Investigation of the Efficacy and Safety of Topical

Vibration Anesthesia to Reduce Pain From Cosmetic

Botulinum Toxin A Injections in Chinese Patients: A
Multicenter, Randomized, Self-Controlled Study
Yiming Li, MD, PhD,*† Weiwei Dong, MD,† Min Wang, MD,‡ and Ning Xu, MDx

BACKGROUND Vibration has been proved to be effective to reduce pain during facial cosmetic injections, but
it has not been studied in Chinese patients.

OBJECTIVE To investigate the efficacy and safety of vibration for pain reduction associated with cosmetic
botulinum toxin A (BTX-A) injections in Chinese patients.

MATERIALS AND METHODS In this prospective, randomized, split-face and right-left, self-controlled study,
53 patients received BTX-A injections for rhytid reduction, lower face, shoulder, and leg reshaping. Injections
were given in a split-face and right-left design randomly assigned. A vibration stimulus was coadministered
with BTX-A injections on one side, whereas the other side received BTX-A injections only. Patients completed
a questionnaire immediately after treatment and were followed up 2 weeks later. A visual analog scale of pain
sensation was statistically analyzed.

RESULTS The patients experienced both clinically and statistically significant pain reduction when a vibra-
tion was coadministered with injections. Patients reported less pain on the treated side compared with the
control side. Overall, 75% of patients preferred to receive vibration with their next treatment. No adverse
events were reported.

CONCLUSION Vibration is an effective and safe way to reduce pain during cosmetic BTX-A injections and
may have applications in other cosmetic procedures.

The authors have indicated no significant interest with commercial supporters. Y. Li and W. Dong contributed
equally to this manuscript.

F acial rhytid reduction, lower face, posterior leg,

and shoulder contour reshaping with botulinum
toxin A (BTX-A) injections are currently the most
popular nonsurgical cosmetic procedures in China
(The China Food and Drug Administration-approved
indication for BTX-A is glabella lines, and the other
application is investigational). The needle puncture
causes a certain degree of pain and is associated with
discomfort and anxiety. Many analgesic modalities
have been used with limited success. Topical analgesics
(e.g., ice packs, 5% compound lidocaine cream, and
vapor-coolant sprays) have been attempted to reduce
pain and discomfort. These modalities may cause
side effects, including contact dermatitis, cold burn,
hyperpigmentation, and hypopigmentation.1–4
Vibration anesthesia has been proved to effectively
and safely alleviate pain in cosmetic BTX-A and filler
injections.5–7 The mechanism of action is explained
partially by the “gate-control” theory. The aim of this
study was to evaluate the efficacy, safety, and prefer-
ence for topical vibration anesthesia for reducing pain
from cosmetic BTX-A injections in Chinese patients.
To the authors’ knowledge, it was also the first study to

*Department of Dermatology and Venereology, Huaxi Hospital, Chengdu, China; †Department of Dermatology, Sichuan
FreSkin Hospital, Chengdu, China; ‡Department of Dermatology, Xian FreSkin Hospital, Xian, China; xDepartment of
Dermatology, Chongqing FreSkin Hospital, Chongqing, China

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
· ·
ISSN: 1076-0512 Dermatol Surg 2017;0:1–7 DOI: 10.1097/DSS.0000000000001349

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
 INVESTIGATION OF TOPICAL VIBRATION ANESTHESIA

examine the use of vibrational anesthesia treatment on

the anatomic sites other than the face.

Methods

Subjects

This multicenter, prospective, randomized, self-

controlled study enrolled 53 patients. All were above
18 years old. Treatment-naive patients and repeated
patients (previously treated with BTX-A and/or other Figure 1. The vibrator used in the study (Face & Eye
facial medical aesthetic procedure) were eligible to Beauty Magic Wand, CS-608; Careshow Ltd., Guangzhou,
China).
participate. Exclusion criteria were previous allergic
reaction to BTX-A, preexisting disorders affecting was completed before the treatment proceeded to
neuromuscular junction function (e.g., myasthenia the next site.
gravis and motor neuron disease), presence of infec-
tion or inflammation at injection sites, pregnancy or Symmetric anatomic sites were treated, including
planning to become pregnant, lactation, and laser glabella, forehead, periorbital, lower face, neck,
resurfacing within 6 months. chin, shoulder, and posterior region of leg.
According to patients’ choice, one of 2 BTX-A
Informed consent was obtained from each patient. The products was used, Botox (100 U/vial; Allergan Ltd.,
principles of the 1975 Declaration of Helsinki were Dublin, Ireland) or Hengli (100 U/vial; Lanzhou
followed. Biological Products Institute, Lanzhou, China). The
same physician administered all the injections.
Study Design
After the procedure, the patients completed an anon-
Injections were given in a split-face and right-left
ymous questionnaire regarding the treatment after the
design, preassigned in an alternating manner. Each
physician left the room. The surveys were collected by
patient acted as his/her own control. A vibration
a nurse. Patients were contacted 2 weeks later to
stimulus was coadministered with the BTX-A injec-
inquire about the BTX-A treatment efficacy and any
tions on one side (treatment), whereas the other side
potential adverse effect they had experienced.
received the BTX-A injections only (control). Patients
were given an information sheet explaining the aim of
the study without describing the specific effects of the
vibration to reduce the risk of biasing their
perception.

