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LipodystrophyESWTNCT03275259

Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

A study testing THORK Shock Wave® (Extracorporeal shock waves) in people with Lipodystrophy and Cellulitis, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Lipodystrophy, Cellulitis, Adiposity
What is being tested?
THORK Shock Wave® (Extracorporeal shock waves)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
3 Apr 2017to 1 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Ibramed - Indústria Brasileira de Equipamentos Médicos

    Amparo, São Paulo, 13901-080

Other trials in Brazil

About this study

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

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.

Read more

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.

Read the 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.

Being tested
THORK Shock Wave® (Extracorporeal shock waves)
Keywords
Shock wave, Gynoid lipodystrophy, Cellulits
Medical subject headings
Lipodystrophy, Cellulitis, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03275259
Study groupRoleWhat they receive
Extracorporeal shock wavesExperimentalComposed 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.
Receives: Device: THORK Shock Wave® (Extracorporeal shock waves)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anthropometric evaluation

    BMI (kg / height m2)

    Measured: Ten minutes

  2. Anthropometric evaluation

    Perimeter in the region to be treated in centimeters.

    Measured: Ten Minutes

  3. Evaluation of the degree of cellulite

    Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.

    Measured: Ten minutes

  4. Assessment of adipose tissue thickness

    Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)

    Measured: Twenty minutes

  5. Assessment of skin elasticity

    Evaluation of skin elasticity (Cutometer® MPA580)

    Measured: Twenty minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2017
  2. Study start3 Apr 2017
  3. Primary completion1 Jan 2018
  4. Study completion1 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03275259
Sponsor's protocol ID
Ibramed -SW
Acronym
ESWT
Status last verified
Mar 2019
First submitted
21 Jul 2017
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data collected and the results of this study will be shared through scientific papers after the end of the study.

Publications

  • 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.

    PubMed 24297647

  • 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.

    PubMed 20590369

  • 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.

    PubMed 18488890

  • 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.

    PubMed 22042359

  • 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.

    PubMed 23688206

  • 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.

    PubMed 16403988

  • 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.

    PubMed 24920933

  • 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.

    PubMed 19083577

  • 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.

    PubMed 25742559

  • 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.

    PubMed 18719762

  • 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.

    PubMed 27578994

  • 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.

    PubMed 18225463

  • 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.

    PubMed 31320894

Questions about this trial

What is this clinical trial studying?

A study testing THORK Shock Wave® (Extracorporeal shock waves) in people with Lipodystrophy and Cellulitis, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anthropometric evaluation (time frame: Ten minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03275259, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.

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