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The
purpose of this trial was to verify the effects of shockwave therapy on
localized adiposity through an experimental study that consisted of 4 weekly
treatment sessions, comparing 50 participants of age between 19 and 35 years
old, females, divided into two groups: the shockwave group (OC) and the group
of ultra-cavitation combined with shockwave (OC+UC). In combined OC+UC, the
results after intervention were greater if compared to OC the plicometry
outcome (p=0.001), comparing both groups, was significant. Analyzing the groups
alone, before and after treatment, significant difference of body weight was
noticed in group OC and in group OC+UC (p=0.03, p=0.02, respectively), making
it more challenging to draw any conclusion when it comes to the effectiveness
of isolated shockwave orits application in association to ultracavitation, as
both presented satisfactory results.
Keywords: Localized adiposity,
Physiotherapy, Shockwave, Mechanical waves
INTRODUCTION AND AIM
The lipolysis process happens through the
body’s need for energy, which comes from protein lipase production increase, so
that more combustion of accumulated and excess fats occurs. Even with the
immense variety of resources that are being used aiming lipolysis and the
consequent reduction of the localized adiposity excess, most are improperly
used or do not present scientifically proven efficacy [1].
The shockwave treatment is one of the tools that aim adiposity
reduction. The wave energy is transferred to the patient’s skin through the
ultrasound gel and it spreads in a radial fashion along the tissue. The energy
is higher at the applicator’s tip and it peripherally decreases by the distance
quadrate. The biological mechanisms by which the extracorporeal radial
shockwave therapy induces therapeutic effects in adipose tissue can make the
healing process easier through damaged a vascular tissues rupture, growth
factors release stimulation, stem cell recruitment and neovascularization [2].
Four reaction phases are postulated as occurring in the body. In the
physical phase, extracellular cavitation, molecules ionization and membrane
permeability increase occur. The physical-chemical phase consists of the
interaction between the diffused radicals and the biomolecules released by the
cells. As a consequence, the chemical phase occurs and it is characterized by
intracellular reactions. The biological phase is established if the changes
occurring in the chemical phase persists [3]. This phenomenon of the cavitation
as a trigger for the lipolysis process was
mentioned in the
studies of
The therapeutic applications of high
intensity ultrasound have gained new parameters, being used in the form of
cavitational ultrasound – also called ultracavitation – for the treatment of
localized adiposity. It is a system of selective action in the adipocytes,
without damaging blood micro vessels. This method consists of the generation of
vapor bubbles that implode in the interstitial zone of the connective tissue,
causing mechanical waves to selectively affect the adipocytes membranes,
releasing their stored fat [6].
Ultracavitation studies are still rare and
its effects have not been fully elucidated. According to Silva et al. [7] in a
descriptive study of 40 ultracavitation patients, the results showed a significant
decrease in localized fat. Another study by Meyer et al. [8], using animal as
subjects, exhibited prosperous effects on fat reduction after undergoing
ultracavitation.
Similar to shock waves, the
ultracavitation process and its implication need further investigation;
therefore, this study aims to investigate shockwaves as an alternative process
or agent for localized adiposity reduction, associated or not to
ultracavitation. More effective conservative treatments for localized adiposity
are constantly sought by researchers and professionals.
MATERIALS
AND METHODS
The study was featured as a blinded and
controlled clinical trial, which consists of the effectiveness testing of a
treatment. The selection of subjects was made under non-probabilistic convenience
and started after approval of the project by the Ethics Committee of the
Potiguar University. The primary sample consisted of 50 active volunteers (19
to 35 years old, female), divided into two groups (n=25). The selection had to
meet the following criteria: presence of infra-abdominal localized adiposity,
comprehension/cognitive ability, preserved local sensitivity and no circulatory
alterations. The exclusion criteria were applied to all individuals who did not
provide timely execution, who lacked participation in the proposed procedures
twice or more, those who did not agree with the proposed procedures, the ones
who were not interested in participating in the project or in using
anticoagulants. They were treated with four shockwave applications/sessions.
The groups were named: shock waves+ultracavitation group (OC+UC) and shock
waves group (OC). The choice of ultracavitation as a method to treat localized
adiposity is due to the already proven efficiency identified in previous
studies [1,7], in which the same equipment was used with the same parameters.
