A Prospective Randomized Study Comparing the Therapeutic Effect of Tendoactive®, Eccentric Training, and a Combination of Both as a Treatment of Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change from Baseline in VISA-A score at 12 weeks
研究概览
简要总结
The purpose of this study is to determine whether Tendoactive, eccentric training, or the combination or both could be effective in the treatment of Achilles tendinopathy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from a gradually evolving painful condition in the Achilles tendon located at the midportion for at least 3 months (Diagnosis based on clinical examination showing a painful thickening of the Achilles tendon located at a level of 2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation).
- •Men and non-pregnant women aged 18-70 years
- •Be informed of the nature of the study and provide written informed consent.
排除标准
- •Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
- •Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
- •Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
- •Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
- •Clinical suspicion of peroneal subluxation
- •Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
- •Condition that prevents the patients from executing an active exercise programme
- •Patient has already performed eccentric exercises, according to the schedule of Alfredson et al (12 weeks)
- •Patient has already received an injection of PRP for this injury
- •Patient does not wish, for whatever reason, to undergo one of the two treatments
- •Known presence of a pregnancy
- •Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins
研究组 & 干预措施
Tendoactive and eccentric training
Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
干预措施: Tendoactive (Drug)
Tendoactive and eccentric training
Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
干预措施: Eccentric training (Behavioral)
Tendoactive
Tendoactive dosage: 3 capsules per day
干预措施: Tendoactive (Drug)
Eccentric training
Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
干预措施: Eccentric training (Behavioral)
结局指标
主要结局
Change from Baseline in VISA-A score at 12 weeks
时间窗: 12 weeks
Functional impairment of the Achilles tendon is measured using VISA-A score. Score of patient-related outcome measure: Achilles tendon: VISA-A \[0=worse, 100=perfect\] derived from eight validated questions on pain and function during activities of daily living
次要结局
- Pain level at rest [VAS 0-10](0, 6, 12 weeks)
- Pain level at exertion [VAS 0-10](0, 6, 12weeks)
- Achilles transverse thickness by ultrasound(0, 6, 12 weeks)
- SF-36 v2 quality of life survey(0, 12 weeks)
- Patient satisfaction(6, 12 weeks)