Extracorporeal Shock Wave Treatment for Cellulite

NCT01974115 | Completed

• 1 other identifier: ConceptClinic-1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Extracorporeal shock wave therapy (ESWT) has been successfully introduced into the treatment of cellulite over the last years. The purpose of this study is to test the following hypotheses: (i) cellulite can be efficiently and safely treated using the radial extracorporeal shock wave device, Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland); and (ii) the individual clinical outcome of cellulite treatment with ESWT can be predicted by means of the patient's individual cellulite grade at baseline, the patient's individual age, body mass index (BMI), weight, and/or height.

Conditions

Cellulitis

Keywords

Cellulite; Extracorporeal shock wave therapy; ESWT; Radial shock wave therapy; RSWT

Outcome Measures

Primary Outcomes (1)

• Cellulite grade of the patient

  Cellulite grades were determined by clinical inspection of the patients' skin (documented by digital photography) as well as by contact thermography. Photographs of the patients were taken before the treatment cycle and at each follow-up, with standardized lighting settings and distance to the patient at each photo shoot. The patients were asked to fully contract the buttock muscles at each time a photograph was taken. This aimed to fully show and standardize the appearance of the cellulite and thus to avoid any 'softening effects' due to varying muscle tones, changing the visibility of the cellulite. Contact thermography was performed using a professional cellulite thermodetector that was applied directly on the skin of the treated areas. At each clinical control, patients submitted a detailed questionnaire with scores for treatment comfort, pain intensity, and satisfaction, while also indicating undesired effects such as bruising, etc..

  Cellulite grade was determined before the treatment and 4 weeks after the completed treatment cycle (8 weeks after the completed treatment cycle in case of bilateral treatment).

Study Arms (1)

Radial extracorporeal shock wave therapy

ACTIVE COMPARATOR

All patients were treated with radial extracorporeal shock waves using the Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland) and the Power+ handpiece with the 36-mm applicator. Patients were treated unilaterally with two weekly treatments for four weeks on a randomly selected leg (left or right), totaling eight treatments on the selected side. After the application of coupling gel, treatment was performed at 3.5 to 4 bar, with 15,000 impulses per session, and applied at 15 Hz. Impulses were applied homogeneously over the posterior thigh and buttock area. One patient was treated on both legs, with each leg considered an independent treatment.

Device: Radial extracorporeal shock wave therapy

Interventions

Radial extracorporeal shock wave therapy DEVICE

All patients were treated with radial extracorporeal shock waves using the Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland) and the Power+ handpiece with the 36-mm applicator. Patients were treated unilaterally with two weekly treatments for four weeks on a randomly selected leg (left or right), totaling eight treatments on the selected side. After the application of coupling gel, treatment was performed at 3.5 to 4 bar, with 15,000 impulses per session, and applied at 15 Hz. Impulses were applied homogeneously over the posterior thigh and buttock area. One patient was treated on both legs, with each leg considered an independent treatment.

Also known as: Swiss Dolorclast

Radial extracorporeal shock wave therapy

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women, \< 60 years of age with cellulite grade 2-3
• Unchanged hormonal treatment for \< 6 months
• Commitment to the study and ability to follow the medical directions during the study
• Signed "informed-consent" form

You may not qualify if:

• Previous surgery in the treated area (especially liposuction)
• Medical and/or cosmetic treatment of cellulite ongoing or within the last three months
• Infection and/or tumor diseases within the treatment area
• Anticoagulation therapy and/or hemorrhagic disorders
• Pregnancy
• Significant weight fluctuations (caused by disease or diet)
• Modified hormonal treatment
• Drugs (corticosteroids, non-steroidal antiinflammatory drugs, etc.)
• Vascular abnormalities
• Previous treatment with ESWT/RSWT

Sponsors & Collaborators

• Concept-Clinic: lead

Study Sites (1)

Concept Clinic

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Cellulitis; Cellulite

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Kai U Schlaudraff, Dr.med.

  Concept Clinic Geneva (Switzerland)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.; owner and medical director of Concept-Clinic

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 1, 2013
• Study Start: December 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

CH (1)