Peripheral Nerve Injury
Conditions
Keywords
extracorporeal shock wave, microsurgical nerve coaptation, nerve regeneration
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.
Interventions
DEVICEMTS Medical UG Orthogold 100
300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)
DEVICESham
Extracorporeal shock wave treatment will be faked.
Sponsors
Ludwig Boltzmann Gesellschaft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant will be wearing an acoustic and visual masking. The outcome assessor won't know if the participant was treated or if he was assigned to the sham group.
Intervention model description
Participants will be randomized into three groups: Two treatment groups with different treatment settings and one sham group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hyperesthesia | 1 year | 0=Hinders function 1=Disturbing 2=Moderate 3=None/minor |
| Two Point Discrimination | 1 year | Two Point Discrimination distal of the nerve lesion in mm |
| Semmes Weinstein Monofilament test | 1 year | Palpable Monofilaments, measured in Newton |
| Pain/Discomfort | 1 year | 0=Hinders function 1=Disturbing 2=Moderate 3=None/minor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tinel Hoffmann sign | 1 year | Progression of TH sign into the periphery |
| Sonography | 1 year | sonography of the coaptation neuroma, measurement of the maximum diameter in mm |
| velocity of nerve conduction | 1 year | Determination of velocity of nerve conduction |
| Medical Research Council Grading of Sensibility | 1 year | 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 |
Countries
Austria
Contacts
Primary ContactRudolf Rosenauer, M.D.
Outcome results
None listed