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临床试验/NCT01184586
NCT01184586Unknown2 期

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

Hannover Medical School2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
2 期
入组人数
60
试验地点
2
主要终点
Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect]

研究概览

简要总结

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Exclusion criteria are suspected or evident pregnancy
  • no Dupuytren's disease
  • evident ulcerations
  • no informed consent
  • age under 18 years or above 80 years.

结局指标

主要结局

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

时间窗: 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).

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karsten Knobloch

Prof. Dr. Karsten Knobloch, FACS

Hannover Medical School

研究点 (2)

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