Clinical Trial: The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

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

Official Title: The Effect of Extracorporeal Shock Wave Therapy on Carpal 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 carpal tunnel syndrome.

Detailed Summary: 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.
Sponsor: Tri-Service General Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in severity of symptoms and functional status on 1st, 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 Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
  • Change from baseline in cross-sectional area of the median nerve on 1st, 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 musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
  • Change from baseline in conduction velocity, ampliture of median nerve on 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment. [ Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment. ]
    The antidromic sensory nerve conduction velocityof the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.
  • Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment. [ Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th,12th and 16th weeks after treatment. ]
    The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch


Original Secondary Outcome: Same as current

Information By: Tri-Service General Hospital

Dates:
Date Received: August 13, 2014
Date Started: August 2014
Date Completion: May 2017
Last Updated: June 10, 2016
Last Verified: June 2016