Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis
2016年9月13日 更新者：Linamara Rizzo Battistella, MD PhD、University of Sao Paulo General Hospital
The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.
研究概览
地位
未知
条件
详细说明
This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG).
The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT.
The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.
研究类型
介入性
注册 (预期的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Sao Paulo、巴西、04116-030
- 招聘中
- Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
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接触：
- Fabíola Cavalieri, MD
- 电话号码：55-11-99212-3999
- 邮箱：fabiola.cavalieri@hc.fm.usp.br
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接触：
- Artur C Santos
- 电话号码：55-11-5180-7897
- 邮箱：artur.santos@hc.fm.usp.br
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren & Lawrence I, II or III);
- Capability to understand the Informed Consent Form;
- Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
- Absence of skin injures, infections or tumor in the target knee;
- Availability to comply with the visits.
Exclusion Criteria:
- History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
- History or onset neurological diseases;
- Generalized pain or fibromyalgia;
- Inability to walk;
- History of knee surgery in the target knee;
- Secondary causes of osteoarthritis;
- Use of statins and quinolones in the previous year;
- Uncontrolled and ongoing psychiatric diseases;
- Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Extracorporeal Shock Waves
Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions.
A total of 7000 pulses will be delivered on a weekly session for four weeks.
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Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
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假比较器：Sham Extracorporeal Shock Waves
Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions.
A total of 7000 pulses will be delivered on a weekly session for four weeks.
A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered.
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Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Knee Pain after one month
大体时间：One month
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Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.
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One month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Knee pain progression
大体时间：One week after each of four weekly ESWT applications
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Mean change in VAS score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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Knee Pain after three months
大体时间：Three months
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Mean change in VAS score three months after the end of the treatment compared to baseline.
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Three months
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Lequesne Knee Function progression
大体时间：One week after each of four weekly ESWT applications
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Mean change in Lequesne score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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Lequesne Knee Function after three months
大体时间：Three months
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Mean change in Lequesne three months after the end of the treatment compared to baseline.
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Three months
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WOMAC Knee Function progression
大体时间：One week after each of four weekly ESWT applications
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Mean change in WOMAC score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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TUG Knee Function progression
大体时间：One week after each of four weekly ESWT applications
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Mean change in TUG score one week after each application compared to baseline.
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One week after each of four weekly ESWT applications
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WOMAC Knee Function after three months
大体时间：Three months
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Mean change in WOMAC score three months after the end of the treatment compared to baseline.
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Three months
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TUG Knee Function after three months
大体时间：Three months
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Mean change in TUG score three months after the end of the treatment compared to baseline.
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Three months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Linamara R Battistella, PhD, MD、University of Sao Paulo
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年5月1日
初级完成 (预期的)
2016年10月1日
研究完成 (预期的)
2016年12月1日
研究注册日期
首次提交
2016年6月29日
首先提交符合 QC 标准的
2016年9月13日
首次发布 (估计)
2016年9月19日
研究记录更新
最后更新发布 (估计)
2016年9月19日
上次提交的符合 QC 标准的更新
2016年9月13日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.