Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

  • STATUS
    Recruiting
  • End date
    Jun 25, 2021
  • participants needed
    60
  • sponsor
    Ludwig Boltzmann Gesellschaft
Updated on 25 January 2021

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.

Details
Treatment SHAM, MTS Medical UG Orthogold 100
Clinical Study IdentifierNCT03147313
SponsorLudwig Boltzmann Gesellschaft
Last Modified on25 January 2021

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 60 yrs?
Gender: Male or Female
Do you have any of these conditions: Peripheral Nerve Injury or Peripheral Neuropathy?
Do you have any of these conditions: Peripheral Neuropathy or Peripheral Nerve Injury?
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
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