Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- In a controlled double blind and randomized study, we want to show that intramuscular injections of botulinum toxin are beneficial to reduced dystonia and associated pain in patient with foot dystonia (compared to placebo injections).
研究概览
简要总结
Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is characterized by an abnormal involuntary movement which is very uncomfortable (difficult to walk) and painful for the patient.
Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum longus, different doses used, heterogeneous population with many types of dystonia included, open studies).
详细描述
Study progress :
After an inclusion visit, patients are randomized in one of the 3 following groups :
-
First group (PL : placebo) :
-
J0 : Patient will receive 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
-
J+1month : First evaluation
-
J+3 months : Patient will receive again 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
-
J+4 months : Last evaluation
-
Second group (ME : Extrinsic muscle)
-
J0 : Patient will receive 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
-
J+1 month : First evaluation
-
J+3 months : Patient will receive again 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
-
J+4 months : Last evaluation
-
Third group (MI : Intrinsic muscle)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 30-75 years
- •Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank"
- •Patient with unilateral tiptoe dystonia. Dystonia must be present more than 1h /day and induce difficulties to walk (severity index ≥ 3 (1 : light, 2 : moderate, 3 : severe, 4 : very severe)).
- •Patients never treated with botulinum toxin or already treated for more than 6 months.
- •Affiliation to social security
- •Agreement of patients
排除标准
- •Patients suffering of an atypical Parkinson syndrome
- •Patient with a bilateral tiptoe dystonia
- •Patients with contraindication to the botulinum toxin use
- •Women without efficient contraception
- •Person who participate to an other study
结局指标
主要结局
In a controlled double blind and randomized study, we want to show that intramuscular injections of botulinum toxin are beneficial to reduced dystonia and associated pain in patient with foot dystonia (compared to placebo injections).
时间窗: one month after the injection of botulinum toxin/placebo
次要结局
- Efficiency comparison of injections made in leg muscle (Flexor digitorum longus) between injections made directly in foot muscle (Flexor digitorum brevis or quadratus plantae) - Effects of injections on pain and quality of life.(one month after injections of placebo or Botulinum toxin)