Brazilian Journal of Physical Therapy 2020;24(5):441---448

Brazilian Journal of
Physical Therapy
https://www.journals.elsevier.com/brazilian-journal-of-physical-therapy

ORIGINAL RESEARCH

Effects of cryolipolysis on lower abdomen fat thickness

of healthy women and patient satisfaction: a
randomized controlled trial
Mariana Falster a , Jociane Schardong a , Débora Piassarollo dos Santos a ,
Bruna Coimbra Machado a , Alessandra Peres b , Patrícia Viana da Rosa a ,
Rodrigo Della Méa Plentz a,∗

a
Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil
b
Department of Basic Health Sciences, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS,
Brazil

Received 27 February 2019; received in revised form 6 July 2019; accepted 12 July 2019
Available online 26 July 2019

KEYWORDS Abstract
Subcutaneous fat; Objective: To analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of
Adiposity; healthy women and patient’s satisfaction.
Cryotherapy; Methods: Design and setting: a randomized controlled trial, with concealed allocation and
Cryolipolysis; blinded assessor. Participants: 34 healthy women between 18 and 48 years, skinfold in the
Physical therapy; lower abdomen ≥3 cm, BMI between 18.5 and 27 kg/m2 , low level of physical activity, and no
Randomized clinical contraindication to cryolipolysis were allocated to intervention group (IG, n = 17) or control
trial group (CG, n = 17). Interventions: The IG received one session of cryolipolysis with −10 ◦ C of
temperature for 50 min. The CG was not submitted to any kind of intervention. Both groups did
the evaluation protocols at baseline, 30, 60 and 90 days after the intervention. Main outcome
measures: fat thickness was measured by ultrasonography (US), skinfold (SF) and abdominal
circumference (AC1 and AC2).
Results: No significant differences between the IG and CG were demonstrated at any evaluation
at any time of follow up for the variables US (30 days: 0.05 cm (95%CI: −0.12; 0.22), 60 days:
0.05 cm (95%CI: −0.11; 0.20) and 90 days: 0.04 cm (95%CI: −0.7; 0.25)), SF (30 days: −0.09 cm
(95%CI: −0.25; 0.08), 60 days: −0.14 cm (95%CI: −0.36; 0.09) and 90 days: −0.001 cm (95%CI:
−0.237; 0.234)), AC1 (30 days: 0.42 cm (95%CI: −1.1; 1.9), 60 days: −0.1 cm (95%CI: −1.74;
1.54) and 90 days: −0.007 cm (−1.9; 1.9)) and AC2 (30 days: 0.183 cm (95%CI: −0.84; 1.20), 60
days: −0.13 cm (95%CI: −1.61; 1.35) and 90 days: −0.31 cm (95%CI: −1.61; 1.00)).

∗ Corresponding author at: Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Rua: Sarmento Leite, 245, CEP: 90050-170,

Porto Alegre, Rio Grande do Sul, Brazil.

E-mail: [email protected] (R.D. Plentz).

https://doi.org/10.1016/j.bjpt.2019.07.005
1413-3555/© 2019 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Published by Elsevier Editora Ltda. All rights reserved.
442 M. Falster et al.

Conclusions: The current study showed that a single application of the utilized protocol of
cryolipolysis does not produce any significant effect on fat thickness of the lower abdomen of
healthy women.
Clinical Trial Registration number: NCT03160976 (https://clinicaltrials.gov/ct2/show/
NCT03160976).
Contribution of the Paper: the study is one of the first studies in the literature with method-
ological rigor to report an unfavorable result for localized abdominal fat treatment with a single
session of cryolipolysis.
© 2019 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Published by Elsevier
Editora Ltda. All rights reserved.

