Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Cervical Dystonia Impact Profile 58 (CDIP-58)
研究概览
简要总结
Botulinum toxin injections are the treatment of choice for cervical dystonia. Even if this treatment is successful for most of the patients, partials or completes failures still remained.
Usually, botulinum toxin injections are realized by clinical localization techniques (observation and palpation of target muscles). The use of Ultrasonography to guide injections of Botulinum toxin has theoretical benefits (as an improved precision, an improved reproducibility, the targeting of deep-seated muscles, and a lower risk of adverse events) but its interest has never been demonstrated.
详细描述
Open label non-randomised controlled clinical trial comparing clinical localization techniques and ultrasonography to guide injections of Botulinum toxin A.
The primary outcome is to compare both techniques of injection regarding to the health impact of cervical dystonia (CDIP-58) measured 1 month after injection.
The results of this clinical trial will help the clinician to decide which strategy of injection is the most effective in terms of benefit/risk ratio to treat the cervical dystonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years old
- •Focal idiopathic cervical dystonia treated by injections of Botulinum toxin type A (onabotulinumtoxinA, Botox® ; abobotulinumtoxinA, Dysport® ; or incobotulinumtoxinA, Xeomin®).
- •Patient who have previously received at least 3 cycles of botulinum toxin A injections in this specific indication
- •Injections realized with clinical targeting exclusively or ultrasonography targeting exclusively
- •Patient who is not opposed to its participation in this study
- •Patient affiliated to the Sécurité Sociale
- •Patient able to comply with study procedures and study duration
排除标准
- •Woman pregnant, woman of childbearing age not taking effective contraception or breastfeeding
- •Contraindication of botulinum toxin injections as :
- •Hypersensivity to the botulinum toxin A or to an excipient of the commercialized treatment (onabotulinumtoxinA, Botox® ; abobotulinumtoxinA, Dysport® ; incobotulinumtoxinA, Xeomin®)
- •Generalized muscular activity disorder (Myasthenia gravis, Lambert-Eaton syndrome)
- •Infection or inflammation of the injection site
- •Concomitant treatment that can interact with botulinum toxin A or modify the function of the neuromuscular synapse junction (anticholinergics, curare and other myorelaxing agents, Aminoglycosides, amino-4-quinolines)
- •Documented resistance to the botulinum toxin A
- •Inability to receive the information, inability to participate to the all study duration, refusal to sign the consent
- •EMG-guided botulinum toxin injections
结局指标
主要结局
Cervical Dystonia Impact Profile 58 (CDIP-58)
时间窗: 1 month after inclusion
Variation of the total score obtained with The Cervical Dystonia Impact Profile
次要结局
- Placement of the injecting needle(the day of the inclusion)
- TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale(1 month after inclusion)
- GCI-I (Clinical Global Impressions - Improvement) patient scale(1 month after inclusion)
- TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only(1 month after inclusion)
- Rate of Adverse Events(1 month after inclusion)