The Value of Platelet-Rich Plasma in Chronic Midportion Achilles Tendinopathy: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- VISA-A Score
研究概览
简要总结
The study will be a double-blind randomized single-center clinical trial comparing 3 treatment groups with chronic midportion Achilles tendinopathy.
详细描述
Introduction- Overuse injury of the Achilles tendon is a common entity in athletes and older athletes are at an increased risk. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment.
Recent studies described new treatment strategies in tendinopathies, such as the use of platelet-rich plasma (PRP). Platelets can participate actively in tissue repair processes and stimulate the release of several growth factors. Recently, it was found that platelet-rich plasma clot releasate stimulates cell proliferation, collagen deposition, and enhances the gene expression of matrix degrading enzymes and endogenous growth factors by human tendon cells in vitro. The only published clinical cohort study in tendon research reported 93% reduction of pain for PRP-treated patients with chronic elbow tendinosis. Also on short term follow-up, the PRP injection was more beneficial than injection with an anaesthetic agent.
Aim- To monitor the potential clinical improvement of chronic midportion Achilles tendinopathy after injection with PRP and to evaluate the recovery process in time using a new Ultrasonographic method (Ultrasonographic Tissue Characterisation).
Hypothesis: The average VISA-A score is higher in the patient group treated with eccentric exercise therapy in combination with a PRP injection in comparison with the group treated with a saline injection in combination with eccentric exercises.
Study population- In total, 54 patients with symptomatic Achilles tendinopathy will be included in the study.
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
- Double (Participant, Outcomes Assessor)
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
- •Clinical diagnosis "chronic midportion Achilles tendinopathy"
- •Age 18-70 years
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 palpabel "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 (visible luxation of the mm. Peroneï spot in combination with localized pain)
- •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
1
Combination of eccentric exercises and injection of PRP
干预措施: PRP Injection with eccentric exercises (Biological)
2
Combination of eccentric exercises and physiological saline injection
干预措施: Placebo Injection with eccentric exercises (Biological)
结局指标
主要结局
VISA-A Score
时间窗: 6, 12, 24 and 52 weeks
次要结局
- Power doppler sound(6, 12, 24 and 52 weeks)
- Complications(Anytime)
- Patient satisfaction(6, 12, 24 and 52 weeks)
- Return to sport(6, 12, 24 and 52 weeks)
- Ultrasonographic Tissue Characterization(6,12, 24 and 52 weeks)