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临床试验/NCT00119704
NCT00119704已完成3 期

Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2002年9月最近更新:
适应症
相关药物

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

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.

研究者

申办方类型
Other

研究点 (2)

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