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Cellulite and Extracorporeal Shock Wave

Primary Purpose

Cellulite, Microcirculation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Extracorporeal shockwave therapy
Sham extracorporeal shock wave plus gluteal strength exercise
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite focused on measuring cellulite; shockwave; microcirculation; skin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy Open wounds Females >18yrs or >65yrs

-

Sites / Locations

  • Plastic, Hand and Reconstructive Surgery, Hannover Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Shockwave plus strength training

Sham extracorporeal shock wave plus gluteal strength exercise

Arm Description

6 sessions of extracorporeal shock wave plus daily gluteal strength exercises

SHAM extracorporeal shock wave plus gluteal strength exercise

Outcomes

Primary Outcome Measures

Nuernberger Score based on photo of cellulite

Secondary Outcome Measures

Circumference of thigh in cm
Capillary blood flow
Tissue oxygen saturation
Postcapillary venous filling pressure

Full Information

First Posted
July 27, 2009
Last Updated
December 1, 2011
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00947414
Brief Title
Cellulite and Extracorporeal Shock Wave
Official Title
Cellulite and Extracorporeal Shock Wave - a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite, Microcirculation
Keywords
cellulite; shockwave; microcirculation; skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shockwave plus strength training
Arm Type
Active Comparator
Arm Description
6 sessions of extracorporeal shock wave plus daily gluteal strength exercises
Arm Title
Sham extracorporeal shock wave plus gluteal strength exercise
Arm Type
Sham Comparator
Arm Description
SHAM extracorporeal shock wave plus gluteal strength exercise
Intervention Type
Device
Intervention Name(s)
Extracorporeal shockwave therapy
Intervention Description
Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises
Intervention Type
Device
Intervention Name(s)
Sham extracorporeal shock wave plus gluteal strength exercise
Intervention Description
Sham extracorporeal shock wave plus gluteal strength exercise
Primary Outcome Measure Information:
Title
Nuernberger Score based on photo of cellulite
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Circumference of thigh in cm
Time Frame
12 weeks
Title
Capillary blood flow
Time Frame
12 weeks
Title
Tissue oxygen saturation
Time Frame
12 weeks
Title
Postcapillary venous filling pressure
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females ages 18-65yrs Cellulite 1°-4° Informed consent Exclusion Criteria: Pregnancy Open wounds Females >18yrs or >65yrs -
Facility Information:
Facility Name
Plastic, Hand and Reconstructive Surgery, Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20977764
Citation
Knobloch K, Joest B, Vogt PM. Cellulite and extracorporeal Shockwave therapy (CelluShock-2009)--a randomized trial. BMC Womens Health. 2010 Oct 26;10:29. doi: 10.1186/1472-6874-10-29.
Results Reference
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PubMed Identifier
20124865
Citation
Knobloch K, Joest B, Vogt PM. Focused ultrasound for noninvasive body contouring in cellulite. Plast Reconstr Surg. 2010 Feb;125(2):751. doi: 10.1097/PRS.0b013e3181c831d1. No abstract available.
Results Reference
background
PubMed Identifier
19083577
Citation
Christ C, Brenke R, Sattler G, Siems W, Novak P, Daser A. Improvement in skin elasticity in the treatment of cellulite and connective tissue weakness by means of extracorporeal pulse activation therapy. Aesthet Surg J. 2008 Sep-Oct;28(5):538-44. doi: 10.1016/j.asj.2008.07.011.
Results Reference
background
PubMed Identifier
18225463
Citation
Angehrn F, Kuhn C, Voss A. Can cellulite be treated with low-energy extracorporeal shock wave therapy? Clin Interv Aging. 2007;2(4):623-30. doi: 10.2147/cia.s1721.
Results Reference
background
PubMed Identifier
20590369
Citation
Adatto M, Adatto-Neilson R, Servant JJ, Vester J, Novak P, Krotz A. Controlled, randomized study evaluating the effects of treating cellulite with AWT/EPAT. J Cosmet Laser Ther. 2010 Aug;12(4):176-82. doi: 10.3109/14764172.2010.500392.
Results Reference
background
PubMed Identifier
19627407
Citation
Bayrakci Tunay V, Akbayrak T, Bakar Y, Kayihan H, Ergun N. Effects of mechanical massage, manual lymphatic drainage and connective tissue manipulation techniques on fat mass in women with cellulite. J Eur Acad Dermatol Venereol. 2010 Feb;24(2):138-42. doi: 10.1111/j.1468-3083.2009.03355.x. Epub 2009 Jul 13.
Results Reference
background
PubMed Identifier
19220646
Citation
Hexsel DM, Dal'forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad Dermatol Venereol. 2009 May;23(5):523-8. doi: 10.1111/j.1468-3083.2009.03101.x. Epub 2009 Feb 13.
Results Reference
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Cellulite and Extracorporeal Shock Wave

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