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Clinical Trials/NCT01184586
NCT01184586
Unknown
Phase 2

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

Hannover Medical School1 site in 1 country60 target enrollmentNovember 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dupuytren Contracture
Sponsor
Hannover Medical School
Enrollment
60
Locations
1
Primary Endpoint
Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect]
Last Updated
14 years ago

Overview

Brief Summary

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 .

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karsten Knobloch

Prof. Dr. Karsten Knobloch, FACS

Hannover Medical School

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 12 weeks

The MHQ is a side-specific questionnaire with 25 unilateral and 12 bilateral questions, including hand function, work performance, and cosmetic appearance. It generates a score from 0 (poor) to 100 (no disability at all). The MHQ is responsive to clinical change. We have performed a validated standardized language adoption of the English MHQ into German, published in Plastic Reconstructive Surgery (Knobloch K et al. PRS 2010 in press).

Secondary Outcomes

  • DASH Score [0=perfect, no impairment, 100=worst](12 weeks)
  • Range of motion [ROM°](12 weeks)
  • Grip strength [JAMAR](12 weeks)

Study Sites (1)

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