Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

Study Overview
=================
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.

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.

Official Title
-----------------
Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration

Conditions
-----------------
Peripheral Nerve Injury

Intervention / Treatment
-----------------
* Device: MTS Medical UG Orthogold 100
* Device: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into three groups: Two treatment groups with different treatment settings and one sham group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br> | Device: Sham<br>* Extracorporeal shock wave treatment will be faked.<br>|
| Active Comparator: Shockwave 300 pulses<br>300 pulses of extracorporeal shock wave will be applied | Device: MTS Medical UG Orthogold 100<br>* 300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)<br>|
| Active Comparator: Shockwave 500 pulses<br>500 pulses of extracorporeal shock wave will be applied | Device: MTS Medical UG Orthogold 100<br>* 300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinel Hoffmann sign | Progression of TH sign into the periphery | 1 year | 
| Sonography | sonography of the coaptation neuroma, measurement of the maximum diameter in mm | 1 year | 
| velocity of nerve conduction | Determination of velocity of nerve conduction | 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 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extracorporeal shock wave, microsurgical nerve coaptation, nerve regeneration