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

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LI ET AL

Patient Questionnaire Pain Reduction

The questionnaire was composed of 3 parts. The first Overall, the mean patient-reported pain scores were
part was the visual analog scale (VAS). Patients were 3.6 6 1.3 for the vibration-treated side and 5.6 6 1.8
asked to describe the pain on the scale, 0 being no pain for the control side, highly statistically significant
and 10 being the worst imaginable pain. The closet (p = .000). On the vibration-treated side, 2% of
integer was recorded by the nurse. The second part patients (n = 1) reported no pain, and none reported
was a preference question: Would you choose vibra- “the worst imaginable pain.” On the control side, zero
tion for the next injection? Four options were no, patients reported no pain, and 3 (6%) reported the
unsure, yes, and yes plus I will recommend the vibra- worst imaginable pain.
tion treatment to the others. The answer was consid-
ered as a preference for vibration treatment. In the Forty-four patients (83%) rated the injections they
third part, patients were allowed to state the feelings received on the vibrated side as less painful than the
and/or questions they might have about the vibration control side, with the score of 3.4 6 1.1 on the treated
treatment. Patients were also given the opportunity to side and 6.0 6 1.6 on the control side (p = .000). Five
report any posttreatment pain, bruising, or adverse patients (9%) rated the pain as being equal on both
effect right after the procedure and at the follow-up 2 sides of the face, with the score of 4.2 6 2.0 for both
weeks later. sides. Four patients (7%) reported an increased pain
on the vibrated side compared with the control side;
Statistical Analysis 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)
Statistical analysis was conducted with SPSS 17.0 (SPSS, (Table 1).
Inc., Chicago, IL). Each patient served as his or her own
control for pain analyses. A paired t-test was used to In 12 treatment-naive patients, the mean score was 3.8
compare the pain scores between the treatment side and 6 1.2 for the treated side and 5.7 6 1.6 for the control
the control side. One-way analysis of variance was used side, statistically significant (p = .005). In 41 repeated
to compare data among 3 or more patient groups. A patients, the mean score was 3.5 6 1.4 for the treated
p < .05 was considered statistically significant. 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
Results
patients concerning the pain score of the treated or
control side.
Patient Demographics

Fifty-three Chinese female subjects participated in the The mean score was 3.8 6 1.3 for the treated side in
trial. The average age was 34 6 9.9 years (range 21–62 28 patients receiving BTX-A by Lanzhou Biological
years). Twelve patients were treatment naive, whereas Products Institute injection, with a mean score of 5.4
41 had previously undergone BTX-A injections, filler 6 1.3 for the control side, statistically significant
injections, intense pulsed light, Thermage, and ultra- (p = .000). The mean score was 3.4 6 1.4 for the
sound procedure. treated side in 25 patients receiving BTX-A by

TABLE 1. Average Patient-Reported Pain With and Without Vibration Anesthesia Treatment

N = 53 Treatment Side Control Side p


Overall average pain, n = 53 3.6 6 1.3 5.6 6 1.8 .000
n = 44 (83%) 3.4 6 1.1 6.0 6 1.6 .000
n = 5 (9%) 4.2 6 2.0 4.2 6 2.0 —
n = 4 (7%) 5.5 6 1.0 3.8 6 1.3 .073

0:0:MONTH 2017 3

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

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

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LI ET AL

on vibration-treated half still preferred to have vibra- burn or insufficient effect to targeted areas.3 Pre-
tion for the subsequent injections, and the other 3 treatment with topical betacaine followed by skin
declined. cooling seemed to have a deleterious impact on BTX-A
effect without a significantly beneficial patient-
Patients’ Statement perceived reduction in injection discomfort.9

Forty patients (75%) regarded the vibration treatment


Vibration has been considered as a method of reducing
as “made me feel better,” “reduced the duration of
pain, mostly in dentistry,10,11 dermatology,6,7,12 upper
pain,” “could alleviate the pain and anxiety,” “had the
eyelid surgery anesthesia,13 and neonates.14 However,
effect of distraction,” and “be willing to choose it for
there is no evidence from randomized controlled trials
the subsequent injections.” Five patients (9%) did not
in Chinese patients. The study applied the gate-control
consider the vibration effective. Two patients (4%)
theory of pain modulation to the BTX-A injection to
stated that the vibration had made the pain worse. One
determine whether large A-b nerve fiber input from
patient (2%) expected a vibration with a higher fre-
a vibration stimulus would inhibit smaller A-d and C-
quency and amplitude.
fiber (nociceptive) inputs from a needle injection.

