Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
2021年4月6日 更新者：Orthopaedic Research Foundation
The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis.
Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace.
Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.
研究概览
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
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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Indiana
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Greenwood、Indiana、美国、46143
- OrthoIndy
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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
21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:
- Subject is being treated for knee joint pain
- Subject is willing and able to comply with the evaluation schedule
Exclusion Criteria:
- Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures
- Subject has current alcohol, opioid, or other drug dependence
- Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Exercise Only
Home exercise program.
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This group will be given a set of 2 exercises to complete at home.
The exercises are designed to strengthen the quadriceps muscle group.
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有源比较器：Brace Only
Reaction Web brace.
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This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.
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有源比较器：Bracing + Exercises
Reaction Web brace and home exercises.
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This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
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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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Assessment of Pain Using the Visual Analog Scale
大体时间：Baseline and 3-month Visit
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The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends.
Participants will be asked to mark on the line where their pain is in relation to the two extremes.
Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100.
The difference between the baseline score and score at the 3-month study visit was compared between study arms.
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Baseline and 3-month Visit
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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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Change in Quadriceps Force
大体时间：Baseline and 3-month Visit
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Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline.
Averages are stratified by study arm.
Negative values indicate a reduction in quadriceps force from baseline to 3-month.
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Baseline and 3-month Visit
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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：Frank R Kolisek, MD、Study Principal Investigator
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
2015年3月1日
初级完成 (实际的)
2016年12月31日
研究完成 (实际的)
2016年12月31日
研究注册日期
首次提交
2015年3月4日
首先提交符合 QC 标准的
2015年3月9日
首次发布 (估计)
2015年3月17日
研究记录更新
最后更新发布 (实际的)
2021年4月12日
上次提交的符合 QC 标准的更新
2021年4月6日
最后验证
2021年4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.
Exercise Only的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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University of Massachusetts, WorcesterAgency for Healthcare Research and Quality (AHRQ); Omnicare Clinical Research; Qualidigm完全的