Vibration was administered with a commercial,

handheld, and battery-operated device (Face & Eye
Beauty Magic Wand, CS-608; Careshow Ltd.,
Guangzhou, China, Figure 1). The BTX-A injec-
tions were administered with a 29-gauge, 1-mL BD
Ultra-Fine insulin syringe. The vibration was pro-
vided 5 seconds before the initial needle stick and
throughout the entire injection, with 1 to 2 cm away
Figure 2. During injection, the vibrator was positioned on
from the injection site (Figure 2). If more than one
the patient’s skin, approximately 1 to 2 cm from the
anatomic site was injected, the treatment to one site injection site.

2 DERMATOLOGIC SURGERY

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

Patient Questionnaire
The questionnaire was composed of 3 parts. The first
part was the visual analog scale (VAS). Patients were
asked to describe the pain on the scale, 0 being no pain
and 10 being the worst imaginable pain. The closet
integer was recorded by the nurse. The second part
was a preference question: Would you choose vibra-
tion for the next injection? Four options were no,
unsure, yes, and yes plus I will recommend the vibra-
tion treatment to the others. The answer was consid-
ered as a preference for vibration treatment. In the
third part, patients were allowed to state the feelings
and/or questions they might have about the vibration
treatment. Patients were also given the opportunity to
report any posttreatment pain, bruising, or adverse
effect right after the procedure and at the follow-up 2
weeks later.
Statistical Analysis
Statistical analysis was conducted with SPSS 17.0 (SPSS,
Inc., Chicago, IL). Each patient served as his or her own
control for pain analyses. A paired t-test was used to
compare the pain scores between the treatment side and
the control side. One-way analysis of variance was used
to compare data among 3 or more patient groups. A
p < .05 was considered statistically significant.
Results
Patient Demographics
Fifty-three Chinese female subjects participated in the
trial. The average age was 34 6 9.9 years (range 21–62
years). Twelve patients were treatment naive, whereas
41 had previously undergone BTX-A injections, filler
injections, intense pulsed light, Thermage, and ultra-
sound procedure.
TABLE 1. Average Patient-Reported Pain With and Without Vibration Anesthesia Treatment
N = 53 Treatment Side
Overall average pain, n = 53 3.6 6 1.3
n = 44 (83%) 3.4 6 1.1
n = 5 (9%) 4.2 6 2.0
n = 4 (7%) 5.5 6 1.0
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LI ET AL
Pain Reduction
Overall, the mean patient-reported pain scores were
3.6 6 1.3 for the vibration-treated side and 5.6 6 1.8
for the control side, highly statistically significant
(p = .000). On the vibration-treated side, 2% of
patients (n = 1) reported no pain, and none reported
“the worst imaginable pain.” On the control side, zero
patients reported no pain, and 3 (6%) reported the
worst imaginable pain.
Forty-four patients (83%) rated the injections they
received on the vibrated side as less painful than the
control side, with the score of 3.4 6 1.1 on the treated
side and 6.0 6 1.6 on the control side (p = .000). Five
patients (9%) rated the pain as being equal on both
sides of the face, with the score of 4.2 6 2.0 for both
sides. Four patients (7%) reported an increased pain
on the vibrated side compared with the control side;
the pain score for these patients was 5.5 6 1.0 on the
treated side and 3.8 6 1.3 on the control side (p = .073)
(Table 1).
In 12 treatment-naive patients, the mean score was 3.8
6 1.2 for the treated side and 5.7 6 1.6 for the control
side, statistically significant (p = .005). In 41 repeated
patients, the mean score was 3.5 6 1.4 for the treated
side and 5.6 6 1.8 for the control side, statistically
significant (p = .000). No difference was found
between the treatment-naive patients and repeated
patients concerning the pain score of the treated or
control side.
The mean score was 3.8 6 1.3 for the treated side in
28 patients receiving BTX-A by Lanzhou Biological
Products Institute injection, with a mean score of 5.4
6 1.3 for the control side, statistically significant
(p = .000). The mean score was 3.4 6 1.4 for the
treated side in 25 patients receiving BTX-A by
Control Side p
5.6 6 1.8 .000
6.0 6 1.6 .000
4.2 6 2.0 —
3.8 6 1.3 .073
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 INVESTIGATION OF TOPICAL VIBRATION ANESTHESIA