Introduction healthy women through a randomized controlled trial with

a blinded assessor.
Socio-cultural aspects, such as the idealization of skinny
and physically perfect bodies, influence female body
perception.1,2 Diets, exercises and esthetic procedures Methods
are alternatives that may help improve the perception
of physical appearance.3---6 Therefore, a few modalities,
Study design and ethical aspects
have been developed for the purpose of sculpting the
body and reducing localized fat more safely and non-
A randomized, controlled trial with outcomes assessor blind-
invasively, such as cryolipolysis.5,7 This technology uses
ing was conducted. The thickness of the subcutaneous
low temperatures8,9 to induce a process of apoptosis and
adipose layer was considered the primary endpoint. Pain,
inflammation that will eliminate the adipocytes and con-
adverse effects and satisfaction were considered as sec-
sequently reduce the adipose layer of the treated region.3
ondary outcomes. The project was approved by the Ethics
According to Manstein et al.,10 this technique generates
Committee of the Universidade Federal de Ciências da Saúde
prolonged, localized and controlled cooling which is capa-
de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil (report
ble of damaging the fatty tissue without damaging the skin
number 1.970.012). It was also prospectively registered
and other adjacent tissues.10 This selective lesion occurs
at Clinical-Trials.gov (NCT03160976 identifier) and written
due to the greater susceptibility of the fat cells to cold
informed consent was obtained from all subjects prior to
exposure.11,12
any procedure.
Research on cryolipolysis has been growing and new evi-
dence is available. The latest systematic review showed
that reduction of the adipose layer can approach 30% per
treated region.3,5 There are a few clinical trials showing Settings and participants
that the reduction of the fat layer can reach 17.4%---20.4%
after 2 months13,14 and 21.5%---25.5% after 6 months of All procedures were conducted at the Physical Therapy Lab-
treatment.7,14 In addition, an epidemiological study showed oratory of UFCSPA between May and October 2017. The
that two sessions per area were required to obtain some individual was enrolled by verbal invitation and electronic
satisfactory result, with the exception of the abdomen that folders in social media and the recruitment was done in the
acquired satisfactory results with only 1 session in 21% of city of Porto Alegre, mainly among the university’s inter-
the cases.15 nal community and university students. Inclusion criteria
Although the literature reports the efficacy and safety were: women between 18 and 48 years; skinfold in the lower
of cryolipolysis4,7,14,16---18 this evidence has some method- abdomen region ≥3 cm; body mass index (BMI) between 18.5
ological issue, such as nonrandomization and no comparator and 27 kg/m2 ,21 low level of physical activity according to
group, which may result in important biases. Also, there is the International Physical Activity Questionnaire (IPAQ).22
no consensus in the literature regarding the ideal treatment Cold intolerance, cryoglobulinemia, cold-induced
protocol, like parameters of the device, periodicity and urticaria, paroxysmal cold hemoglobinuria, Raynaud’s
number of sessions required per body region.3,5 Another con- disease, current or recent pregnancy, areas of hypoes-
tradictory point concerns the population that presents the thesia in the abdomen, cutaneous lesion, skin disease,
best therapeutic response, since the studies do not present skin laxity, skin healing problems, sickle cell anemia,
a specific range of body mass index.13,19,20 chronic infections, cardiovascular or metabolic diseases,
These divergences between studies are a factor of impre- use of anti-inflammatory drugs, antidyslipidemic drugs,
cision for clinical decision-making and elaboration of the immunosuppressants or anticoagulants, umbilical hernia,
treatment plan. Thus, the objective of the present study was surgeries in the abdominal region, muscular diastasis and up
to evaluate the effects of one single session of cryolipolysis to 5% weight change throughout the study were considered
on the subcutaneous adipose layer thickness of the lower exclusion criteria. All volunteers were instructed not to
abdomen, adverse effects, pain and patient satisfaction of change their daily living, eating and physical activity habits
Effects of cryolipolysis on lower abdomen 443

