Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

Adiposity Clinical Trial

— ESWT  

Official title:

Effect of Extracorporeal Shock Wave Therapy in the Treatment of Gynoid Lipodystrophy and Localized Fat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275259
• Other study ID #: Ibramed -SW
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2019
• Source: Indústria Brasileira Equipamentos Médicos - IBRAMED
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adiposity
• Cellulitis
• Lipodystrophy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Ibramed - Indústria Brasileira de Equipamentos Médicos	Amparo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Indústria Brasileira Equipamentos Médicos - IBRAMED

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

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. — View 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. Review. — View 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. — View 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. — View Citation

Knobloch K, Joest B, Krämer 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. — View 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. — View Citation

Milani GB, Natal Filho A, Amado João SM. Correlation between lumbar lordosis angle and degree of gynoid lipodystrophy (cellulite) in asymptomatic women. Clinics (Sao Paulo). 2008 Aug;63(4):503-8. — View 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. — View Citation

Pianez LR, Custódio 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. — View 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(®)) 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]. — View Citation

Schlaudraff KU, Kiessling MC, Császár 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric evaluation	BMI (kg / height m2)	Ten minutes
Primary	Anthropometric evaluation	Perimeter in the region to be treated in centimeters.	Ten Minutes
Primary	Evaluation of the degree of cellulite	Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.	Ten minutes
Primary	Assessment of adipose tissue thickness	Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)	Twenty minutes
Primary	Assessment of skin elasticity	Evaluation of skin elasticity (Cutometer® MPA580)	Twenty minutes