NCT00149240已完成2 期
A Phase II, Multicentre, Randomised, Double-blind, Parallel and Controlled With Placebo Pilot Study to Evaluate the Efficacy and Safety of a Single Dose of Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment, in Patients With Primary Myofascial Syndrome of Cervical and Dorsal Localisation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.
研究概览
简要总结
The main purpose of this study is to determine the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in patients with a type of back pain called primary myofascial pain syndrome.
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
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
- •Patients with primary myofascial pain syndrome of cervical and dorsal localization, less than two years of length, who must have been diagnosed with the evidence of "trigger points" in which conventional treatment with oral analgesia, rehabilitation and local anesthesia has not been clinically successful for more than 15 days.
- •Punctuation of 4cm or more in a 10cm visual analog scale.
- •Previous positive response (self-limited reduction -less than 15 days- of pain) after an anaesthetic infiltration in the trigger point.
排除标准
- •Patients diagnosed with fibromyalgia or with a spread pain.
- •Patients having received previously botulinum toxin.
- •Patients having received anesthetic injections at the trigger points within the month before the visit.
- •Patients having received corticosteroids injections at the trigger points within three months before the selection visit.
结局指标
主要结局
Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.
The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study:
Pain evaluated by the patient through a visual analog scale.
Evaluation of the Clinical Global Impressions of Change by the Investigator and by the patient.
Usual analgesic intake modification (on a daily basis by filling out a Patient's diary).
次要结局
未报告次要终点
研究者
研究点 (8)
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