Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
研究概览
简要总结
A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.
详细描述
In this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. Subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. After randomization subjects completed a baseline questionnaire regarding how pain affects their lives. Then they began therapy with their blinded product. This same questionnaire was administered after the second day of therapy and after the final day on day 10. Responses at the day two and ten endpoints were compared to baseline to access the response of each arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of back pain
- •Diagnosis of arthritis
排除标准
- •Pregnancy or expected pregnancy in the next three months
- •Allergic to any lidocaine, menthol and methylparaben
- •No reliable access to the internet
- •Baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to
- •Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)
研究组 & 干预措施
Lidocaine5% v Lidocaine3.6%,Menthol1.25%
Daily patch Q12 followed by Q12 of no patch
干预措施: lidocaine 5% patch (Drug)
Lidocaine5% v Lidocaine3.6%,Menthol1.25%
Daily patch Q12 followed by Q12 of no patch
干预措施: lidocaine 3.6%, menthol 1.25% (Drug)
Lidocaine 3.6%, menthol 1.25% v placebo
Daily patch Q12 followed by Q12 of no patch
干预措施: lidocaine 3.6%, menthol 1.25% (Drug)
Lidocaine 3.6%, menthol 1.25% v placebo
Daily patch Q12 followed by Q12 of no patch
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
时间窗: Day ten
Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten
次要结局
- Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day ten)
- Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day 10)
- Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day 10)
- Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale(Day 10)