Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

NCT03275259 | Completed

• 1 other identifier: Ibramed -SW
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipodystrophy; Cellulitis; Adiposity

Keywords

Shock wave; Gynoid lipodystrophy; Cellulits

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)

Extracorporeal shock waves

EXPERIMENTAL

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.

Device: THORK Shock Wave® (Extracorporeal shock waves)

Interventions

THORK Shock Wave® (Extracorporeal shock waves) DEVICE

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.

Extracorporeal shock waves

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indústria Brasileira Equipamentos Médicos - IBRAMED: lead

Study Sites (1)

Ibramed - Indústria Brasileira de Equipamentos Médicos

Amparo, São Paulo, 13901-080, Brazil

Location

Related Publications (13)

• 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.

  PMID: 24297647 BACKGROUND

• 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.

  PMID: 20590369 BACKGROUND

• 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.

  PMID: 18488890 BACKGROUND

• 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.

  PMID: 22042359 BACKGROUND

• 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.

  PMID: 23688206 BACKGROUND

• 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.

  PMID: 16403988 BACKGROUND

• 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.

  PMID: 24920933 BACKGROUND

• 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.

  PMID: 19083577 BACKGROUND

• 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.

  PMID: 25742559 BACKGROUND

• 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.

  PMID: 18719762 BACKGROUND

• 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.

  PMID: 27578994 BACKGROUND

• 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.

  PMID: 18225463 BACKGROUND

• 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.

  PMID: 31320894 DERIVED

MeSH Terms

Conditions

Lipodystrophy; Cellulitis; Obesity

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Débora O Modena, M.S

  Ibramed - Industria Brasileira de Equipamentos Médicos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants and evaluator are blinded. They will not be informed about the parameters applied in this study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: September 7, 2017
• Study Start: April 3, 2017
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)