Comparison of Botulinum Toxin Injection Techniques in Spasticity

Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spastic Hemiplegia
• Intervention / Treatment: Drug: Onabotulinumtoxina for Injection

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Savaş Karpuz, M.D.; Phone Number: +905552057860; Email: svskrpz@hotmail.com

Study Locations

• Turkey
  • Selçuklu
    • Konya, Selçuklu, Turkey, 42060
      • Konya Beyhekim Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Classic injection; 200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle	Drug: Onabotulinumtoxina for Injection; 200iu/2ml in both groups
Experimental: İnjection along the length of the muscle; A total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle	Drug: Onabotulinumtoxina for Injection; 200iu/2ml in both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity assessment (change between pre-injection and 1-month control)	Modified ashworth scale	before injection and 1 month after injection
Spasticity assessment (change between pre-injection and 1-month control)	Tardieu scale	before injection and 1 month after injection
Spasticity assessment (change between pre-injection and 1-month control)	Joint range of motion measurement	before injection and 1 month after injection
ambulation level (change between pre-injection and 1-month control)	functional ambulation scale	before injection and 1 month after injection
ambulation velocity (change between pre-injection and 1-month control)	preferred walking speed	before injection and 1 month after injection

Collaborators and Investigators

• Sponsor: Konya Beyhekim Training and Research Hospital
• Investigators: Principal Investigator: Savaş Karpuz, Konya Beyhekim Training and Research Hospital

Publications and helpful links

General Publications

• Kim MW, Kim JH, Yang YJ, Ko YJ. Anatomic localization of motor points in gastrocnemius and soleus muscles. Am J Phys Med Rehabil. 2005 Sep;84(9):680-3. doi: 10.1097/01.phm.0000176341.85398.a9.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2022-01-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Shared if requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No