<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03275259</url>
  </required_header>
  <id_info>
    <org_study_id>Ibramed -SW</org_study_id>
    <nct_id>NCT03275259</nct_id>
  </id_info>
  <brief_title>Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat</brief_title>
  <acronym>ESWT</acronym>
  <official_title>Effect of Extracorporeal Shock Wave Therapy in the Treatment of Gynoid Lipodystrophy and Localized Fat</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indústria Brasileira Equipamentos Médicos - IBRAMED</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indústria Brasileira Equipamentos Médicos - IBRAMED</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PURPOSE: To evaluate the efficacy of shock waves extracorporea in improving body&#xD;
      contour,decrease fat localized and appearance of gynoid lipodystrophy.&#xD;
&#xD;
      SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be&#xD;
      performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted&#xD;
      data collection and assessments and before and after treatment.&#xD;
&#xD;
      HYPOTHESES: It is expected that the patients will present improvement in the body contour,&#xD;
      decrease fat localized and in the picture of the gynoid lipodystrophy after of the therapies.&#xD;
&#xD;
      STATISTICAL ANALYSIS: A descriptive analysis will be done before and after&#xD;
      vibration-oscillatory therapy, with frequency tables for categorical and descriptive&#xD;
      variables (mean, standard deviation, median, minimum and maximum values) for continuous or&#xD;
      numerical variables. In order to compare the main variables between the groups and the&#xD;
      collection times, the analysis of variance (ANOVA) for repeated measurements will be used.&#xD;
      Tukey's test will be used to compare groups. The level of significance adopted for the&#xD;
      statistical tests will be 5% or p &lt;0.05.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing the informed consent, the participants will be evaluated by two&#xD;
      physiotherapists where the data collected will be personal data, anthropometrics and&#xD;
      complementary diagnostic tests, such as: ultrasound diagnosis to evaluate the thickness of&#xD;
      the adipose tissue and Cutomiter analysis of the Viscoelasticity of skin. They then started&#xD;
      treatment with another physiotherapist who will perform the following study protocol: placing&#xD;
      a light layer of neutral gel on the treatment area, applying extracorporeal shock waves with&#xD;
      the stainless steel tip with 180mJ of energy totaling 4 thousand shots , in abdomens,&#xD;
      buttocks and posterior thigh and 2 thousand shots in flanks, then performs the change of the&#xD;
      tip to the plastic and performs 2 thousand shots in the regions of abdomens, buttocks,&#xD;
      posterior thigh emil shots in the region of flanks. The protocol will be performed twice a&#xD;
      week for 1 and 20 hours each, totaling 10 sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The participants and evaluator are blinded. They will not be informed about the parameters applied in this study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Anthropometric evaluation</measure>
    <time_frame>Ten minutes</time_frame>
    <description>BMI (kg / height m2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometric evaluation</measure>
    <time_frame>Ten Minutes</time_frame>
    <description>Perimeter in the region to be treated in centimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the degree of cellulite</measure>
    <time_frame>Ten minutes</time_frame>
    <description>Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of adipose tissue thickness</measure>
    <time_frame>Twenty minutes</time_frame>
    <description>Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of skin elasticity</measure>
    <time_frame>Twenty minutes</time_frame>
    <description>Evaluation of skin elasticity (Cutometer® MPA580)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lipodystrophy</condition>
  <condition>Cellulitis</condition>
  <condition>Adiposity</condition>
  <arm_group>
    <arm_group_label>Extracorporeal shock waves</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>THORK Shock Wave® (Extracorporeal shock waves)</intervention_name>
    <description>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.</description>
    <arm_group_label>Extracorporeal shock waves</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women older than 18 years of age up to premenopausal age (50 years of age).&#xD;
&#xD;
          -  With body mass index considered eutrophic and / or overweight.&#xD;
&#xD;
          -  Patients with lipodystrophy and localized abdominal fat.&#xD;
&#xD;
          -  non smokers.&#xD;
&#xD;
          -  Who agree to participate and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male gender.&#xD;
&#xD;
          -  Possible.&#xD;
&#xD;
          -  Haemophilia carriers and hemorrhagic disorders.&#xD;
&#xD;
          -  Carriers diabetes mellitus.&#xD;
&#xD;
          -  Women in menopause.&#xD;
&#xD;
          -  Performed aesthetic treatment in the gluteal, thigh and abdominal regions in the last&#xD;
             1 months.&#xD;
&#xD;
          -  Patients with skin lesions, such as dermatitis and dermatoses.&#xD;
&#xD;
          -  Patients with acute deep vein thrombosis (DVT).&#xD;
&#xD;
          -  About or close to cancerous lesions.&#xD;
&#xD;
          -  Patients with cardiac pacemaker or other implanted electronic device.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Débora O Modena, M.S</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ibramed - Industria Brasileira de Equipamentos Médicos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ibramed - Indústria Brasileira de Equipamentos Médicos</name>
      <address>
        <city>Amparo</city>
        <state>São Paulo</state>
        <zip>13901-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>24297647</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20590369</PMID>
  </reference>
  <reference>
    <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. doi: 10.2147/cia.s2334.</citation>
    <PMID>18488890</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22042359</PMID>
  </reference>
  <reference>
    <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((R))) 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].</citation>
    <PMID>23688206</PMID>
  </reference>
  <reference>
    <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. doi: 10.1002/biof.5520240132.</citation>
    <PMID>16403988</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24920933</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19083577</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25742559</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18719762</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27578994</PMID>
  </reference>
  <reference>
    <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. doi: 10.2147/cia.s1721.</citation>
    <PMID>18225463</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>March 18, 2019</last_update_submitted>
  <last_update_submitted_qc>March 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shock wave</keyword>
  <keyword>Gynoid lipodystrophy</keyword>
  <keyword>Cellulits</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulitis</mesh_term>
    <mesh_term>Lipodystrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data collected and the results of this study will be shared through scientific papers after the end of the study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03275259
org study id: Ibramed -SW
nct id: NCT03275259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: The participants and evaluator are blinded. They will not be informed about the parameters applied in this study.
measure: Anthropometric evaluation
time frame: Ten minutes
description: BMI (kg / height m2)
measure: Anthropometric evaluation
time frame: Ten Minutes
description: Perimeter in the region to be treated in centimeters.
measure: Evaluation of the degree of cellulite
time frame: Ten minutes
description: Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
measure: Assessment of adipose tissue thickness
time frame: Twenty minutes
description: Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
measure: Assessment of skin elasticity
time frame: Twenty minutes
description: Evaluation of skin elasticity (Cutometer® MPA580)
arm group label: Extracorporeal shock waves
arm group type: Experimental
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.
intervention type: Device
intervention name: THORK Shock Wave® (Extracorporeal shock waves)
description: 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.
arm group label: Extracorporeal shock waves
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Débora O Modena, M.S
role: Principal Investigator
affiliation: Ibramed - Industria Brasileira de Equipamentos Médicos
facility: 
country: Brazil
citation: 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
citation: 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
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. doi: 10.2147/cia.s2334.
PMID: 18488890
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.
PMID: 22042359
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((R))) 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].
PMID: 23688206
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. doi: 10.1002/biof.5520240132.
PMID: 16403988
citation: 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
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.
PMID: 19083577
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.
PMID: 25742559
citation: 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
citation: 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
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. doi: 10.2147/cia.s1721.
PMID: 18225463
responsible party type: Sponsor
mesh term: Cellulitis
mesh term: Lipodystrophy
sharing ipd: No
ipd description: The data collected and the results of this study will be shared through scientific papers after the end of the study.