NCT00134810已完成2 期
A Phase II Multicentre Multinational Prospective Randomised Double-blind Placebo-controlled Study Assessing the Efficacy and Safety of a Single Application of Three Doses of Dysport® in Patients With Upper Back Myofascial Pain Syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 381
- 试验地点
- 44
- 主要终点
- Change in pain score for 'overall pain of the day during activity' between baseline and Week 6
研究概览
简要总结
The main purpose of this study is to determine which is the best dose of a drug known as Dysport to give when treating one's type of upper back pain. The study will also examine the side effects of this treatment and its overall effect on one's disorder.
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
- •Moderate-severe pain in upper back
- •Myofascial pain syndrome for more than 6 months
- •Active trigger points in upper back
排除标准
- •Fibromyalgia and other non-myofascial pain conditions of upper back
- •Duration of myofascial pain syndrome no longer than 24 months
- •Steroid injections during previous 3 months
- •Anaesthetic injection at trigger points during previous 1 month
结局指标
主要结局
Change in pain score for 'overall pain of the day during activity' between baseline and Week 6
次要结局
- Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16
- Change in pain score for 'overall pain of the day at rest' between baseline and Week 6
- Change in each of the 8 dimensions of the Short Form Quality of Life questionnaire with 36 items (SF36) at Weeks 6, 12 and 16 from baseline
- Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline
- Time to onset of pain relief
- Patient's Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16
- Change in pain score for 'worst pain of the day during activity' between baseline and Week 6
- Spontaneously reported adverse events and changes in physical examination and vital signs
- Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16
研究者
研究点 (44)
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