TABLE 2. Patient-Reported Pain Versus Number of Injection Sites

N = 53 Treatment Side Control Side p

1 injection site (n = 41) 3.5 6 1.4 5.7 6 1.7 .000
2 injection sites (n = 10) 4.2 6 1.0 6.0 6 1.6 .007
3 injection sites (n = 1) 2 2 —
4 injection sites (n = 1) 4 2 —

Allergan Ltd. injection, with a mean score of 6.0 6
2.1 for the control side, statistically significant
(p = .000). No difference was found between the
patients receiving BTX-A by Lanzhou Biological
Products Institute and BTX-A by Allergan Ltd.
injection concerning the pain score of the treated or
control side.
Forty-one patients who received injections on a single
site rated pain at 3.5 6 1.4 on the treated side and at
5.7 6 1.7 on the control side (p = .000). Pain scores of
12 patients who received injections on 2 or more sites
are listed in Table 2. The pain scores for different
anatomic sites are listed in Table 3.
Preference for Vibration
Eight patients (15%) were uncertain; all these patients
rated a lower pain score on the treated sides except for
1 who rated equally on both sides. Several patients
(9%, n = 5) declined vibration with subsequent injec-
tions, none of which cited decreased BTX-A efficacy as
the reason during the follow-up survey. Two of the 5
patients rated equally on both sides, and 3 rated
a higher pain score on the treated sides.
Nine (75%) of the 12 naive patients reported that
they would prefer to receive vibration with future
injections, and 31 (76%) of the 41 repeated patients
preferred vibration. There was no statistically sig-
nificant difference between first-time and repeated
patients in terms of preference (Fisher exact test,
p = 1.000).

Forty of 53 patients (75%) indicated a desire for Among the 5 patients who rated pain score equally on
vibration anesthesia with future injections (answers both sides, 2 preferred vibration for the future injec-
were yes or yes plus I will recommend the vibration tions, 1 was uncertain, and 2 declined. Interestingly,
treatment to the others to the preference question). one of the 4 patients who reported more injection pain

TABLE 3. Patient-Reported Pain Versus Anatomic Sites

N = 53 Treatment Side Control Side p

Periorbital (n = 29) 3.6 6 1.3* 6.3 6 1.5† .000
Lower face (n = 10) 3.3 6 1.6* 4.3 6 1.6‡ .132
Lower face + neck (n = 6) 4.5 6 0.8* 6.0 6 2.1† .135
Forehead + glabella (n = 1) 4 6 —
Posterior region of leg (n = 1) 5 6 —
Shoulder (n = 1) 2 4 —
Periorbital + lower face (n = 1) 4 6 —
Periorbital + lower face + neck (n = 1) 2 2 —
Periorbital + glabella (n = 1) 2 6 —
Lower face + chin (n = 1) 5 6 —
Lower face + chin + glabella (n = 1) 4 2 —

*No significant difference among pain scores on the treatment side.

†No significant difference between periorbital and lower face + neck (p = .692).
‡Significant difference between lower face and periorbital (p = .001), lower face and lower face + neck (p = .039).

