Clinical trial NCT05615987: Comparison of Botulinum Toxin Injection Techniques in Spasticity
Official title: Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spastic Hemiplegia
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Spasticity assessment (change between pre-injection and 1-month control)
timeFrame: before injection and 1 month after injection
measure: Spasticity assessment (change between pre-injection and 1-month control)
timeFrame: before injection and 1 month after injection
measure: Spasticity assessment (change between pre-injection and 1-month control)
timeFrame: before injection and 1 month after injection
measure: ambulation level (change between pre-injection and 1-month control)
timeFrame: before injection and 1 month after injection
measure: ambulation velocity (change between pre-injection and 1-month control)
timeFrame: before injection and 1 month after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Research and Training Hospital
state: Selçuklu
Study officials:
affiliation: Konya Beyhekim Training and Research Hospital
name: Savaş Karpuz
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Prodanov D, Nagelkerke N, Marani E. Spatial clustering analysis in neuroanatomy: applications of different approaches to motor nerve fiber distribution. J Neurosci Methods. 2007 Feb 15;160(1):93-108. doi: 10.1016/j.jneumeth.2006.08.017. Epub 2006 Oct 17.
citation: Shaari CM, Sanders I. Quantifying how location and dose of botulinum toxin injections affect muscle paralysis. Muscle Nerve. 1993 Sep;16(9):964-9. doi: 10.1002/mus.880160913.
citation: Prodanov D, Thil MA, Marani E, Delbeke J, Holsheimer J. Three-dimensional topography of the motor endplates of the rat gastrocnemius muscle. Muscle Nerve. 2005 Sep;32(3):292-302. doi: 10.1002/mus.20378.
citation: Childers MK, Kornegay JN, Aoki R, Otaviani L, Bogan DJ, Petroski G. Evaluating motor end-plate-targeted injections of botulinum toxin type A in a canine model. Muscle Nerve. 1998 May;21(5):653-5. doi: 10.1002/(sici)1097-4598(199805)21:53.0.co;2-w.
citation: Kaymak B, Kara M, Tok F, Ulasli AM, Ozturk GT, Chang KV, Hsiao MY, Hung CY, Yagiz On A, Ozcakar L. Sonographic guide for botulinum toxin injections of the lower limb: EUROMUSCULUS/USPRM spasticity approach. Eur J Phys Rehabil Med. 2018 Jun;54(3):486-498. doi: 10.23736/S1973-9087.17.04667-6. Epub 2017 Apr 4.