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| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin treatment with extracorporeal shock wave therapy | Active Comparator | 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. |
|
| Botulinum toxin treatment only | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock wave therapy | Device | Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea university guro hospital | Seoul | South Korea |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2024 | |
| Reset | Sep 12, 2024 |
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| Botulinum toxin treatment | Procedure | The toxin dose was established for each patient: it ranged between 80 unit and 300 unit. |
|
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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2024 | Sep 12, 2024 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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