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CellulitisNCT01974115

Extracorporeal Shock Wave Treatment for Cellulite

A study testing Radial extracorporeal shock wave therapy in people with Cellulitis, run by Concept-Clinic at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Extracorporeal shock wave therapy (ESWT) has been successfully introduced into the treatment of cellulite over the last years. The purpose of this study is to test the following hypotheses: (i) cellulite can be efficiently and safely treated using the radial extracorporeal shock wave device, Swiss Dolorclast (Electro… Read more about this study

Who is it for?
Ages 20 to 59 years, women only
Conditions the study is for
Cellulitis
What is being tested?
Radial extracorporeal shock wave therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSwitzerland
Study dates
Dec 2008to Jul 2011
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 20 to 59 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Healthy women, < 60 years of age with cellulite grade 2-3
  • Unchanged hormonal treatment for < 6 months
  • Commitment to the study and ability to follow the medical directions during the study
  • Signed "informed-consent" form

Who cannot join

  • Previous surgery in the treated area (especially liposuction)
  • Medical and/or cosmetic treatment of cellulite ongoing or within the last three months
  • Infection and/or tumor diseases within the treatment area
  • Anticoagulation therapy and/or hemorrhagic disorders
  • Pregnancy
  • Significant weight fluctuations (caused by disease or diet)
Show all 10Show fewer
  • Modified hormonal treatment
  • Drugs (corticosteroids, non-steroidal antiinflammatory drugs, etc.)
  • Vascular abnormalities
  • Previous treatment with ESWT/RSWT

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Concept Clinic

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: Clinical Effects of the Radial Extracorporeal Shock Wave Therapy (rESWT) Using the EMS Swiss Dolorclast and the Power+ Handpiece for Local Treatment of Cellulite

Extracorporeal shock wave therapy (ESWT) has been successfully introduced into the treatment of cellulite over the last years. The purpose of this study is to test the following hypotheses: (i) cellulite can be efficiently and safely treated using the radial extracorporeal shock wave device, Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland); and (ii) the individual clinical outcome of cellulite treatment with ESWT can be predicted by means of the patient's individual cellulite grade at baseline, the patient's individual age, body mass index (BMI), weight, and/or height.

Read the detailed description

Gynoid lipodystrophy - better known as cellulite - represents the most common lipodystrophic disease and is found in 85% of post-adolescent women. Cellulite usually develops in particular anatomical areas such as the thighs, buttocks, abdomen, and upper arms and becomes visible through its classical 'orange peel' appearance - an irregular, dimpled skin surface with thinning of the epidermis/dermis and the presence of nodular clusters of fat cells. It represents not only a cosmetic concern for women, but often becomes a major psychological problem impairing sports activities, clothing choice, and social interaction.

The pathophysiology of cellulite is related to various predisposing factors such as biotype, heredity, race, body weight, age, hormonal changes, smoking, and genetic predisposition. Four main hypotheses regarding the etiopathogenesis of cellulite have emerged over the last decades: a different anatomical conformation of the subcutaneous tissue in women compared to men, changes of the biomechanical properties of epidermal and dermal tissues, excessive hydrophilia of the extracellular matrix increasing interstitious pressure and causing edema of the fatty tissue, and alterations of both microvascular and lymphatic circulation that result in the often painful protrusion of subcutaneous adipose tissue into the lower reticular dermis, causing the distinctive mattress-like surface irregularities. However, these hypotheses are mutually conflicting and do not consider recent advances in our understanding of the complex physiopathology of the adipose organ. For instance, one cannot exclude that inflammation also contributes to the formation of cellulite.

Nevertheless, various treatments for cellulite have been developed over the last decades, focusing on skin tightening with radiofrequency or lasers, improving blood and lymphatic circulation using both physical treatments and pharmacotherapy, and treating deeper deformities with surgical subcision, laser treatments, ultrasound devices, or liposuction. However, there is no single treatment of cellulite that is completely effective.

