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

Phase 2

• Conditions: Dupuytren Contracture
• Interventions: Device: Intervention - ESWT Storz Duolith high energy; Device: CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]

• Registration Number: NCT01184586
• Lead Sponsor: Hannover Medical School

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Study Start: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-01
• Last Update Posted: 2011-12-02
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm - ESWT Storz Duolith high energy	Intervention - 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)
Control - SHAM ESWT STORZ DUOLITH [0.01mJ/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)

Primary Outcome Measures

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

Name	Time	Method
DASH Score [0=perfect, no impairment, 100=worst]	12 weeks	The DASH is a 30-item patient-reported questionnaire with two adjuncts, DASH-Sport (4 items) and DASH-Work (4-items). Notably, the validation of the aformentioned DASH score included patients suffering from Dupuytren's disease. Longitudinal construct validity has been assessed in patients including those with Dupuytren's disease and the responsiveness is moderate (effect size 0,5). The DASH questionnaire has a good validity with the subscale of SF-36 . The test-retest reliability of the DASH questionnaire has been found to be excellent (ICC = 0.96) .
Range of motion [ROM°]	12 weeks	Range of motion (ROM) measured in \[°\] using a goniometer
Grip strength [JAMAR]	12 weeks	Hand grip strength \[kg\] using a JAMAR dynanometer in three repetitions on each hand with elbow totally extended (0° flexion) and 90° flexion

Trial Locations

Locations (1)

Hannover Medical School, Plastic, Hand and Reconstructive Surgery; 🇩🇪 Hannover, Germany