NCT00437762已完成3 期
Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo
University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2007年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Principal criteria of assessment is pain intensity three months after injection.
研究概览
简要总结
Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
详细描述
- Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
- Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
- Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
- Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
- Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
- Study plan: randomized parallel groups
- Number of subjects : 60
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tennis elbow during more than 6 months
- •Signature of consent
排除标准
- •Less than 18 years old
- •Osteoarthritis elbow
- •Referred cervical pain
- •Fibromyalgia
- •Pregnancy
- •Myasthenia
- •Polymyositis
- •Anticoagulant treatment
- •Aminosides
- •Alcoholism
- •Previous botulinum toxin A injections
研究组 & 干预措施
2
Placebo Comparator
Placebo injection
干预措施: Placebo injection (Drug)
1
Experimental
Botulinum Toxin A Injection
干预措施: Botulinum Toxin A Injection (Drug)
结局指标
主要结局
Principal criteria of assessment is pain intensity three months after injection.
时间窗: at 3 month
次要结局
- Number of painful days(to day 30, 90,180, 365)
- Number of associated treatments.(to day 30, 90,180, 365)
- Rate of recidivism after initial relief(to day 30, 90,180, 365)
- pain intensity(to day 30, 90,180, 365)
- Free pain grip strength(to day 30, 90,180, 365)
研究者
研究点 (2)
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