In recent years, extracorporeal shock wave therapy (ESWT) and radial shock wave therapy (RSWT) have been introduced as safe and effective treatment options for cellulite. A shock wave is an acoustic pressure wave that is produced in any elastic medium such as air, water, or even a solid substance. Shock waves differ from sound waves in that the wave front, where compression takes place, is a region of sudden change in stress and density. Therapeutic shock waves are characterized by a high positive peak pressure (usually between 10 and 100 MPa), a fast initial rise in pressure (less than 1 µs), a diffraction-induced tensile wave (up to -10 MPa) following the positive pressure amplitude, and a short life cycle of approximately 10-20 µs. Extracorporeal shock wave lithotripsy (ESWL) is widely used for stone management in urology. ESWT and RSWT are byproducts of lithotriptor technology. Since the late 1980's they have been introduced into the treatment for various diseases of the musculoskeletal system such as plantar fasciopathy, Achilles tendinopathy, medial tibial stress syndrome, greater trochanteric pain syndrome, lateral and medial epicondylitis, and calcifying tendonitis of the shoulder. Shock waves have both a direct and indirect effect on treated tissues. The direct effect is the result of the energy of the shock wave being transferred to the targeted tissues. The indirect effect is the result of the creation of cavitation bubbles in the treated tissue. It has been hypothesized that both the direct and indirect effects produce a biological response in the treated tissues. ESWT devices share two technical key characteristics of ESWL devices used for stone management, namely the electrohydraulic, electromagnetic, or piezoelectric generation of pressure waves and the generation of focused or so-called defocused pressure waves. Radial shock waves are generated ballistically, i.e., by accelerating a bullet that strikes an applicator, transforming the kinetic energy of the bullet into a radially expanding pressure wave.

Unaddressed in the studies on ESWT/RSWT for cellulite carried out to date is whether the individual clinical outcome of the therapy can be predicted by means of the patient's cellulite grade at baseline, age, body mass index (BMI), weight, height, and/or age. This was addressed in the present study using RSWT. We hypothesized that the individual clinical outcome of RSWT for cellulite can be predicted by means of the patient's cellulite grade at baseline and the patient's BMI.

Conditions
Cellulitis
Being tested
Radial extracorporeal shock wave therapy
Keywords
Cellulite, Extracorporeal shock wave therapy, ESWT, Radial shock wave therapy, RSWT
Medical subject headings
Cellulitis, Cellulite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radial extracorporeal shock wave therapyDevice

    Also called Swiss Dolorclast

    All patients were treated with radial extracorporeal shock waves using the Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland) and the Power+ handpiece with the 36-mm applicator. Patients were treated unilaterally with two weekly treatments for four weeks on a randomly selected leg (left or right), totaling eight treatments on the selected side. After the application of coupling gel, treatment was performed at 3.5 to 4 bar, with 15,000 impulses per session, and applied at 15 Hz. Impulses were applied homogeneously over the posterior thigh and buttock area. One patient was treated on both legs, with each leg considered an independent treatment.

Study groups in NCT01974115
Study groupRoleWhat they receive
Radial extracorporeal shock wave therapyActive comparatorAll patients were treated with radial extracorporeal shock waves using the Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland) and the Power+ handpiece with the 36-mm applicator. Patients were treated unilaterally with two weekly treatments for four weeks on a randomly selected leg (left or right), totaling eight treatments on the selected side. After the application of coupling gel, treatment was performed at 3.5 to 4 bar, with 15,000 impulses per session, and applied at 15 Hz. Impulses were applied homogeneously over the posterior thigh and buttock area. One patient was treated on both legs, with each leg considered an independent treatment.
Receives: Device: Radial extracorporeal shock wave therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cellulite grade of the patient

    Cellulite grades were determined by clinical inspection of the patients' skin (documented by digital photography) as well as by contact thermography.

    Photographs of the patients were taken before the treatment cycle and at each follow-up, with standardized lighting settings and distance to the patient at each photo shoot. The patients were asked to fully contract the buttock muscles at each time a photograph was taken. This aimed to fully show and standardize the appearance of the cellulite and thus to avoid any 'softening effects' due to varying muscle tones, changing the visibility of the cellulite.

    Contact thermography was performed using a professional cellulite thermodetector that was applied directly on the skin of the treated areas.

    At each clinical control, patients submitted a detailed questionnaire with scores for treatment comfort, pain intensity, and satisfaction, while also indicating undesired effects such as bruising, etc..

    Measured: Cellulite grade was determined before the treatment and 4 weeks after the completed treatment cycle (8 weeks after the completed treatment cycle in case of bilateral treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startDec 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01974115
Sponsor's protocol ID
ConceptClinic-1
Status last verified
Oct 2013
First submitted
28 Oct 2013
Last updated
1 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Radial extracorporeal shock wave therapy in people with Cellulitis, run by Concept-Clinic at 1 site in Switzerland.

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 10 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 1 Nov 2013. 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 Switzerland. 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 of the patient (time frame: Cellulite grade was determined before the treatment and 4 weeks after the completed treatment cycle (8 weeks after the completed treatment cycle in case of bilateral treatment).). 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 1 Nov 2013.

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