The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
NCT ID: NCT05889026
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2020-08-06
2021-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum toxin treatment with extracorporeal shock wave therapy
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.
Extracorporeal shock wave therapy
Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.
Botulinum toxin treatment
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.
Botulinum toxin treatment only
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.
Botulinum toxin treatment
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.
Interventions
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Extracorporeal shock wave therapy
Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.
Botulinum toxin treatment
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.
Eligibility Criteria
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Inclusion Criteria
2. upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score \> 2
3. ability to stand and walk safely without help or assistance
Exclusion Criteria
2. previous contracture and/or deformity of the upper extremities
3. concurrent peripheral neuropathy and/or myopathy
4. difficulty in participating in the study due to cognitive impairment.
19 Years
80 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Korea University Guro Hospital
OTHER
Responsible Party
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Locations
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Korea university guro hospital
Seoul, , South Korea
Countries
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Other Identifiers
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ESWT RCT
Identifier Type: -
Identifier Source: org_study_id
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