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

NCT ID: NCT03199781

Last Updated: 2017-06-27

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2017-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cellulitis of Leg

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics

Intervention Type DEVICE

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.

Interventions

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Motorized 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.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indústria Brasileira Equipamentos Médicos - IBRAMED

INDUSTRY

Sponsor Role lead

Responsible Party

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Renata Michelini Guidi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Débora modena

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

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Ibramed - Indústria Brasileira de Equipamentos Médicos

Amparo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Renata M Guidi

Role: CONTACT

Débora Modena

Role: CONTACT

019991319016

Facility Contacts

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Débora Modena, MsC

Role: primary

19991319016

Caroline Silva

Role: backup

01938179633

References

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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.

Reference Type RESULT
PMID: 9502849 (View on PubMed)

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.

Reference Type RESULT
PMID: 11420530 (View on PubMed)

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.

Reference Type RESULT
PMID: 16401454 (View on PubMed)

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.

Reference Type RESULT
PMID: 18719762 (View on PubMed)

Other Identifiers

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Ibramed

Identifier Type: -

Identifier Source: org_study_id

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