Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

NCT03147313 | Unknown

• 1 other identifier: MPG 07/2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral Nerve Injury

Keywords

extracorporeal shock wave; microsurgical nerve coaptation; nerve regeneration

Outcome Measures

Primary Outcomes (4)

• Two Point Discrimination

  Two Point Discrimination distal of the nerve lesion in mm

  1 year

• Semmes Weinstein Monofilament test

  Palpable Monofilaments, measured in Newton

  1 year

• Pain/Discomfort

  0=Hinders function 1=Disturbing 2=Moderate 3=None/minor

  1 year

• hyperesthesia

  0=Hinders function 1=Disturbing 2=Moderate 3=None/minor

  1 year

Secondary Outcomes (4)

• Tinel Hoffmann sign

  1 year

• Sonography

  1 year

• velocity of nerve conduction

  1 year

• Medical Research Council Grading of Sensibility

  1 year

Study Arms (3)

Sham

SHAM COMPARATOR

Device: Sham

Shockwave 300 pulses

ACTIVE COMPARATOR

300 pulses of extracorporeal shock wave will be applied

Device: MTS Medical UG Orthogold 100

Shockwave 500 pulses

ACTIVE COMPARATOR

500 pulses of extracorporeal shock wave will be applied

Device: MTS Medical UG Orthogold 100

Interventions

MTS Medical UG Orthogold 100 DEVICE

300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)

Shockwave 300 pulses; Shockwave 500 pulses

Sham DEVICE

Extracorporeal shock wave treatment will be faked.

Sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig Boltzmann Gesellschaft: lead

Study Sites (2)

Meidling Trauma Hospital

Vienna, 1120, Austria

RECRUITING

Lorenz Böhler Trauma Hospital

Vienna, 1200, Austria

RECRUITING

Related 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. doi: 10.2746/042516407x180408.

  PMID: 17520973 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Rudolf Rosenauer, M.D.

CONTACT

0043 59393 41270; rudolf.rosenauer@auva.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant will be wearing an acoustic and visual masking. The outcome assessor won't know if the participant was treated or if he was assigned to the sham group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants will be randomized into three groups: Two treatment groups with different treatment settings and one sham group.

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 10, 2017
• Study Start: April 18, 2017
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)