Cellulite and Extracorporeal Shock Wave

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karsten Knobloch, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00947414
First received: July 27, 2009
Last updated: December 1, 2011
Last verified: December 2011
  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:


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

-

  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:
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 April 16, 2014