Skip to main content
Clinical Trials/NCT02221011
NCT02221011
Completed
Not Applicable

The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Tri-Service General Hospital1 site in 1 country60 target enrollmentAugust 2014
ConditionsSpasticity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spasticity
Sponsor
Tri-Service General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Status
Completed
Last Updated
10 years ago

Overview

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 Description

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).

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yung-Tsan Wu

Attending Physician

Tri-Service General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age between 20-80 year-old Spasticity measured as Modified Asthow Scale more than 1+ point and persist at least 6 months Clear consciousness No receive Phenol injection or Botulinum toxin in past 6 months

Exclusion Criteria

  • Cancer Joint contracture Coagulopathy Pregnancy Pacemaker Inflammation status

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.)
  • Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.)
  • Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.(Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.)

Study Sites (1)

Loading locations...

Similar Trials