Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
botulinum toxin injections
The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.
干预措施: Botulinum toxin injection (Device)
ultrasound guidance
The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance
干预措施: Botulinum toxin injection (Device)
结局指标
主要结局
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
时间窗: at day 150
次要结局
- Duration of tracking and injection(at D1, D120)
- Angle of apparition of the muscle reaction at slow speed and fast speed(at Inclusion, D1, D60, D120 and D150)
- Tardieu scale: quality of muscle reaction at slow speed and fast speed(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)
- Spasticity of the triceps surae on the modified Ashworth scale(at Inclusion, D1, D60, D120 and D150)