Cellulitis Clinical Trial
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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