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Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction

Primary Purpose

Cellulite

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Extracorporeal shock wave
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients
  • age ranged from 25-45 years old,
  • non- pregnant females
  • grade 3 cellulite at thigh area after liposuction

Exclusion Criteria:

  • Breastfeeding females
  • Inflammatory skin disorders in the treatment area
  • Edema
  • Varicose veins-
  • Any therapy or disease that may affect treatment

Sites / Locations

  • Marwa Eid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Shock wave group

Manual lympharic group

Arm Description

Received Extracorporeal shock wave therapy twice/week for 4 weeks

Received manual lymphatic drainage twice a week for four weeks

Outcomes

Primary Outcome Measures

Cellulite grade
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

Secondary Outcome Measures

Full Information

First Posted
July 28, 2020
Last Updated
August 9, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04498312
Brief Title
Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction
Official Title
Comparison of Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainage on Cellulite Post Liposuction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
December 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shock wave group
Arm Type
Experimental
Arm Description
Received Extracorporeal shock wave therapy twice/week for 4 weeks
Arm Title
Manual lympharic group
Arm Type
Experimental
Arm Description
Received manual lymphatic drainage twice a week for four weeks
Intervention Type
Other
Intervention Name(s)
Extracorporeal shock wave
Other Intervention Name(s)
Manual lymphatic drainage
Intervention 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
Primary Outcome Measure Information:
Title
Cellulite grade
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
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients age ranged from 25-45 years old, non- pregnant females grade 3 cellulite at thigh area after liposuction Exclusion Criteria: Breastfeeding females Inflammatory skin disorders in the treatment area Edema Varicose veins- Any therapy or disease that may affect treatment
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction

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