Comparison of Botulinum Toxin Injection Techniques in Spasticity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-10-01

Brief Summary

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The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle.

The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection.

Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.

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Detailed Description

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Conditions

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Spastic Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Classic injection

200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle

Group Type ACTIVE_COMPARATOR

Onabotulinumtoxina for Injection

Intervention Type DRUG

200iu/2ml in both groups

İnjection along the length of the muscle

A total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle

Group Type EXPERIMENTAL

Onabotulinumtoxina for Injection

Intervention Type DRUG

200iu/2ml in both groups

Interventions

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Onabotulinumtoxina for Injection

200iu/2ml in both groups

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with spastic hemiplegia
* Spasticity in the gastrocnemius muscle

Exclusion Criteria

* Those who have spasticity in other muscles that will affect ankle movements
* Those who use myorelaxant or myospasm-effective drugs
* Those who have been applied botulinum toxin in the last 3 months
* Those who have contractures in the ankle and knee due to orthopedic reasons.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No