Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat (ESWT)
Primary Purpose
Lipodystrophy, Cellulitis, Adiposity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
THORK Shock Wave® (Extracorporeal shock waves)
Sponsored by
About this trial
This is an interventional treatment trial for Lipodystrophy focused on measuring Shock wave, Gynoid lipodystrophy, Cellulits
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.
Sites / Locations
- Ibramed - Indústria Brasileira de Equipamentos Médicos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Extracorporeal shock waves
Arm Description
Composed of 30 female patients with glandular lipodystrophy in the buttocks and posterior thigh and fat located in abdomen and flanks that received the treatment of extracorporeal shock waves with energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.
Outcomes
Primary Outcome Measures
Anthropometric evaluation
BMI (kg / height m2)
Anthropometric evaluation
Perimeter in the region to be treated in centimeters.
Evaluation of the degree of cellulite
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Assessment of adipose tissue thickness
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Assessment of skin elasticity
Evaluation of skin elasticity (Cutometer® MPA580)
Secondary Outcome Measures
Full Information
NCT ID
NCT03275259
First Posted
July 21, 2017
Last Updated
March 18, 2019
Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
1. Study Identification
Unique Protocol Identification Number
NCT03275259
Brief Title
Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat
Acronym
ESWT
Official Title
Effect of Extracorporeal Shock Wave Therapy in the Treatment of Gynoid Lipodystrophy and Localized Fat
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy, Cellulitis, Adiposity
Keywords
Shock wave, Gynoid lipodystrophy, Cellulits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The participants and evaluator are blinded. They will not be informed about the parameters applied in this study.
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extracorporeal shock waves
Arm Type
Experimental
Arm Description
Composed of 30 female patients with glandular lipodystrophy in the buttocks and posterior thigh and fat located in abdomen and flanks that received the treatment of extracorporeal shock waves with energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.
Intervention Type
Device
Intervention Name(s)
THORK Shock Wave® (Extracorporeal shock waves)
Intervention Description
Treatment with extracorporeal shock waves: energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.
Primary Outcome Measure Information:
Title
Anthropometric evaluation
Description
BMI (kg / height m2)
Time Frame
Ten minutes
Title
Anthropometric evaluation
Description
Perimeter in the region to be treated in centimeters.
Time Frame
Ten Minutes
Title
Evaluation of the degree of cellulite
Description
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Time Frame
Ten minutes
Title
Assessment of adipose tissue thickness
Description
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Time Frame
Twenty minutes
Title
Assessment of skin elasticity
Description
Evaluation of skin elasticity (Cutometer® MPA580)
Time Frame
Twenty minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Débora O Modena, M.S
Organizational Affiliation
Ibramed - Industria Brasileira de Equipamentos Médicos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ibramed - Indústria Brasileira de Equipamentos Médicos
City
Amparo
State/Province
São Paulo
ZIP/Postal Code
13901-080
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data collected and the results of this study will be shared through scientific papers after the end of the study.
Citations:
PubMed Identifier
24297647
Citation
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PubMed Identifier
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PubMed Identifier
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Citation
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PubMed Identifier
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PubMed Identifier
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Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat
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