and also were not to be submitted to any other esthetic of the expiration movement. Then the demarcations were
intervention throughout the study. transcribed onto an individual map to ensure that follow
up images were made at the same points. These 3 images
Randomization were analyzed with the ImageJ software. To measure the fat
layer thickness of each image, five cuts were made from the
The randomization was performed using the online soft- internal border of the dermis to the superficial aponeuro-
ware www.random.org. The random sequence of numbers sis of the rectus abdominis muscle23 (Fig. 1B). These cuts
was generated by a researcher external to the study team gave a mean value for each image, and these 3 images
and concealment of the allocation was assured until the gave a mean value of the fat layer for each side of the
moment of the intervention, stored in opaque envelopes. lower abdomen. The average thickness for the entire lower
The volunteers were allocated to the intervention group (IG) abdomen was then calculated using the following equa-
or to the control group (CG) by a researcher who did not tion: mean value right side + mean value left side divided
apply the intervention or evaluated the outcomes. The IG by 2.
received one application in a single session of cryolipoly- The skinfold measurements were obtained with the vol-
sis in the lower abdomen within 15 days after the baseline unteers in the orthostatic position at 1 cm below and 3 cm
assessment and performed the evaluation protocol. The CG to the right side of the umbilical scar and the plicometer
was only evaluated and re-evaluated throughout the follow- (Cescorf, Mitutoyo, Brazil) was positioned in parallel to the
up. transversal axis of the body.24 Three consecutive measures
were performed and the average value was used for each
skinfold measurement time.25
Evaluations Abdominal circumference was measured with a tape
measure (RCM. Brazil) positioned parallel to the floor and at
All evaluations were performed at baseline, 30, 60 and two points on the same region of the skinfold and ultrasound
90 days after cryolipolysis by the same researcher blinded images: umbilical scar line (AC1) and 3 cm below (AC2).26
to the allocation. The volunteers did not perform the
assessments in the pre-menstrual or menstrual period.
Anthropometric data such as body weight, height and BMI
were evaluated during the follow up only for characteri-
zation of the sample and for the eligibility criteria, with
participants altering their baseline BMI and body weight Evaluation of pain, adverse effects and satisfaction
more than 5% of baseline being excluded from the study.
A numerical pain rating scale (NPRS) was used during cry-
Evaluations of the adipose layer thickness olipolysis session to register the pain level of the GI at the
following moments: (M1) first minutes of treatment, (M2)
Ultrasound equipment (GE Vivid I Ultrasound, General Elec- half of treatment, (M3) end of treatment, (M4) during mas-
tric Company, USA) with a high-resolution linear transducer sage.
(8 L) of 7.5 MHz and depth of 8 cm was used to capture the For the record of the adverse effects, the research team
images of the adipose layer of the lower abdomen. This contacted the participants 15 and 30 days after the inter-
evaluation was performed with the subject in dorsal decu- vention. The Individual Global Esthetic Improvement Scale
bitus position, with the transducer placed parallel to the (IGAIS) was also used to assess the perception of the results
longitudinal axis of the body and the points marked for skin- obtained: 0 --- no change, 1 --- mild improvement, 2 --- moder-
fold were used as reference (Fig. 1A). Three images were ate improvement and 3 --- significant improvement with the
obtained on each side of the lower abdomen at the end treatment.7

Fig. 1 (A) Ultrasound measurement, (B) image measurement: (x) internal border of the dermis, (y) superficial aponeurosis of the
rectus abdominis muscle and (z) inferior aponeurosis of the rectus abdominis muscle.
444 M. Falster et al.

Intervention protocol promoted initial heating of 3 min followed by progressive

and continuous cooling. The treatment parameters were
Cryolipolysis was performed with the Crio Top Body Redux adapted from the Kilmer protocol27 and the findings of the
equipment (Advice, RO & SU IND E COM, LTDA, Brazil), review conducted by Derrick et al.3 : temperature of −10 ◦ C,
which is registered with ANVISA under number 80093310027 total time of application of 50 min and moderate vacuum
and pre-calibrated. During the application the room tem- pressure. As soon as the single cooling device was posi-
perature was maintained between 18 ◦ C and 25 ◦ C and the tioned in the target region, suction in the continuous mode
volunteers were positioned in supine with a 45◦ elevation was activated and small circular movements were made to
of the trunk. The area for placing the antifreeze mem- better couple the skinfold. At the end of treatment, the
brane (Iceprotection. Multigel Industria e Comercio --- Brazil. membrane was removed and the area was massaged for
ANVISA 8.03.161-1) and for the application was demarcated 5 min with kneading movements to stimulate local blood
based on the individual evaluation map. The cryolipolysis reperfusion and to normalize the appearance of the skin.7
was executed by a single researcher, who was only respon- The volunteers were aware that they could stop the proce-
sible for the intervention. The treatment protocol used dure at any moment.

