Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

Ludwig Boltzmann Gesellschaft

Status: Unknown

Conditions: Peripheral Nerve Injury

Treatments: Device: MTS Medical UG Orthogold 100; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT03147313

MPG 07/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

Sham

Sham Comparator group

Treatment:

Device: Sham

Shockwave 300 pulses

Active Comparator group

Description:

300 pulses of extracorporeal shock wave will be applied

Treatment:

Device: MTS Medical UG Orthogold 100

Shockwave 500 pulses

Active Comparator group

Description:

500 pulses of extracorporeal shock wave will be applied

Treatment:

Device: MTS Medical UG Orthogold 100