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Status unknownNCT03199781Updated Jun 27, 2017

Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy

An interventional study of Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics in Cellulitis of Leg, sponsored by Indústria Brasileira Equipamentos Médicos - IBRAMED. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-27.

Sponsored by Indústria Brasileira Equipamentos Médicos - IBRAMED · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics in improving body contour and appearance of gynoid lipodystrophy.

SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment.

HYPOTHESES: It is expected that the patients will present improvement in the body contour and in the picture of the gynoid lipodystrophy after the association of the therapies.

STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p \<0.05.

Read the detailed description

After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be from personal data, anthropometric and complementary diagnostic tests such as: ultrasound diagnosis in order to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of the skin. Afterwards they will be divided and started the treatment with another physiotherapist who will perform the following protocol of the study: exfoliation of the skin, application of the motorized mechanical massage with the device Dermotonus Slim with 550mg of vacuum, continuous mode, for 20 minutes subdivided into region Abdominal and posterior thigh, after the end will be applied the creams for lipolytic purposes. The protocol will be performed twice a week for 1 hour each, totaling 10 sessions.

02

Conditions studied

  • Cellulitis of Leg

Keywords

  • cellulits of leg
  • Motorized power massage
  • massage
03

In context

Cellulitis

147 studies on the registry are indexed under Cellulitis; 14 are open to participants now.

This study's planned enrollment of 30 is below the median of 157 across 118 interventional studies indexed under Cellulitis.

Browse Cellulitis studies →

Lead sponsor

Indústria Brasileira Equipamentos Médicos - IBRAMED is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female gender, over 18 years of age;
  • With a body mass index up to 29.9 considered overweight;
  • Carriers of GI lipodystrophy;
  • Non smokers;
  • That they agree to participate and sign the term of free and informed commitment - TCLE

Exclusion criteria

Exclusion Criteria:

  • Male gender;
  • Performed esthetic treatment in the gluteal region and thighs in the last month;
  • Patients with skin lesions, such as dermatitis and dermatoses;
  • Patients with capillary fragility;
  • Patients with acute deep vein thrombosis (DVT);
  • On or near cancerous lesions;
  • Patients with cardiac pacemaker or other implanted electronic device.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intervention of mechanical massage with cosmetics

    Patients will be treated with motorized mechanical massage and associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.

    Device: Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics

Interventions

  • DeviceMotorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics

    Patients will be treated with motorized mechanical massage with the Dermothonus Slim® electromedical equipment (Ibramed- Brazilian Industry of Electrical Equipment) associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.

06

What researchers measure

Primary outcomes

  1. Anthropometric evaluation

    BMI (kg / height m2)

    Time frame: Ten minutes

  2. Anthropometric evaluation

    Perimeter in the region to be treated in centimeters.

    Time frame: Ten Minutes

  3. Evaluation of the degree of cellulite

    Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.

    Time frame: Ten minutes

  4. Assessment of adipose tissue thickness

    Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)

    Time frame: Twenty minutes

  5. Assessment of skin elasticity

    Evaluation of skin elasticity (Cutometer® MPA580)

    Time frame: Twenty minutes

07

Study locations

1 of 1 sites recruiting
  • Ibramed - Indústria Brasileira de Equipamentos Médicos
    Amparo, São Paulo 13901-080, Brazil
    Recruiting
08

References and documents

Publications

  • Chang P, Wiseman J, Jacoby T, Salisbury AV, Ersek RA. Noninvasive mechanical body contouring: (Endermologie) a one-year clinical outcome study update. Aesthetic Plast Surg. 1998 Mar-Apr;22(2):145-53. doi: 10.1007/s002669900182. PubMed 9502849 ↗
  • Adcock D, Paulsen S, Jabour K, Davis S, Nanney LB, Shack RB. Analysis of the effects of deep mechanical massage in the porcine model. Plast Reconstr Surg. 2001 Jul;108(1):233-40. doi: 10.1097/00006534-200107000-00038. PubMed 11420530 ↗
  • Gordon C, Emiliozzi C, Zartarian M. Use of a mechanical massage technique in the treatment of fibromyalgia: a preliminary study. Arch Phys Med Rehabil. 2006 Jan;87(1):145-7. doi: 10.1016/j.apmr.2005.08.125. PubMed 16401454 ↗
  • Milani GB, Natal Filho A, Amado Joao SM. Correlation between lumbar lordosis angle and degree of gynoid lipodystrophy (cellulite) in asymptomatic women. Clinics (Sao Paulo). 2008 Aug;63(4):503-8. doi: 10.1590/s1807-59322008000400015. PubMed 18719762 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03199781
Lead sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
Responsible party
Renata Michelini Guidi (Principal Investigator, Indústria Brasileira Equipamentos Médicos - IBRAMED) — Principal investigator
First posted
Jun 27, 2017
Start date
May 30, 2017
Primary completion
Aug 20, 2017 (estimated)
Completion
Sep 15, 2017 (estimated)
Last update
Jun 27, 2017

Study contacts

Renata M Guidi
Contact
re_guidi@yahoo.com.br
38179633
Débora Modena
Contact
de_modena@yahoo.com.br
019991319016
Débora modena
principal investigator · University of Campinas, Brazil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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