Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- WOMAC score
研究概览
简要总结
Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate osteoarthritis of the knee
- •Age 60 to 80 years
- •Ambulatory
排除标准
- •Other conditions that affect mobility
- •Severe chronic diseases such as cardiac or renal failure
- •Presence of gout
- •Cognitive impairment
研究组 & 干预措施
Biofreeze
干预措施: Biofreeze (Drug)
Placebo
Use of placebo ointment
干预措施: Placebo (Other)
结局指标
主要结局
WOMAC score
时间窗: 60 days
WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis
次要结局
- Quality of life measured using SF 36(60 days)
研究者
Daniel Bunout
Medical Doctor
University of Chile