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OpenTrials
Completed

NCT Number: NCT00947414

Cellulite and Extracorporeal Shock Wave

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

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Key information

Conditions

Cellulite Microcirculation Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Plastic, Hand and Reconstructive Surgery, Hannover Medical School

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnancy Open wounds Females >18yrs or >65yrs

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Treatment and study plan

Extracorporeal shockwave therapy

Device

Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises

Sham extracorporeal shock wave plus gluteal strength exercise

Device

Sham extracorporeal shock wave plus gluteal strength exercise

Primary outcomes

  1. Nuernberger Score based on photo of cellulite

    Time frame: 12 weeks

Secondary outcomes

  1. Circumference of thigh in cm

    Time frame: 12 weeks

  2. Capillary blood flow

    Time frame: 12 weeks

  3. Tissue oxygen saturation

    Time frame: 12 weeks

  4. Postcapillary venous filling pressure

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

Cellulite and Extracorporeal Shock Wave - a Randomized Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2009
Registry last updated
Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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