Back to results

Comparison of Botulinum Toxin Injection Techniques in Spasticity

Primary Purpose

Spastic Hemiplegia

Status

Not yet recruiting

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Onabotulinumtoxina for Injection

About this trial

This is an interventional treatment trial for Spastic Hemiplegia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Konya Beyhekim Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Classic injection

İnjection along the length of the muscle

Arm Description

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

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

Outcomes

Primary Outcome Measures

Spasticity assessment (change between pre-injection and 1-month control)

Modified ashworth scale

Spasticity assessment (change between pre-injection and 1-month control)

Tardieu scale

Spasticity assessment (change between pre-injection and 1-month control)

Joint range of motion measurement

ambulation level (change between pre-injection and 1-month control)

functional ambulation scale

ambulation velocity (change between pre-injection and 1-month control)

preferred walking speed

Secondary Outcome Measures

Full Information

NCT ID

NCT05615987

First Posted

November 2, 2022

Last Updated

November 8, 2022

Sponsor

Konya Beyhekim Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05615987

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2022 (Anticipated)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Konya Beyhekim Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spastic Hemiplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Classic injection

Arm Type

Active Comparator

Arm Description

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

Arm Title

İnjection along the length of the muscle

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Onabotulinumtoxina for Injection

Intervention Description

200iu/2ml in both groups

Primary Outcome Measure Information:

Title

Spasticity assessment (change between pre-injection and 1-month control)

Description

Modified ashworth scale

Time Frame

before injection and 1 month after injection

Title

Spasticity assessment (change between pre-injection and 1-month control)

Description

Tardieu scale

Time Frame

before injection and 1 month after injection

Title

Spasticity assessment (change between pre-injection and 1-month control)

Description

Joint range of motion measurement

Time Frame

before injection and 1 month after injection

Title

ambulation level (change between pre-injection and 1-month control)

Description

functional ambulation scale

Time Frame

before injection and 1 month after injection

Title

ambulation velocity (change between pre-injection and 1-month control)

Description

preferred walking speed

Time Frame

before injection and 1 month after injection

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Savaş Karpuz, M.D.

Phone

+905552057860

svskrpz@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Savaş Karpuz

Organizational Affiliation

Konya Beyhekim Training and Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Konya Beyhekim Research and Training Hospital

City

Konya

State/Province

Selçuklu

ZIP/Postal Code

42060

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Shared if requested.

Citations:

PubMed Identifier

16141745

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. doi: 10.1097/01.phm.0000176341.85398.a9.

Results Reference

background

PubMed Identifier

17049615

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.

Results Reference

background

PubMed Identifier

8355728

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.

Results Reference

background

PubMed Identifier

15948200

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.

Results Reference

background

PubMed Identifier

9572248

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.

Results Reference

background

PubMed Identifier

28382814

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.

Results Reference

background

Learn more about this trial

Comparison of Botulinum Toxin Injection Techniques in Spasticity

We'll reach out to this number within 24 hrs