RecruitingACTRN12619000092190

The impact of oscilating-cycloid vibration therapy interventions on skin condition, skin temperature and selected biochemical indices in blood in women with cellulite

The impact of oscilating-cycloid vibration therapy interventions on skin condition, skin temperature and selected biochemical indices in blood in women with gynoid lipodystrophy (cellulite)


Sponsor

prof. Wanda Pilch

Enrollment

100 participants

Start Date

Oct 1, 2018

Study Type

Interventional

Conditions

Summary

Cellulite (gynoid lipodystrophy - GL) is a fibromatous degeneration of the connective tissue. It affects 80–90% of women aged over 20 years. It can occur on the surface of any part of the body that contains subcutaneous adipose tissue. The superior and posterior regions of the thighs and buttocks are the most susceptible areas. They usually begin with microcirculation disorders and dysfunction of blood and lymphatic vessels with an increase in their ermeability. Effectiveness of intervention to advanced stages of GL is quite limited; most often, lowering of the GL signs is only possible. There are numerous anti-cellulite interventions available, they involve three common directions of action: microcirculation improvement, enhancing lipolysis, and restoration of skin and blood vessel walls. These are diversified with respect to the instruments and materials used. In a given context, mechanical vibrations have not been applied in the therapy of GL till now. The aim of this study is to assess the changes in condition and temperature of skin affected by cellulite after a series of oscilating-cycloid vibration treatments and also the changes in levels of selected biochemical indices in blood of subjects.


Eligibility

Sex: FemalesMin Age: 20 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Cellulite — the dimpled skin appearance commonly seen on the thighs and buttocks — affects the majority of women and is thought to involve changes in the connective tissue and impaired circulation beneath the skin. Many treatments exist, but few have strong evidence behind them. This study tests a new approach: oscillating-cycloid vibration therapy, a form of mechanical vibration that has not previously been studied for cellulite. Women with visible cellulite undergo a series of vibration therapy sessions, and researchers measure changes in skin condition, skin temperature, and certain blood markers before and after the treatment course. The goal is to understand whether this approach can improve the appearance and underlying biology of cellulite. You may be eligible if you are a woman aged 20 to 60, have visible cellulite (at least level 1 on the Nürnberger-Müller scale), and have a low physical activity level. Women who do not have cellulite or who have medical conditions that contraindicate vibration therapy are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In our study a 4-weeks series of cycloid-oscillatory vibration therapy treatments consists of 20 interventions, 60 minutes each (a 30-minutes cycle repeated 2 times), applied daily (excluding the week

In our study a 4-weeks series of cycloid-oscillatory vibration therapy treatments consists of 20 interventions, 60 minutes each (a 30-minutes cycle repeated 2 times), applied daily (excluding the weekends) with use of Rehabilitation Massage Device RAM Vitberg+. This device is a mattress with electric drive (medical device, class I) that generates cycloid-oscillatory vibration which affects cells by exerting compression, traction and shear forces. This type of vibration stimulus, transmitted through the skin ameliorates function of lymphatic pump, increases fluids flow in soft tissues and increases microvasculature. The treatments are carried out in seated position. A randomly chosen part of the study group will be asked to use body lotion which is supposed to help to reduce cellulite changes. The cosmetic used in the study contains caffeine (7%) which is used in majority of anti-cellulite cosmetics. Lotion should be applied by a participant 2 times a day on the areas of thighs and buttocks affected by cellulite during 4 weeks. The amount for each application is individually adapted for each participant in relation to the area of skin affected by cellulite (0,5 ml/10 square centimeters). The participants will be asked to return the unused product and/or empty packaging(s) – its amount will allow the research team to monitor the adherence to the intervention. Each volunteer will be qualified by a physician before participation in the study. The therapy will take place at Academy of Physical Education in Kraków and will be supervised by the members of our research team, as well as all of the tests which will be performed. Before and after the first and last interventions thermographic images will be taken and analyzed. Before the beginning, after 4 weeks and 2 weeks after the end of the program measurements of anthropometric indices, body composition are performed. Venous blood is collected from the volunteers by an experienced phlebotomist before the start of the program, after the last treatment and 2 weeks after its completion. The blood components are prepared and stored in -80C for the subsequent biochemical tests.


Locations(1)

Lesser Poland, Poland

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ACTRN12619000092190