Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

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Brief Title

Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

Official Title

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

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.

Study Type

Interventional

Primary Outcome

Anthropometric evaluation

Condition

Lipodystrophy

Intervention

THORK Shock Wave® (Extracorporeal shock waves)

Study Arms / Comparison Groups

 Extracorporeal shock waves
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

30

Start Date

April 3, 2017

Completion Date

December 1, 2018

Primary Completion Date

January 1, 2018

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.

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Débora O Modena, M.S, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT03275259

Organization ID

Ibramed -SW

Responsible Party

Sponsor

Study Sponsor

Indústria Brasileira Equipamentos Médicos - IBRAMED

Study Sponsor

Débora O Modena, M.S, Principal Investigator, Ibramed - Industria Brasileira de Equipamentos Médicos

Verification Date

March 2019