Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) (DupuyShock)
Primary Purpose
Dupuytren Contracture
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Intervention - ESWT Storz Duolith high energy
CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren Contracture focused on measuring function, DASH, MHQ, pain, strength
Eligibility 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.
Sites / Locations
- Hannover Medical School, Plastic, Hand and Reconstructive SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Intervention arm - ESWT Storz Duolith high energy
Control - SHAM ESWT STORZ DUOLITH [0.01mJ/mm2]
Arm Description
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (STORZ DUOLITH, 1000 impulses, 0.55-0,8mJ/mm2)
Three weekly sessions of sham extracorporeal shock wave with modified probe without shockwave transduction (1000 impulses)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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) .
Range of motion [ROM°]
Range of motion (ROM) measured in [°] using a goniometer
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
Full Information
NCT ID
NCT01184586
First Posted
August 17, 2010
Last Updated
December 1, 2011
Sponsor
Hannover Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01184586
Brief Title
Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010)
Acronym
DupuyShock
Official Title
Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) - a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Contracture
Keywords
function, DASH, MHQ, pain, strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm - ESWT Storz Duolith high energy
Arm Type
Active Comparator
Arm Description
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (STORZ DUOLITH, 1000 impulses, 0.55-0,8mJ/mm2)
Arm Title
Control - SHAM ESWT STORZ DUOLITH [0.01mJ/mm2]
Arm Type
Sham Comparator
Arm Description
Three weekly sessions of sham extracorporeal shock wave with modified probe without shockwave transduction (1000 impulses)
Intervention Type
Device
Intervention Name(s)
Intervention - ESWT Storz Duolith high energy
Intervention Description
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2)
Intervention Type
Device
Intervention Name(s)
CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]
Intervention Description
Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2)
Primary Outcome Measure Information:
Title
Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect]
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
DASH Score [0=perfect, no impairment, 100=worst]
Description
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) .
Time Frame
12 weeks
Title
Range of motion [ROM°]
Description
Range of motion (ROM) measured in [°] using a goniometer
Time Frame
12 weeks
Title
Grip strength [JAMAR]
Description
Hand grip strength [kg] using a JAMAR dynanometer in three repetitions on each hand with elbow totally extended (0° flexion) and 90° flexion
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karsten Knobloch, MD
Phone
0049511532
Ext
8864
Email
knobloch.karsten@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Kuehn
Phone
0049511532
Ext
8864
Email
Marie.Kuehn@stud.mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, MD
Organizational Affiliation
Hannover Medical School, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter M Vogt, MD, PhD
Organizational Affiliation
Hannover Medical School, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Hannover Medical School, Plastic, Hand and Reconstructive Surgery
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, MD, FACS
Phone
00495115328864
Email
knobloch.karsten@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21701313
Citation
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.
Results Reference
background
PubMed Identifier
19726137
Citation
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.
Results Reference
background
PubMed Identifier
21277691
Citation
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.
Results Reference
background
PubMed Identifier
33483776
Citation
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.
Results Reference
derived
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Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010)
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