Cellulite and Extracorporeal Shock Wave

December 1, 2011 updated by: Karsten Knobloch, Hannover Medical School

Cellulite and Extracorporeal Shock Wave - a Randomized Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Plastic, Hand and Reconstructive Surgery, Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy Open wounds Females >18yrs or >65yrs

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nuernberger Score based on photo of cellulite
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Circumference of thigh in cm
Time Frame: 12 weeks
12 weeks
Capillary blood flow
Time Frame: 12 weeks
12 weeks
Tissue oxygen saturation
Time Frame: 12 weeks
12 weeks
Postcapillary venous filling pressure
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2011

Last Update Submitted That Met QC Criteria

December 1, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELLUSHOCK-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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