A Comparison of Endoscopic Surgery and Conservative Treatment in Patients With Longstanding Mid-portion Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
研究概览
简要总结
Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite this, as many as 44 % of achilles tendinopathy patients do not respond to exercise treatment.
Surgery for midportion achilles tendinopathy has for many years been done as an open procedure. New knowledge resulted in a variety of minimally invasive procedures and the development of endoscopic surgery.
In this study, the effect of non-open surgery and conservative treatment (physiotherapy and exercises) will be compared.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of mid-portion achilles tendinopathy
- •pain during at least 3 months
- •decreased function (a score less than 80 on VISA-A)
排除标准
- •Physiotherapy during previous three months
- •history of major achilles trauma
- •cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance
研究组 & 干预措施
Endoscopic surgery
Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
干预措施: endoscopic surgery (Procedure)
Endoscopic surgery
Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
干预措施: physiotherapy and exercise (Behavioral)
Conservative treatment
Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.
干预措施: physiotherapy and exercise (Behavioral)
结局指标
主要结局
pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
时间窗: 6 months after 12 week exercising
pain using The Victorian Institute of Sports Assessment - Achilles
时间窗: 3 months (immediately following 12 week exercising)
次要结局
- Time-to-exhaustion(6 months after 12 week exercising)
- Hospital Anxiety and Depression Scale (HAD)(6 months after 12 week exercising)
- pain using a numeric rating scale (NRS)(6 months after 12 week exercising)
- Patient-clinician therapeutic relationship(6 months after 12 week exercising)
- Tampa Scale of Kinesiophobia [TSK](6 months after 12 week exercising)
- Maximal strength (one repetition maximum, 1RM)(6 months after 12 week exercising)
- Physical activity level(6 months follow-up after rehabilitation)
- Hospital Anxiety and Depression Scale (HAD)(3 months (immediately following 12 week exercising))
- Tampa Scale of Kinesiophobia [TSK](3 months (immediately following 12 week exercising))
- pain using a numeric rating scale (NRS)(3 months (immediately following 12 week exercising)
- Patient-clinician therapeutic relationship(3 months (immediately following 12 week exercising))
- Maximal strength (one repetition maximum, 1RM)(3 months (immediately following 12 week exercising))
- Time-to-exhaustion(3 months (immediately following 12 week exercising))