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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014