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Cellulite and Extracorporeal Shock Wave

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ClinicalTrials.gov Identifier: NCT00947414
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : December 2, 2011
Sponsor:
Information provided by (Responsible Party):
Karsten Knobloch, Hannover Medical School

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Nuernberger Score based on photo of cellulite [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Circumference of thigh in cm [ Time Frame: 12 weeks ]
  2. Capillary blood flow [ Time Frame: 12 weeks ]
  3. Tissue oxygen saturation [ Time Frame: 12 weeks ]
  4. Postcapillary venous filling pressure [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947414


Locations
Germany
Plastic, Hand and Reconstructive Surgery, Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School

Publications:

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
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011

Keywords provided by Karsten Knobloch, Hannover Medical School:
cellulite; shockwave; microcirculation; skin

Additional relevant MeSH terms:
Cellulite
Skin Manifestations
Signs and Symptoms