Effectiveness of fESWT in the Treatment of CTS

NCT ID: NCT04302909

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Comparator

fESWT

Group Type ACTIVE_COMPARATOR

focused extracorporeal shock wave therapy

Intervention Type OTHER

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.

night splint

Intervention Type OTHER

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.

Sham Comparator

Sham fESWT

Group Type SHAM_COMPARATOR

sham focused extracorporeal shock wave therapy

Intervention Type OTHER

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.

night splint

Intervention Type OTHER

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.

Interventions

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focused extracorporeal shock wave therapy

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

sham focused extracorporeal shock wave therapy

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

night splint

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Richard Crevenna

Ao.Univ.-Prof. Dr., MMSc. MBA, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Christina Gesslbauer, Dr.

Role: CONTACT

0043 40040043330

Christina Gesslbauer

Role: CONTACT

Facility Contacts

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Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA

Role: primary

Other Identifiers

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1080/2019

Identifier Type: -

Identifier Source: org_study_id

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