Cellulite and Extracorporeal Shock Wave - Full Text View

Purpose

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

Condition	Intervention
Cellulite Microcirculation	Device: Extracorporeal shockwave therapy Device: Sham extracorporeal shock wave plus gluteal strength exercise

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Cellulite and Extracorporeal Shock Wave - a Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Shock

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

Nuernberger Score based on photo of cellulite [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Circumference of thigh in cm [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Capillary blood flow [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Tissue oxygen saturation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Postcapillary venous filling pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Shockwave plus strength training 6 sessions of extracorporeal shock wave plus daily gluteal strength exercises	Device: Extracorporeal shockwave therapy Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises
Sham Comparator: Sham extracorporeal shock wave plus gluteal strength exercise SHAM extracorporeal shock wave plus gluteal strength exercise	Device: Sham extracorporeal shock wave plus gluteal strength exercise Sham extracorporeal shock wave plus gluteal strength exercise

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females ages 18-65yrs Cellulite 1°-4° Informed consent

Exclusion Criteria:

Pregnancy Open wounds Females >18yrs or >65yrs

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947414

Locations

Germany
Plastic, Hand and Reconstructive Surgery, Hannover Medical School
Hannover, Germany, 30625

Sponsors and Collaborators

Hannover Medical School

More Information

Publications:

Knobloch Facs K, Joest B, Vogt PM. Cellulite and extracorporeal shockwave therapy (CelluShock-2009) - a Randomized Trial. BMC Womens Health. 2010 Oct 26;10(1):29 [Epub ahead of print]

Knobloch K, Joest B, Vogt PM. Focused ultrasound for noninvasive body contouring in cellulite. Plast Reconstr Surg. 2010 Feb;125(2):751. No abstract available.

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.

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. Review.

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.

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. 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. Epub 2009 Feb 13.

Responsible Party:	Karsten Knobloch, Prof. Dr. Karsten Knobloch, FACS, Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00947414 History of Changes
Other Study ID Numbers:	CELLUSHOCK-2009
Study First Received:	July 27, 2009
Last Updated:	December 1, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:

cellulite; shockwave; microcirculation; skin

ClinicalTrials.gov processed this record on May 23, 2013