Clinical Trial: The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Brief Summary: The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has been used to treat the spasticity with expressively response and the effect could persist for 1-3 months in different studies. However most sutdies lack the sham or control group. The purpose of this study was to assess the effect of shock wave for spasticity in wrist and hand.

Detailed Summary: The patients with spasticity for at least 6 months were randomized for 3 groups. Group I: patients receive one session of shock wave per week for 3 weeks; Group II: patients receive only one session of shock wave; Group III: patients receive the sham shock wave per week for 3 weeks. The outcome measurements include Modified Asthow scale, passive range of motion, Disability Assessment Scale and Fugl-Meyer Assessment Scale (hand function and wrist control).
Sponsor: Tri-Service General Hospital

Current Primary Outcome: Change from baseline of spasticity 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 modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline of range of motion 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 digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
  • Change from baseline of pain 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 Visual analog scale (VAS) to measure the pain from spasticity scale before treatment and multiple time frame after treatment.
  • Change from baseline of disability 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 Disability Assessment Scale to measure the disabilty scale before treatment and multiple time frame after treatment.


Original Secondary Outcome: Same as current

Information By: Tri-Service General Hospital

Dates:
Date Received: August 14, 2014
Date Started: August 2014
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016