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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01935544
First received: May 6, 2013
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Stroke
Device: Botulinum toxin injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight [ Time Frame: at day 1 (first injection) ] [ Designated as safety issue: No ]
  • Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight [ Time Frame: at day 60 ] [ Designated as safety issue: No ]
  • Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight [ Time Frame: at day 120 (second injection) ] [ Designated as safety issue: No ]
  • Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight [ Time Frame: at day 150 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tardieu scale: quality of muscle reaction at slow speed and fast speed [ Time Frame: at Inclusion, D1, D60, D120 and D150 ] [ Designated as safety issue: Yes ]
  • Angle of apparition of the muscle reaction at slow speed and fast speed [ Time Frame: at Inclusion, D1, D60, D120 and D150 ] [ Designated as safety issue: Yes ]
  • Spasticity of the triceps surae on the modified Ashworth scale [ Time Frame: at Inclusion, D1, D60, D120 and D150 ] [ Designated as safety issue: Yes ]
  • Walking speed [ Time Frame: at Inclusion, D1, D60, D120 and D150 ] [ Designated as safety issue: Yes ]
  • Extent of pain at the injection site by visual analogue scale [ Time Frame: at D1, D120 ] [ Designated as safety issue: Yes ]
  • Duration of tracking and injection [ Time Frame: at D1, D120 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
ultrasound guidance
The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance
Device: Botulinum toxin injection

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935544

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Isabelle HAURET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01935544     History of Changes
Other Study ID Numbers: CHU-0153
Study First Received: May 6, 2013
Last Updated: September 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Botulinum Toxin
Ultrasound-guidance
Stroke
Spasticity
Ultrasonography
Hemiplegia

Additional relevant MeSH terms:
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014