Extracorporeal Shock Wave Treatment for Cellulite
Condition: Cellulitis
MeSH terms: Cellulitis; Cellulite
Study type: Interventional

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 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.
    

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.
    

Intervention name(s): Radial extracorporeal shock wave therapy
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Swiss Dolorclast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cellulite; Extracorporeal shock wave therapy; ESWT; Radial shock wave therapy; RSWT