Spasticity
Conditions
Keywords
Shock wave, Spasticity, Effect
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).
Interventions
DEVICEShock 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.
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Using the Disability Assessment Scale to measure the disabilty scale before treatment and multiple time frame 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. | 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 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. | Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment. |
Countries
Taiwan
Outcome results
None listed