Cellulite and Extracorporeal Shock Wave
December 1, 2011 updated by: Karsten Knobloch, Hannover Medical School
Cellulite and Extracorporeal Shock Wave - a Randomized Trial
Hypothesis: The combination of extracorporeal shockwave and a daily gluteal muscle strength programme is superior to the gluteal muscle strength programme alone in cellulite.
Study design: Randomized-controlled trial
Analysis: Intention-to-treat
Outcome parameters: a) Photo, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow
Intervention: Extracorporeal shock wave for six sessions with 2000 impulses at both gluteal and thigh regions plus a specific gluteal strength exercise training
Follow-up: 12 weeks
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hannover, Germany, 30625
- Plastic, Hand and Reconstructive Surgery, Hannover Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Females ages 18-65yrs Cellulite 1°-4° Informed consent
Exclusion Criteria:
Pregnancy Open wounds Females >18yrs or >65yrs
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Shockwave plus strength training
6 sessions of extracorporeal shock wave plus daily gluteal strength exercises
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Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises
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Sham Comparator: Sham extracorporeal shock wave plus gluteal strength exercise
SHAM extracorporeal shock wave plus gluteal strength exercise
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Sham extracorporeal shock wave plus gluteal strength exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Nuernberger Score based on photo of cellulite
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Circumference of thigh in cm
Time Frame: 12 weeks
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12 weeks
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Capillary blood flow
Time Frame: 12 weeks
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12 weeks
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Tissue oxygen saturation
Time Frame: 12 weeks
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12 weeks
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Postcapillary venous filling pressure
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Adatto M, Adatto-Neilson R, Servant JJ, Vester J, Novak P, Krotz A. Controlled, randomized study evaluating the effects of treating cellulite with AWT/EPAT. J Cosmet Laser Ther. 2010 Aug;12(4):176-82. doi: 10.3109/14764172.2010.500392.
- Christ C, Brenke R, Sattler G, Siems W, Novak P, Daser A. Improvement in skin elasticity in the treatment of cellulite and connective tissue weakness by means of extracorporeal pulse activation therapy. Aesthet Surg J. 2008 Sep-Oct;28(5):538-44. doi: 10.1016/j.asj.2008.07.011.
- Angehrn F, Kuhn C, Voss A. Can cellulite be treated with low-energy extracorporeal shock wave therapy? Clin Interv Aging. 2007;2(4):623-30. doi: 10.2147/cia.s1721.
- Knobloch K, Joest B, Vogt PM. Cellulite and extracorporeal Shockwave therapy (CelluShock-2009)--a randomized trial. BMC Womens Health. 2010 Oct 26;10:29. doi: 10.1186/1472-6874-10-29.
- Knobloch K, Joest B, Vogt PM. Focused ultrasound for noninvasive body contouring in cellulite. Plast Reconstr Surg. 2010 Feb;125(2):751. doi: 10.1097/PRS.0b013e3181c831d1. No abstract available.
- Bayrakci Tunay V, Akbayrak T, Bakar Y, Kayihan H, Ergun N. Effects of mechanical massage, manual lymphatic drainage and connective tissue manipulation techniques on fat mass in women with cellulite. J Eur Acad Dermatol Venereol. 2010 Feb;24(2):138-42. doi: 10.1111/j.1468-3083.2009.03355.x. Epub 2009 Jul 13.
- Hexsel DM, Dal'forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad Dermatol Venereol. 2009 May;23(5):523-8. doi: 10.1111/j.1468-3083.2009.03101.x. Epub 2009 Feb 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
July 27, 2009
First Submitted That Met QC Criteria
July 27, 2009
First Posted (Estimate)
July 28, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2011
Last Update Submitted That Met QC Criteria
December 1, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CELLUSHOCK-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.