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

Sponsor

Korea University Guro Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05889026

Collaborator

Daewoong Pharmaceutical Co. LTD. (Industry)

Enrollment

Location

Arms

13.1

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiplegia, Spastic Muscle Spasticity	Device: Extracorporeal shock wave therapy Procedure: Botulinum toxin treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 6, 2020

Actual Primary Completion Date :

Sep 8, 2021

Actual Study Completion Date :

Sep 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Sham Comparator: 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.	Procedure: Botulinum toxin treatment The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Sham Comparator: 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.

Procedure: Botulinum toxin treatment

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

Outcome Measures

Primary Outcome Measures

Modified ashworth scale of upper extremities spasticity [Pre-treatment (baseline)]
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Modified ashworth scale of upper extremities spasticity [Three weeks after treatment]
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea university guro hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Korea University Guro Hospital
Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Korea University Guro Hospital

ClinicalTrials.gov Identifier:

NCT05889026

Other Study ID Numbers:

ESWT RCT

First Posted:

Jun 5, 2023

Last Update Posted:

Jun 5, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023