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Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

Primary Purpose

Peripheral Nerve Injury

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
MTS Medical UG Orthogold 100
Sham
Sponsored by
Ludwig Boltzmann Gesellschaft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Injury focused on measuring extracorporeal shock wave, microsurgical nerve coaptation, nerve regeneration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meidling Trauma HospitalRecruiting
  • Lorenz Böhler Trauma HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Sham

Shockwave 300 pulses

Shockwave 500 pulses

Arm Description

300 pulses of extracorporeal shock wave will be applied

500 pulses of extracorporeal shock wave will be applied

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tinel Hoffmann sign
Progression of TH sign into the periphery
Sonography
sonography of the coaptation neuroma, measurement of the maximum diameter in mm
velocity of nerve conduction
Determination of velocity of nerve conduction
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

Full Information

First Posted
April 21, 2017
Last Updated
September 3, 2021
Sponsor
Ludwig Boltzmann Gesellschaft
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1. Study Identification

Unique Protocol Identification Number
NCT03147313
Brief Title
Extracorporal Shock Wave Treatment to Improve Nerve Regeneration
Official Title
Extracorporal Shock Wave Treatment After Microsurgical Coaptation to Improve Nerve Regeneration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig Boltzmann Gesellschaft

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury
Keywords
extracorporeal shock wave, microsurgical nerve coaptation, nerve regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into three groups: Two treatment groups with different treatment settings and one sham group.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Title
Shockwave 300 pulses
Arm Type
Active Comparator
Arm Description
300 pulses of extracorporeal shock wave will be applied
Arm Title
Shockwave 500 pulses
Arm Type
Active Comparator
Arm Description
500 pulses of extracorporeal shock wave will be applied
Intervention Type
Device
Intervention Name(s)
MTS Medical UG Orthogold 100
Intervention Description
300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Extracorporeal shock wave treatment will be faked.
Primary Outcome Measure Information:
Title
Two Point Discrimination
Description
Two Point Discrimination distal of the nerve lesion in mm
Time Frame
1 year
Title
Semmes Weinstein Monofilament test
Description
Palpable Monofilaments, measured in Newton
Time Frame
1 year
Title
Pain/Discomfort
Description
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
Time Frame
1 year
Title
hyperesthesia
Description
0=Hinders function 1=Disturbing 2=Moderate 3=None/minor
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Tinel Hoffmann sign
Description
Progression of TH sign into the periphery
Time Frame
1 year
Title
Sonography
Description
sonography of the coaptation neuroma, measurement of the maximum diameter in mm
Time Frame
1 year
Title
velocity of nerve conduction
Description
Determination of velocity of nerve conduction
Time Frame
1 year
Title
Medical Research Council Grading of Sensibility
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rudolf Rosenauer, M.D.
Phone
0043 59393 41270
Email
rudolf.rosenauer@auva.at
Facility Information:
Facility Name
Meidling Trauma Hospital
City
Vienna
ZIP/Postal Code
1120
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rainer Mittermayr, M.D.
Phone
0043 5 939345263
Email
rainer.mittermayr@auva.at
First Name & Middle Initial & Last Name & Degree
Rainer Mittermayr, M.D.
Facility Name
Lorenz Böhler Trauma Hospital
City
Vienna
ZIP/Postal Code
1200
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rudolf Rosenauer, M.D.
Phone
0043 59393 41270
Email
rudolf.rosenauer@auva.at
First Name & Middle Initial & Last Name & Degree
Stefan Quadlbauer, M.D.
Phone
0043 59393 41000
Email
stefan.quadlbauer@auva.at
First Name & Middle Initial & Last Name & Degree
Rudolf Rosenauer, M.D.
First Name & Middle Initial & Last Name & Degree
Stefan Quadlbauer, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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17520973
Citation
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Citation
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Citation
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Extracorporal Shock Wave Treatment to Improve Nerve Regeneration

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