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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)
Extracorporeal shock wave treatment will be faked.
Meidling Trauma Hospital
Vienna, Austria
RECRUITINGLorenz Böhler Trauma Hospital
Vienna, Austria
RECRUITINGTwo Point Discrimination
Two Point Discrimination distal of the nerve lesion in mm
Time frame: 1 year
Semmes Weinstein Monofilament test
Palpable Monofilaments, measured in Newton
Time frame: 1 year
Pain/Discomfort
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
Time frame: 1 year
hyperesthesia
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
Time frame: 1 year
Tinel Hoffmann sign
Progression of TH sign into the periphery
Time frame: 1 year
Sonography
sonography of the coaptation neuroma, measurement of the maximum diameter in mm
Time frame: 1 year
velocity of nerve conduction
Determination of velocity of nerve conduction
Time frame: 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
Time frame: 1 year
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