The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Victorian Institute of Sport Assessment - Achilles (VISA-A)
研究概览
简要总结
this study evaluates the addition of initial short term NSAID treatment to physiotherapy prescribed exercise treatment in patient with early phase tendinopathy. Half of the participants will initially receive NSAID (naproxen) for 7 days, while the other half will receive a placebo, where after both groups will be subjected to 3 months heavy slow resistance training.
详细描述
NSAID is effective in short term pain relief in musculoskeletal disorders, but little is known about the long-term effect in early phase tendinopathy, when used as a supplement to treatment as usual, namely heavy slow resistance training and training load reduction. In this study, NSAIDs will be used, which works through COX inhibition, which again inhibits Prostaglandins, in this way investigators attempt to dampen the initial inflammation and pronounced cell activity that is thought to be present in early phase tendinopathy. With this project, it will be attempted to investigate whether initial dampening adds to the effect achieved through heavy load resistance training, which is thought to stimulate structural repair and regeneration in the tendon, by applying appropriate load to the tendon tissue, thereby stimulating the tendon cells to repair and regeneration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Activity related pain in the achilles tendon
- •Palpation pain in the achilles tendon
- •Onset of symptoms within the last 3 months
排除标准
- •Previous injury in the achilles tendon on the ipsilateral side.
- •Recent infection around the achilles tendon
- •Previous surgery in the achilles tendon.
- •Contraindications for NSAID treatment.
- •NSAID treatment for the current injury
- •Medication with NSAID interaction
研究组 & 干预措施
Naproxen & Heavy resistance training
Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
干预措施: Naproxen 500 Mg (Drug)
Naproxen & Heavy resistance training
Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
干预措施: Heavy resistance training (Other)
Placebo & Heavy resistance training
Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
干预措施: Placebo Oral Tablet (Drug)
Placebo & Heavy resistance training
Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
干预措施: Heavy resistance training (Other)
结局指标
主要结局
Victorian Institute of Sport Assessment - Achilles (VISA-A)
时间窗: 0-3 months
Standardised score of functional capability, in patient with achilles tendinopathy. Total score will be reported; scale (0-100). 100=full functional capacity 0=poor functional capacity.
次要结局
- Height(0-3 months)
- Magnetic Resonance Imaging (MRI) - scannings(0-3 months)
- Ultrasonography -Power doppler(0-1 week; 0-3 months)
- Ultrasonography - Greyscale(0-1 week; 0-3 months)
- Questionnaires - activity (time consumption)(0-1 week; 0-3 months; 0-12 months)
- Questionnaires - activity (number of sessions)(0-1 week; 0-3 months; 0-12 months)
- Questionnaires - activity (intensity)(0-1 week; 0-3 months; 0-12 months)
- Questionnaires - Numerical Rating Scale (NRS) - Pain(0-1 week; 0-3 months; 0-12 months)
- Victorian Institute of Sport Assessment - Achilles (VISA-A)(0-1 week; 0-12 months)
- Weight(0-3 months)
研究者
Nikolaj Mølkjær Malmgaard-Clausen
Medical Doctor
Bispebjerg Hospital