4 DERMATOLOGIC SURGERY

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

on vibration-treated half still preferred to have vibra-
tion for the subsequent injections, and the other 3
declined.
Patients’ Statement
Forty patients (75%) regarded the vibration treatment
as “made me feel better,” “reduced the duration of
pain,” “could alleviate the pain and anxiety,” “had the
effect of distraction,” and “be willing to choose it for
the subsequent injections.” Five patients (9%) did not
consider the vibration effective. Two patients (4%)
stated that the vibration had made the pain worse. One
patient (2%) expected a vibration with a higher fre-
quency and amplitude.
Adverse Effects
Based on both the reports collected right after the
injection and the follow-up 2 weeks later, no patient
experienced side effects perceived to be associated with
vibration. No patient reported a delayed or declined
toxin effect due to vibration treatment.
Discussion
This is the first multi-center, randomized, self-
controlled study to evaluate the efficacy and safety of
topical vibration to reduce pain from cosmetic BTX-A
injections in Chinese patients. Maximizing patient
comfort is an important consideration for medical
aesthetic procedures, since most of them are elective.
The ideal topical anesthetic is supposed to be rapid
onset, consistently efficacious, and with a negligible
adverse effect profile.7
Each strategy has certain limitations. For example,
topical anesthetics such as 5% compound lidocaine
cream may require 30 to 45 minutes for optimal
analgesic effect, thereby limiting their usefulness in
a busy outpatient setting. Many patients regard the
cosmetic BTX-A injection as a “lunch break” pro-
cedure. Cases of contact allergy and cross-reactions
have also been reported.8 The vasoconstrictive effects
of coldness may provide reduced ecchymosis and
swelling. However, the effect of applying ice or cooled
air is unpredictable because these modalities do not
deliver precise temperature, which may result in cold
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
LI ET AL
burn or insufficient effect to targeted areas.3 Pre-
treatment with topical betacaine followed by skin
cooling seemed to have a deleterious impact on BTX-A
effect without a significantly beneficial patient-
perceived reduction in injection discomfort.9
Vibration has been considered as a method of reducing
pain, mostly in dentistry,10,11 dermatology,6,7,12 upper
eyelid surgery anesthesia,13 and neonates.14 However,
there is no evidence from randomized controlled trials
in Chinese patients. The study applied the gate-control
theory of pain modulation to the BTX-A injection to
determine whether large A-b nerve fiber input from
a vibration stimulus would inhibit smaller A-d and C-
fiber (nociceptive) inputs from a needle injection.
Neurologically, large nerves conduct nonnociceptive
information and that smaller fibers conduct nocicep-
tive information. Nociceptive and nonnociceptive
signals are summated within the substantia gelatinosa
(spinal cord). If nociceptive signals outweigh non-
nociceptive signals, a pain signal is propagated. This is
the gate-control theory by Melzack and Wall, which
suggests that pain can be reduced by simultaneous
activation of nerve fibers that conduct nonnoxious
stimuli. In the meantime, it has been recognized that
the sensitivity of the nociceptive system can be
decreased or increased and that this “gain control” can
occur at peripheral, spinal, and supraspinal levels.
After the proposition of the theory, researchers tested
it by electrically stimulating large fibers. In a variety of
studies, this type of stimulation has been found to
provide pain relief. Researchers continued to use the
rationale to propose new methods including whole-
body vibration therapy for achieving clinical pain
relief. It has since been recognized that pain trans-
mission is likely more complex, since the gate-control
theory is insufficient to explain all types of pain (i.e.,
phantom limb syndrome).15–19
In 2004, Melzack presented a novel neuromatrix
theory of pain in which he proposed that pain is
a multidimensional experience produced by charac-
teristic “neurosignature” patterns of nerve impulses
generated by a widely distributed neural network in
the brain. The neuromatrix, which is genetically
determined and modified by sensory experience, is the
0:0:MONTH 2017 5
 INVESTIGATION OF TOPICAL VIBRATION ANESTHESIA
primary mechanism that generates the neural pattern
that produces pain, as opposed to the traditional view
that pain is directly produced by sensory input evoked
by injury or inflammation.13
Occupational studies indicated that chronic exposure
to high-intensity whole-body vibration might be
associated with increased risk of headache, eyestrain,
spinal degeneration, and vascular or neural
changes.20,21 However, exposure to brief period of
topical vibration is not associated with any significant
temporary or permanent side effect.
Psychologically, subjects may also benefit from the
vibration stimulation as a distraction from the injec-
tion. It explains why some patients who rated an equal
or more pain score on the vibration-treated side still
preferred to have vibration for the subsequent injec-
tions. Their preference was influenced by a factor
other than pain reduction. This distraction effect was
also indicated in the patients’ statement.
Reviewing the other similar studies, the authors
adapted the study design. First, the study involved
injection sites more than just glabella lines. Currently
in China, BTX-A injections deal with not only facial
rhytid reduction but also lower face, shoulder, and
posterior leg contour reshaping. These procedures
require deeper injection and larger toxin dosage. The
authors noticed that there was no significant difference
on pain scores between the treated sides and the con-
trol sides for lower face (masseter) and lower face plus
neck (masseter and platysma) (Table 3). Similarly, all 4
patients who rated a higher pain score on the treated
sides received lower face injections. A larger sample
size is needed to determine whether it means the
vibration treatment on the skin does not affect deep
muscle injections, or optimized vibration parameters
are required. Second, the authors used both BTX-A
products commercially available to evaluate whether
there would be any difference. Third, considering that
the VAS and preference question may not cover all the
experience the patients had during the injection, the
authors also allowed them to state any possible feeling
they might have for the vibration treatment in the third
part of the questionnaire. As it turned out, the patients’
statement allowed the authors to identify some issues
6 DERMATOLOGIC SURGERY
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
that the VAS or preference question did not cover, such
as the distraction effect and needs for optimizing
vibration parameters such as frequency and ampli-
tude. The results gained from this study may have an
important place in medical aesthetic practice and
support previous studies that have shown the benefits
of using vibration stimulus to increase patient comfort
in other painful procedures.
The authors’ qualitative analysis demonstrated that
the majority of patients subjectively preferred the
vibrated side. Although vibration anesthesia does not
eliminate pain completely, the technique could be used
in conjunction with other modalities if additional pain
reduction is desired. In terms of clinical significance,
further research is needed to determine the change in
pain intensity rating that can be deemed clinically
significant.
Whether vibration may be applied during other med-
ical and cosmetic procedures needs further investiga-
tion. Besides, further study is needed to determine the
optimal parameters of vibration as an anesthetic
treatment. In this study, 44 of 53 patients experienced
less pain when BTX-A injections were coadministered
with vibration, whereas 9 patients reported no pain
alleviation quantitatively. This could be due to the
anatomy, the subjective nature of grading, or an ele-
vated or lowered pain tolerance in certain patients. It is
also possible that anesthetic effect may vary because of
different vibration amplitude, frequency, or time of
application. Also, the effect of age and sex needs to be
examined, and this could be undertaken with a larger
sample size.
Despite the results from this study, the authors rec-
ommend clinicians avoid using a vibration device
when injecting a particular site such as under-eye area
or a risky area where the vibration could cause liquid
medicine to spread into the orbit.
The authors did not include the subjects receiving filler
injection. The consideration was that BTX-A injection
is a multiple-shot procedure, whereas filler injection
needs only 2 or 3 puncture sites whether a cannula or
a needle is applied. Although lidocaine-containing
formulation of a hyaluronic acid filler could alleviate

