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

Not Applicable
Recruiting
Conditions
Abdominal Fat
Interventions
Procedure: Transcutaneous Electrolipolysis
Procedure: Percutaneous Electrolipolysis
Registration Number
NCT05973526
Lead Sponsor
Universidade Federal de Pernambuco
Brief Summary

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

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
20
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
TranscutaneousTranscutaneous ElectrolipolysisIn 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.
PercutaneousPercutaneous ElectrolipolysisIn 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.
Primary Outcome Measures
NameTimeMethod
Reduction of Adipose TissueFrom 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

Secondary Outcome Measures
NameTimeMethod
Satisfaction EvaluationFrom 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.

Vascularization ChangesFrom 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.

Trial Locations

Locations (1)

Federal University of Pernambuco

🇧🇷

Recife, Pernambuco, Brazil

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