Comparison of Botulinum Toxin Injection Techniques in Spasticity

Spastic Hemiplegia Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05615987
• Other study ID #: 2022-01-14
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2022
• Source: Konya Beyhekim Training and Research Hospital
• Contact: Savas Karpuz, M.D.
• Phone: +905552057860
• Email: svskrpz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Spastic Hemiplegia

Intervention

Drug:
• Onabotulinumtoxina for Injection
200iu/2ml in both groups

Locations

Country	Name	City	State
Turkey	Konya Beyhekim Research and Training Hospital	Konya	Selçuklu

Sponsors (1)

Lead Sponsor	Collaborator
Konya Beyhekim Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Kaymak B, Kara M, Tok F, Ulasli AM, Öztürk GT, Chang KV, Hsiao MY, Hung CY, Yagiz On A, Özçakar 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. Review. — View Citation

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. — View 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. Epub 2006 Oct 17. — View 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. — View 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. — View Citation

Outcome

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