Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2017
CompletedStudy Start
First participant enrolled
May 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2017
CompletedJune 27, 2017
June 1, 2017
3 months
May 19, 2017
June 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Anthropometric evaluation
BMI (kg / height m2)
Ten minutes
Anthropometric evaluation
Perimeter in the region to be treated in centimeters.
Ten Minutes
Evaluation of the degree of cellulite
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Ten minutes
Assessment of adipose tissue thickness
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Twenty minutes
Assessment of skin elasticity
Evaluation of skin elasticity (Cutometer® MPA580)
Twenty minutes
Study Arms (1)
Intervention of mechanical massage with cosmetics
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ibramed - Indústria Brasileira de Equipamentos Médicos
Amparo, São Paulo, 13901-080, Brazil
Related Publications (4)
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.
PMID: 9502849RESULTAdcock 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.
PMID: 11420530RESULTGordon 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.
PMID: 16401454RESULTMilani 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.
PMID: 18719762RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Débora modena
University of Campinas, Brazil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 19, 2017
First Posted
June 27, 2017
Study Start
May 30, 2017
Primary Completion
August 20, 2017
Study Completion
September 15, 2017
Last Updated
June 27, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share