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

Not Applicable

Completed

• Conditions: Muscle Spasticity; Stroke; Hemiplegia, Spastic
• Interventions: Device: Extracorporeal shock wave therapy; Procedure: Botulinum toxin treatment

• Registration Number: NCT05889026
• Lead Sponsor: Korea University Guro Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-08-06
• Primary Completion: 2021-09-08
• Study Completion: 2021-09-08
• Status Verified: 2023-05
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-06-05
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. at least 6 weeks after stroke diagnosis
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

1. improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin treatment with extracorporeal shock wave therapy	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.
Botulinum toxin treatment with extracorporeal shock wave therapy	Botulinum toxin treatment	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	Botulinum toxin treatment	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.

Primary Outcome Measures

Name	Time	Method
Modified ashworth scale of upper extremities spasticity	Three months after treatment	minimum grade 0, maximum grade 4 / higher grade means severe spasticity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Korea university guro hospital; 🇰🇷 Seoul, Korea, Republic of