Optimal Dose 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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Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity

Conditions
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Post-Stroke Elbow Spasticity

Intervention / Treatment
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* Procedure: Extracorporeal shock wave therapy 60mj
* Procedure: Extracorporeal shock wave therapy 120mj
* Procedure: non extracorporeal shock wave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age ≥20 years inpatients Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii Modified Ashworth scale (MAS) ≥2, At least a 3-month period from stroke, Written informed consent has been obtained Exclusion Criteria: Fixed contractures and/or deformities at the elbow, Previous fractures of the paretic upper limb, Peripheral nervous system disorders/myopathies, Previous BTX-A treatment and/or ESWT, Structural alterations in the soft tissue (e.g., fibrosis), Known allergy or sensitivity to the study medication or its components Presence of an unstable medical condition or uncontrolled systemic disease Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function. Bleeding tendency and/or anticoagulation therapy Presence of infection or skin disorder at injection sites Females were are pregnant, nursing, or are planning a pregnancy during the study Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception Participant who should be withdrawn from the study in the opinion of the investigator for any reason

Ages Eligible for Study
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Minimum Age: 20 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: 60mJ ESWT<br>ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ | Procedure: Extracorporeal shock wave therapy 60mj<br> <br> |
| Experimental: 120mJ ESWT<br>ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ | Procedure: Extracorporeal shock wave therapy 120mj<br> <br> |
| Placebo Comparator: sham ESWT stimulation<br>ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ | Procedure: non extracorporeal shock wave therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) of elbow flexor |  | 5 weeks |