CelluliteNCT04498312
Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction
A study testing Extracorporeal shock wave in people with Cellulite, run by Cairo University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Cellulite
- What is being tested?
- Extracorporeal shock wave
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2018to 7 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients
- age ranged from 25-45 years old,
- non- pregnant females
- grade 3 cellulite at thigh area after liposuction
Who cannot join
- Breastfeeding females
- Inflammatory skin disorders in the treatment area
- Edema
- Varicose veins-
- Any therapy or disease that may affect treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cellulite
- Being tested
- Extracorporeal shock wave
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock waveOther
Also called Manual lymphatic drainage
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
| Study group | Role | What they receive |
|---|---|---|
| Shock wave group | Experimental | Received Extracorporeal shock wave therapy twice/week for 4 weeks Receives: Other: Extracorporeal shock wave |
| Manual lympharic group | Experimental | Received manual lymphatic drainage twice a week for four weeks Receives: Other: Extracorporeal shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start10 Jan 2018
- Primary completion5 Jul 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498312
- Sponsor's protocol ID
- 68mn
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainage on Cellulite Post Liposuction
- ClinicalTrials.gov ID
- NCT04498312
- Acronym / sponsor ID
- 68mn
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock wave group | Experimental | Other: Extracorporeal shock waveReceived Extracorporeal shock wave therapy twice/week for 4 weeks |
| Manual lympharic group | Experimental | Other: Extracorporeal shock waveReceived manual lymphatic drainage twice a week for four weeks |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients
- age ranged from 25-45 years old,
- non- pregnant females
- grade 3 cellulite at thigh area after liposuction
Key exclusion criteria (5 listed)
- Breastfeeding females
- Inflammatory skin disorders in the treatment area
- Edema
- Varicose veins-
- Any therapy or disease that may affect treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock waveAlso: Manual lymphatic drainageThe 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 | Manual lympharic group, Shock wave group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave in people with Cellulite, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellulite grade (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.