Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010)
NCT ID: NCT01184586
Last Updated: 2011-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2011-11-30
2012-12-31
Brief Summary
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Dupuytren's disease contains nodules and cords in the fascia as the epicenter of disease progression. Nodules contain whorls of collagen bundles and are densely packed with contractile fibroblasts and myofibroblasts. These highly contractile cells are linked to the fascia matrix through transmembrane integrin receptors. The cytoplasmic tail domains of the alpha beta integrin receptors provide a structural link between extracellular matrix and the actomyosin cytoskeleton.
Complications of surgical partial or total aponeurectomy in Dupuytren's disease are reported in up to 10% of cases . Often, surgical complications lead to compromised flexion limiting grasping function of the involved hand . A recent 20-year-review of the literature included 41 clinical trials with complication rates reported from 3.6%to 39.1% . 16% major complications occurred with 3% digital nerve injuries, digital artery injuries in 2%, infections in 2%, and complex regional pain syndrome in 6%. Besides selective or total aponeurectomy, soft-tissue distraction has been suggested using either pneumatic devices or external fixateur .
Non-invasive options include percutaneous fasciotomy or collagenase injection. The latter has been tested in a randomized-controlled trial published in the New England Journal of Medicine with 308 patients enrolled (NCT00528606) . Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease. In the long-term the cords at the level of the proximal interphalangeal joint appear to more recurrent than at the metacarpophalangeal joint after collagenase injection with an eight year follow-up .
In early stage Dupuytren's contracture, radiotherapy has been suggested to limit disease progression. A cohort study of 135 patients with 208 hands involved received orthovoltage radiotherapy with a total dose of 30Gray separated by a six to eight week interval . After a follow-up of 13 years nodules and cords remained stable in 59%, improved in 10% and progressed in 31%.
Beside Dupuytren's disease, there are a number of further less common fibromatosis, such as knuckle pads, M. Ledderhose , of the plantar fascia and peyronie disease at the penis. The latter has been treated by extracorporeal shockwave therapy. A randomized-controlled trial using 2000 focused shock waves reduced pain significantly and improved erectile function and quality of life . About half of the patients in one series of 44 patients had a significant reduction in angulation following shockwave therapy .
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention arm - ESWT Storz Duolith high energy
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (STORZ DUOLITH, 1000 impulses, 0.55-0,8mJ/mm2)
Intervention - ESWT Storz Duolith high energy
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2)
Control - SHAM ESWT STORZ DUOLITH [0.01mJ/mm2]
Three weekly sessions of sham extracorporeal shock wave with modified probe without shockwave transduction (1000 impulses)
CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]
Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2)
Interventions
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Intervention - ESWT Storz Duolith high energy
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2)
CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]
Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2)
Eligibility Criteria
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Inclusion Criteria
* Dupuytren's disease of stage 1-4 involving one or more fingers or the palm only
Exclusion Criteria
* evident ulcerations
* no informed consent
* age under 18 years or above 80 years.
18 Years
80 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Karsten Knobloch
Prof. Dr. Karsten Knobloch, FACS
Principal Investigators
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Karsten Knobloch, MD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School, Germany
Peter M Vogt, MD, PhD
Role: STUDY_CHAIR
Hannover Medical School, Germany
Locations
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Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hanover, , Germany
Countries
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Central Contacts
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Facility Contacts
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Karsten Knobloch, MD, FACS
Role: primary
References
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Knobloch K, Kuehn M, Papst S, Kraemer R, Vogt PM. German standardized translation of the michigan hand outcomes questionnaire for patient-related outcome measurement in Dupuytren disease. Plast Reconstr Surg. 2011 Jul;128(1):39e-40e. doi: 10.1097/PRS.0b013e318218fd70. No abstract available.
Knobloch K, Redeker J, Vogt PM. Antifibrotic medication using a combination of N-acetyl-L-cystein (NAC) and ACE inhibitors can prevent the recurrence of Dupuytren's disease. Med Hypotheses. 2009 Nov;73(5):659-61. doi: 10.1016/j.mehy.2009.08.011. Epub 2009 Sep 1.
Knobloch K, Kuehn M, Vogt PM. Focused extracorporeal shockwave therapy in Dupuytren's disease--a hypothesis. Med Hypotheses. 2011 May;76(5):635-7. doi: 10.1016/j.mehy.2011.01.018. Epub 2011 Feb 1.
Knobloch K, Hellweg M, Sorg H, Nedelka T. Focused electromagnetic high-energetic extracorporeal shockwave (ESWT) reduces pain levels in the nodular state of Dupuytren's disease-a randomized controlled trial (DupuyShock). Lasers Med Sci. 2022 Feb;37(1):323-333. doi: 10.1007/s10103-021-03254-9. Epub 2021 Jan 23.
Other Identifiers
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DupuyShock-2010
Identifier Type: -
Identifier Source: org_study_id