Assessed for eligibility (n = 44)

Excluded (n = 6)
♦ Did not meet inclusion criteria
(n = 3)
♦ Other reasons (n = 3)

Randomized (n = 38)

Allocated to intervention group (n = 19) Allocated to control group (n = 19)

♦ Received allocated intervention (n = 19) ♦ Received allocated intervention (n = 19)
♦ Did not receive allocated intervention ♦ Did not receive allocated intervention
(n = 0) (n = 0)

Lost to follow-up (n = 2) Lost to follow-up (n = 2)

Weight variation above 5% (n = 1) Weight variation above 5% (n = 2)

Withdrawal (n = 1) Withdrawal (n = 0)

Analysed (n = 17) Analysed (n= 17)

♦ Excluded from analysis (n = 0) ♦ Excluded from analysis (n = 0)

Fig. 2 Flowchart of the study.

Effects of cryolipolysis on lower abdomen 445

Statistical analysis The median point on NPRS was 7 (range 3---8) at M1, also
7 (range 5---10) at M4, 3 (range 1---5) at M2 and 2 (range
The sample size was calculated with the GPower soft- 1---5) at M3. None of the volunteers interrupted the pro-
ware (version 3.1) based on the study of Mahmoud cedure due to pain. The most reported side effects were
et al.13 , using skinfold values (IG: 25.14 mm ± 2.79 and CG: change in sensitivity, bruises, petechia, edema, pain and
27.69 mm ± 2.73) after cryolipolysis intervention. The level itchiness which resolved within the first 30 days after inter-
of significance was set at 5% and statistical power was set at vention.
80%. Thus, the sample size established was of 14 individuals The IGAIS, that evaluated the patient’s satisfaction,
per group. showed that 59% of the participants noticed no change after
The normality of the data was verified with Shapiro---Wilk. the protocol, while only 18% and 23% of them reported slight
Quantitative data were presented through mean, standard and moderate improvements, respectively. None of the indi-
deviation and frequencies. The main effects of the cry- viduals of the IG reported great improvement.
olipolysis on the studied outcomes were evaluated through
Generalized Estimation Equations (GEE) and the post-hoc
Bonferroni. An ANCOVA was use to calculate difference Discussion
between groups and 95% confidence intervals. The analyses
were performed by protocol in SPSS 23.0 software (Chicago, We aimed to evaluate the effects of a cryolipolysis proto-
USA) and the significance level adopted was 5%. col on the thickness of the lower abdomen adipose layer of
women. No significant changes were noticed between the
groups at any follow up time points. The current study is
Results one of the first studies to report an unfavorable result for
this localized fat treatment adding to the scientific litera-
Forty-four women were evaluated for eligibility criteria, but ture new observations about the application of cryolipolysis
only 38 were included for randomization and 34 completed on the lower abdomen of healthy women.
the study. Fig. 2 shows the detailed flowchart of participant Sasaki et. al. treated 55 abdomens with a cooling inten-
selection, group allocation and follow up losses. The groups sity factor (CIF) of 42 (−72.9 mW/cm2 ) for 60 min followed
were homogeneous at the beginning of the study as can be by massage and found a decrease of 27% (average of 1 cm)
seen in Table 1. of the skinfold between baseline and 6 months after a single
