NCT00947414

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 2, 2011

Status Verified

December 1, 2011

Enrollment Period

2.3 years

First QC Date

July 27, 2009

Last Update Submit

December 1, 2011

Conditions

CelluliteMicrocirculation

Keywords

cellulite; shockwave; microcirculation; skin

Outcome Measures

Primary Outcomes (1)

  • Nuernberger Score based on photo of cellulite

    12 weeks

Secondary Outcomes (4)

  • Circumference of thigh in cm

    12 weeks

  • Capillary blood flow

    12 weeks

  • Tissue oxygen saturation

    12 weeks

  • Postcapillary venous filling pressure

    12 weeks

Study Arms (2)

Shockwave plus strength training

ACTIVE COMPARATOR

6 sessions of extracorporeal shock wave plus daily gluteal strength exercises

Device: Extracorporeal shockwave therapy

Sham extracorporeal shock wave plus gluteal strength exercise

SHAM COMPARATOR

SHAM extracorporeal shock wave plus gluteal strength exercise

Device: Sham extracorporeal shock wave plus gluteal strength exercise

Interventions

Extracorporeal shockwave therapyDEVICE

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

Shockwave plus strength training
Sham extracorporeal shock wave plus gluteal strength exerciseDEVICE

Sham extracorporeal shock wave plus gluteal strength exercise

Sham extracorporeal shock wave plus gluteal strength exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy Open wounds Females \>18yrs or \>65yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plastic, Hand and Reconstructive Surgery, Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (7)

  • 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.

    PMID: 20977764BACKGROUND

  • 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.

    PMID: 20124865BACKGROUND

  • 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.

    PMID: 19083577BACKGROUND

  • 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.

    PMID: 18225463BACKGROUND

  • 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.

    PMID: 20590369BACKGROUND

  • 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.

    PMID: 19627407BACKGROUND

  • 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.

    PMID: 19220646BACKGROUND

MeSH Terms

Conditions

Cellulite

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Karsten Knobloch, FACS

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 28, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 2, 2011

Record last verified: 2011-12

Locations

DE(1)