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Effectiveness of fESWT in the Treatment of CTS

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
focused extracorporeal shock wave therapy
sham focused extracorporeal shock wave therapy
night splint
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring focused extracorporeal shock wave therapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- mild to moderate CTS verified by nerve conduction velocity

Exclusion Criteria:

  • metabolic diseases
  • blood clotting problems
  • systemic diseases
  • polyneuropathy
  • chemotherapy during the study
  • corticosteroid therapy
  • use of anticoagulation
  • history of trauma/surgery or nerve lesion of the teated extremity
  • CTS surgery on the affected hand
  • ICD/ pacemaker implantation
  • other therapy for the affected hand during the study
  • acute inflammation or infections
  • severe mental illnesses/psychiatric diseases
  • severe neurological diseases

Sites / Locations

  • Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Comparator

Sham Comparator

Arm Description

fESWT

Sham fESWT

Outcomes

Primary Outcome Measures

VAS
Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment.

Secondary Outcome Measures

hand grip strength
hand grip strength:
distal motor latency of the median nerve
electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment.
sensory conduction velocity of the median nerve
electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment.
SF-36
36-item Short Form Health Survey: Change from baseline in quality of life 3th,12th and 24th weeks after treatment.
Boston Scale
Boston Symptom Severity Score: Change from baseline in severity of symptoms and functional status 3th,12th and 24th weeks after treatment.

Full Information

First Posted
March 2, 2020
Last Updated
March 6, 2020
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04302909
Brief Title
Effectiveness of fESWT in the Treatment of CTS
Official Title
The Effectiveness of Focused Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

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
The carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . But there is still little known about the effects and long term effects of fESWT in the treatment of CTS.
Detailed Description
The aim of this study is to determine the effectiveness of fESWT in patients with carpal tunnel syndrome compared to participants receiving only night splint. Therefore 40 patients with mild to moderate CTS (verified by nerve conduction velocity) will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints. Evaluation will be performed at baseline (VAS, hand grip, electrodiagnostic parameters, questionnaires), 3 weeks (VAS, hand grip, questionnaires), 12 and 24 weeks (VAS, hand grip, electrodiagnostic parameters, questionnaires) after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
focused extracorporeal shock wave therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
fESWT
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
Sham fESWT
Intervention Type
Other
Intervention Name(s)
focused extracorporeal shock wave therapy
Intervention Description
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
Intervention Type
Other
Intervention Name(s)
sham focused extracorporeal shock wave therapy
Intervention Description
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
Intervention Type
Other
Intervention Name(s)
night splint
Intervention Description
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
Primary Outcome Measure Information:
Title
VAS
Description
Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment.
Time Frame
baseline, 3th,12th and 24th weeks after treatment
Secondary Outcome Measure Information:
Title
hand grip strength
Description
hand grip strength:
Time Frame
baseline, 3th,12th and 24th weeks after treatment
Title
distal motor latency of the median nerve
Description
electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment.
Time Frame
baseline,12th and 24th weeks after treatment
Title
sensory conduction velocity of the median nerve
Description
electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment.
Time Frame
baseline, 12th and 24th weeks after treatment
Title
SF-36
Description
36-item Short Form Health Survey: Change from baseline in quality of life 3th,12th and 24th weeks after treatment.
Time Frame
baseline, 3th,12th and 24th weeks after treatment
Title
Boston Scale
Description
Boston Symptom Severity Score: Change from baseline in severity of symptoms and functional status 3th,12th and 24th weeks after treatment.
Time Frame
baseline, 3th,12th and 24th weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - mild to moderate CTS verified by nerve conduction velocity Exclusion Criteria: metabolic diseases blood clotting problems systemic diseases polyneuropathy chemotherapy during the study corticosteroid therapy use of anticoagulation history of trauma/surgery or nerve lesion of the teated extremity CTS surgery on the affected hand ICD/ pacemaker implantation other therapy for the affected hand during the study acute inflammation or infections severe mental illnesses/psychiatric diseases severe neurological diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Gesslbauer, Dr.
Phone
0043 40040043330
Email
christina.gesslbauer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Gesslbauer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA
Organizational Affiliation
Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA
Email
richard.crevenna@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of fESWT in the Treatment of CTS

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