Cellulite and Extracorporeal Shock Wave

NCT ID: NCT00947414

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Cellulite Microcirculation

Keywords

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cellulite; shockwave; microcirculation; skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Shockwave plus strength training

6 sessions of extracorporeal shock wave plus daily gluteal strength exercises

Group Type ACTIVE_COMPARATOR

Extracorporeal shockwave therapy

Intervention Type DEVICE

Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises

Sham extracorporeal shock wave plus gluteal strength exercise

SHAM extracorporeal shock wave plus gluteal strength exercise

Group Type SHAM_COMPARATOR

Sham extracorporeal shock wave plus gluteal strength exercise

Intervention Type DEVICE

Sham extracorporeal shock wave plus gluteal strength exercise

Interventions

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Extracorporeal shockwave therapy

Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises

Intervention Type DEVICE

Sham extracorporeal shock wave plus gluteal strength exercise

Sham extracorporeal shock wave plus gluteal strength exercise

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Pregnancy Open wounds Females \>18yrs or \>65yrs

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Karsten Knobloch

Prof. Dr. Karsten Knobloch, FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Plastic, Hand and Reconstructive Surgery, Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 20977764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20124865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19083577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18225463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20590369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19627407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19220646 (View on PubMed)

Other Identifiers

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CELLUSHOCK-2009

Identifier Type: -

Identifier Source: org_study_id