search
Back to results

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
Indústria Brasileira Equipamentos Médicos - IBRAMED
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipodystrophy focused on measuring Shock wave, Gynoid lipodystrophy, Cellulits

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
July 21, 2017
Last Updated
March 18, 2019
Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
search

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
Knobloch K, Joest B, Kramer R, Vogt PM. Cellulite and focused extracorporeal shockwave therapy for non-invasive body contouring: a randomized trial. Dermatol Ther (Heidelb). 2013 Dec;3(2):143-55. doi: 10.1007/s13555-013-0039-5. Epub 2013 Dec 3.
Results Reference
background
PubMed Identifier
20590369
Citation
Adatto M, Adatto-Neilson R, Servant JJ, Vester J, Novak P, Krotz A. Controlled, randomized study evaluating the effects of treating cellulite with AWT/EPAT. J Cosmet Laser Ther. 2010 Aug;12(4):176-82. doi: 10.3109/14764172.2010.500392.
Results Reference
background
PubMed Identifier
18488890
Citation
Kuhn C, Angehrn F, Sonnabend O, Voss A. Impact of extracorporeal shock waves on the human skin with cellulite: a case study of an unique instance. Clin Interv Aging. 2008;3(1):201-10. doi: 10.2147/cia.s2334.
Results Reference
background
PubMed Identifier
22042359
Citation
Ferraro GA, De Francesco F, Cataldo C, Rossano F, Nicoletti G, D'Andrea F. Synergistic effects of cryolipolysis and shock waves for noninvasive body contouring. Aesthetic Plast Surg. 2012 Jun;36(3):666-79. doi: 10.1007/s00266-011-9832-7. Epub 2011 Nov 1.
Results Reference
background
PubMed Identifier
23688206
Citation
Russe-Wilflingseder K, Russe E, Vester JC, Haller G, Novak P, Krotz A. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT((R))) for cellulite treatment. J Cosmet Laser Ther. 2013 Jun;15(3):155-62. doi: 10.3109/14764172.2012.759235. Epub 2013 May 21. Erratum In: J Cosmet Laser Ther. 2013 Jun;15(3):162. Russe-Wilfingsleder, Katharina [corrected to Russe-Wilflingseder, Katharina]; Russe, Elisabeth [added].
Results Reference
background
PubMed Identifier
16403988
Citation
Siems W, Grune T, Voss P, Brenke R. Anti-fibrosclerotic effects of shock wave therapy in lipedema and cellulite. Biofactors. 2005;24(1-4):275-82. doi: 10.1002/biof.5520240132.
Results Reference
background
PubMed Identifier
24920933
Citation
Schlaudraff KU, Kiessling MC, Csaszar NB, Schmitz C. Predictability of the individual clinical outcome of extracorporeal shock wave therapy for cellulite. Clin Cosmet Investig Dermatol. 2014 May 23;7:171-83. doi: 10.2147/CCID.S59851. eCollection 2014.
Results Reference
background
PubMed Identifier
19083577
Citation
Christ C, Brenke R, Sattler G, Siems W, Novak P, Daser A. Improvement in skin elasticity in the treatment of cellulite and connective tissue weakness by means of extracorporeal pulse activation therapy. Aesthet Surg J. 2008 Sep-Oct;28(5):538-44. doi: 10.1016/j.asj.2008.07.011.
Results Reference
background
PubMed Identifier
25742559
Citation
Nassar AH, Dorizas AS, Shafai A, Sadick NS. A randomized, controlled clinical study to investigate the safety and efficacy of acoustic wave therapy in body contouring. Dermatol Surg. 2015 Mar;41(3):366-70. doi: 10.1097/DSS.0000000000000290.
Results Reference
background
PubMed Identifier
18719762
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.
Results Reference
background
PubMed Identifier
27578994
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.
Results Reference
background
PubMed Identifier
18225463
Citation
Angehrn F, Kuhn C, Voss A. Can cellulite be treated with low-energy extracorporeal shock wave therapy? Clin Interv Aging. 2007;2(4):623-30. doi: 10.2147/cia.s1721.
Results Reference
background
PubMed Identifier
31320894
Citation
Modena DAO, Nogueira da Silva C, Delinocente TCP, Bianca de Araujo T, de Carvalho TM, Grecco C, Moreira RG, Campos G, de Souza JR, Michelini Guidi R. Effectiveness of the Electromagnetic Shock Wave Therapy in the Treatment of Cellulite. Dermatol Res Pract. 2019 Jun 20;2019:8246815. doi: 10.1155/2019/8246815. eCollection 2019.
Results Reference
derived

Learn more about this trial

Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

We'll reach out to this number within 24 hrs