Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tendon structure
研究概览
简要总结
The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.
详细描述
Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic patellar tendinopathy (> 3 months)
- •anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
- •hypo-echoic area with enhanced vascularization
排除标准
- •corticosteroid injection within the last 12 months
- •Knee operation
- •Knee osteoarthritis
- •Body mass index >30
研究组 & 干预措施
Insulin-like growth factor I
3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention
干预措施: Insulin-like growth factor I (Drug)
Placebo injections
3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period
干预措施: Placebo (Drug)
结局指标
主要结局
Tendon structure
时间窗: After 12 weeks intervention (tendon biopsy)
次要结局
- Tendon Pain(1 year (before and after 12 weeks intervention and 1 year after intervention start))
研究者
Mette Hansen
Associated Professor, PhD
Bispebjerg Hospital