The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change of Ankle Dorsiflexion Range of Motion
研究概览
简要总结
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the first week, there will be a clinical examination by a physiotherapist, an ultrasonographic examination, and the patient will complete a VISA-A questionnaire. At the end of the examination, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
详细描述
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the initial session, there will be a clinical examination by a physiotherapist, which includes case history questions, measuring range of motion (measured by weight-bearing lunge test), functional loading tests (1-leg heel rise test, 1-leg hop test) and an ultrasonographic examination (tendon cross section area and width at the maximal tendon antero-posterior width place). In addition, the patient will complete a VISA-A questionnaire. At the end of the initial session, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
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
- Single (Participant)
盲法说明
Participants don't know which group (either treatment or placebo) they are in.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patient complains about Achilles tendon pain, which limits (at least partially) his quality of life during daily activities or sport, and this condition would be referred as a tendinopathy
- •the patient's other leg is asymptomatic
- •the patient is not aware of the symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
- •the patient has no previous experience with extracorporeal shockwave therapy treatment
排除标准
- •the patient has condition which is contraindication for extracorporeal shock wave therapy treatment
- •the patient had symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
结局指标
主要结局
Change of Ankle Dorsiflexion Range of Motion
时间窗: Change of initial values at 3 weeks follow up after last application (8th week).
Measured using weight-bearing lunge test in cm.
Change in Maximum Pain in the Achilles Tendon Area
时间窗: Change in maximum pain in the timeframe of the last application (5th week)
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Change in Maximum Pain in the Achilles Tendon Area (Follow up)
时间窗: Change in maximum pain at 3 weeks follow up after last application (8th week).
Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Change in Cross-sectional Area at the Place of Maximum Tendon Width
时间窗: Change of initial values at 3 weeks follow up after last application (8th week).
Measured by measuring tools in ultrasound machine in cm2. In linear view is selected maximal width place, then the position of ultrasound head is rotated to horizontal view and in this view cross section area is measured.
次要结局
- Number of Participants With Hypoechogenic Areas(Change of the echostructure at 3 weeks follow up after last application (8th week).)
- Number of Participants With Increased Thickness of Achilles Tendon(Change of the tendon continuity at 3 weeks follow up after last application (8th week).)
- Change in VISA-A Questionnaire Score(Change of initial values at 3 weeks follow up after last application (8th week).)
- Change in Single Leg Heel Rise Test(Change of initial values at 3 weeks follow up after last application (8th week))
- Change in Single Leg Hop Test(Change of initial values at 3 weeks follow up after last application (8th week).)
研究者
Stanislav Machač, Ph.D
Academic worker
Charles University, Czech Republic