Clinical trial NCT03199781: Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
Official title: Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cellulitis of Leg
Keywords: cellulits of leg
Motorized power massage
massage
Lead sponsor: Indústria Brasileira Equipamentos Médicos - IBRAMED
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anthropometric evaluation
timeFrame: Ten minutes
measure: Anthropometric evaluation
timeFrame: Ten Minutes
measure: Evaluation of the degree of cellulite
timeFrame: Ten minutes
measure: Assessment of adipose tissue thickness
timeFrame: Twenty minutes
measure: Assessment of skin elasticity
timeFrame: Twenty minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Amparo
country: Brazil
facility: Ibramed - Indústria Brasileira de Equipamentos Médicos
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Débora modena
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.