<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/NCT04498312</url>
  </required_header>
  <id_info>
    <org_study_id>68mn</org_study_id>
    <nct_id>NCT04498312</nct_id>
  </id_info>
  <brief_title>Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction</brief_title>
  <official_title>Comparison of Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainage on Cellulite Post Liposuction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether extracorporeal shock wave therapy (ESWT) or manual lymphatic drainage&#xD;
      (MLD) is more effective for decreasing post-liposuction cellulite.&#xD;
&#xD;
      Thirty females with grade 3 cellulite were randomly distributed into two equal groups: group&#xD;
      A (ESWT group) (n=15) and group B (MLD group) (n=15). The cellulite grade was assessed by&#xD;
      using the cellulite grading scale, and the thickness of subcutaneous fat was assessed by the&#xD;
      skinfold caliper. The assessment was carried out before starting the treatment and after 4&#xD;
      weeks. All participants received treatment 2 times/ week for 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">December 7, 2019</completion_date>
  <primary_completion_date type="Actual">July 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cellulite grade</measure>
    <time_frame>4 weeks</time_frame>
    <description>Cellulite grading scale grade 0: means a smooth surface of the skin while standing, grade 1: means mattress phenomena upon pinch-test, grade 2: means mattress phenomena spontaneously while standing, grade 3: means mattress phenomena while in standing and lying position Higher score means bad progression</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Cellulite</condition>
  <arm_group>
    <arm_group_label>Shock wave group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received Extracorporeal shock wave therapy twice/week for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual lympharic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received manual lymphatic drainage twice a week for four weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extracorporeal shock wave</intervention_name>
    <description>The participant was placed into supine lying position then the head of the shock wave was applied on the anterior or posterior aspect of the thigh which was scanned with 2000 shots for both horizontal direction and vertical direction. The period of each session was 15 minutes, 2 times/week for 4 weeks</description>
    <arm_group_label>Manual lympharic group</arm_group_label>
    <arm_group_label>Shock wave group</arm_group_label>
    <other_name>Manual lymphatic drainage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients&#xD;
&#xD;
          -  age ranged from 25-45 years old,&#xD;
&#xD;
          -  non- pregnant females&#xD;
&#xD;
          -  grade 3 cellulite at thigh area after liposuction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breastfeeding females&#xD;
&#xD;
          -  Inflammatory skin disorders in the treatment area&#xD;
&#xD;
          -  Edema&#xD;
&#xD;
          -  Varicose veins-&#xD;
&#xD;
          -  Any therapy or disease that may affect treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marwa Eid</name>
      <address>
        <city>Cairo</city>
        <zip>2011</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 9, 2020</last_update_submitted>
  <last_update_submitted_qc>August 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Marwa Eid</investigator_full_name>
    <investigator_title>assistant professor of physical therapy for surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulite</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04498312
org study id: 68mn
nct id: NCT04498312
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determine whether extracorporeal shock wave therapy (ESWT) or manual lymphatic drainage
      (MLD) is more effective for decreasing post-liposuction cellulite.

      Thirty females with grade 3 cellulite were randomly distributed into two equal groups: group
      A (ESWT group) (n=15) and group B (MLD group) (n=15). The cellulite grade was assessed by
      using the cellulite grading scale, and the thickness of subcutaneous fat was assessed by the
      skinfold caliper. The assessment was carried out before starting the treatment and after 4
      weeks. All participants received treatment 2 times/ week for 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Cellulite grade
time frame: 4 weeks
description: Cellulite grading scale grade 0: means a smooth surface of the skin while standing, grade 1: means mattress phenomena upon pinch-test, grade 2: means mattress phenomena spontaneously while standing, grade 3: means mattress phenomena while in standing and lying position Higher score means bad progression
arm group label: Shock wave group
arm group type: Experimental
description: Received Extracorporeal shock wave therapy twice/week for 4 weeks
arm group label: Manual lympharic group
arm group type: Experimental
description: Received manual lymphatic drainage twice a week for four weeks
intervention type: Other
intervention name: Extracorporeal shock wave
description: The participant was placed into supine lying position then the head of the shock wave was applied on the anterior or posterior aspect of the thigh which was scanned with 2000 shots for both horizontal direction and vertical direction. The period of each session was 15 minutes, 2 times/week for 4 weeks
arm group label: Manual lympharic group
arm group label: Shock wave group
other name: Manual lymphatic drainage
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Marwa Eid
investigator title: assistant professor of physical therapy for surgery
mesh term: Cellulite
sharing ipd: Undecided