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

NCT01935544 | Completed

• 1 other identifier: CHU-0153
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Botulinum Toxin; Ultrasound-guidance; Stroke; Spasticity; Ultrasonography; Hemiplegia

Outcome Measures

Primary Outcomes (5)

• Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight

  at inclusion

• Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight

  at day 1 (first injection)

• Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight

  at day 60

• Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight

  at day 120 (second injection)

• Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight

  at day 150

Secondary Outcomes (6)

• Tardieu scale: quality of muscle reaction at slow speed and fast speed

  at Inclusion, D1, D60, D120 and D150

• Angle of apparition of the muscle reaction at slow speed and fast speed

  at Inclusion, D1, D60, D120 and D150

• Spasticity of the triceps surae on the modified Ashworth scale

  at Inclusion, D1, D60, D120 and D150

• Walking speed

  at Inclusion, D1, D60, D120 and D150

• Extent of pain at the injection site by visual analogue scale

  at D1, D120

Study Arms (2)

botulinum toxin injections

EXPERIMENTAL

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

OTHER

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

Device: Botulinum toxin injection

Interventions

Botulinum toxin injection DEVICE

botulinum toxin injections; ultrasound guidance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 27852706 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Isabelle HAURET

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: September 5, 2013
• Study Start: November 19, 2013
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

FR (1)