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

Cellulitis of Leg Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03199781
• Other study ID #: Ibramed
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2017
• Last updated: June 24, 2017
• Start date: May 30, 2017
• Est. completion date: September 15, 2017

Study information

• Verified date: June 2017
• Source: Indústria Brasileira Equipamentos Médicos - IBRAMED
• Contact: Renata M Guidi
• Phone: 38179633
• Email: re_guidi[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 15, 2017
• Est. primary completion date: August 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cellulitis
• Cellulitis of Leg
• Lipodystrophy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Ibramed - Indústria Brasileira de Equipamentos Médicos	Amparo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Indústria Brasileira Equipamentos Médicos - IBRAMED

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Milani GB, Natal Filho A, Amado João SM. Correlation between lumbar lordosis angle and degree of gynoid lipodystrophy (cellulite) in asymptomatic women. Clinics (Sao Paulo). 2008 Aug;63(4):503-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric evaluation	BMI (kg / height m2)	Ten minutes
Primary	Anthropometric evaluation	Perimeter in the region to be treated in centimeters.	Ten Minutes
Primary	Evaluation of the degree of cellulite	Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.	Ten minutes
Primary	Assessment of adipose tissue thickness	Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)	Twenty minutes
Primary	Assessment of skin elasticity	Evaluation of skin elasticity (Cutometer® MPA580)	Twenty minutes