Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration
| Registry | NCT03147313 |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 60 (Estimated) |
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| Sponsor | Ludwig Boltzmann Gesellschaft (Other) |
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| Conditions | Peripheral Nerve Injury |
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| Interventions | MTS Medical UG Orthogold 100, Sham (Device) |
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| Dates | start 2017-04-18, primary completion 2023-04-01 (estimated), completion 2023-06-01 (estimated), first posted 2017-05-10, last updated 2021-09-05 |
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| Locations | 2 sites in Austria |
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-Summary
This study evaluates the impact of extracorporeal shock wave treatment after microsurgical coaptation of finger nerves. Participants will be randomized into two treatment groups with different settings and a sham group. The participants will thereafter followed-up in a prospective, double-blind study design.
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+Detailed description
Extracorporeal shock wave treatment is CE certified in Austria, Europe and licensed for indications like achillodynia, epicondylitis, or tendinitis calcanea. The Orthogold 100 device by MTS Medical UG will be used for this study.
Defocused low-energy extracorporeal shock wave therapy (ESWT) has gained acceptance as a therapeutic tool in different medical settings. It has been shown, that shock waves stimulate of the metabolic activity of different cell type, including osteoblasts, tenocytes, endothelial cells and chondrocytes. Furthermore, it has proved effective in clinical applications relating to bone and wound healing and myocardial ischaemia. Until now, no studies have been performed regarding the effects of ESWT on regeneration of peripheral nerve injuries in humans.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Sham | Sham comparator | Device: Sham | |
| Shockwave 300 pulses | Active comparator | Device: MTS Medical UG Orthogold 100 | 300 pulses of extracorporeal shock wave will be applied |
| Shockwave 500 pulses | Active comparator | Device: MTS Medical UG Orthogold 100 | 500 pulses of extracorporeal shock wave will be applied |
- MTS Medical UG Orthogold 100 (Device): 300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)
- Sham (Device): Extracorporeal shock wave treatment will be faked.
+Outcome measures
Primary outcomes
- Two Point Discrimination [1 year]: Two Point Discrimination distal of the nerve lesion in mm
- Semmes Weinstein Monofilament test [1 year]: Palpable Monofilaments, measured in Newton
- Pain/Discomfort [1 year]: 0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
- hyperesthesia [1 year]: 0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
Secondary outcomes
- Tinel Hoffmann sign [1 year]: Progression of TH sign into the periphery
- Sonography [1 year]: sonography of the coaptation neuroma, measurement of the maximum diameter in mm
- velocity of nerve conduction [1 year]: Determination of velocity of nerve conduction
- Medical Research Council Grading of Sensibility [1 year]: Grading by the british medical research council. S0: No recovery of sensibility S1: Deep cutaneous pain sensibility S1+: superficial pain sensibility S2: superficial pain and some touch sensibility S2+: As in S2 but with overresponse S3: Pain and touch sensibility with over response, 2PD > 15mm S3+: As S3 but with imperfect recovery of 2PD (7-15mm) S4: Complete recovery
+Eligibility
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria:
* complete lossless transection of one or more digital nerves distal to the branching out of the commune median or ulnar nerves
* direct, tension-free coaptation of the nerve stumps
Exclusion Criteria:
* segment loss of the nerve
* tension after direct coaptation
* diabetic neuropathy or other peripheral neuropathies
* other disease with reduced sensibility of the fingers
