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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Muscle Spasticity; Hemiplegia, Spastic
• Intervention / Treatment: Device: Extracorporeal shock wave therapy; Procedure: Botulinum toxin treatment

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Collaborators: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): September 8, 2021

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Paralysis; Muscle Hypertonia; Stroke; Hemiplegia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: ESWT RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No