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Abdominal FatNCT05973526

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

A study testing Percutaneous Electrolipolysis and Transcutaneous Electrolipolysis in people with Abdominal Fat, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Abdominal Fat
What is being tested?
Percutaneous Electrolipolysis and Transcutaneous Electrolipolysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
16 May 2023to 30 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Smokers
  • Alcoholics
  • Pregnant women
  • Metabolic and circulatory system disorders
  • Pacemaker
  • Metallic implants
Show all 15Show fewer
  • 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 locations and contacts

1 site in 1 country.

Rennatha Moura Medeiros contact

+55 (81) 997166634

rennathamedeiros@outlook.com

Brazil1 site, 1 recruiting

  • Federal University of Pernambuco

    Recife, Pernambuco, 50670-901

    Rennatha Moura Medeiros, +55 (81) 997166634, rennathamedeiros@outlook.com

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.

Conditions
Abdominal Fat
Being tested
Percutaneous Electrolipolysis, Transcutaneous Electrolipolysis
Keywords
adipose tissue, subcutaneous fat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous ElectrolipolysisProcedure or surgery

    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 ElectrolipolysisProcedure or surgery

    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.

Study groups in NCT05973526
Study groupRoleWhat they receive
PercutaneousExperimentalIn 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.
Receives: Procedure: Percutaneous Electrolipolysis
TranscutaneousExperimentalIn 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.
Receives: Procedure: Transcutaneous Electrolipolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From enrollment to end of treatment at 6 weeks

Secondary outcomes (2)

  1. 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.

    Measured: From enrollment to end of treatment at 6 weeks

  2. 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.

    Measured: From enrollment to end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start16 May 2023
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05973526
Sponsor's protocol ID
Eletrolipolysis
Status last verified
Jul 2023
First submitted
21 Jul 2023
Last updated
3 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23317303

  • 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.

    PubMed 34799702

  • 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.

    PubMed 29230714

  • 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.

    PubMed 29205814

  • 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.

    PubMed 23068073

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Electrolipolysis and Transcutaneous Electrolipolysis in people with Abdominal Fat, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rennatha Moura Medeiros (+55 (81) 997166634, rennathamedeiros@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of Adipose Tissue (time frame: From enrollment to end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05973526, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.

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