Evaluation of Predictors of Response for the Efficacy of Topical Lidocaine Patch (Versatis) on Chronic Neuropathic Pain After Peripheral Nerve Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in pain intensity (measured daily on a 10 point NRS)of spontaneous pain from baseline week to last week of treatment
研究概览
简要总结
The primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. The primary outcome measure is the predictive role for these three measures for obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point pain reduction to lidocaine (change in median pain intensity (measured on a 10 point numeric rating scale) of pain from the baseline week to the last week of lidocaine treatment). Secondary effect variable will be efficacy of lidocaine on pain reduction (baseline week versus last week of each treatment) and pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain, and effect on ongoing pain, brush evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia evaluated on each visit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 or more with neuropathic pain after a peripheral nerve injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale.
排除标准
- •pregnancy or lactation,
- •allergy to lidocaine,
- •alcohol abuse,
- •psychiatric disorders,
- •skin diseases in the area where the patches are to be applied,
- •treatment with class I antiarrhythmic agents,
- •any treatment within the past one month or concomitantly with Na2+-channel blockers (e.g., mexiletine, phenytoine, propafenone),
- •any topical treatment with capsaicin within the last three months before entering the study, or any other topical treatment in the area of neuropathic pain,
- •concomitant therapy with TENS or acupuncture.
结局指标
主要结局
Change in pain intensity (measured daily on a 10 point NRS)of spontaneous pain from baseline week to last week of treatment
时间窗: 4 or 12 weeks
The primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. The primary outcome measure is the predictive role for these three measures for obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point pain reduction to lidocaine (change in median pain intensity (measured on a 10 point NRS) of pain from the baseline week to the last week.
次要结局
- Pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain(4 or 12 weeks)
- Effect on ongoing pain, brush-evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia(4 or 12 weeks)