Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain during physical activity which usually causes pain
研究概览
简要总结
Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.
详细描述
48 patients with chronic achilles tendinopathy for more than 3 months who have tried excentric exercises without success will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18 year old, Ultrasound verified Achilles tendinopathy with neo-vascularisation, pain duration more than three months, excentric exercises for at least three months, women: negative pregnancy test, safe anticonceptive
排除标准
- •Dementia, mental disease or other illness incompatible with participation, no ultrasound verified neo-vascularisation, any illness which contraindicate the use of Polidocanol or Lidocaine, granulation tissue of more than 50 % of the Achilles tendon, ability of lying in prone position, women: pregnancy or breastfeeding,
研究组 & 干预措施
2 drug
injections of lidocaine
干预措施: Aethoxysclerol (Drug)
1, drug
Injections of polidocanol
干预措施: Aethoxysclerol (Drug)
结局指标
主要结局
Pain during physical activity which usually causes pain
时间窗: 3 and 6 months
次要结局
- Patient evaluation of treatment efficacy(3 and 6 months)
- AOFAS(3 and 6 months)
- Number of neo-vascularisation.(day 0, 1 and 3 months)
- Achilles tendon pressure measuring until pain release.(3 and 6 months)
- FAOS(3 and 6 months)
- Pain while resting.(3 and 6 months)
- Localisation of the neo-vascularisation(day 0, 1 and 3 months)