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

Abdominal Fat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973526
• Other study ID #: Eletrolipolysis
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: July 2023
• Source: Universidade Federal de Pernambuco
• Contact: Rennatha Moura Medeiros
• Phone: +55 (81) 997166634
• Email: rennathamedeiros[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Fat

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Pernambuco	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco	Coordination for the Improvement of Higher Education Personnel (CAPES)

Country where clinical trial is conducted

Brazil, 

References & 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.

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.

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

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.

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. — View Citation

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.

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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

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.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vascularization Changes	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
Secondary	Satisfaction Evaluation	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

External Links

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