Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000092190
Ethics application status
Approved
Date submitted
11/01/2019
Date registered
22/01/2019
Date last updated
24/04/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of oscilating-cycloid vibration therapy interventions on skin condition, skin temperature and selected biochemical indices in blood in women with cellulite
Scientific title
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)
Secondary ID [1] 297034 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynoid lipodystrophy 311017 0
Condition category
Condition code
Skin 309665 309665 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313313 0
Treatment: Devices
Comparator / control treatment
A group without vibration therapy
Control group
Active

Outcomes
Primary outcome [1] 318635 0
Influence of vibrotherapy treatment (with and without anti-cellulite cosmetic) on the temperature of skin affected by cellulite.
Will be assessed by thermographic images taken with use of thermal camera.
Timepoint [1] 318635 0
Baseline, after 20th treatment, 2 weeks after the last treatment.
Primary outcome [2] 318636 0
Influence of vibrotherapy treatment (with and without anti-cellulite cosmetic) on anthropometric parameters.
Will be assessed with use of anthropometric tape and body composition analyzer.
Timepoint [2] 318636 0
Baseline, after 20th treatment, 2 weeks after the last treatment.
Primary outcome [3] 318754 0
Influence of vibrotherapy treatment (with and without anti-cellulite cosmetic) on cellulite level.
Will be assessed visually with use of Nümberg-Müller scale.
Timepoint [3] 318754 0
Baseline, after 20th treatment, 2 weeks after the last treatment.
Secondary outcome [1] 365924 0
Influence of vibrotherapy treatment (with and without anti-cellulite cosmetic) on the levels of selected adipokines in venous blood collected from the participants (exploratory outcome).
The biochemical tests will be performed after the end of the program. Biological material will be stored at -80C.
Timepoint [1] 365924 0
Baseline, after 20th treatment, 2 weeks after the last treatment.
Secondary outcome [2] 365998 0
Influence of vibrotherapy treatment (with and without anti-cellulite cosmetic) on the levels of selected biochemical indices of inflammation in venous blood collected from the participants (exploratory outcome).
The biochemical tests will be performed after the end of the program. Biological material will be stored at -80C.
Timepoint [2] 365998 0
Baseline, after 20th treatment, 2 weeks after the last treatment.

Eligibility
Key inclusion criteria
Presence of cellulite lesions (level 1 on the Nürnberger-Müller scale or higher) and low physical activity level (measured with use of IPAQ questionnaire).
Minimum age
20 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of cellulite lesions, contradictions for vibration therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are randomly assigned to the groups.
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using dice-rolling.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 21185 0
Poland
State/province [1] 21185 0
Lesser Poland

Funding & Sponsors
Funding source category [1] 301603 0
University
Name [1] 301603 0
University of Physical Education in Kraków
Country [1] 301603 0
Poland
Primary sponsor type
Individual
Name
prof. Wanda Pilch
Address
University of Physical Education in Kraków
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 301306 0
University
Name [1] 301306 0
University of Physical Education in Kraków
Address [1] 301306 0
al. Jana Pawla II 78
31-571 Krakow
Country [1] 301306 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302331 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 302331 0
ul. Krupnicza 11a
31-123 Krakow, Poland
Ethics committee country [1] 302331 0
Poland
Date submitted for ethics approval [1] 302331 0
20/02/2018
Approval date [1] 302331 0
07/03/2018
Ethics approval number [1] 302331 0
36/KBL/OIL/2018

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89846 0
A/Prof Wanda Pilch
Address 89846 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 89846 0
Poland
Phone 89846 0
+48 12 6831149
Fax 89846 0
Email 89846 0
[email protected]
Contact person for public queries
Name 89847 0
Mrs Olga Czerwinska-Ledwig and Natalia Totko-Borkusewicz
Address 89847 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 89847 0
Poland
Phone 89847 0
+48 12 6831154
Fax 89847 0
Email 89847 0
[email protected]
Contact person for scientific queries
Name 89848 0
Dr Anna Piotrowska
Address 89848 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 89848 0
Poland
Phone 89848 0
+48 12 6831154
Fax 89848 0
Email 89848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Impact of Vibration Therapy Interventions on Skin Condition and Skin Temperature Changes in Young Women with Lipodystrophy: A Pilot Study.2019https://dx.doi.org/10.1155/2019/8436325
N.B. These documents automatically identified may not have been verified by the study sponsor.