Effect of Unloader Knee Brace and Biomechanical Footwear Device on Symptoms and Physical Function in Knee Osteoarthritis Patients - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline Pain intensity at 4 months: VAS
研究概览
简要总结
This study investigates the effects of unloader knee brace, biomechanical footwear device and exercise therapy on pain, physical function and quality of life in patients with knee osteoarthritis. The aim is to find more effective treatment strategies to delay or prevent heavy knee replacement surgeries.
详细描述
The aim of this study is to investigate the effects of exercising, and using a knee brace and exercising, and using of biomechanical footwear device on clinically important symptoms, physical function and quality of life in patients with osteoarthritis of the knee. The hypothesis is that the groups of using knee brace and biomechanical footwear can alleviate pain, improve physical function and quality of life more efficiently, than the group doing home exercises only.
The subjects (n = 120) will be randomized into three groups mentioned above, after which they will start to do exercises, or to use a knee brace and do exercises, or to use biomechanical footwear at home according to the instructions for 4 months. Physical function, symptoms and quality of life will be measured before and after 4-month intervention. In addition, at 12-month time point follow-up surveys will be addressed with regard to symptoms and quality of life, as well as to cost-effectiveness of the study.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate or severe knee pain (>40mm on a VAS scale 0-100mm)
- •radiographic knee osteoarthritis (Kellgren-Lawrence grades 1-3)
- •age between 45 and 70 years
排除标准
- •inflammatory joint disease
- •acute (<6 months) knee trauma
- •arthroscopic surgery in the past six months
- •a planned knee replacement surgery or other planned surgical treatment of the knee
- •knee injections in the past 3 months
- •superficial wounds at the knee area
- •arterial insufficiency
- •severe varicosities
- •impaired vision
- •postural difficulties
- •body-mass index (BMI) >35kg/m2
- •fibromyalgia
- •rheumatoid arthritis or other active rheumatoid inflammatory disease.
结局指标
主要结局
Change from baseline Pain intensity at 4 months: VAS
时间窗: 4 months
Visual Analog Scale for Pain (score of 100 mm). No pain (score of 0), worst imaginable pain (score of 100).
次要结局
- Change from baseline clinical symptoms at 4 months.(4 months)
- Change from baseline Health-Related Quality of Life at 4 months: SF-36(4 months)
- Change from baseline isometric knee extension and flexion forces at 4 months.(4 months)
- Change from baseline walking speed gait parameter at 4 months.(4 months)
- Change from baseline cadence gait parameter at 4 months.(4 months)
- Change from baseline stride length gait parameter at 4 months.(4 months)
- Change from baseline step length gait parameter at 4 months.(4 months)
- Change from baseline stance time and % stance gait parameter at 4 months.(4 months)
- Change from baseline swing time and % swing gait parameter at 4 months.(4 months)
- Change from baseline 40 m Fast-paced Walk Test at 4 months.(4 months)
- Change from baseline Stair Ascend/Descend Test at 4 months.(4 months)
- Change from baseline 30s Timed Chair Stand Test at 4 months.(4 months)
- Change from baseline knee range of movement at 4 months.(4 months)
- Change from baseline physical activity at 4 months.(4 months)
- Change from baseline cost-utility at 4 months.(4 months)