Comparison of Botulinum Toxin Injection Techniques in Spasticity

Konya Beyhekim Training and Research Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Spastic Hemiplegia

Treatments: Drug: Onabotulinumtoxina for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05615987

2022-01-14

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Classic injection

Active Comparator group

Description:

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

Treatment:

Drug: Onabotulinumtoxina for Injection

İnjection along the length of the muscle

Experimental group

Description:

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

Treatment:

Drug: Onabotulinumtoxina for Injection