Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change of pain assessed on the visual analogue scale
研究概览
简要总结
The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.
详细描述
Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups:
- Botox-Epic group received 20 units of Botox injection into lateral epicondyle;
- Botox-Tend group had 20 units of Botox injected into tender point of muscles;
- Steroid group had 40mg of triamcinolone injected into lateral epicondyle.
The aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications,
- •local tenderness around the lateral epicondyle, and
- •pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors.
排除标准
- •local steroid injection within the past six months,
- •coexisting elbow arthritis or arthralgia,
- •previous trauma or surgery history over the lateral epicondyle,
- •pregnancy or lactation, and
- •other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.
研究组 & 干预措施
Botox-Epic group
20 units of Botox injection into lateral epicondyle in Botox-Epic group
干预措施: Botox-Epic (Drug)
Botox-Tend group
20 units of Botox injected into tender point of muscles in Botox-Tend group
干预措施: Botox-Tend (Drug)
Steroid group
40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group
干预措施: triamcinolone acetonide (Steroid) (Drug)
结局指标
主要结局
Change of pain assessed on the visual analogue scale
时间窗: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
次要结局
- Change of grip strength by dynamometer(baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
- Change of self-assessment by Patient-Rated Tennis Elbow Evaluation(baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks)
研究者
Yu-Ching Lin
Visiting Physician
National Cheng-Kung University Hospital