NCT04498312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

July 28, 2020

Last Update Submit

August 9, 2020

Conditions

Outcome Measures

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

    4 weeks

Study Arms (2)

Shock wave group

EXPERIMENTAL

Received Extracorporeal shock wave therapy twice/week for 4 weeks

Other: Extracorporeal shock wave

Manual lympharic group

EXPERIMENTAL

Received manual lymphatic drainage twice a week for four weeks

Other: Extracorporeal shock wave

Interventions

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
Manual lympharic groupShock wave group

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Cellulite

Interventions

Extracorporeal Shockwave TherapyManual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesDrainage

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 4, 2020

Study Start

January 10, 2018

Primary Completion

July 5, 2019

Study Completion

December 7, 2019

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations