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

July 31, 2023 updated by: Rennatha de Moura Medeiros, Universidade Federal de Pernambuco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Recruiting
        • Federal University of Pernambuco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous
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
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.
Experimental: Transcutaneous
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Adipose Tissue
Time Frame: From enrollment to end of treatment at 6 weeks
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
Time Frame: From enrollment to end of treatment at 6 weeks
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
Time Frame: From enrollment to end of treatment at 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Collaborators

Coordination for the Improvement of Higher Education Personnel (CAPES)

Investigators

  • Study Director: Marcelo Renato Guerino, PhD, Physical Therapy Department, Universidade Federal de Pernambuco
  • Study Director: Juliana Netto Maia, PhD, Physical Therapy Department, Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Eletrolipolysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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