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Clinical Trials/NCT02800187
NCT02800187
Completed
Not Applicable

The Effect of Extracorporeal Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome

Tri-Service General Hospital1 site in 1 country69 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Tri-Service General Hospital
Enrollment
69
Locations
1
Primary Endpoint
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th 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 dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Detailed Description

The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
October 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 of Physical medicine and rehabilitation

Tri-Service General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age between 20-80 year-old.
  • Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria

  • Coagulopathy
  • Inflammation status
  • Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.

Outcomes

Primary Outcomes

Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.

Time Frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

Visual analog scale (VAS)

Secondary Outcomes

  • Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)
  • Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)
  • Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment)

Study Sites (1)

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