Muscle Selection for Botulinum Toxin A Injection in Poststroke Elbow Flexor Spasticity

June 18, 2021 updated by: ilker şengül, Izmir Katip Celebi University

The Effect of Muscle Selection for Botulinum Toxin A Injection on the Treatment Outcome in Poststroke Elbow Flexor Spasticity

Botulinum toxin A (BoNT A) has been reported to be effective in the treatment of elbow flexor spasticity. Although BoNT A is an efficacious treatment option, there is a debate in the selection of target muscle(s) for BoNT injection in the treatment of poststroke elbow flexor spasticity. The decision of muscle selection for BoNT A injection is mostly made according to the physical examination findings in real life practice.One of the guiding findings in this decision is the position of the spastic arm.

In this study, hypothesis is that the change in severity of spasticity with BoNT A injection differs depending on the muscle selection in chronic stroke patients with elbow flexor and forearm pronator spasticity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Botulinum neurotoxin A (BoNT A) has been reported to be effective in the treatment of elbow flexor spasticity. In the treatment of poststroke elbow flexor spasticity with BoNT A, three main muscles injected individually or in combination are musculus biceps brachii, musculus brachialis and musculus brachioradialis. Although BoNT is an efficacious treatment option, there is a debate in the selection of target muscle(s) for BoNT A injection in the treatment of poststroke elbow flexor spasticity. Superficiality of the biceps brachii muscle makes it an easy target for botulinum toxin injection. In dynamic electromyography studies, it has been reported that brachioradialis muscle is the most common contributor one to elbow flexion spasticity, followed by biceps brachii muscle. In the diagnostic selective nerve blocks, the brachialis muscle has been reported to be foreground. In a recent study using the modified Delphi Method Design, the expert committee was only fully agree on the application of BoNT A into the brachioradialis muscle.

The decision of muscle selection for BoNT A injection is mostly made according to the physical examination findings in real life practice. One of the guiding findings in this decision is the position of the spastic arm. The typical pattern of spastic elbow and forearm in patients with stroke is characterized by flexion at the elbow, and pronation in the forearm. As far as the investigators know, there has not been carried out any study investigating the effect of muscle selection for BoNT application on the treatment outcome (severity of spasticity) in chronic stroke patients with elbow flexor and forearm pronator spasticity.

The aim of this study is to investigate whether treatment response (change in severity of spasticity) differs according to BoNT A injected muscle in chronic stroke patients with elbow flexor and forearm pronator spasticity.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • In The USA Or Canada, Please Select...
      • İzmir, In The USA Or Canada, Please Select..., Turkey, 35360
        • İlker Şengül

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stroke patients with elbow flexor and forearm pronator spasticity

Description

Inclusion Criteria:

  • Chronic (equal to or upper than 1 year) stroke patients with position of elbow flexion and forearm pronation while standing or sitting
  • Grade 2 or 3 elbow flexor spasticity and grade 1 to 3 forearm pronator spasticity according to Modified Ashworth Scale
  • Stage 2 or 3 Brunnstrom's motor recovery stage of upper extremity
  • To agree to participate in the study

Exclusion Criteria:

  • <18 years old
  • Pregnancy
  • Botulinum toxin injection within the last three months
  • Presence of elbow contracture
  • History of operation to spastic upper extremity
  • Spasticity due to other causes other than stroke
  • Do not agree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brachialis
Targeted muscle for BoNT A injection
Drug: Botulinum toxin type A
Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
Other Names:
  • Botox
  • Dysport
Biceps
Targeted muscle for BoNT A injection
Drug: Botulinum toxin type A
Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
Other Names:
  • Botox
  • Dysport
Brachialis plus Brachioradialis
Targeted muscles for BoNT A injection
Drug: Botulinum toxin type A
Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
Other Names:
  • Botox
  • Dysport

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic Component of Spasticity (Spasticity Angle)
Time Frame: up to 4 week
According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) of elbow joint at forearm pronation position will be evaluated.
up to 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2019

Primary Completion (ACTUAL)

May 3, 2021

Study Completion (ACTUAL)

June 1, 2021

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (ACTUAL)

July 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-KAE-0230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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