Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of Pain Using the Visual Analog Scale
研究概览
简要总结
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is being treated for knee joint pain
- •Subject is willing and able to comply with the evaluation schedule
排除标准
- •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)
研究组 & 干预措施
Exercise Only
Home exercise program.
干预措施: Exercise Only (Other)
Brace Only
Reaction Web brace.
干预措施: Brace Only (Device)
Bracing + Exercises
Reaction Web brace and home exercises.
干预措施: Bracing + Exercises (Other)
结局指标
主要结局
Assessment of Pain Using the Visual Analog Scale
时间窗: Baseline and 3-month Visit
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.
次要结局
- Change in Quadriceps Force(Baseline and 3-month Visit)