Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity

Medy-Tox0 sites59 target enrollmentMay 30, 2016

InterventionsUltrasonography guidance injection of Meditoxin®.Electrical stimulation guidance injection of Meditoxin®.Manual needle placement injection of Meditoxin®.

DrugsUltrasonography guidance injection of Meditoxin®.Electrical stimulation guidance injection of Meditoxin®.Manual needle placement injection of Meditoxin®.

Overview

Phase: Phase 4
Intervention: Ultrasonography guidance injection of Meditoxin®.
Conditions: Muscle Spasticity
Sponsor: Medy-Tox
Enrollment: 59
Primary Endpoint: Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.

Detailed Description

This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".

Registry

clinicaltrials.gov

Start Date

May 30, 2016

End Date

August 16, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medy-Tox

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subject aged over
•Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
•Subjects who was diagnosed stroke at least 1 month prior to study participation.
•Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.

Exclusion Criteria

•Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
•Subjects with allergy or hypersensitivity to the Botulinum Toxin.
•Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
•Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
•Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
•Subjects who have been injected with botulinum toxin within past 3 months before the injection.
•Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
•Subjects who are scheduled to take part in other clinical trial during the study period.
•Patients who are not eligible for this study at the medical discretion of the investigator.

Arms & Interventions

Ultrasonography guidance

Ultrasonography guidance injection of Meditoxin®.

Intervention: Ultrasonography guidance injection of Meditoxin®.

Electrical stimulation guidance

Electrical stimulation guidance injection of Meditoxin®.

Intervention: Electrical stimulation guidance injection of Meditoxin®.

Manual needle placement

Manual needle placement injection of Meditoxin®.

Intervention: Manual needle placement injection of Meditoxin®.

Outcomes

Primary Outcomes

Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.

Time Frame: 4 weeks

Secondary Outcomes

Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.(4 weeks)
Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.(4 weeks)