Clinical Trial: Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve 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 Summary:

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.


Sponsor: Ludwig Boltzmann Gesellschaft

Current Primary Outcome:

  • Two Point Discrimination [ Time Frame: 1 year ]
    Two Point Discrimination distal of the nerve lesion in mm
  • Semmes Weinstein Monofilament test [ Time Frame: 1 year ]
    Palpable Monofilaments, measured in Newton
  • Pain/Discomfort [ Time Frame: 1 year ]
    0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
  • hyperesthesia [ Time Frame: 1 year ]
    0=Hinders function 1=Disturbing 2=Moderate 3=None/minor


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tinel Hoffmann sign [ Time Frame: 1 year ]
    Progression of TH sign into the periphery
  • Sonography [ Time Frame: 1 year ]
    sonography of the coaptation neuroma, measurement of the maximum diameter in mm
  • velocity of nerve conduction [ Time Frame: 1 year ]
    Determination of velocity of nerve conduction
  • Medical Research Council Grading of Sensibility [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Ludwig Boltzmann Gesellschaft

Dates:
Date Received: April 21, 2017
Date Started: April 18, 2017
Date Completion: June 2020
Last Updated: May 9, 2017
Last Verified: May 2017