Effect of Shock Wave Therapy Without Biological and Immuno-histochemical Analysis.

Summary

Informative Summary: Extracorporeal shockwave therapy (ESWT) is a new method for treating aesthetic disorders within the field of aesthetic medicine, its mechanisms of action and physiological effects promise to combat localized fat accumulation, improve skin appearance, favor neocolagenesis and neovascularization. There are currently few studies on ESWT that can claim this benefit, but therapy has been shown to be safe and does not generate adverse reactions to individuals.

Objective: To evaluate the physiological effects and mechanisms of ESWT acting on subcutaneous adipose tissue and adjacent structures through an experimental study.

Methods: A randomized experimental clinical study will be performed in 30 women with grade I, II and III obesity who participated in the multidisciplinary preoperative preparation group for bariatric surgery with previously scheduled surgery. Participants will receive ESWT application within hours of surgery, or in the weeks prior to bariatric surgery, during the surgical procedure a small sample of subcutaneous adipose tissue will be taken for histological and immunohistochemical analysis.

Hypotheses: Through histological and immunohistochemical analysis of the subcutaneous adipose tissue sample, the investigators can identify which real physiological effect and mechanism of action the ESWT has on subcutaneous adipose tissue, epidermis and adjacent structures, thus confirming the benefits of therapy.

Statistical analysis: A descriptive analysis of the results obtained in the histological analysis will be performed initially, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between groups and session number, the analysis of variance (ANOVA) will be used for repeated measures. For comparison between groups the Tukey test will be used. The significance level adopted for the statistical tests will be 5% or p \<0.05.

Conditions

• Obesity

Interventions

DEVICE

shock wave therapy

The participants received the treatment protocol established by the manufacturer of the Thork Shock Wave® device, IBRAMED- Industria Brasileira de Equipamentos Electromédicos, Amparo, São Paulo approved by Anvisa No. 10360310036. (Figure 1). The parameters were, 4,000 thousand shots with energy of 180mJ and frequency of 15Hz with 15mm stainless steel tip and 2,000 shots with energy of 100mJ and frequency of 15Hz with 15mm plastic tip, and for the tip slip, Neutral Thork® Lotion, RMC was used. Seven ESWT sessions were held, the average time of each was seven minutes, twice a week and the seventh session was held minutes before the surgical procedure of bariatric surgery, therapy was performed in an area of 150cm² on the left side of the abdominal region following the midline. The right side of the participants' abdomen did not receive ESWT and was termed as control.

Sponsors & Collaborators

• Indústria Brasileira Equipamentos Médicos - IBRAMED

  lead INDUSTRY

Principal Investigators

• Debora Modena, Dr · University of Campinas, Brazil

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-07

Primary Completion

2019-03-28

Completion

2019-10-28

Countries

• Brazil

Study Locations