TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies
试验速览
- 阶段
- 2 期
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]
研究概览
简要总结
Athletic tendinopathies of the upper and lower extremity are often therapeutically challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in painful tendons, which are associated with pain-mediating nerve fibres in such tendinopathies. These neovessels are represented by an increased capillary blood flow at the point of pain. Painful eccentric training reduces pain and improves function in Achilles tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with eccentric training is superior to eccentric training alone (evidence level Ib). Long-term results suggest a collagen induction and reduced pain following topical glyceryl trinitrate (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence level Ib). The role of proprioceptive training in tendinopathy has to be determined in future randomized-controlled trials (evidence level II).
The investigators thought to evaluate the combination of the aforementioned individually successfully therapeutic options in athletes to shorten the recovery period and return to play interval.
详细描述
Interventions:
Combined Power-Doppler-guided sclerosing therapy using Polidocanol (0.5%, 2ml) in 6-8 week intervals combined with extracorporeal focused shockwave therapy (STORZ Duolith 2000impulses 0.25mJ/mm2) every 6-8weeks plus painful daily eccentric training plus daily topical NO
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)
- •patella tendinopathy
- •elbow tendinopathy
- •informed consent
排除标准
- •no informed consent
- •no painful tendons
- •allergy against Polidocanol
- •current treatment with Marcumar
研究组 & 干预措施
Achilles tendinopathy
Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Polidocanol (Drug)
Achilles tendinopathy
Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Focused extracorporeal shock wave therapy (Device)
Achilles tendinopathy
Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Topical NO (Drug)
Achilles tendinopathy
Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Painful eccentric training in Achilles tendinopathy (Behavioral)
Patella tendinopathy
Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Polidocanol (Drug)
Patella tendinopathy
Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Focused extracorporeal shock wave therapy (Device)
Patella tendinopathy
Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Topical NO (Drug)
Patella tendinopathy
Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Painful eccentric training for patella tendinopathy on 25° decline board (Behavioral)
Epikondylitis
Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Polidocanol (Drug)
Epikondylitis
Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Focused extracorporeal shock wave therapy (Device)
Epikondylitis
Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Topical NO (Drug)
Epikondylitis
Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
干预措施: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar (Behavioral)
结局指标
主要结局
Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]
时间窗: up to 4 years
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
Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect]
时间窗: up to 4 years
Score of patient-related outcome measure: Patella tendon: VISA-P \[0=worse, 100=perfect\] derived from eight validated questions on pain and function during daily activities
Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse]
时间窗: up to four years
Score of patient-related outcome measure: Epicondylitis: DASH score \[0=perfect, 100=worse\] derived from 30 validated questions regarding the impairment in activities of daily living
次要结局
- Pain level at rest [VAS 0-10](up to 4 years)
- Pain level at exertion [VAS 0-10](up to 4 years)
- Patient satisfaction on Likert scale [1-6](up to 4 years)