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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498312
Other study ID # 68mn
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date December 7, 2019

Study information

Verified date August 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 7, 2019
Est. primary completion date July 5, 2019
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Extracorporeal shock wave
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

Locations

Country Name City State
Egypt Marwa Eid Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 weeks
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