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

Primary Purpose

Stroke, Hemiplegia, Spastic, Muscle Spasticity

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
Botulinum toxin treatment
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: at least 6 weeks after stroke diagnosis upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2 ability to stand and walk safely without help or assistance Exclusion Criteria: improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy previous contracture and/or deformity of the upper extremities concurrent peripheral neuropathy and/or myopathy difficulty in participating in the study due to cognitive impairment.

Sites / Locations

  • Korea university guro hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Botulinum toxin treatment with extracorporeal shock wave therapy

Botulinum toxin treatment only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Modified ashworth scale of upper extremities spasticity
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Modified ashworth scale of upper extremities spasticity
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Modified ashworth scale of upper extremities spasticity
minimum grade 0, maximum grade 4 / higher grade means severe spasticity

Secondary Outcome Measures

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

Full Information

First Posted
May 9, 2023
Last Updated
May 25, 2023
Sponsor
Korea University Guro Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05889026
Brief Title
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
Official Title
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
September 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea University Guro Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia, Spastic, Muscle Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin treatment with extracorporeal shock wave therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Botulinum toxin treatment only
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy
Intervention Description
Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.
Intervention Type
Procedure
Intervention Name(s)
Botulinum toxin treatment
Intervention Description
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.
Primary Outcome Measure Information:
Title
Modified ashworth scale of upper extremities spasticity
Description
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Time Frame
Pre-treatment (baseline)
Title
Modified ashworth scale of upper extremities spasticity
Description
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Time Frame
Three weeks after treatment
Title
Modified ashworth scale of upper extremities spasticity
Description
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Time Frame
Three months after treatment
Secondary Outcome Measure Information:
Title
Modified tardieu scale of upper extremities spasticity
Description
Unit : degree / higher degree means little limitation of range of motion
Time Frame
Pre-treatment (baseline)
Title
Modified tardieu scale of upper extremities spasticity
Description
Unit : degree / higher degree means little limitation of range of motion
Time Frame
Three weeks after treatment
Title
Modified tardieu scale of upper extremities spasticity
Description
Unit : degree / higher degree means little limitation of range of motion
Time Frame
Three months after treatment
Title
Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity
Description
Minimum score 0, maximum score 66 / higher score means better function of upper extremity
Time Frame
Pre-treatment (baseline)
Title
Fugl-Meyer assessment of upper extremity
Description
Minimum score 0, maximum score 66 / higher score means better function of upper extremity
Time Frame
Three months after treatment
Title
Action research arm test
Description
Minimum score 0, maximum score 57 / higher score means better function of upper extremity
Time Frame
Pre-treatment (baseline)
Title
Action research arm test
Description
Minimum score 0, maximum score 57 / higher score means better function of upper extremity
Time Frame
Three weeks after treatment
Title
Action research arm test
Description
Minimum score 0, maximum score 57 / higher score means better function of upper extremity
Time Frame
Three months after treatment
Title
Modified barthel index
Description
Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living
Time Frame
Pre-treatment (baseline)
Title
Modified barthel index
Description
Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living
Time Frame
Three weeks after treatment
Title
Modified barthel index
Description
Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living
Time Frame
Three months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 6 weeks after stroke diagnosis upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2 ability to stand and walk safely without help or assistance Exclusion Criteria: improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy previous contracture and/or deformity of the upper extremities concurrent peripheral neuropathy and/or myopathy difficulty in participating in the study due to cognitive impairment.
Facility Information:
Facility Name
Korea university guro hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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