An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Osteoarthritis knee pain according to Visual Analog Scale
研究概览
简要总结
The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time.
The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects with age 18 to 70 years and a self-reported foot size between 8 and 14
- •Subjects with regular knee pain
- •Subjects with a baseline pain level of pain of ≥20 mm to ≤90 mm on 100 mm VAS scale at baseline (Visit 1)
- •Subjects must be able to walk unaided by cane or walker.
排除标准
- •Subjects with knee pain which is due to a recent injury
研究组 & 干预措施
Patients with knee pain
Adults patients suffering from osteoarthritis pain or general knee pain
干预措施: BPI 1000013 (Dr Scholls Insole) (Device)
结局指标
主要结局
Osteoarthritis knee pain according to Visual Analog Scale
时间窗: Up to 4 weeks
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
General anterior knee pain according to Visual Analog Scale
时间窗: Up to 4 weeks
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
次要结局
- Shoe Fit according to Likert scale(Up to 4 weeks)
- Foot Comfort according to Likert scale(Up to 4 weeks)
- Number of subjects with serious adverse events(Up to 4 weeks)
- Number of subjects with adverse events(Up to 4 weeks)