Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain on visual analogue scale (VAS 0-10)
研究概览
简要总结
Lateral epicondylitis is a painful overuse condition also described as lateral elbow tendinopathy. As at the Achilles tendon or the patella tendon, lateral elbow tendinopathy has striking clinically and histologically similarities. As such, neovascularisation closely related to pain-mediating fibers are encountered. Eccentric painful exercise is of clinical use in Achilles and patella tendinopathy. We sought to evaluate the clinical effect of a painful eccentric training (supination and pronation) with or without a orthopedic elbow brace in lateral epicondylitis.
详细描述
Two study arms are planned with both groups performed a home-based eccentric training using a Thera-Band Flex-Bar device. Supination and pronation are performed with each position on hold for 2s with 15 repetitions. This is repeated in three sets of 15 repetitions each twice daily. In other words, 6x15 repetitions of supination and pronation per day are suggested in the eccentric training using the Thera-Band Flex-Bar.
The combination group performs the same eccentric training. In addition, patients wear a orthopedic elbow brace (Epi-Hit) in order to overcome the elbow pain.
This is a clinical trial, thus pain reduction on a visual analogue scale is the primary outcome parameter. Evaluation will be performed after 12 weeks of intervention.
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
- None
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
- •lateral elbow tendinopathy
- •18-80 years informed consent
排除标准
- •no elbow tendinopathy <18 or > 80 years no informed consent
结局指标
主要结局
Pain on visual analogue scale (VAS 0-10)
时间窗: 12 weeks
Pain on VAS (0=no pain, 10=worst pain)
次要结局
- Grip strength (JAMAR)(12 weeks)
- Elbow microcirculation(12 weeks)
- DASH Score [0-100](12 weeks)