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

U

Universidade Federal de Pernambuco

Status

Enrolling

Conditions

Abdominal Fat

Treatments

Procedure: Transcutaneous Electrolipolysis
Procedure: Percutaneous Electrolipolysis

Study type

Interventional

Funder types

Other

Identifiers

NCT05973526
Eletrolipolysis

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Percutaneous
Experimental group
Description:
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.
Treatment:
Procedure: Percutaneous Electrolipolysis
Transcutaneous
Experimental group
Description:
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.
Treatment:
Procedure: Transcutaneous Electrolipolysis

Trial contacts and locations

1

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Central trial contact

Rennatha Moura Medeiros

Data sourced from clinicaltrials.gov

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