Mariana Falster1, Jociane Schardong1, Débora Piassarollo Dos Santos1, Bruna Coimbra Machado1, Alessandra Peres2, Patrícia Viana da Rosa1, Rodrigo Della Méa Plentz3. 1. Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. 2. Department of Basic Health Sciences, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. 3. Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: roplentz@yahoo.com.br.
Abstract
OBJECTIVE: To analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of healthy women and patient's satisfaction. METHODS: Design and setting: a randomized controlled trial, with concealed allocation and blinded assessor. PARTICIPANTS: 34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥3cm, BMI between 18.5 and 27kg/m2, low level of physical activity, and no contraindication to cryolipolysis were allocated to intervention group (IG, n=17) or control group (CG, n=17). INTERVENTIONS: The IG received one session of cryolipolysis with -10°C of temperature for 50min. 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: 0.05cm (95%CI: -0.12; 0.22), 60 days: 0.05cm (95%CI: -0.11; 0.20) and 90 days: 0.04cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09cm (95%CI: -0.25; 0.08), 60 days: -0.14cm (95%CI: -0.36; 0.09) and 90 days: -0.001cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42cm (95%CI: -1.1; 1.9), 60 days: -0.1cm (95%CI: -1.74; 1.54) and 90 days: -0.007cm (-1.9; 1.9)) and AC2 (30 days: 0.183cm (95%CI: -0.84; 1.20), 60 days: -0.13cm (95%CI: -1.61; 1.35) and 90 days: -0.31cm (95%CI: -1.61; 1.00)). 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 methodological rigor to report an unfavorable result for localized abdominal fat treatment with a single session of cryolipolysis.
RCT Entities:
OBJECTIVE: To analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of healthy women and patient's satisfaction. METHODS: Design and setting: a randomized controlled trial, with concealed allocation and blinded assessor. PARTICIPANTS: 34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥3cm, BMI between 18.5 and 27kg/m2, low level of physical activity, and no contraindication to cryolipolysis were allocated to intervention group (IG, n=17) or control group (CG, n=17). INTERVENTIONS: The IG received one session of cryolipolysis with -10°C of temperature for 50min. 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: 0.05cm (95%CI: -0.12; 0.22), 60 days: 0.05cm (95%CI: -0.11; 0.20) and 90 days: 0.04cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09cm (95%CI: -0.25; 0.08), 60 days: -0.14cm (95%CI: -0.36; 0.09) and 90 days: -0.001cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42cm (95%CI: -1.1; 1.9), 60 days: -0.1cm (95%CI: -1.74; 1.54) and 90 days: -0.007cm (-1.9; 1.9)) and AC2 (30 days: 0.183cm (95%CI: -0.84; 1.20), 60 days: -0.13cm (95%CI: -1.61; 1.35) and 90 days: -0.31cm (95%CI: -1.61; 1.00)). 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 methodological rigor to report an unfavorable result for localized abdominal fat treatment with a single session of cryolipolysis.
Authors: G A Ferraro; F De Francesco; C Cataldo; F Rossano; G Nicoletti; F D'Andrea Journal: Aesthetic Plast Surg Date: 2011-11-01 Impact factor: 2.326