Peripheral Nerve InjuryNCT03147313

Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

A study testing MTS Medical UG Orthogold 100 in people with Peripheral Nerve Injury, run by Ludwig Boltzmann Gesellschaft at 2 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Peripheral Nerve Injury
What is being tested?: MTS Medical UG Orthogold 100
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 2 sitesAustria
Study dates: 18 Apr 2017to Jun 2023
Phase: Interventional
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Rudolf Rosenauer, M.D. contact

0043 59393 41270

rudolf.rosenauer@auva.at

Austria2 sites, 2 recruiting

Meidling Trauma Hospital
Vienna, 1120
Rainer Mittermayr, M.D., 0043 5 939345263, rainer.mittermayr@auva.at
Rainer Mittermayr, M.D.
Recruiting
Lorenz Böhler Trauma Hospital
Vienna, 1200
Rudolf Rosenauer, M.D., 0043 59393 41270, rudolf.rosenauer@auva.at
Stefan Quadlbauer, M.D., 0043 59393 41000, stefan.quadlbauer@auva.at
Recruiting

Other trials in Austria

About this study

Official title: Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration

Read the 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.

Conditions: Peripheral Nerve Injury
Being tested: MTS Medical UG Orthogold 100, Sham
Keywords: extracorporeal shock wave, microsurgical nerve coaptation, nerve regeneration
Medical subject headings: Peripheral Nerve Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03147313
Study group	Role	What they receive
Sham	Sham comparator	Not described Receives: Device: Sham
Shockwave 300 pulses	Active comparator	300 pulses of extracorporeal shock wave will be applied Receives: Device: MTS Medical UG Orthogold 100
Shockwave 500 pulses	Active comparator	500 pulses of extracorporeal shock wave will be applied Receives: Device: MTS Medical UG Orthogold 100

What is being measured

The primary outcome is the main question the study is designed to answer.

Two Point Discrimination
Two Point Discrimination distal of the nerve lesion in mm
Measured: 1 year
Semmes Weinstein Monofilament test
Palpable Monofilaments, measured in Newton
Measured: 1 year
Pain/Discomfort
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
Measured: 1 year
hyperesthesia
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
Measured: 1 year

Secondary outcomes (4)

Tinel Hoffmann sign
Progression of TH sign into the periphery
Measured: 1 year
Sonography
sonography of the coaptation neuroma, measurement of the maximum diameter in mm
Measured: 1 year
velocity of nerve conduction
Determination of velocity of nerve conduction
Measured: 1 year
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
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 2017Jun 2023

First posted10 May 2017
Study start18 Apr 2017
Primary completionApr 2023 (estimated)
Study completionJun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Peripheral Nerve InjuryStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized into three groups: Two treatment groups with different treatment settings and one sham group.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03147313
Sponsor's protocol ID: MPG 07/2016
Status last verified: Sep 2021
First submitted: 21 Apr 2017
Last updated: 5 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 19327525

Want to know more?

Rudolf Rosenauer, M.D.

0043 59393 41270

rudolf.rosenauer@auva.at

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Nerve Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration
ClinicalTrials.gov ID: NCT03147313
Acronym / sponsor ID: MPG 07/2016
Conditions: Peripheral Nerve Injury
Keywords: extracorporeal shock wave, microsurgical nerve coaptation, nerve regeneration
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Ludwig Boltzmann GesellschaftUniversity, hospital or other
Study start: 18 Apr 2017 (actual)
Primary completion: Apr 2023 (estimated)
Study completion: Jun 2023 (estimated)
First posted: 10 May 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: Participants will be randomized into three groups: Two treatment groups with different treatment settings and one sham group.

Arm	Type	Receives
Sham	Sham comparator	Device: Sham
Shockwave 300 pulses	Active comparator	Device: MTS Medical UG Orthogold 100300 pulses of extracorporeal shock wave will be applied
Shockwave 500 pulses	Active comparator	Device: MTS Medical UG Orthogold 100500 pulses of extracorporeal shock wave will be applied

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (11 listed)

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)

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
MTS Medical UG Orthogold 100300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)	Device	Shockwave 300 pulses, Shockwave 500 pulses
ShamExtracorporeal shock wave treatment will be faked.	Device	Sham

Primary outcome

Two Point Discrimination
Time frame: 1 year
Two Point Discrimination distal of the nerve lesion in mm
Semmes Weinstein Monofilament test
Time frame: 1 year
Palpable Monofilaments, measured in Newton
Pain/Discomfort
Time frame: 1 year
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
hyperesthesia
Time frame: 1 year
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor

4 secondary outcomes

Tinel Hoffmann sign
Time frame: 1 year
Sonography
Time frame: 1 year
velocity of nerve conduction
Time frame: 1 year
Medical Research Council Grading of Sensibility
Time frame: 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Background: PubMed 17520973Bosch 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.
Background: PubMed 8888690Corson 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.
Background: PubMed 9546377Fleming 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.
Background: PubMed 16374144Fukumoto 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.
Background: PubMed 20730589Hausdorf 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.
Background: PubMed 12897619Martini 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.
Background: PubMed 19243882Moretti 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.
Background: PubMed 19473538Moretti 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.
Background: PubMed 17537650Murata 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.
Background: PubMed 15520304Nishida 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.
Background: PubMed 11400900Schaden 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.
Background: PubMed 17904157Schaden 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.
Individual participant dataSharing planned: No

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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.

Rudolf Rosenauer, M.D. contact

0043 59393 41270

rudolf.rosenauer@auva.at

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MTS Medical UG Orthogold 100 in people with Peripheral Nerve Injury, run by Ludwig Boltzmann Gesellschaft at 2 sites in Austria.

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 11 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. 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.

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 Rudolf Rosenauer, M.D. (0043 59393 41270, rudolf.rosenauer@auva.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two Point Discrimination (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT03147313, which also lists 13 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 5 Sep 2021.