Cellulite and Extracorporeal Shock Wave

• Sponsor: Hannover Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT00947414
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cellulite; Microcirculation	Device: Extracorporeal shockwave therapy; Device: Sham extracorporeal shock wave plus gluteal strength exercise	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Cellulite and Extracorporeal Shock Wave - a Randomized Trial
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Nuernberger Score based on photo of cellulite [12 weeks]

Secondary Outcome Measures

1. Circumference of thigh in cm [12 weeks]

2. Capillary blood flow [12 weeks]

3. Tissue oxygen saturation [12 weeks]

4. Postcapillary venous filling pressure [12 weeks]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Plastic, Hand and Reconstructive Surgery, Hannover Medical School	Hannover		Germany	30625

Sponsors and Collaborators

• Hannover Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Karsten Knobloch, Prof. Dr. Karsten Knobloch, FACS, Hannover Medical School
• ClinicalTrials.gov Identifier: NCT00947414
• Other Study ID Numbers: CELLUSHOCK-2009
• First Posted: Jul 28, 2009
• Last Update Posted: Dec 2, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Karsten Knobloch, Prof. Dr. Karsten Knobloch, FACS, Hannover Medical School: cellulite; shockwave; microcirculation; skin
• Additional relevant MeSH terms: Cellulite

Study Results

No Results Posted as of Dec 2, 2011