Adverse Effects
Neurologically, large nerves conduct nonnociceptive
Based on both the reports collected right after the information and that smaller fibers conduct nocicep-
injection and the follow-up 2 weeks later, no patient tive information. Nociceptive and nonnociceptive
experienced side effects perceived to be associated with signals are summated within the substantia gelatinosa
vibration. No patient reported a delayed or declined (spinal cord). If nociceptive signals outweigh non-
toxin effect due to vibration treatment. 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
Discussion
activation of nerve fibers that conduct nonnoxious
This is the first multi-center, randomized, self- stimuli. In the meantime, it has been recognized that
controlled study to evaluate the efficacy and safety of the sensitivity of the nociceptive system can be
topical vibration to reduce pain from cosmetic BTX-A decreased or increased and that this “gain control” can
injections in Chinese patients. Maximizing patient occur at peripheral, spinal, and supraspinal levels.
comfort is an important consideration for medical After the proposition of the theory, researchers tested
aesthetic procedures, since most of them are elective. it by electrically stimulating large fibers. In a variety of
The ideal topical anesthetic is supposed to be rapid studies, this type of stimulation has been found to
onset, consistently efficacious, and with a negligible provide pain relief. Researchers continued to use the
adverse effect profile.7 rationale to propose new methods including whole-
body vibration therapy for achieving clinical pain
Each strategy has certain limitations. For example, relief. It has since been recognized that pain trans-
topical anesthetics such as 5% compound lidocaine mission is likely more complex, since the gate-control
cream may require 30 to 45 minutes for optimal theory is insufficient to explain all types of pain (i.e.,
analgesic effect, thereby limiting their usefulness in phantom limb syndrome).15–19
a busy outpatient setting. Many patients regard the
cosmetic BTX-A injection as a “lunch break” pro- In 2004, Melzack presented a novel neuromatrix
cedure. Cases of contact allergy and cross-reactions theory of pain in which he proposed that pain is
have also been reported.8 The vasoconstrictive effects a multidimensional experience produced by charac-
of coldness may provide reduced ecchymosis and teristic “neurosignature” patterns of nerve impulses
swelling. However, the effect of applying ice or cooled generated by a widely distributed neural network in
air is unpredictable because these modalities do not the brain. The neuromatrix, which is genetically
deliver precise temperature, which may result in cold determined and modified by sensory experience, is the

0:0:MONTH 2017 5

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INVESTIGATION OF TOPICAL VIBRATION ANESTHESIA

primary mechanism that generates the neural pattern that the VAS or preference question did not cover, such
that produces pain, as opposed to the traditional view as the distraction effect and needs for optimizing
that pain is directly produced by sensory input evoked vibration parameters such as frequency and ampli-
by injury or inflammation.13 tude. The results gained from this study may have an
important place in medical aesthetic practice and
Occupational studies indicated that chronic exposure support previous studies that have shown the benefits
to high-intensity whole-body vibration might be of using vibration stimulus to increase patient comfort
associated with increased risk of headache, eyestrain, in other painful procedures.
spinal degeneration, and vascular or neural
changes.20,21 However, exposure to brief period of The authors’ qualitative analysis demonstrated that
topical vibration is not associated with any significant the majority of patients subjectively preferred the
temporary or permanent side effect. vibrated side. Although vibration anesthesia does not
eliminate pain completely, the technique could be used
Psychologically, subjects may also benefit from the in conjunction with other modalities if additional pain
vibration stimulation as a distraction from the injec- reduction is desired. In terms of clinical significance,
tion. It explains why some patients who rated an equal further research is needed to determine the change in
or more pain score on the vibration-treated side still pain intensity rating that can be deemed clinically
preferred to have vibration for the subsequent injec- significant.
tions. Their preference was influenced by a factor
other than pain reduction. This distraction effect was Whether vibration may be applied during other med-
also indicated in the patients’ statement. ical and cosmetic procedures needs further investiga-
tion. Besides, further study is needed to determine the
Reviewing the other similar studies, the authors optimal parameters of vibration as an anesthetic
adapted the study design. First, the study involved treatment. In this study, 44 of 53 patients experienced
injection sites more than just glabella lines. Currently less pain when BTX-A injections were coadministered
in China, BTX-A injections deal with not only facial with vibration, whereas 9 patients reported no pain
rhytid reduction but also lower face, shoulder, and alleviation quantitatively. This could be due to the
posterior leg contour reshaping. These procedures anatomy, the subjective nature of grading, or an ele-
require deeper injection and larger toxin dosage. The vated or lowered pain tolerance in certain patients. It is
authors noticed that there was no significant difference also possible that anesthetic effect may vary because of
on pain scores between the treated sides and the con- different vibration amplitude, frequency, or time of
trol sides for lower face (masseter) and lower face plus application. Also, the effect of age and sex needs to be
neck (masseter and platysma) (Table 3). Similarly, all 4 examined, and this could be undertaken with a larger
patients who rated a higher pain score on the treated sample size.
sides received lower face injections. A larger sample
size is needed to determine whether it means the Despite the results from this study, the authors rec-
vibration treatment on the skin does not affect deep ommend clinicians avoid using a vibration device
muscle injections, or optimized vibration parameters when injecting a particular site such as under-eye area
are required. Second, the authors used both BTX-A or a risky area where the vibration could cause liquid
products commercially available to evaluate whether medicine to spread into the orbit.
there would be any difference. Third, considering that
the VAS and preference question may not cover all the The authors did not include the subjects receiving filler
experience the patients had during the injection, the injection. The consideration was that BTX-A injection
authors also allowed them to state any possible feeling is a multiple-shot procedure, whereas filler injection
they might have for the vibration treatment in the third needs only 2 or 3 puncture sites whether a cannula or
part of the questionnaire. As it turned out, the patients’ a needle is applied. Although lidocaine-containing
statement allowed the authors to identify some issues formulation of a hyaluronic acid filler could alleviate

6 DERMATOLOGIC SURGERY

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LI ET AL

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