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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05889026
• Other study ID #: ESWT RCT
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: September 8, 2021

Study information

• Verified date: May 2023
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Hemiplegia, Spastic
• Muscle Spasticity
• Stroke

Intervention

Device:
• Extracorporeal shock wave therapy
Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.

Procedure:
• Botulinum toxin treatment
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.

Locations

Country	Name	City	State
Korea, Republic of	Korea university guro hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified ashworth scale of upper extremities spasticity	minimum grade 0, maximum grade 4 / higher grade means severe spasticity	Pre-treatment (baseline)
Primary	Modified ashworth scale of upper extremities spasticity	minimum grade 0, maximum grade 4 / higher grade means severe spasticity	Three weeks after treatment
Primary	Modified ashworth scale of upper extremities spasticity	minimum grade 0, maximum grade 4 / higher grade means severe spasticity	Three months after treatment
Secondary	Modified tardieu scale of upper extremities spasticity	Unit : degree / higher degree means little limitation of range of motion	Pre-treatment (baseline)
Secondary	Modified tardieu scale of upper extremities spasticity	Unit : degree / higher degree means little limitation of range of motion	Three weeks after treatment
Secondary	Modified tardieu scale of upper extremities spasticity	Unit : degree / higher degree means little limitation of range of motion	Three months after treatment
Secondary	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)
Secondary	Fugl-Meyer assessment of upper extremity	Minimum score 0, maximum score 66 / higher score means better function of upper extremity	Three months after treatment
Secondary	Action research arm test	Minimum score 0, maximum score 57 / higher score means better function of upper extremity	Pre-treatment (baseline)
Secondary	Action research arm test	Minimum score 0, maximum score 57 / higher score means better function of upper extremity	Three weeks after treatment
Secondary	Action research arm test	Minimum score 0, maximum score 57 / higher score means better function of upper extremity	Three months after treatment
Secondary	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)
Secondary	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
Secondary	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