSM201612001).
required experienced doctors for the needling process and
the patients’ careful experience and cooperation. Thus, it is References
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Data Availability
The data used to support the findings of this study are in-
cluded within the article.