The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Conditions
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Spasticity

Intervention / Treatment
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* Device: Shock wave


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shock wave (three times)<br>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<br>* 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.<br>* Other names: E-SWT;|
| Sham Comparator: Sham shock wave<br>E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle | Device: Shock wave<br>* 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.<br>* Other names: E-SWT;|
| Experimental: Shock wave (one time)<br>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<br>* 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.<br>* Other names: E-SWT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock wave, Spasticity, Effect