After study/sessions conclusion and according to the exclusion criteria, the
final sample consisted of 37 volunteers, whose results were compared and
analyzed (18 in the OC group and 19 in the OC+UC group). The instruments to
collect the data of this research were the Physiotherapeutic Evaluation
Protocol of Localized Adiposity (PAFAL), validated by Meyer et al. [8], which
addressed the following topics: identification, anamnesis, smoking habit, physical
examination, measurements and indicators such as: body weight, height, BMI,
skin folds and circumference measurements. A high frequency (7.5 MHz) SamsungTM
ultrasonography device, model XG was used for evaluation, as well as a NIKONTM
D5000 camera, the Liposonic ultracavitation device, model Meditea, Argentina
and the D-actor 200, Storz MedicalTM, Switzerland, used for the
shockwave treatment.
After selection,
the volunteers were guided on the procedures, and signed a consent form (TCLE).
Then, they were submitted to an evaluation under the PAFAL Validated Protocol,
for the collection of general and anthropometric data. Perimetry was registered
by measuring the abdominal circumference, 5 cm below the umbilical scar. The
plicometry was performed with a SannyTM plicometer, which has a
measurement range of 0 to 65 mm. The skin fold test was performed three times
in the infra-abdominal region, 5 cm below the umbilical scar and the result was
based on the mean values obtained in the three measurements.
Posteriorly, the volunteers underwent
ultrasound examination in the outlined infra-abdominal region, an area of 10
cm², below the umbilical scar. The ultrasound transducer was used with no
pressure to the skin, initially on the alba line and then moving left and
right, obtaining two measurements: US1 and US2. The photographs were taken
before and after treatment under the same parameters.
The application of the shock
waves was made with the subject in dorsal decubitus with the applicator
positioned in the same body area where the ultrasound was applied, that is, the
infra-abdominal region below the umbilical line. The device settings were:
intensity 3.4 bars, 4000 pulses and frequency of 16 Hz. The session time length
was approximately 10 min. Ultracavitation was effected in the same area, after
shockwave application, in the OC+UC group, using the following device settings:
frequency of 3 MHz, intensity of 70%, 21 min application. The treatment
consisted of one session per week, totalizing 4 sessions. The OC+UC group also received four
ultracavitation applications performed on the same day.
The photos were recorded in orthostatism and
frontal/lateral view (right) and the volunteer was asked to perform a 90°
shoulder flexion. The used camera was the same in all photos and positioned on
a 76 cm tripod placed 80 cm from the volunteer. The photos were forwarded to
the evaluators in a text file format (docx). This photogrammetry, suggested by
Mendonça et al. [9], has the purpose of analyzing any signs of clinical
improvement with “before and after” photos to verify the effects of shockwaves
on adipose tissue and to compare “before and after” treatment viewable changes.
Descriptive and inferential statistics were
performed through SPSS 20.0 (Statistical Package for the Social Science version
20.0). Data normality was observed using the Kolmogorov-Smirnov (KS) test. For
intragroup comparisons, whose data were parametric, the t-paired test was
applied. In the analysis between the groups, the t-independent test was
applied. The significance level was set at 5% (p<0.05). Qualitative data
(descriptive analysis of ultrasound images) were based on medical reports [10].
RESULTS
Fifty volunteers
were selected. At the end of the study, the results from 37 volunteers were
analyzed according to the exclusion criteria, 18 in the OC group and 19 in the
OC+UC group. Throughout the research, some volunteers withdrew. The withdrawal
occurred in greater quantity when scheduling the last evaluation, compromising
the result.
Initially, the Table
1 refers to the comparison between moment before and final moments.
Initially, the comparison between before and end,
perimetry OC (p=0.04) and OC+UC (p=0.02), plicometry (p=0.02) and OC+UC (p=0.001)
and ultrasound exams US1 OC (p=0.04) and OC+UC (p=0.04). The US2 OC (p=0.03)
and OC+UC (0.04).
The comparison between OC+UC and OC groups before
intervention was statistically effected regarding weight (p=0.21), BMI
(p=0.47), perimetry (p=0.64), plicometry (p=0.70) and ultrasound exams US1
(p=0.95) and US2 (p=0.49) and due to the non-significant results, the groups
were found to be homogeneous concerning such parameters.
