Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Botulinum toxin injection
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Botulinum Toxin, Ultrasound-guidance, Stroke, Spasticity, Ultrasonography, Hemiplegia
Eligibility Criteria
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.
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
botulinum toxin injections
ultrasound guidance
Arm Description
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
Outcomes
Primary Outcome Measures
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Secondary Outcome Measures
Tardieu scale: quality of muscle reaction at slow speed and fast speed
Angle of apparition of the muscle reaction at slow speed and fast speed
Spasticity of the triceps surae on the modified Ashworth scale
Walking speed
Extent of pain at the injection site by visual analogue scale
Duration of tracking and injection
Full Information
NCT ID
NCT01935544
First Posted
May 6, 2013
Last Updated
October 8, 2019
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT01935544
Brief Title
Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
Official Title
Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 19, 2013 (Actual)
Primary Completion Date
February 12, 2019 (Actual)
Study Completion Date
February 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Botulinum Toxin, Ultrasound-guidance, Stroke, Spasticity, Ultrasonography, Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin injections
Arm Type
Experimental
Arm Description
The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.
Arm Title
ultrasound guidance
Arm Type
Other
Arm Description
The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance
Intervention Type
Device
Intervention Name(s)
Botulinum toxin injection
Primary Outcome Measure Information:
Title
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame
at inclusion
Title
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame
at day 1 (first injection)
Title
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame
at day 60
Title
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame
at day 120 (second injection)
Title
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame
at day 150
Secondary Outcome Measure Information:
Title
Tardieu scale: quality of muscle reaction at slow speed and fast speed
Time Frame
at Inclusion, D1, D60, D120 and D150
Title
Angle of apparition of the muscle reaction at slow speed and fast speed
Time Frame
at Inclusion, D1, D60, D120 and D150
Title
Spasticity of the triceps surae on the modified Ashworth scale
Time Frame
at Inclusion, D1, D60, D120 and D150
Title
Walking speed
Time Frame
at Inclusion, D1, D60, D120 and D150
Title
Extent of pain at the injection site by visual analogue scale
Time Frame
at D1, D120
Title
Duration of tracking and injection
Time Frame
at D1, D120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle HAURET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27852706
Citation
Morel C, Hauret I, Andant N, Bonnin A, Pereira B, Coudeyre E. Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke. BMJ Open. 2016 Nov 15;6(11):e011751. doi: 10.1136/bmjopen-2016-011751.
Results Reference
derived
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Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
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