NCT00246142已完成3 期
A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.
研究概览
简要总结
The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic neck and shoulder pain for at least 6 months, refractory with other conservative treatments
- •Presents at baseline with pain score greater than 50mm on 100mm length VAS. Pain score will be measured as overall pain over the 7 days preceding the visit during activities
- •Active trigger point (TrP) defined as a tender spot localised in a taut band of muscle fibres associated with tenderness AND referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation AND preferably local twitch response at palpation AND/OR jump sign at palpation
排除标准
- •Disc/bone disease
- •History of surgery on neck
- •Neurological deficits, neuromuscular junction disorder, Motor Neuron disease
- •Patient has received anesthetic injections to the target trigger point within 4 weeks of study enrolment, or corticosteroid injections within 3 months
- •Systemic inflammatory disease
- •Hypersensitivity to Dysport®
- •Diffuse tender points, or diagnosed with fibromyalgia
- •Previous electrical stimulation
- •Previous injection of Dysport® within 6 months of study enrolment
结局指标
主要结局
Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.
时间窗: Before Dysport® injection and at 16 weeks after injection
Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed.
时间窗: Comparison of VAS will be performed before Dysport® injection and at 16 weeks after injection
次要结局
- Pain threshold measured by pressure algometer.(At each visit)
- Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.(At each visit)
研究者
研究点 (2)
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