Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

Not Applicable

• Conditions: Peripheral Nerve Injury
• Interventions: Device: MTS Medical UG Orthogold 100; Device: Sham

• Registration Number: NCT03147313
• Lead Sponsor: Ludwig Boltzmann Gesellschaft

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.

Study Timeline

• Study Start: 2017-04-18
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-04
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shockwave 500 pulses	MTS Medical UG Orthogold 100	500 pulses of extracorporeal shock wave will be applied
Shockwave 300 pulses	MTS Medical UG Orthogold 100	300 pulses of extracorporeal shock wave will be applied
Sham	Sham	-

Primary Outcome Measures

Name	Time	Method
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
hyperesthesia	1 year	0=Hinders function 1=Disturbing 2=Moderate 3=None/minor

Secondary Outcome Measures

Name	Time	Method
velocity of nerve conduction	1 year	Determination of velocity of nerve conduction
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
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

Trial Locations

Locations (2)

Lorenz Böhler Trauma Hospital; 🇦🇹 Vienna, Austria

Meidling Trauma Hospital; 🇦🇹 Vienna, Austria