An interventional study of Shock wave in Spasticity, sponsored by Tri-Service General Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-14.
Sponsored by Tri-Service General Hospital · Not applicable, Interventional, and Treatment
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.
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).
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 60 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Tri-Service General Hospital is the lead sponsor of 109 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
Device: Shock wave
E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle
Device: Shock wave
E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Only one dose
Device: Shock wave
Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (\< 10 ns) and short duration (10 μs) is conveyed by an appropriate generator to a specific target area with an energy density in the range of 0.003-0.890 mJ/mm2. Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies, calcific tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, and several tendon diseases.
Also known as: E-SWT
Change from baseline of spasticity on 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.
Time frame: 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.
Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
Time frame: 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.
Using the Visual analog scale (VAS) to measure the pain from spasticity scale before treatment and multiple time frame after treatment.
Time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Change from baseline of disability on 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.
Time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Tri-Service General Hospital