Comparison of Botulinum Toxin Injection Techniques in Spasticity

NCT05615987 | Unknown Phase 4

• 1 other identifier: 2022-01-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Hemiplegia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Classic injection

ACTIVE COMPARATOR

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

Drug: Onabotulinumtoxina for Injection

İnjection along the length of the muscle

EXPERIMENTAL

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

Drug: Onabotulinumtoxina for Injection

Interventions

Onabotulinumtoxina for Injection DRUG

200iu/2ml in both groups

Classic injection; İnjection along the length of the muscle

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with spastic hemiplegia
• Spasticity in the gastrocnemius muscle

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead

Study Sites (1)

Konya Beyhekim Research and Training Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 16141745 BACKGROUND

• 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.

  PMID: 17049615 BACKGROUND

• 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.

  PMID: 8355728 BACKGROUND

• 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.

  PMID: 15948200 BACKGROUND

• 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.

  PMID: 9572248 BACKGROUND

• 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.

  PMID: 28382814 BACKGROUND

• Karpuz S, Yilmaz R, Yilmaz H. Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-Blind Controlled Study. Arch Phys Med Rehabil. 2025 Mar;106(3):327-332. doi: 10.1016/j.apmr.2024.09.011. Epub 2024 Sep 27.

  PMID: 39343047 DERIVED

MeSH Terms

Conditions

Hemiplegia

Interventions

Botulinum Toxins, Type A; Injections

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Savaş Karpuz

  Konya Beyhekim Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savaş Karpuz, M.D.

CONTACT

+905552057860; svskrpz@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)