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

NCT05973526 | Unknown

• 1 other identifier: Eletrolipolysis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Fat

Keywords

adipose tissue; subcutaneous fat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Vascularization Changes

  From enrollment to end of treatment at 6 weeks

• Satisfaction Evaluation

  From enrollment to end of treatment at 6 weeks

Study Arms (2)

Percutaneous

EXPERIMENTAL

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

Transcutaneous

EXPERIMENTAL

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

Interventions

Percutaneous Electrolipolysis PROCEDURE

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.

Percutaneous

Transcutaneous Electrolipolysis PROCEDURE

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.

Transcutaneous

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Related Publications (14)

• AROCA, Graciele Guimarães Pitelli et al. Thermographic and anthropometric assessment of electrical stimulation on localized body fat. Fisioterapia em movimento, v. 30, p. 29-37, 2017.

  BACKGROUND

• CASTILLO, Carlos et al. Efeitos imediatos do ultrassom estacionário sobre a gordura subcutânea e retenção hídrica na região abdominal. Revista Inspirar Movimento & Saude, v. 22, n. 2, 2022.

  BACKGROUND

• MELLO, Pâmela Billig et al. Comparação dos efeitos da eletrolipólise transcutânea e percutânea sobre a gordura localizada na região abdominal e de flancos através da perimetria e análise de bioimpedância elétrica. Fisioterapia Brasil, v. 11, n. 3, p. 198-203, 2010.

  BACKGROUND

• CUNHA, Marisa; CUNHA, Ana Lucia; MACHADO, Carlos. Fisiopatologia da lipodistrofiaginoide. Surgical&Cosmetic Dermatology., v. 7, n. 2, p. 98-102 2015.

  BACKGROUND

• EÇA, Lilian Piñeiro Marcolin et al. Estudo histológico comparativo e controlado de fibras colágenas da pele humana após terapia celular com fibroblastos. Surgical&Cosmetic Dermatology, v. 7, n. 3, p. 206-210, 2015.

  BACKGROUND

• Feng B, Zhang T, Xu H. Human adipose dynamics and metabolic health. Ann N Y Acad Sci. 2013 Apr;1281(1):160-77. doi: 10.1111/nyas.12009. Epub 2013 Jan 14.

  PMID: 23317303 BACKGROUND

• FERREIRA, Susan Caroline Santos et al. Ação e eficácia do tratamento com a Radiofrequência na adiposidade abdominal em mulheres. Revista de psicologia, v. 11, n. 38, p. 349-358, 2017.

  BACKGROUND

• GONÇALVES, Michel Moraes et al. Alterações fisiológicas, percepção subjetiva de esforço e percepção de conforto durante formatura militar: um estudo experimental. Revista de Educação Física/Journal of Physical Education, v. 88, n. 3, 2019.

  BACKGROUND

• Grabner GF, Xie H, Schweiger M, Zechner R. Lipolysis: cellular mechanisms for lipid mobilization from fat stores. Nat Metab. 2021 Nov;3(11):1445-1465. doi: 10.1038/s42255-021-00493-6. Epub 2021 Nov 19.

  PMID: 34799702 BACKGROUND

• Guglielmi V, Sbraccia P. Obesity phenotypes: depot-differences in adipose tissue and their clinical implications. Eat Weight Disord. 2018 Feb;23(1):3-14. doi: 10.1007/s40519-017-0467-9. Epub 2017 Dec 11.

  PMID: 29230714 BACKGROUND

• Guth F, Bitencourt S, Bedinot C, Sinigaglia G, Tassinary JAF. Immediate effect and safety of HIFU single treatment for male subcutaneous fat reduction. J Cosmet Dermatol. 2018 Jun;17(3):385-389. doi: 10.1111/jocd.12466. Epub 2017 Dec 4.

  PMID: 29205814 BACKGROUND

• Lee MJ, Wu Y, Fried SK. Adipose tissue heterogeneity: implication of depot differences in adipose tissue for obesity complications. Mol Aspects Med. 2013 Feb;34(1):1-11. doi: 10.1016/j.mam.2012.10.001. Epub 2012 Oct 13.

  PMID: 23068073 BACKGROUND

• RIBEIRO, Ricardo et al. A ultrassonografia enquanto método para caracterização do tecido adiposo abdominal. Saúde & Tecnologia, n. 22, p. 13-21, 2019.

  BACKGROUND

• SILVA, Julianna; ARAÚJO, Maria; GUERINO, Marcelo. The use of a thermographic camera in aiding the diagnosis of cellulite appearance. O mundo da saúde, v. 46, p. 279-288, 2022.

  BACKGROUND

Related Links

• Thermographic and anthropometric assessment of electrical stimulation on localized body fat.
• Efeitos imediatos do ultrassom estacionário sobre a gordura subcutânea e retenção hídrica na região abdominal.
• Comparação dos efeitos da eletrolipólise transcutânea e percutânea sobre a gordura localizada na região abdominal e de flancos através da perimetria e análise de bioimpedância elétrica.
• Fisiopatologia da lipodistrofiaginoide.
• Estudo histológico comparativo e controlado de fibras colágenas da pele humana após terapia celular com fibroblastos.
• Human adipose dynamics and metabolic health.
• Ação e eficácia do tratamento com a Radiofrequência na adiposidade abdominal em mulheres.
• Alterações fisiológicas, percepção subjetiva de esforço e percepção de conforto durante formatura militar: um estudo experimental.
• Lipolysis: cellular mechanisms for lipid mobilization from fat stores.
• Obesity phenotypes: depot-differences in adipose tissue and their clinical implications.
• Immediate effect and safety of HIFU single treatment for male subcutaneous fat reduction.
• Adipose tissue heterogeneity: implication of depot differences in adipose tissue for obesity complications.
• A ultrassonografia enquanto método para caracterização do tecido adiposo abdominal.
• The use of a thermographic camera in aiding the diagnosis of cellulite appearance.

Study Officials

• Marcelo Renato Guerino, PhD

  Physical Therapy Department, Universidade Federal de Pernambuco

  STUDY DIRECTOR

• Juliana Netto Maia, PhD

  Physical Therapy Department, Universidade Federal de Pernambuco

  STUDY DIRECTOR

Central Study Contacts

Rennatha Moura Medeiros

CONTACT

+55 (81) 997166634; rennathamedeiros@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 3, 2023
• Study Start: May 16, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-07

Locations

BR (1)