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Clinical Trials/NCT02218229
NCT02218229
Completed
Not Applicable

The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

Tri-Service General Hospital1 site in 1 country60 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Tri-Service General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline of pain on1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Detailed Description

Recently, many studies show the potential effect of shock wave for the reinnervation for peripheral neuropathy in the animal mode. Only one study reveal the potential benefit of shock wave in patients with carpal tunnel syndrome. Althouh its expressive finding, the number of cases is relatively too small to make a conclusive remark. Large and well-designed study would expand the new field.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yung-Tsan Wu

Attending Physician

Tri-Service General Hospital

Eligibility Criteria

Inclusion Criteria

  • Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test and numbness/tingling in at least two of the first, second, and third digits and were all confirmed by electrophysiological study, were considered and enrolled.

Exclusion Criteria

  • The patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist surgery or steroid injection for CTS, were all excluded.

Outcomes

Primary Outcomes

Change from baseline of pain on1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.

Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

Secondary Outcomes

  • Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.)
  • Change from baseline in severity of symptoms and functional status on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.)
  • Change from baseline in cross-sectional area of the median nerve on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.)
  • Change from baseline in conduction velocity, ampliture of median nerve on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment.)

Study Sites (1)

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