No significant differences were demonstrated between application.7 With the same treatment protocol, Boey and
the IG and CG at any evaluation time for fat thickness mea- Wasilenchuk17 evaluated 9 abdomens with ultrasound and
sured by US (30 days: 0.05 cm (95% CI −0.12, 0.22), 60 days: reported a mean reduction of 12.6% ± 7.2% (0.26 ± 0.19 cm)
0.05 cm (95% CI −0.11, 0.20) and 90 days: 0.04 cm (95% CI on the non-massaged side and 21% ± 8.5% (0.42 ± 2.2 cm) on
−0.7, 0.25)), SF (30 days: −0.09 cm (95% CI 0.25, 0.08), 60 the massaged side after two months.17 However, is impor-
days: −0.14 cm (95% CI −0.36, 0.09) and 90 days: −0.001 cm tant to be careful when interpreting these findings due to
(95% CI −0.24, 0.23)), AC1 (30 days: 0.42 cm (95% CI −1.14, the absence of a control group.
1.9), 60 days: −0.1 cm (95% CI −1.74, 1.54) and 90 days: Even though no favorable results were found for the
−0.007 cm (−1.9, 1.9)) and AC2 (30 days: 0.18 cm (95% CI reduction of the fatty layer, our treatment protocol was
−0.84, 1.20), 60 days: −0.13 cm (95%CI: −1.61, 1.35) and based on previous studies that demonstrated the efficacy
90 days: −0.31 cm (95%CI: −1.61, 1.00)). See Table 2. of cryolipolysis.3,27 Moreover, we chose an intervention pro-
tocol that resembled the clinical practice, since there is
still no consensus in the literature regarding the parame-
Table 1 Characteristics of the groups at baseline. ters of the device, periodicity and number of sessions.3,5
IG (n = 17) CG (n = 17) The CIF values vary between 33 (−64 mW/cm2 ) and 42
(−72 mW/cm2 ),3 or go up to −15 ◦ C.8,9 The minimum appli-
Age (years) 24.94 ± 5.04 29.35 ± 8.77
cation time reported is of 30 min while the maximum time
Weight (kg) 63.05 ± 6.07 62.14 ± 6.69
is of 120 min/cycle.3 An in vivo study with subdermal analy-
Height (m) 1.62 ± 0.06 1.63 ± 0.07
sis observed that when performing an external exposure to
BMI (kg/m2 ) 23.93 ± 1.26 23.43 ± 1.72
cold with CIF of 42 for 60 min, the adipose tissue can reach
Skinfold (cm) 3.66 ± 0.46 3.64 ± 0.50
temperatures between 7 ◦ C and 17 ◦ C.7 According to Pinto
US (cm) 3.33 ± 0.40 3.28 ± 0.59
et al.,28 direct exposure of adipose cells (in vitro) at 8 ◦ C
AC1 (cm) 85.79 ± 5.94 84.79 ± 5.81
for 10 or 25 min induces lipid crystallization.28 We applied
AC2 (cm) 89.56 ± 5.10 88.38 ± 5.03
the cryolipolysis for 50 min and used −10 ◦ C external expo-
Use of contraceptive pill 82.4 (14) 76.5 (13)
sure temperature, equivalent to a CIF of 42,29 which fits the
% (n)
parameters noted above.
Pregnancy history % (n) The adverse effects found are in agreement with those
Yes 11.8 (2) 35.3 (6) already reported in the literature: erythema, pruritus,
No 88.2 (15) 64.7 (11) edema, altered sensitivity and pain.5 The pain was more
Data are expressed in mean ± SD and frequency. IG, interven- intense in the first minutes of intervention, but tolerable,
tion group; CG, control group; n, number of participants; BMI, considering that no volunteer asked to interrupt the pro-
body mass index; US, ultrasound measurement; AC1, abdominal cedure. These findings are similar to the ones reported by
circumference at umbilical scar; AC2, abdominal circumference Dierickx et al.,30 who reported that 96% of the subjects
3 cm under the umbilical scar. reported minimal discomfort during the procedure and only
446 M. Falster et al.

