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Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010)

Information source: Hannover Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dupuytren Contracture

Intervention: Intervention - ESWT Storz Duolith high energy (Device); CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2] (Device)

Phase: Phase 2

Status: Recruiting

Sponsored by: Hannover Medical School

Official(s) and/or principal investigator(s):
Karsten Knobloch, MD, Principal Investigator, Affiliation: Hannover Medical School, Germany
Peter M Vogt, MD, PhD, Study Chair, Affiliation: Hannover Medical School, Germany

Overall contact:
Karsten Knobloch, MD, Phone: 0049511532, Ext: 8864, Email: knobloch.karsten@mh-hannover.de


Dupuytren's disease is a progressive disease due to unknown causal agents or genetics. 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 .

Clinical Details

Official title: Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) - a Randomized Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect]

Secondary outcome:

DASH Score [0=perfect, no impairment, 100=worst]

Range of motion [ROMĀ°]

Grip strength [JAMAR]


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- Eligible patients are patients aged 18 or over and 80 or younger

- Dupuytren's disease of stage 1-4 involving one or more fingers or the palm only

Exclusion Criteria:

- Exclusion criteria are suspected or evident pregnancy

- no Dupuytren's disease

- evident ulcerations

- no informed consent

- age under 18 years or above 80 years.

Locations and Contacts

Karsten Knobloch, MD, Phone: 0049511532, Ext: 8864, Email: knobloch.karsten@mh-hannover.de

Hannover Medical School, Plastic, Hand and Reconstructive Surgery, Hannover 30625, Germany; Recruiting
Karsten Knobloch, MD, FACS, Phone: 00495115328864, Email: knobloch.karsten@mh-hannover.de
Karsten Knobloch, MD, Principal Investigator
Additional Information

Related publications:

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.

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.

Starting date: November 2011
Last updated: December 1, 2011

Page last updated: August 23, 2015

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