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

NCT05017636 | Completed DMC

• 1 other identifier: shock wave
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fat localized; sagging skin; Obesity

Outcome Measures

Primary Outcomes (1)

• Immunohistochemical procedures

  Immunohistochemical reactions were performed on 3μm-thick sections, arranged on silanized slides. The antibodies used were: polyclonal anti-Caspase3 , monoclonal anti-Cleaved Caspase 3 ; monoclonal anti-CD68, monoclonal anti-hormone-sensitive lipase - HSL - and Adipophilin. After preparing the slides, they were analyzed with a DMR microscope (Leica), and photographs were taken at 400x magnification. To quantify the analyses, the ImageJ® software (NIH, Bethesda, USA) was used. All reactions were performed following the manufacturers' protocol and all were standardized by the pathological analysis laboratory of the Hospital de Clínicas da Unicamp. The quantification of immunostaining was performed considering the number of positive cells and intensity, with final scores ranging from 0-300

  one month

Study Arms (2)

Treatment groupThorck Shock Wave Ibramed (terapia ESWT)- fat cell death

ACTIVE COMPARATOR

The shock wave treatment was performed on the left side of the abdomen

Device: shock wave therapy

Without intervention.

NO INTERVENTION

no shockwave treatment was performed on the right side of the abdomen, which was specified as a control group no shockwave treatment was performed on the right side of the abdomen, which was specified as a control group without intervention.

Interventions

shock wave therapy DEVICE

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.

Treatment groupThorck Shock Wave Ibramed (terapia ESWT)- fat cell death

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: women with obesity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The study will include patients:
• female gender, over 18 years of age;
• With obesity grade I, II and III;
• Patient with surgical indication for bariatric surgery;
• Roux-en-Y gastric bypass type surgical procedure;
• Agree to participate and sign the consent form;

You may not qualify if:

• Male gender;
• smoking;
• cognitive limitations
• Carriers diabetes mellitus;
• Performed aesthetic treatment on the abdomen in the last month;
• Patients with skin lesions such as dermatitis and dermatosis;
• Patients with acute deep vein thrombosis (DVT);
• About or near cancerous lesions;
• Patients with cardiac pacemakers or other implanted electronic devices.

Sponsors & Collaborators

• Indústria Brasileira Equipamentos Médicos - IBRAMED: lead

Study Sites (1)

Unicamp

Campinas, São Paulo, 13083-872, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Debora Modena, Dr

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: N/D
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: experimental study

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: August 24, 2021
• Study Start: January 7, 2018
• Primary Completion: March 28, 2019
• Study Completion: October 28, 2019
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

BR (1)