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

NCT01184586 | Unknown Phase 2

• 1 other identifier: DupuyShock-2010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Dupuytren Contracture

Keywords

function; DASH; MHQ; pain; strength

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

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

  12 weeks

• Range of motion [ROM°]

  12 weeks

• Grip strength [JAMAR]

  12 weeks

Study Arms (2)

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)

Device: Intervention - ESWT Storz Duolith high energy

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)

Device: CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]

Interventions

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)

Intervention arm - ESWT Storz Duolith high energy

CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2] DEVICE

Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2)

Control - SHAM ESWT STORZ DUOLITH [0.01mJ/mm2]

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no Dupuytren's disease
• evident ulcerations
• no informed consent
• age under 18 years or above 80 years.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Hanover, 30625, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 21701313 BACKGROUND

• 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.

  PMID: 19726137 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.

  PMID: 21277691 BACKGROUND

• 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.

  PMID: 33483776 DERIVED

MeSH Terms

Conditions

Dupuytren Contracture; Pain

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karsten Knobloch, MD

  Hannover Medical School, Germany

  PRINCIPAL INVESTIGATOR

• Peter M Vogt, MD, PhD

  Hannover Medical School, Germany

  STUDY CHAIR

Central Study Contacts

Karsten Knobloch, MD

CONTACT

0049511532; knobloch.karsten@mh-hannover.de

Marie Kuehn

CONTACT

0049511532; Marie.Kuehn@stud.mh-hannover.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Karsten Knobloch, FACS

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 2, 2011

Record last verified: 2011-12

Locations

DE (1)