Efficacy and Safety of Synera in OA Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Index Knee Pain Scores on a Numeric Rating Scale (NRS)
研究概览
简要总结
Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.
详细描述
Subjects participated in two visits each at least 1 week apart, where they underwent two exercise interventions - a baseline exercise without treatment and a experimental exercise with intervention (Synera patch or Inactive patch). Participants rated their pain on a NRS-11 1 minute, 5 minutes, and 60 minutes after both exercises, as well as 6 hours after the experimental exercise, before bedtime, and the following morning. Subjects were randomized to receive either Synera at the first visit and the inactive patch at the second visit or the inactive patch at the first visit and Synera patch at the second visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 40 years and above
- •Meet American College of Rheumatology criteria for knee OA
- •Knee pain most days of the week for the past month
- •Knee pain > 5/10 after exercise intervention
- •Capable of undertaking exercise intervention
- •Stable cardiovascular function
- •Able to return for all clinic visits
- •Able to read and understand the informed consent document
排除标准
- •Use of a walker to ambulate or inability to ambulate
- •Other forms of arthritis
- •Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
- •History of myocardial infarction
- •Blood Pressure > 140 systolic/100 diastolic
- •Scheduled for and likely to need joint replacement surgery in the next 3 months
- •Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
- •Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.
研究组 & 干预措施
Synera
lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.
干预措施: Synera (Drug)
Inactive Patch
placebo patch identical in appearance and composition (namely, the heating components) to the active patch other than lacking the lidocaine and tetracaine active ingredients.
干预措施: Inactive patch (Drug)
结局指标
主要结局
Index Knee Pain Scores on a Numeric Rating Scale (NRS)
时间窗: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application)
Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.
次要结局
未报告次要终点
研究者
Thomas J. Schnitzer
Professor
Northwestern University