Effectiveness of fESWT in the Treatment of CTS

Sponsor

Medical University of Vienna (Other)

Overall Status

Unknown status

CT.gov ID

NCT04302909

Collaborator

(none)

Enrollment

Location

Arms

25.3

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Other: focused extracorporeal shock wave therapy Other: sham focused extracorporeal shock wave therapy Other: night splint	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effectiveness of Focused Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: A Pilot Study

Actual Study Start Date :

Apr 24, 2019

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Comparator fESWT	Other: 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. 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.
Sham Comparator: Sham Comparator Sham fESWT	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. 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.

Arm

Intervention/Treatment

Active Comparator: Active Comparator

fESWT

Other: 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.

Other: night splint

Sham Comparator: Sham Comparator

Sham fESWT

Other: sham focused extracorporeal shock wave therapy

Other: night splint

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

hand grip strength [baseline, 3th,12th and 24th weeks after treatment]
hand grip strength:
distal motor latency of the median nerve [baseline,12th and 24th weeks after treatment]
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 [baseline, 12th and 24th weeks after treatment]
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 [baseline, 3th,12th and 24th weeks after treatment]
36-item Short Form Health Survey: Change from baseline in quality of life 3th,12th and 24th weeks after treatment.
Boston Scale [baseline, 3th,12th and 24th weeks after treatment]
Boston Symptom Severity Score: Change from baseline in severity of symptoms and functional status 3th,12th and 24th weeks after treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine	Vienna		Austria

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA, Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc. MBA, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04302909

Other Study ID Numbers:

1080/2019

First Posted:

Mar 10, 2020

Last Update Posted:

Mar 10, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc. MBA, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna

focused extracorporeal shock wave therapy

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Syndrome

Study Results

No Results Posted as of Mar 10, 2020