Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.

October 8, 2019 updated by: University Hospital, Clermont-Ferrand

Botulinum toxin injections are an effective treatment of limb spasticity after stroke. Different tracking techniques are used to locate a proper injection spot. Palpatory technique is barely effective and induces a high risk of error. Localization by electro stimulation is frequently used in adults, but often requires multiple painful repositioning of the needle. Ultrasound tracking is sometimes used in children but not much in adults.

The advantages of ultrasound-guided botulinum toxin injections are a painless localization and greater injection accuracy. Safety is therefore enhanced since intravascular injection is easily avoided.

The few existing publications on the subject are essentially case reports. Few studies have focused on comparing different injection techniques and so far, no well-conducted study has highlighted superior efficiency of ultrasound-guided injections.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objectives:

The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.

The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance.

Evaluations:

The primary endpoint is the variation of passive range of motion of ankle dorsiflexion at slow speed and high speed ("Tardieu scale") while keeping knee straight.

The secondary endpoints are:

  • The other components of the "Tardieu scale": quality of muscle reaction (X) at slow speed and fast speed, angle of apparition of the muscle reaction (Y) at slow speed and fast speed.
  • Assessment of spasticity of the triceps surae on the modified Ashworth scale.
  • The walking speed.
  • The extent of pain at the injection site by visual analogue scale.
  • The duration of tracking and injection.

Methodology:

This prospective, randomized, single-center, single-blind, cross-over, study will be conducted in chronic stroke patients with spasticity of the triceps surae.

Patients will receive two injections during the protocol, each with a different technique of localization. Randomization will determine which technique will be used in the first and the second place.

Patients will be selected from the cohort of patients supported by consultation of Physical Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand. Injections of botulinum toxin and assessments will take place in the same department.

The study period is five months for each patient. This study does not present a major risk for the subjects. The main inconvenience is injection pain or side effects of botulinum toxin (increase of motor deficits or dysphagia).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • France
      • Clermont-Ferrand, France, 63003
        • CHU clermont-ferrand

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80 years.
  • Hemiplegia sequelae of stroke
  • Spasticity of the triceps surae listed at least 1 + / 4 on the modified Ashworth scale
  • Ability to give written consent

Exclusion Criteria:

  • Injection of botulinum toxin older than 3 months
  • Patient who has already received ultrasound-guided injection of botulinum toxin
  • Indication of botulinum toxin injection in other muscle groups in the lower limb than triceps surae
  • Swallowing impairment
  • Ongoing AVK anticoagulation treatment with INR greater than 3 during one week before randomization.
  • Ongoing treatment by aminoglycosides
  • General anesthesia with injection of curare planned during the participation in the protocol
  • Wearing a pacemaker
  • History of ankle arthrodesis
  • Other cons-indication for botulinum toxin injection: myasthenia gravis, pregnancy, lactation.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: botulinum toxin injections
The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.
Device: Botulinum toxin injection
Other: ultrasound guidance
The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance
Device: Botulinum toxin injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame: at inclusion
at inclusion
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame: at day 1 (first injection)
at day 1 (first injection)
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame: at day 60
at day 60
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame: at day 120 (second injection)
at day 120 (second injection)
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame: at day 150
at day 150

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Tardieu scale: quality of muscle reaction at slow speed and fast speed
Time Frame: at Inclusion, D1, D60, D120 and D150
at Inclusion, D1, D60, D120 and D150
Angle of apparition of the muscle reaction at slow speed and fast speed
Time Frame: at Inclusion, D1, D60, D120 and D150
at Inclusion, D1, D60, D120 and D150
Spasticity of the triceps surae on the modified Ashworth scale
Time Frame: at Inclusion, D1, D60, D120 and D150
at Inclusion, D1, D60, D120 and D150
Walking speed
Time Frame: at Inclusion, D1, D60, D120 and D150
at Inclusion, D1, D60, D120 and D150
Extent of pain at the injection site by visual analogue scale
Time Frame: at D1, D120
at D1, D120
Duration of tracking and injection
Time Frame: at D1, D120
at D1, D120

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabelle HAURET, University Hospital, Clermont-Ferrand

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHU-0153

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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