pain,22 no dermal filler product containing lidocaine is
available in China market to date. Several hyaluronic
acid brands containing lidocaine are on their Phase III
study and hopefully will be available in the near future.
Dermal filler without lidocaine injection makes it
necessary to use infiltration anesthesia or nerve block
before injection. Most cosmetic physicians prefer
infiltration anesthesia, which is easier to operate
compared with nerve block. It would be more appro-
priate to study the efficacy of vibration in assisting
infiltration anesthesia or nerve block anesthesia.
One limitation of this study was the lack of a placebo.
The authors did not find a suitable medium that can
make the same buzzing sound as the vibration without
providing a vibration treatment. Some used a placebo
consisted of a switched-off vibrating device applied to
the injection sites, whereas another switched-on
vibrating device was held nearby. The authors con-
sidered placing a vibrating device on the skin, and the
sound from a switched-on device might have a psy-
chological effect. Another possible weakness was the
absence of male subjects. The situation that most
subjects seeking for medical aesthetic procedures are
female made it difficult to recruit male ones.
Conclusion
Vibration anesthesia during cosmetic BTX-A injec-
tions has a beneficial effect that is highly statistically
and clinically significant in terms of patients’ assess-
ment of pain. It is safe and effective to achieve local
anesthesia and maximize patients’ comfort. The
advantages include easy application, rapid onset, and
affordability. It may have a particularly beneficial
effect in patients who are anxious about the anesthetic
injection or have a low pain tolerance.
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Address correspondence and reprint requests to: Yiming Li,
MD, PhD, Department of Dermatology and Venereology,
Huaxi Hospital, 37 Guoxue Alley, Wuhou District,
Chengdu 610041, China, or e-mail: yimingli96@163.com
0:0:MONTH 2017 7