Cellulite and Extracorporeal Shock Wave

Not Applicable

Completed

• Conditions: Cellulite; Microcirculation
• Interventions: Device: Extracorporeal shockwave therapy; Device: Sham extracorporeal shock wave plus gluteal strength exercise

• Registration Number: NCT00947414
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-01
• Last Update Posted: 2011-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Pregnancy Open wounds Females >18yrs or >65yrs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shockwave plus strength training	Extracorporeal shockwave therapy	6 sessions of extracorporeal shock wave plus daily gluteal strength exercises
Sham extracorporeal shock wave plus gluteal strength exercise	Sham extracorporeal shock wave plus gluteal strength exercise	SHAM extracorporeal shock wave plus gluteal strength exercise

Primary Outcome Measures

Name	Time	Method
Nuernberger Score based on photo of cellulite	12 weeks

Secondary Outcome Measures

Name	Time	Method
Circumference of thigh in cm	12 weeks
Capillary blood flow	12 weeks
Tissue oxygen saturation	12 weeks
Postcapillary venous filling pressure	12 weeks

Trial Locations

Locations (1)

Plastic, Hand and Reconstructive Surgery, Hannover Medical School; 🇩🇪 Hannover, Germany