Cellulite and Extracorporeal Shock Wave

Hannover Medical School (MHH)

Status: Completed

Conditions: Cellulite; Microcirculation

Treatments: Device: Extracorporeal shockwave therapy; Device: Sham extracorporeal shock wave plus gluteal strength exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00947414

CELLUSHOCK-2009

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Pregnancy Open wounds Females >18yrs or >65yrs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Shockwave plus strength training

Active Comparator group

Description:

6 sessions of extracorporeal shock wave plus daily gluteal strength exercises

Treatment:

Device: Extracorporeal shockwave therapy

Sham extracorporeal shock wave plus gluteal strength exercise

Sham Comparator group

Description:

SHAM extracorporeal shock wave plus gluteal strength exercise

Treatment:

Device: Sham extracorporeal shock wave plus gluteal strength exercise