Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat
NCT ID: NCT03275259
Last Updated: 2019-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-04-03
2018-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Extracorporeal shock waves
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.
THORK Shock Wave® (Extracorporeal shock waves)
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.
Interventions
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THORK Shock Wave® (Extracorporeal shock waves)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Indústria Brasileira Equipamentos Médicos - IBRAMED
INDUSTRY
Responsible Party
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Principal Investigators
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Débora O Modena, M.S
Role: PRINCIPAL_INVESTIGATOR
Ibramed - Industria Brasileira de Equipamentos Médicos
Locations
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Ibramed - Indústria Brasileira de Equipamentos Médicos
Amparo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Ibramed -SW
Identifier Type: -
Identifier Source: org_study_id
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