NCT03147313

Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ludwig Boltzmann Gesellschaft · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2017-04-18
• Primary completion: 2023-04-01
• Completion: 2023-06-01
• First posted: 2017-05-10
• Last updated: 2021-09-05

Locations

2 sites across 1 country: Austria