Table 2 refers to the
evaluation comparison after the applications between the OC and OC+UC groups.
It was verified that in the OC group, the results after
the intervention were greater in comparison to OC+UC results. The result of the
plicometry (p=0.001) in the comparison between groups was substantial. The mean
values of weight (p=0.91), BMI (p=0.47), perimetry (p=0.30) and ultrasound
exams US1 (p=0.64) and US2 (p=0.35) did not present significant difference. In
the OC group, the averages remained larger after the intervention in comparison
to the OC+UC group.
However, when analyzing each group
separately before and after the intervention, it was noticed that, in the OC
group, mean weight increased from 68.16 kg to 68.83 kg and BMI from 20.88 to
21.07, besides reduction of the mean perimetry from 92.80 cm to 92.30 cm and
plicometry from 22.94 mm to 21.33 mm, increase of thickness of US1 fat layer
from 2.29 cm to 2.34 cm and reduction of US2 from 2.08 cm to 2.02 cm in
comparison to before and after the intervention. Therefore, there was a
statistically significant fluctuation in the weight variables (p=0.03),
perimetry (p=0.03) and plicometry (p=0.05). Nevertheless, there was no
statistically significant variation in BMI (p=0.22), US 1 (p=0.39) and US 2
(p=0.13).
The OC+UC group, when
isolatedly analyzed before and after the intervention, presented a reduction of
mean weight from 64.00 kg to 63.24 kg, BMI from 20.14 to 19.92, perimetry from
91 cm to 89.28 cm and plicometry of 21.05 mm to 16 mm. reducing the thickness
of the US1 fat layer from 1.95 cm to 1.93 cm and an increase in US2 from 1.40 cm
to 1.42 cm in comparison to before and after the intervention. It was verified
that there was a statistically significant fluctuation in the variables of
weight (p=0.02), perimetry (p=0.007) and plicometry (p=0.0001). However, there
was a statistically significant variation in BMI (p=0.21), US1 (p=0.68) and US2
(p=0.81).
Regarding the photogrammetry
analysis, each participant received scores varying from 0 to 10, according to
the results presented in the photos, attributed by expert evaluators in the area.
Table
2
presents the results of the evaluators on the clinical improvement based on the
photos analysis.
In both groups,
there was a clinical improvement in localized adiposity after the
interventions. Clinical improvement was observed by the evaluators in frontal
and lateral views in the OC group, respectively (71.1% frontal and 62.8%
lateral) and the OC+UC group (74.4% frontal and 77.8% lateral).
Table 3 presents the average of the evaluators' scores attributed
to the observed results.
It was verified that both
frontal (p=0.04) and lateral views (p=0.03) had the OC+UC group presenting
higher mean scores than the group that underwent shock wave intervention only (Table 4).
DISCUSSION
According to Adatto et al. [5],
high-impact (focal) planar waves have several effects on the cells and their
metabolism; among them it increases the permeability of the cell wall,
increases the release of fat and triglycerides, respectively, as well as
promotes regeneration of connective tissue. While the radial acoustic waves
(low impact), used in this study, have the feature of promoting the increase of
blood and lymphatic flow [11].
Nevertheless, other authors
affirm that shock waves produce rupture of the adipose membrane through
unstable cavitation, since it is a mechanical therapy [3]. According to Liang
et al. [4], through the observation of adipose tissue laminae in animals, it was
verified that adipose tissue is damaged by two types of mechanism: Compression
and cavitation. It is then believed that the effect of the compression pressure
causes shape modification with rupture of the adipose cells and that the
cavitation effect causes an irregularity and consequently, lipolysis.
Analyzing the OC group, it was
noticed that weight gain was significant after treatment, which may have had a
negative influence on shockwave results alone. On the other hand, the shockwave
group associated with ultracavitation (OC+UC) presented statistically
significant reduction of weight, perimetry, plicometry and in the ultrasound
examination, therefore, the results more satisfactory than in the OC group.
Literature states that the ultracavitation foments the vibration of the
adipocyte membrane, thus the microbubbles rupture and as they are close to the
adipocytes, they also end up having their membranes fragmented and promoting
fat spillage and flow, apart from preserving other tissue structures such as vessels,
nerves and especially the lymphatic system, which is essential for
triglycerides and diglycerides to be eliminated [1,3,6]. Yet, with the
significant influence of the weight reduction presented by the group, it is
difficult to consider that the results presented are only due to the
association of shock waves with ultracavitation.
