Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction

August 9, 2020 updated by: Marwa Eid, Cairo University

Comparison of Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainage on Cellulite Post Liposuction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 2011
        • Marwa Eid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Shock wave group
Received Extracorporeal shock wave therapy twice/week for 4 weeks
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
Other Names:
  • Manual lymphatic drainage
EXPERIMENTAL: Manual lympharic group
Received manual lymphatic drainage twice a week for four weeks
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
Other Names:
  • Manual lymphatic drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellulite grade
Time Frame: 4 weeks
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2018

Primary Completion (ACTUAL)

July 5, 2019

Study Completion (ACTUAL)

December 7, 2019

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (ACTUAL)

August 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 9, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68mn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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