CelluliteNCT00947414
Cellulite and Extracorporeal Shock Wave
A study testing Extracorporeal shockwave therapy in people with Cellulite and Microcirculation, run by Hannover Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cellulite, Microcirculation
- What is being tested?
- Extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ages 18-65yrs Cellulite 1°-4° Informed consent
Who cannot join
- Pregnancy Open wounds Females >18yrs or >65yrs
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Plastic, Hand and Reconstructive Surgery, Hannover Medical School
Hanover, 30625
About this study
Official title: Cellulite and Extracorporeal Shock Wave - a Randomized Trial
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
- Conditions
- Cellulite, Microcirculation
- Being tested
- Extracorporeal shockwave therapy, Sham extracorporeal shock wave plus gluteal strength exercise
- Keywords
- cellulite; shockwave; microcirculation; skin
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapyDevice
Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises
Sham extracorporeal shock wave plus gluteal strength exerciseDevice
Sham extracorporeal shock wave plus gluteal strength exercise
| Study group | Role | What they receive |
|---|---|---|
| Shockwave plus strength training | Active comparator | 6 sessions of extracorporeal shock wave plus daily gluteal strength exercises Receives: Device: Extracorporeal shockwave therapy |
| Sham extracorporeal shock wave plus gluteal strength exercise | Sham comparator | SHAM extracorporeal shock wave plus gluteal strength exercise Receives: Device: Sham extracorporeal shock wave plus gluteal strength exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nuernberger Score based on photo of cellulite
Measured: 12 weeks
Secondary outcomes (4)
Circumference of thigh in cm
Measured: 12 weeks
Capillary blood flow
Measured: 12 weeks
Tissue oxygen saturation
Measured: 12 weeks
Postcapillary venous filling pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Knobloch, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947414
- Sponsor's protocol ID
- CELLUSHOCK-2009
- Status last verified
- Dec 2011
- First submitted
- 27 Jul 2009
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20977764Knobloch 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.
PubMed 20124865Christ 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.
PubMed 19083577Angehrn 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.
PubMed 18225463Adatto 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.
PubMed 20590369Bayrakci 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.
PubMed 19627407Hexsel 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.
PubMed 19220646
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellulite and Extracorporeal Shock Wave - a Randomized Trial
- ClinicalTrials.gov ID
- NCT00947414
- Acronym / sponsor ID
- CELLUSHOCK-2009
- Conditions
- Cellulite, Microcirculation
- Keywords
- cellulite; shockwave; microcirculation; skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave plus strength training | Active comparator | Device: Extracorporeal shockwave therapy6 sessions of extracorporeal shock wave plus daily gluteal strength exercises |
| Sham extracorporeal shock wave plus gluteal strength exercise | Sham comparator | Device: Sham extracorporeal shock wave plus gluteal strength exerciseSHAM extracorporeal shock wave plus gluteal strength exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females ages 18-65yrs Cellulite 1°-4° Informed consent
Key exclusion criteria (2 listed)
- Pregnancy Open wounds Females >18yrs or >65yrs
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shockwave therapyExtracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises | Device | Shockwave plus strength training |
| Sham extracorporeal shock wave plus gluteal strength exerciseSham extracorporeal shock wave plus gluteal strength exercise | Device | Sham extracorporeal shock wave plus gluteal strength exercise |
Primary outcome
Nuernberger Score based on photo of cellulite
Time frame: 12 weeks
4 secondary outcomes
Circumference of thigh in cm
Time frame: 12 weeks
Capillary blood flow
Time frame: 12 weeks
Tissue oxygen saturation
Time frame: 12 weeks
Postcapillary venous filling pressure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Background: PubMed 20977764Knobloch 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.
- Background: PubMed 20124865Knobloch 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.
- Background: PubMed 19083577Christ 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.
- Background: PubMed 18225463Angehrn 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.
- Background: PubMed 20590369Adatto 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.
- Background: PubMed 19627407Bayrakci 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.
- Background: PubMed 19220646Hexsel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave therapy in people with Cellulite and Microcirculation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nuernberger Score based on photo of cellulite (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00947414, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011.