The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity

Study Overview
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Brief Summary
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There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.

Detailed Description
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If the study results can be drawn that the group receiving extracorporeal shock wave therapy along with botulinum toxin treatment can increase the effect of botulinum toxin treatment and lengthen the treatment period compared to the group with botulinum toxin treatment only, it can be widely used as an auxiliary treatment for botulinum toxin treatment. This study was carried out with the expectation that it would be possible to provide a basis for this.

Official Title
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The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials

Conditions
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Stroke, Hemiplegia, Spastic, Muscle Spasticity

Intervention / Treatment
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* Device: Extracorporeal shock wave therapy
* Procedure: Botulinum toxin treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 6 weeks after stroke diagnosis upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2 ability to stand and walk safely without help or assistance Exclusion Criteria: improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy previous contracture and/or deformity of the upper extremities concurrent peripheral neuropathy and/or myopathy difficulty in participating in the study due to cognitive impairment.

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Active Comparator: Botulinum toxin treatment with extracorporeal shock wave therapy<br>Nabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles. ESWT was performed immediately after botulinum toxin injection and was performed once a day for 5 days. Three weeks and 3 months after ESWT, spasticity was evaluated. | Device: Extracorporeal shock wave therapy<br>* Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.<br>Procedure: Botulinum toxin treatment<br>* The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.<br>|
| Sham Comparator: Botulinum toxin treatment only<br>Nabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles. Three weeks and 3 months after Botox treatment, spasticity was evaluated. | Procedure: Botulinum toxin treatment<br>* The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified ashworth scale of upper extremities spasticity | minimum grade 0, maximum grade 4 / higher grade means severe spasticity | Pre-treatment (baseline) | 
| Modified ashworth scale of upper extremities spasticity | minimum grade 0, maximum grade 4 / higher grade means severe spasticity | Three weeks after treatment | 
| Modified ashworth scale of upper extremities spasticity | minimum grade 0, maximum grade 4 / higher grade means severe spasticity | Three months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified tardieu scale of upper extremities spasticity | Unit : degree / higher degree means little limitation of range of motion | Pre-treatment (baseline) | 
| Modified tardieu scale of upper extremities spasticity | Unit : degree / higher degree means little limitation of range of motion | Three weeks after treatment | 
| Modified tardieu scale of upper extremities spasticity | Unit : degree / higher degree means little limitation of range of motion | Three months after treatment | 
| Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity | Minimum score 0, maximum score 66 / higher score means better function of upper extremity | Pre-treatment (baseline) | 
| Fugl-Meyer assessment of upper extremity | Minimum score 0, maximum score 66 / higher score means better function of upper extremity | Three months after treatment | 
| Action research arm test | Minimum score 0, maximum score 57 / higher score means better function of upper extremity | Pre-treatment (baseline) | 
| Action research arm test | Minimum score 0, maximum score 57 / higher score means better function of upper extremity | Three weeks after treatment | 
| Action research arm test | Minimum score 0, maximum score 57 / higher score means better function of upper extremity | Three months after treatment | 
| Modified barthel index | Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living | Pre-treatment (baseline) | 
| Modified barthel index | Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living | Three weeks after treatment | 
| Modified barthel index | Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living | Three months after treatment |