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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Karsten Knobloch, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01184586
First received: August 17, 2010
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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 .


Condition Intervention Phase
Dupuytren Contracture
Device: Intervention - ESWT Storz Duolith high energy
Device: CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) - a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • DASH Score [0=perfect, no impairment, 100=worst] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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°] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Range of motion (ROM) measured in [°] using a goniometer

  • Grip strength [JAMAR] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Hand grip strength [kg] using a JAMAR dynanometer in three repetitions on each hand with elbow totally extended (0° flexion) and 90° flexion


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention arm - 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)
Device: Intervention - ESWT Storz Duolith high energy
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2)
Sham Comparator: Control - SHAM ESWT STORZ DUOLITH [0.01mJ/mm2]
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]
Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184586

Contacts
Contact: Karsten Knobloch, MD 0049511532 ext 8864 knobloch.karsten@mh-hannover.de
Contact: Marie Kuehn 0049511532 ext 8864 Marie.Kuehn@stud.mh-hannover.de

Locations
Germany
Hannover Medical School, Plastic, Hand and Reconstructive Surgery Recruiting
Hannover, Germany, 30625
Contact: Karsten Knobloch, MD, FACS    00495115328864    knobloch.karsten@mh-hannover.de   
Principal Investigator: Karsten Knobloch, MD         
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Karsten Knobloch, MD Hannover Medical School, Germany
Study Chair: Peter M Vogt, MD, PhD Hannover Medical School, Germany
  More Information

Publications:
Responsible Party: Karsten Knobloch, Prof. Dr. Karsten Knobloch, FACS, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01184586     History of Changes
Other Study ID Numbers: DupuyShock-2010
Study First Received: August 17, 2010
Last Updated: December 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
function
DASH
MHQ
pain
strength

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 20, 2014