Table 2 Behavior of fat thickness variables during follow up.

Baseline 30 days 60 days 90 days
Ultrasound (cm)
IG 3.32 ± 0.39 3.26 ± 0.41 3.29 ± 0.43 3.33 ± 0.44
CG 3.28 ± 0.57 3.16 ± 0.63 3.2 ± 0.62 3.23 ± 0.67
Between-group differences (95% CI) 0.05 (−0.12, 0.22) 0.05 (−0.11, 0.20) 0.04 (−0.7, 0.25)
Skinfold (cm)
IG 3.66 ± 0.45 3.72 ± 0.47 3.61 ± 0.51 3.55 ± 0.51
CG 3.64 ± 0.49 3.77 ± 0.57 3.71 ± 0.64 3.55 ± 0.61
Between-group differences (95% CI) −0.09 (0.25, 0.08) −0.14 (−0.36, 0.09) −0.001 (−0.24, 0.23)
AC1 (cm)
IG 85.79 ± 5.76 85.35 ± 6.24 84.44 ± 6.05 84.23 ± 6.28
CG 84.79 ± 5.63 83.91 ± 6.11 83.56 ± 6.00 83.36 ± 6.36
Between-group differences (95% CI) 0.42 (−1.14, 1.9) −0.1 (−1.74, 1.54) −0.007 (−1.9, 1.9)
AC2 (cm)
IG 89.56 ± 4.95 89.06 ± 5.40 88.52 ± 5.65 88.5 ± 5.83
CG 88.38 ± 4.88 87.56 ± 5.93 87.38 ± 5.75 87.31 ± 6.73
Between-group differences (95% CI) 0.18 (−0.84, 1.20) −0.13 (−1.61, 1.35) −0.31 (−1.61, 1.00)
Data are mean ± SD. IG, intervention group; CG, control group; AC1, abdominal circumference at umbilical scar; AC2, abdominal
circumference 3 cm under the umbilical scar.

4% reported severe pain, which also occurred within the first between 18.5 and 27 kg/m2 , since the literature lacks evi-
few minutes of treatment and also did not cause discontin- dence with high methodological rigor. In addition, there
uation of treatment.30 are some studies that have already demonstrated the
The observation of any changes in the fat thickness of benefits of cryolipolysis after more than one session,32,33
the IG at any assessment time reflected on the results of the even associated with diet13 or with other therapeutic
IGAIS. While 59% of the subjects in our intervention group resources such as shock waves.34 However, besides the
did not notice any change after treatment, the individual in study design these studies have different populations,13
the study by Sasaki et al.7 showed a significant improvement parameters and periodicity13,32---34 and outcomes.34 Despite
of the fat thickness and reported a moderate change in body this, the studies mentioned above should be taken into
remodeling after cryolipolysis.7 account and new research is encouraged, with method-
Among the limitations of this study we can mention the ological rigor, whether cryolipolysis associated with other
absence of a food diary referring to the nutritional habits resources or diet or with more than one session is
of volunteers and a better control of the level of physical able to reduce the infra-abdominal fat layer of healthy
activity, two topics that would have helped us to better women.
characterize and analyze the sample during the follow up.
Although it is difficult to blind the volunteers due to the Conclusion
characteristics of the treatment, maybe a placebo applica-
tion could have been used so that the bias of the absence
of treatment could be minimized. The absence of biochem- A single session of the cryolipolysis with the protocol used
ical analyzes can also be considered a limitation of the was not effective for reducing infra-abdominal adipose layer
study, since these could help in the understanding of our thickness after 30, 60 and 90 days of its application. Also,
findings. the majority of the healthy women were not satisfied since
Despite the limitations, this is the first randomized the treatment did not show an improvement in fat thick-
clinical trial with blinded assessor of the outcomes that eval- ness. Cryolipolysis caused pain and some adverse effects,
uated the effect of a single application/session cryolipolysis such as change in sensitivity, bruises, petechia, edema, and
on the thickness of the adipose layer in healthy women com- itchiness, that were quickly resolved.
pared to a control group. The design is one of the strengths
of this study, since randomized controlled trials are the gold Acknowledgement
standard to analyze the efficacy of an intervention.31 Our
This research did not receive any specific grant from fund-
study also stands out for including only one gender, one
ing agencies in the public, commercial, or not-for-profit
specific range of BMI and for respecting the physiological
sectors.
menstruation period.
Finally, the results of this study should be consid-
ered to help clinical decision regarding the use of this Conflicts of interest
therapy in healthy Brazilian women between 18 and 48
years old, with low level of physical activity and BMI The authors declare no conflicts of interest.
Effects of cryolipolysis on lower abdomen 447

