Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

Peripheral Nerve Injury Clinical Trial

Official title:

Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03147313
• Other study ID #: MPG 07/2016
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: June 2023

Study information

• Verified date: September 2021
• Source: Ludwig Boltzmann Gesellschaft
• Contact: Rudolf Rosenauer, M.D.
• Phone: 0043 59393 41270
• Email: rudolf.rosenauer[@]auva.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury

Intervention

Device:
• MTS Medical UG Orthogold 100
300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)
• Sham
Extracorporeal shock wave treatment will be faked.

Locations

Country	Name	City	State
Austria	Lorenz Böhler Trauma Hospital	Vienna
Austria	Meidling Trauma Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig Boltzmann Gesellschaft

Country where clinical trial is conducted

Austria, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 May 29. — View Citation

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. Epub 2004 Nov 1. — View Citation

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. — View Citation

Schaden W, Thiele R, Kölpl 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. Epub 2007 Sep 27. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two Point Discrimination	Two Point Discrimination distal of the nerve lesion in mm	1 year
Primary	Semmes Weinstein Monofilament test	Palpable Monofilaments, measured in Newton	1 year
Primary	Pain/Discomfort	0=Hinders function 1=Disturbing 2=Moderate 3=None/minor	1 year
Primary	hyperesthesia	0=Hinders function 1=Disturbing 2=Moderate 3=None/minor	1 year
Secondary	Tinel Hoffmann sign	Progression of TH sign into the periphery	1 year
Secondary	Sonography	sonography of the coaptation neuroma, measurement of the maximum diameter in mm	1 year
Secondary	velocity of nerve conduction	Determination of velocity of nerve conduction	1 year
Secondary	Medical Research Council Grading of Sensibility	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	1 year