Clinical trial NCT03275259: Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat
Official title: Effect of Extracorporeal Shock Wave Therapy in the Treatment of Gynoid Lipodystrophy and Localized Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipodystrophy
Cellulitis
Adiposity
Keywords: Shock wave
Gynoid lipodystrophy
Cellulits
Lead sponsor: Indústria Brasileira Equipamentos Médicos - IBRAMED
Sponsor class: INDUSTRY
First posted: 2017-09-07
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 shock waves extracorporea in improving body contour,decrease fat localized 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, decrease fat localized and in the picture of the gynoid lipodystrophy after 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 personal data, anthropometrics and complementary diagnostic tests, such as: ultrasound diagnosis to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of skin. They then started treatment with another physiotherapist who will perform the following study protocol: placing a light layer of neutral gel on the treatment area, applying extracorporeal shock waves with the stainless steel tip with 180mJ of energy totaling 4 thousand shots , in abdomens, buttocks and posterior thigh and 2 thousand shots in flanks, then performs the change of the tip to the plastic and performs 2 thousand shots in the regions of abdomens, buttocks, posterior thigh emil shots in the region of flanks. The protocol will be performed twice a week for 1 and 20 hours each, totaling 10 sessions.

Eligibility criteria: Inclusion Criteria:

* Women older than 18 years of age up to premenopausal age (50 years of age).
* With body mass index considered eutrophic and / or overweight.
* Patients with lipodystrophy and localized abdominal fat.
* non smokers.
* Who agree to participate and sign the informed consent form.

Exclusion Criteria:

* Male gender.
* Possible.
* Haemophilia carriers and hemorrhagic disorders.
* Carriers diabetes mellitus.
* Women in menopause.
* Performed aesthetic treatment in the gluteal, thigh and abdominal regions in the last 1 months.
* Patients with skin lesions, such as dermatitis and dermatoses.
* Patients with acute deep vein thrombosis (DVT).
* About or close to 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: Ibramed - Industria Brasileira de Equipamentos Médicos
name: Débora O Modena, M.S
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pianez LR, Custodio FS, Guidi RM, de Freitas JN, Sant'Ana E. Effectiveness of carboxytherapy in the treatment of cellulite in healthy women: a pilot study. Clin Cosmet Investig Dermatol. 2016 Aug 22;9:183-90. doi: 10.2147/CCID.S102503. eCollection 2016.
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