Clinical Trial: The Effect of ESWT for Cubital Tunnel Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Tri-Service General Hospital

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment ]
    Using the Disabilities of the Arm, Shoulder and Hand to measure the symptoms and functional status before treatment and multiple time frame after treatment.
  • Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment ]
    electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA


Original Secondary Outcome: Same as current

Information By: Tri-Service General Hospital

Dates:
Date Received: June 10, 2016
Date Started: April 2016
Date Completion: December 2017
Last Updated: June 14, 2016
Last Verified: June 2016