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

Korea University Guro Hospital16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke Hemiplegia, Spastic Muscle Spasticity

Interventions

Extracorporeal shock wave therapyDEVICE

Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.

Botulinum toxin treatmentPROCEDURE

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Korea university guro hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Modified ashworth scale of upper extremities spasticity

minimum grade 0, maximum grade 4 / higher grade means severe spasticity

Time frame: Pre-treatment (baseline)

Modified ashworth scale of upper extremities spasticity

minimum grade 0, maximum grade 4 / higher grade means severe spasticity

Time frame: Three weeks after treatment

Modified ashworth scale of upper extremities spasticity

minimum grade 0, maximum grade 4 / higher grade means severe spasticity

Time frame: Three months after treatment

Secondary Outcomes

Modified tardieu scale of upper extremities spasticity

Unit : degree / higher degree means little limitation of range of motion

Time frame: Pre-treatment (baseline)

Modified tardieu scale of upper extremities spasticity

Unit : degree / higher degree means little limitation of range of motion

Time frame: Three weeks after treatment

Modified tardieu scale of upper extremities spasticity

Unit : degree / higher degree means little limitation of range of motion

Time frame: 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

Time frame: Pre-treatment (baseline)

Data from ClinicalTrials.gov

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