* injuries in the course of the nerve (plexus brachialis, median or ulnar nerve)
* chronic inflammatory disease
* rheumatoid arthritis
* pregnancy
* patients not able to give written consent
* patients with an implantable cardiac defibrillator or pacemaker
* patients which are sensitive to electromagnetic radiance
+Locations (2)
| Facility | City | Country | Status |
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| Meidling Trauma Hospital | Vienna | Austria | Recruiting |
| Lorenz Böhler Trauma Hospital | Vienna | Austria | Recruiting |
+Publications
- Bosch G, Lin YL, van Schie HT, van De Lest CH, Barneveld A, van Weeren PR. Effect of extracorporeal shock wave therapy on the biochemical composition and metabolic activity of tenocytes in normal tendinous structures in ponies. Equine Vet J. 2007 May;39(3):226-31. doi: 10.2746/042516407x180408. PMID 17520973
- Corson MA, James NL, Latta SE, Nerem RM, Berk BC, Harrison DG. Phosphorylation of endothelial nitric oxide synthase in response to fluid shear stress. Circ Res. 1996 Nov;79(5):984-91. doi: 10.1161/01.res.79.5.984. PMID 8888690
- Fleming I, Bauersachs J, Fisslthaler B, Busse R. Ca2+-independent activation of the endothelial nitric oxide synthase in response to tyrosine phosphatase inhibitors and fluid shear stress. Circ Res. 1998 Apr 6;82(6):686-95. doi: 10.1161/01.res.82.6.686. PMID 9546377
- Fukumoto Y, Ito A, Uwatoku T, Matoba T, Kishi T, Tanaka H, Takeshita A, Sunagawa K, Shimokawa H. Extracorporeal cardiac shock wave therapy ameliorates myocardial ischemia in patients with severe coronary artery disease. Coron Artery Dis. 2006 Feb;17(1):63-70. doi: 10.1097/00019501-200602000-00011. PMID 16374144
- Hausdorf J, Sievers B, Schmitt-Sody M, Jansson V, Maier M, Mayer-Wagner S. Stimulation of bone growth factor synthesis in human osteoblasts and fibroblasts after extracorporeal shock wave application. Arch Orthop Trauma Surg. 2011 Mar;131(3):303-9. doi: 10.1007/s00402-010-1166-4. Epub 2010 Aug 22. PMID 20730589
- Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd. PMID 12897619
- Moretti B, Notarnicola A, Garofalo R, Moretti L, Patella S, Marlinghaus E, Patella V. Shock waves in the treatment of stress fractures. Ultrasound Med Biol. 2009 Jun;35(6):1042-9. doi: 10.1016/j.ultrasmedbio.2008.12.002. Epub 2009 Feb 25. PMID 19243882
- Moretti B, Notarnicola A, Maggio G, Moretti L, Pascone M, Tafuri S, Patella V. The management of neuropathic ulcers of the foot in diabetes by shock wave therapy. BMC Musculoskelet Disord. 2009 May 27;10:54. doi: 10.1186/1471-2474-10-54. PMID 19473538
- Murata R, Nakagawa K, Ohtori S, Ochiai N, Arai M, Saisu T, Sasho T, Takahashi K, Moriya H. The effects of radial shock waves on gene transfer in rabbit chondrocytes in vitro. Osteoarthritis Cartilage. 2007 Nov;15(11):1275-82. doi: 10.1016/j.joca.2007.04.001. Epub 2007 May 29. PMID 17537650
- Nishida T, Shimokawa H, Oi K, Tatewaki H, Uwatoku T, Abe K, Matsumoto Y, Kajihara N, Eto M, Matsuda T, Yasui H, Takeshita A, Sunagawa K. Extracorporeal cardiac shock wave therapy markedly ameliorates ischemia-induced myocardial dysfunction in pigs in vivo. Circulation. 2004 Nov 9;110(19):3055-61. doi: 10.1161/01.CIR.0000148849.51177.97. Epub 2004 Nov 1. PMID 15520304
- Schaden W, Fischer A, Sailler A. Extracorporeal shock wave therapy of nonunion or delayed osseous union. Clin Orthop Relat Res. 2001 Jun;(387):90-4. doi: 10.1097/00003086-200106000-00012. PMID 11400900
- Schaden W, Thiele R, Kolpl C, Pusch M, Nissan A, Attinger CE, Maniscalco-Theberge ME, Peoples GE, Elster EA, Stojadinovic A. Shock wave therapy for acute and chronic soft tissue wounds: a feasibility study. J Surg Res. 2007 Nov;143(1):1-12. doi: 10.1016/j.jss.2007.01.009. Epub 2007 Sep 27. PMID 17904157
- Zimpfer D, Aharinejad S, Holfeld J, Thomas A, Dumfarth J, Rosenhek R, Czerny M, Schaden W, Gmeiner M, Wolner E, Grimm M. Direct epicardial shock wave therapy improves ventricular function and induces angiogenesis in ischemic heart failure. J Thorac Cardiovasc Surg. 2009 Apr;137(4):963-70. doi: 10.1016/j.jtcvs.2008.11.006. PMID 19327525