Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Visual Analogue Pain Scale (Burning Pain)
研究概览
简要总结
Nursing study, prospective, randomized, two-center open-label.
Patients will be randomized into two groups during their first laying Qutenza®:
- Patients receiving the laying of Qutenza® without refrigerated cushion
- Patients receiving the laying of Qutenza® associated with a refrigerated cushion
The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Do not opposing the participation in the study
- •Monitoring in the case of localized neuropathic pain
- •Diagnostic with neuropathic pain score ≥ 4
- •Neuropathic pain conventional treatment failure of first-line
- •Front advantage of laying a first patch Qutenza®
- •With ability to understand the proposed study
排除标准
- •Patch Installation on the feet, face, mucous membranes
- •Eutectic mixture of local anesthetics (EMLA) Pose premedication
- •Having Already received prior to the installation of a patch of Qutenza®
- •Allergy to components Qutenza®
- •Known and poorly stabilized hypertension
- •Known cryoglobulinaemia
- •Pregnant or lactating women
- •Patient enjoying a measure of legal protection (guardianship, guardianship ...)
- •Private Patient freedom
- •No affiliation to a social security scheme.
- •Refusal to participate in the study
结局指标
主要结局
Visual Analogue Pain Scale (Burning Pain)
时间窗: after 1 hour of installation of Qutenza patch
Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10. The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?
次要结局
未报告次要终点