Skip to main content
Clinical Trials/NCT03671473
NCT03671473
Withdrawn
Not Applicable

Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome

Tri-Service General Hospital1 site in 1 countryJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Tri-Service General Hospital
Locations
1
Primary Endpoint
Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief Summary

Extracorporeal shock wave is a novel treatment for peripheral nerve entrapment. This study was designed to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

Detailed Description

Both focused and radial extracorporeal shock wave had been proved to treat carpal tunnel syndrome by several studies. However, there was no study comparing these two methods. Considering different mechanisms and costs, this randomized comparative trial would be conducted to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yung-Tsan Wu

Principal Investigator

Tri-Service General Hospital

Eligibility Criteria

Inclusion Criteria

  • Clinical and electrophysiological diagnosis of CTS

Exclusion Criteria

  • Cervical radiculopathy
  • Polyneuropathy
  • Brachial plexopathy
  • Thoracic outlet syndrome
  • Previous wrist surgery or steroid injection for CTS

Outcomes

Primary Outcomes

Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment

Time Frame: Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment

Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses two components. eleven questions and eight items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Each question or item ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score of SSS ranges from 11-55 and FSS from 8-40. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary Outcomes

  • Cross-sectional area (CSA) of the median nerve(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)
  • Nerve conduction amplitude(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)
  • Nerve conduction velocity(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)
  • Visual analogue scale (VAS)(Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment)

Study Sites (1)

Loading locations...

Similar Trials