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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm - ESWT Storz Duolith high energy | Active Comparator | 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] | Sham Comparator | Three weekly sessions of sham extracorporeal shock wave with modified probe without shockwave transduction (1000 impulses) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention - ESWT Storz Duolith high energy | Device | Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect] | 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). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DASH Score [0=perfect, no impairment, 100=worst] | 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) . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karsten Knobloch, MD | Contact | 0049511532 | 8864 | knobloch.karsten@mh-hannover.de |
| Marie Kuehn | Contact | 0049511532 | 8864 | Marie.Kuehn@stud.mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Karsten Knobloch, MD | Hannover Medical School, Germany | Principal Investigator |
| Peter M Vogt, MD, PhD | Hannover Medical School, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School, Plastic, Hand and Reconstructive Surgery | Recruiting | Hanover | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21701313 | Background | 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. | |
| 19726137 | Background |
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| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2] | Device | Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2) |
|
| 12 weeks |
| Range of motion [ROM°] | Range of motion (ROM) measured in [°] using a goniometer | 12 weeks |
| Grip strength [JAMAR] | Hand grip strength [kg] using a JAMAR dynanometer in three repetitions on each hand with elbow totally extended (0° flexion) and 90° flexion | 12 weeks |
| 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. |
| 21277691 | Background | 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. |
| 33483776 | Derived | 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. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |