NCT00246155已完成3 期
A Prospective Study to Evaluate the Potential Effects on Function and Size in Back Muscle After Injection of Botulinum Toxin Type A (Dysport®) in the Treatment of Chronic Low Back Pain
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain reduction as assessed by the mean Visual Analogue Scale (VAS) during last 2 weeks. Assessments will be made at the initial time before injection and 1, 2, 3 months after injection.
研究概览
简要总结
The purpose of this study is to analyse the changes in back muscle size and strength following use of Dysport®, and to establish whether there is any association between pain reduction and change in strength, in patients suffering from chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from muscular low back pain (between L-1 and S-1 level).
- •Symptoms of more than six months duration.
- •No benefit from previous treatments.
- •Patient must present with bilaterally more than 2 active trigger points (TrPs) in the region of the low back musculature.
- •CT scan or MRI examination of the lumbar spine was performed within the past year.
- •Absence of significant pathology, such as bone fracture, nerve damage or severe psychiatric condition.
排除标准
- •Constant or persistent severe pain due to nerve root compression or fibromyalgia.
- •The patient has received surgery on the spine.
- •Other musculoskeletal disabilities e.g. myasthenia gravis, or disorders of the neuromuscular junction.
- •Any serious pathology, such as cancer, systemic inflammatory disease, vertebral fractures, neurological signs, spinal infection.
- •Epidural injection of local anaesthetics and steroids within 12 weeks proceeding inclusion.
- •Trigger point injection of local anaesthetics and steroid within 8 weeks proceeding inclusion.
- •Pain associated with urinary tract infections, or gynaecological disorders.
- •Bleeding disturbances or currently using coumarin derivatives.
结局指标
主要结局
Pain reduction as assessed by the mean Visual Analogue Scale (VAS) during last 2 weeks. Assessments will be made at the initial time before injection and 1, 2, 3 months after injection.
Improvement in daily life activities and quality of life using the Oswestry Low Back Pain Questionnaire (OLBPQ), and Short Form-36 (SF-36). Assessments will be made at the initial time before injection and 1, 2, 3 months after injection.
次要结局
- Change of the lumbar extensor muscular size in CT Measurement will be performed at baseline and 3 months after injection.
- Changes of the total isometric lumbar extensor strength and separated angle using lumbar MedX machine.
- Association between pain reduction and strength. Measurements will be performed at baseline, and 1, 2, 3 months after injection.
研究者
研究点 (2)
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