The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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.
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
shock wave (three times)
E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Once a week for 3 weeks
Intervention: Shock wave (Device)
Sham shock wave
E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle
Intervention: Shock wave (Device)
Shock wave (one time)
E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Only one dose
Intervention: Shock wave (Device)
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.)
Investigators
Yung-Tsan Wu
Attending Physician
Tri-Service General Hospital