Appendix A. Supplementary data gordura localizada. Surg Cosmet Dermatol. 2015;7(4):316---319,

http://dx.doi.org/10.5935/scd1984-8773.201574697.
Supplementary data associated with this article can be 16. Grant Stevens W, Pietrzak LK, Spring MA. Broad overview
found, in the online version, at doi:10.1016/j.bjpt.2019. of a clinical and commercial experience with coolsculpting.
07.005. Aesthet Surg J. 2013;33(6):835---846, http://dx.doi.org/10.
1177/1090820X13494757.
17. Boey GE, Wasilenchuk JL. Enhanced clinical outcome with man-
References ual massage following cryolipolysis treatment: a 4-month study
1. Moraes C, Anjos LA, Marinho SMSA. Construção, adaptação of safety and efficacy. Lasers Surg Med. 2014;46(1):20---26,
e validação de escalas de silhuetas para autoavaliação http://dx.doi.org/10.1002/lsm.22209.
do estado nutricional: uma revisão sistemática da lit- 18. Stevens WG, Bachelor EP. Cryolipolysis conformable-surface
eratura. Cad Saude Publ. 2012;28(1):7---20, http://dx.doi. applicator for nonsurgical fat reduction in lateral thighs.
org/10.1590/S0102-311X2012000100002. Aesthetic Surg J. 2015;35(1):66---71, http://dx.doi.org/
2. Lykins AD, Ferris T, Graham CA. Body region dissatisfaction 10.1093/asj/sju024.
predicts attention to body regions on other women. Body 19. Mostafa MSEM, Elshafey MA. Cryolipolysis versus laser lipol-
Image. 2014;11(4):404---408, http://dx.doi.org/10.1016/j. ysis on adolescent abdominal adiposity. Lasers Surg Med.
bodyim.2014.05.003. 2016;48(4):365---370, http://dx.doi.org/10.1002/lsm.22475.
3. Derrick CD, Shridharani SM, Broyles JM. The safety and 20. Boey GE, Wasilenchuk JL. Fat reduction in the inner
efficacy of cryolipolysis: a systematic review of available lit- thigh using a prototype cryolipolysis applicator. Derma-
erature. Aesthetic Surg J. 2015;35(7):830---836, http://dx.doi. tol Surg. 2014;40(9):1004---1009, http://dx.doi.org/10.1097/
org/10.1093/asj/sjv039. 01.DSS.0000452628.99209.4f.
4. Garibyan L, Sipprell WH, Jalian HR, Sakamoto FH, Avram 21. Nevill AM, Metsios GS. The need to redefine age- and
M, Anderson RR. Three-dimensional volumetric quantifica- gender-specific overweight and obese body mass index cut-
tion of fat loss following cryolipolysis. Lasers Surg Med. off points. Nutr Diabetes. 2015;5(11):e186---e192, http://dx.
2014;46(2):75---80, http://dx.doi.org/10.1002/lsm.22207. doi.org/10.1038/nutd.2015.36.
5. Ingargiola MJ, Motakef S, Chung MT, Vasconez HC, Sasaki 22. Matsudo S, Araújo T, Matsudo V, et al. Questionário Inter-
GH. Cryolipolysis for fat reduction and body contour- nacional De Atividade Física (Ipaq): Estupo De Validade
ing: safety and efficacy of current treatment paradigms. E Reprodutibilidade No Brasil. Rev Bras Atividade Física
Plast Reconstr Surg. 2015;135(6):1581---1590, http://dx.doi. Saúde. 2001;6(2):5---18, http://dx.doi.org/10.12820/rbafs.
org/10.1097/PRS.0000000000001236. v.6n2p5-18.
6. Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri 23. Toomey C, Mccreesh K, Leahy S, Jakeman P. Technical consid-
K. Non-invasive subcutaneous fat reduction: a review. erations for accurate measurement of subcutaneous adipose
J Eur Acad Dermatology Venereol. 2015;29(9):1679---1688, tissue thickness using B-mode ultrasound. Sage J. 2011:91---96.
http://dx.doi.org/10.1111/jdv.12994. 24. Heywaid V, Stolarczyk L. Avaliação Da Composição Corporal
7. Sasaki GH, Abelev N, Tevez-Ortiz A. Noninvasive selec- Aplicada: Fundamentos Da Composição Corporal. São Paulo:
tive cryolipolysis and reperfusion recovery for localized Manole; 2000.
