Dupuytren ContracturePhase 2DupuyShockNCT01184586
Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010)
A Phase 2 study testing Intervention - ESWT Storz Duolith high energy in people with Dupuytren Contracture, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Intervention - ESWT Storz Duolith high energy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no Dupuytren's disease
- evident ulcerations
- no informed consent
- age under 18 years or above 80 years.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hanover, 30625
Karsten Knobloch, MD, FACS, 00495115328864, knobloch.karsten@mh-hannover.de
Karsten Knobloch, MD
About this study
Official title: Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) - a Randomized Trial
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.
Read more
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
- Being tested
- Intervention - ESWT Storz Duolith high energy, CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]
- Keywords
- function, DASH, MHQ, pain, strength
- Medical subject headings
- Dupuytren Contracture, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention - ESWT Storz Duolith high energyDevice
Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2)
CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]Device
Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (3)
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) .
Measured: 12 weeks
Range of motion [ROM°]
Range of motion (ROM) measured in [°] using a goniometer
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startNov 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Knobloch, Hannover Medical School
- Investigators
- Karsten Knobloch, MD, Principal investigator, Hannover Medical School, GermanyPeter M Vogt, MD, PhD, Study chair, Hannover Medical School, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184586
- Sponsor's protocol ID
- DupuyShock-2010
- Acronym
- DupuyShock
- Status last verified
- Dec 2011
- First submitted
- 17 Aug 2010
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21701313Knobloch 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.
PubMed 19726137Knobloch 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.
PubMed 21277691Knobloch 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.
PubMed 33483776
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) - a Randomized Trial
- ClinicalTrials.gov ID
- NCT01184586
- Acronym / sponsor ID
- DupuyShock / DupuyShock-2010
- Conditions
- Dupuytren Contracture
- Keywords
- function, DASH, MHQ, pain, strength
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - ESWT Storz Duolith high energy | Active comparator | Device: Intervention - ESWT Storz Duolith high energyThree 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 | Device: CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]Three weekly sessions of sham extracorporeal shock wave with modified probe without shockwave transduction (1000 impulses) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- no Dupuytren's disease
- evident ulcerations
- no informed consent
- age under 18 years or above 80 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention - ESWT Storz Duolith high energyThree weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2) | Device | Intervention arm - ESWT Storz Duolith high energy |
| CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2) | Device | Control - SHAM ESWT STORZ DUOLITH [0.01mJ/mm2] |
Primary outcome
Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect]
Time frame: 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).
3 secondary outcomes
DASH Score [0=perfect, no impairment, 100=worst]
Time frame: 12 weeks
Range of motion [ROM°]
Time frame: 12 weeks
Grip strength [JAMAR]
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Background: PubMed 21701313Knobloch 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.
- Background: PubMed 19726137Knobloch 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.
- Background: PubMed 21277691Knobloch 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.
- Derived from this study: PubMed 33483776Knobloch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karsten Knobloch, MD principal investigator
Hannover Medical School, Germany
Peter M Vogt, MD, PhD study chair
Hannover Medical School, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intervention - ESWT Storz Duolith high energy in people with Dupuytren Contracture, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karsten Knobloch, MD (0049511532 ext. 8864, knobloch.karsten@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect] (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01184586, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011.