Regarding the photogrammetry
analysis, the OC+UC group received higher scores and better clinical
improvement evaluation compared to the OC group, but despite this significant
result, the variable weight reduction may have contributed in this analysis.
Further studies, with greater
control of the volunteers of both groups concerning the weight variable are
suggested, so that there are no significant variations to interfere in the
results, as they make it difficult to analyze the localized physical agent
effect. Another suggestion is to increase the treatment period and, the number
of applications/sessions, as there are studies with 6 and 8 applications of
shockwaves which presented positive results. In the case of this study, the
lending period of the shockwave machine was only one month, limited to 04
applications [12].
CONCLUSION
OC group, which
performed the treatment using only shockwaves, compared to OC+UC group, which underwent
associated treatment (ultracavitation and shockwaves), presented poorer
results, showing that the conjunction of ultracavitation with shockwaves is
more effective than shockwaves alone for lipolysis effect. Upon plicometry,
this difference was statistically significant; in other words, the OC group
values were higher after treatment compared to the ones obtained with the OC+UC
group.
ACKNOWLEDGMENT
The authors thank the Potiguar
University – UnP and Biofísio Clinic, both located in the city of Natal – RN,
Brazil; who made their infrastructure available for this research.
1.
Meyer PF,
Carvalho MGF, Andrade LL, Lopes RNS, Delgado AM, et al. (2012) Efeitos da
ultracavitação no tecido adiposo de coelhos. Fisioterapia Brasil 13: 113-118.
2.
Malliaropoulos
N, Jury R, Pyne D, Padhiar N, Turner J, et al. (2016) Radial extracorporeal
shockwave therapy for the treatment of finger tenosynovitis (trigger digit).
Open Access J Sports Med 7: 143-151.
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Alves
ALG, Fonseca BPA, Nicoletti JLM, Hussni CA, Soare LV (2009) Tratamento de
desmite supra e interespinhosa em equinos utilizando a terapia por ondas de
choque extracorpóreas. Veterinária e Zootecnia 16: 143-151.
4.
Liang SM,
Yeh CN, Yan JJ, Wan LR, Lee JW (2008) An in
vitro experiment on lysing adipose tissue by shock waves. J Med Biol Eng
28: 203-209.
5.
Adatto
MA, Adatto-Neilson R, Novak P, Krotz A, Haller G (2011) Body shaping with
acoustic wave therapy AWT®/EPAT®: Randomized, controlled
study on 14 subjects. J Cosmetic Laser Ther 13: 291-296.
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Ronzio
OA, Antonelli C, Fuchs K, Brienza D, Deveikis I, et al. (2012) Ultracavitación
de Baja Frecuencia. Catussaba 1: 11-20.
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Silva
RMV, Meyer PF, Santos BR, Félix JLO, Ronzio OA (2015) Efectos Del ultrasonido
de alta potencia em La adiposidad localizada. Fisioterapia Revista de
SaludDiscapacidade y TerapeuticaFisica 37: 55-59.
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Mendonça
AG, Rodrigues RD, Corradi DP, Cruz LB, Meyer PF, et al. (2008) Protocolo de
avaliação fisioterapêutica em adiposidade localizada. Fisioterapia Brasil Suplemento
Especial, pp: 26-31.
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AMS, Pádual M, Ribeiro AP, Milani GB, João SMA (2009) Confiabilidade e
interexaminadores da fotogrametria na classificação do grau de
lipodistrofiaginóide em mulheres assintomáticas. Fisioterapia e Pesquisa 16:
102-106.
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Bonfanti
PLA, Paula MRD, Simoes NDP (2013) Análise das taxas lipídicas sanguíneas no
tratamento com tecnologia de ultracavitação. Faculdade Cidade Verde Faculdade
de Tecnologia Ibrate. Tese de Doutorado 24 f.
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Jens UQ,
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Aesthetic Guide Spring 1: 1-11.
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Liang SM,
Zheng KF, Yan JJ, Wan RR, Wen CY (2009) Animal study on lysing adipose tissues
by shock waves. J Med Biol Eng 30: 145-151.
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Table 1 -
Table 2
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Table 3
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Table 4
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