Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 100 mm visual analog scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).
详细描述
Tennis elbow (lateral epicondylitis) is a common cause of chronic elbow pain and wrist extensor dysfunction in adults, affecting 1% to 3% of the general population per year.
There is currently no consensus on its optimal treatment with wide-ranging options available. The best available scientific evidence suggests that only topical non-steroidal anti-inflammatory drugs and possibly, oral non-steroidal anti-inflammatory drugs may be useful for short term pain relief, while corticosteroid injections presented both benefits and harms as a short term measure.
Botulinum toxin has been reported in the treatment of lateral epicondylitis with promising results but these studies lack a control group bringing up the question whether recovery was a result of intervention or the natural history of the disease.
Method:
A twin-center, prospective, randomized, double-blind, placebo-controlled trial in which all patients received either a botulinum injection or a placebo saline injection.
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 aged 18 years and up
- •Pain at the lateral side of the elbow
- •Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension
- •Pain for longer than 3 months
排除标准
- •Previous operations (including previous steroid injections for the disorder)
- •Nerve entrapment
- •Pregnancy and while breast-feeding
- •Presence of systemic neuromuscular disorders such as myasthenia gravis
结局指标
主要结局
100 mm visual analog scale (VAS)
次要结局
- Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
