Comparison of the Effects of Electric Current With Needles and Surface Electrodes on the Abdominal Contour of Women
NCT ID: NCT05973526
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2023-05-16
2024-10-30
Brief Summary
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• 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Percutaneous
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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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Coordination for the Improvement of Higher Education Personnel
OTHER
Universidade Federal de Pernambuco
OTHER
Responsible Party
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Rennatha de Moura Medeiros
Principal Investigator
Principal Investigators
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Marcelo Renato Guerino, PhD
Role: STUDY_DIRECTOR
Physical Therapy Department, Universidade Federal de Pernambuco
Juliana Netto Maia, PhD
Role: STUDY_DIRECTOR
Physical Therapy Department, Universidade Federal de Pernambuco
Locations
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Federal University of Pernambuco
Recife, Pernambuco, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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.
Other Identifiers
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Eletrolipolysis
Identifier Type: -
Identifier Source: org_study_id
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