Clinical trial NCT05973526: Comparison of the Effects of Electric Current With Needles and Surface Electrodes on the Abdominal Contour of Women
Official title: Comparative Acute Effects of the Application of Percutaneous and Transcutaneous Electrolipolysis on the Female Abdominal Contour: a Cross Over Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Fat
Keywords: adipose tissue
subcutaneous fat
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
First posted: 2023-08-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of Adipose Tissue
timeFrame: From enrollment to end of treatment at 6 weeks
Secondary outcomes:
measure: Vascularization Changes
timeFrame: From enrollment to end of treatment at 6 weeks
measure: Satisfaction Evaluation
timeFrame: From enrollment to end of treatment at 6 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
affiliation: Physical Therapy Department, Universidade Federal de Pernambuco
name: Marcelo Renato Guerino, PhD
role: STUDY_DIRECTOR
affiliation: Physical Therapy Department, Universidade Federal de Pernambuco
name: Juliana Netto Maia, PhD
role: STUDY_DIRECTOR
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