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CompletedNCT04498312Updated Aug 11, 2020

Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction

An interventional study of Extracorporeal shock wave in Cellulite, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cellulite

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03

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Breastfeeding females
  • Inflammatory skin disorders in the treatment area
  • Edema
  • Varicose veins-
  • Any therapy or disease that may affect treatment
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Shock wave group

    Received Extracorporeal shock wave therapy twice/week for 4 weeks

    Other: Extracorporeal shock wave

  • Experimental
    Manual lympharic group

    Received manual lymphatic drainage twice a week for four weeks

    Other: Extracorporeal shock wave

Interventions

  • OtherExtracorporeal 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

    Also known as: Manual lymphatic drainage

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 weeks

06

Study locations

1 site
  • Marwa Eid
    Cairo, 2011, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04498312
Lead sponsor
Cairo University
Responsible party
Marwa Eid (assistant professor of physical therapy for surgery, Cairo University) — Principal investigator
First posted
Aug 4, 2020
Start date
Jan 10, 2018
Primary completion
Jul 5, 2019
Completion
Dec 7, 2019
Last update
Aug 11, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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