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Clinical Trials/NCT02801461
NCT02801461
Completed
Not Applicable

The Effect of Extracorporeal Shock Wave Therapy in Patients With Cubital Tunnel Syndrome

Tri-Service General Hospital1 site in 1 country7 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cubital Tunnel Syndrome
Sponsor
Tri-Service General Hospital
Enrollment
7
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 effect of extracorporeal shock wave therapy on cubital tunnel syndrome.

Detailed Description

Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome. Patients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. 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
October 2016
End Date
December 31, 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 cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria

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

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 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)
  • 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)

Study Sites (1)

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