natural fat reduction and contouring. Aesthetic Surg 25. Guedes DP. Clinical procedures used for analysis of the
J. 2014;34(3):420---431, http://dx.doi.org/10.1177/ body composition. Braz J Kinanthropometry Hum Perform.
1090820X13520320. 2012;(July):113---129, http://dx.doi.org/10.5007/1980-0037.
8. Borges S, Scorza FA. Fundamentos de criolipólise [Fundamen- 2013v15n1p113.
tals of cryolipolysis]. Fisioterapia Ser. 2014;9:219---224. 26. Agarwal SK, Misra A, Aggarwal P, et al. Waist circum-
9. Leal Silva H, Carmona Hernandez E, Grijalva Vazquez M, ference measurement by site, posture, respiratory phase,
Leal Delgado S, Perez Blanco A. Noninvasive submental fat and meal time: implications for methodology. Obesity.
reduction using colder cryolipolysis. J Cosmet Dermatol. 2009;17(5):1056---1061, http://dx.doi.org/10.1038/oby.2008.
2017;16(4):460---465, http://dx.doi.org/10.1111/jocd.12383. 635.
10. Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski 27. Kilmer SL. Prototype CoolCup cryolipolysis applicator with over
D, Anderson RR. Selective cryolysis: a novel method of non- 40% reduced treatment time demonstrates equivalent safety
invasive fat removal. Lasers Surg Med. 2008;40(9):595---604, and efficacy with greater patient preference. Lasers Surg Med.
http://dx.doi.org/10.1002/lsm.20719. 2017;49(1):63---68, http://dx.doi.org/10.1002/lsm.22550.
11. Epstein EH OM Jr. N Engl J Med. 1970;282(5):966---967. 28. Pinto H, Arredondo E, Ricart-Jané D. Evaluation of adipocytic
12. Beacham BE, Cooper PH, Buchanan CS, Weary PE. changes after a simil-lipocryolysis stimulus. Cryo-Letters.
Equestrian cold panniculitis in women. Arch Derma- 2013;34(1):100---105.
tol. 1980;116(9):1025---1027, http://dx.doi.org/10.1001/ 29. Harrington JL, Capizzi PJ. Cryolipolysis for nonsurgical
archderm.1980.01640330063014. reduction of fat in the lateral chest wall post-mastectomy. Aes-
13. Mahmoud ELdesoky MT, Mohamed Abutaleb EE, Mohamed thet Surg J. 2017;37(6):715---722, http://dx.doi.org/10.1093/
Mousa GS. Ultrasound cavitation versus cryolipolysis for non- asj/sjw250.
invasive body contouring. Aust J Dermatol. 2015;(January), 30. Dierickx CC, Mazer JM, Sand M, Koenig S, Arigon V. Safety,
http://dx.doi.org/10.1111/ajd.12386. tolerance, and patient satisfaction with noninvasive cry-
14. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. olipolysis. Dermatol Surg. 2013;39(8):1209---1216, http://dx.
Clinical efficacy of noninvasive cryolipolysis and its effects on doi.org/10.1111/dsu.12238.
peripheral nerves. Aesthetic Plast Surg. 2009;33(4):482---488, 31. Schulz KF, Altman DG, Moher D. CONSORT 2010 state-
http://dx.doi.org/10.1007/s00266-008-9286-8. ment: updated guidelines for reporting parallel group
15. Almeida GOO, Antonio CR, Oliveira GB, et al. Estudo epi- randomised trials. BMJ. 2010;340(Mar (1)):c332, http://dx.
demiológico de 740 áreas tratadas com criolipólise para doi.org/10.1136/bmj.c332.
448 M. Falster et al.

32. Brightman L, Geronemus R. Can Second Tx Enhance 34. Ferraro GA, De Francesco F, Cataldo C, Rossano F, Nico-
Clinical Results in Cryolipo 2.pdf; 2011:85---88. letti G, D’Andrea F. Synergistic effects of cryolipolysis and
33. Shek SY, Chan NPY, Chan HH. Non-invasive cryolipolysis for shock waves for noninvasive body contouring. Aesth Plast
body contouring in Chinese --- a first commercial experi- Surg. 2012;36(3):666---679, http://dx.doi.org/10.1007/s00266-
ence. Lasers Surg Med. 2012;44(2):125---130, http://dx.doi. 011-9832-7.
org/10.1002/lsm.21145.