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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01184586
Acronym
DupuyShock
Enrollment
60
Registered
2010-08-19
Start date
2011-11-30
Completion date
2012-12-31
Last updated
2011-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren Contracture

Keywords

function, DASH, MHQ, pain, strength

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 .

Interventions

DEVICEIntervention - ESWT Storz Duolith high energy

Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2)

DEVICECONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]

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

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect]12 weeksThe 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

MeasureTime frameDescription
DASH Score [0=perfect, no impairment, 100=worst]12 weeksThe 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°]12 weeksRange of motion (ROM) measured in \[°\] using a goniometer
Grip strength [JAMAR]12 weeksHand grip strength \[kg\] using a JAMAR dynanometer in three repetitions on each hand with elbow totally extended (0° flexion) and 90° flexion

Countries

Germany

Contacts

Primary ContactKarsten Knobloch, MD
knobloch.karsten@mh-hannover.de0049511532
Backup ContactMarie Kuehn
Marie.Kuehn@stud.mh-hannover.de0049511532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026