Comparison of the Effects of Electric Current With Needles and Surface Electrodes on the Abdominal Contour of Women

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the acute effects of percutaneous and transcutaneous eletroclipolysis on abdominal contour in women. The main question it aims to answer are: • Is there superiority in percutaneous and transcutaneous electrolipolysis techniques? Participants will undergo 12 sessions of 50 minutes each performed twice a week, totaling 6 weeks, after randomizing the hemibody for each technique. Researchers will compare the hemibody with the percutaneous technique with the hemibody with the transcutaneous technique to see if there is a reduction of the adipose tissue.

Detailed Description
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Abdominal Adiposity consists of an increase in adipose tissue in the abdomen region, which may be associated as a risk factor for cardiovascular pathologies, metabolic disorders and dyslipidemias, in addition to affecting self-esteem and social life due to aesthetics body provided by the volume increase of the contour. Electrolipolysis proves to be one of the accessible and low-cost resources, capable of promoting good therapeutic results through the passage of electric current to the adipose tissue, either with its percutaneous or transcutaneous technique. The study aims to compare the acute effects of percutaneous and transcutaneous electrolipolysis, considering comfort during execution.

Official Title
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Comparative Acute Effects of the Application of Percutaneous and Transcutaneous Electrolipolysis on the Female Abdominal Contour: a Cross Over Clinical Trial

Conditions
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Abdominal Fat

Intervention / Treatment
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* Procedure: Percutaneous Electrolipolysis
* Procedure: Transcutaneous Electrolipolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between with localized abdominal fat Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (adequate weight and overweight) Who have not undergone any treatment for the condition experienced in the last 6 months Sedentary Not on a supervised diet Exclusion Criteria: Smokers Alcoholics Pregnant women Metabolic and circulatory system disorders Pacemaker Metallic implants Tumors/metastasis Dermatitis In treatment with corticosteroids and/or prolonged progesterone Skin ulcers/lesions Needle phobia (aichmophobia) Sensitivity alteration in the region to be treated Unable to understand the form and/or procedure Not completing the suggested protocol Dietary changes during the research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous<br>In one of the infraumbilical hemibody, for percutaneous electrolipolysis, 2 pairs of needles will be introduced (0 ,25mm x 40mm) paired at a distance of 5 cm at 45º reaching the dermis-hypodermis tissue. The needles will be positioned at a distance of 2 cm laterally to the umbilicus and 5 cm below this marking, covering an area of about 10 cm laterally. This technique will have their electrodes connected to the Neurodyn 10-channel device belonging to the brand Ibramed®, in the electrolipolysis program. | Procedure: Percutaneous Electrolipolysis<br>* Electrolipolysis consists in the passage of electric current to the adipose tissue, causing lipolysis. The proposed protocol consists of 2 weekly sessions for 6 weeks, totaling 12 sessions, using needles.<br>|
| Experimental: Transcutaneous<br>In one of the infraumbilical hemibody, for transcutaneous electrolipolysis, 1 pair of silicone electrodes with conductive gel will be fixed with adhesive tape. The surface electrodes will be positioned at a distance of 2 cm laterally to the umbilicus and 5 cm below this marking, This technique will have their electrodes connected to the Neurodyn 10-channel device belonging to the brand Ibramed®, in the electrolipolysis program. | Procedure: Transcutaneous Electrolipolysis<br>* Electrolipolysis consists in the passage of electric current to the adipose tissue, causing lipolysis. The proposed protocol consists of 2 weekly sessions for 6 weeks, totaling 12 sessions, using the surface electrodos.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Adipose Tissue | It is expected to find a reduction in adipose tissue in both techniques, with similar results, verified by ultrasonography and adipometry, from the verification of a variation in the pre- and post-intervention measurements of thickness of adipose tissue in centimeters | From enrollment to end of treatment at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascularization Changes | Evaluate the possible alterations in the vascularization of the infraumbilical region through thermography, from the verification of variation in the pre- and post-intervention measures in body temperature in degrees celsius. | From enrollment to end of treatment at 6 weeks | 
| Satisfaction Evaluation | Evaluate satisfaction with each technique using a Likert-type scoring scale. The satisfaction scale ranges from 1 to 5, where 1 is the worst score and means no satisfaction, and 5 is the best score, extremely satisfied. | From enrollment to end of treatment at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipose tissue, subcutaneous fat