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Cellulite and Extracorporeal Shock Wave

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947414
First Posted: July 28, 2009
Last Update Posted: December 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karsten Knobloch, Hannover Medical School
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cellulite and Extracorporeal Shock Wave - a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Karsten Knobloch, Hannover Medical School:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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

  Contacts and Locations
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
  More Information

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 Submitted: July 27, 2009
First Posted: July 28, 2009
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