Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as Treatment for Achilles Enthesopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
研究概览
简要总结
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
详细描述
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Symptoms are pain and swelling at the calcaneal insertion of the achilles tendon during and after exercise. Achilles entesopathy has not been thoroughly investigated and consequently, very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
It is hypothesized that treatment that includes corticosteroid injection is more effective than treatment that includes injection with local anaesthesia.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Corticosteroid injections + resistance training
Corticosteroid injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months
干预措施: Corticosteroid injection (Drug)
Local anesthesia injections + resistance training
Local anesthesia injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months
干预措施: Local anesthesia injections (Drug)
结局指标
主要结局
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
时间窗: 6 months
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome
次要结局
- Evaluation of treatment effect measured on a Likert scale.(1, 2, 3, 6, 9 and 12 months)
- Ultrasonographic measurement of achilles tendon thickness(1, 2, 3, 6, 9 and 12 months)
- Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)(3, 9 and 12 months)
- Patient self reported activity level in percentage of the pre-injury activity level(3, 6 and 12 months)
- Ultrasonographic measurement of achilles tendon doppler activity(1, 2, 3, 6, 9 and 12 months)
研究者
Simon Doessing, M.D., PhD
Senior Surgeon
Bispebjerg Hospital