EUCTR2020-001022-57-DK进行中(未招募)1 期
The effect of Qutenza application in patients with post-operative neuropathic pain: A double-blind, randomized, controlled pilot study - Qutenza-FM-20
Wojciech Zbigniew Pawlak0 个研究点目标入组 26 人开始时间: 2020年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age > 18 years old
- •Patients with chronic pain for =3 months, with a daily VAS pain scores =40 mm (VAS 0-100mm, 0=no pain and 100=worst possible pain) after sur-gery
- •Patients have a score =7 in the neuropathic pain questionnaire DN4
- •Negative pregnancy test in fertile women.
- •Patients with at least one identifiable trigger point in relation to incision in a mobile body part or a positive outcome from our first study (7). A trigger point is defined as an area in relation to the incision from surgery, in which a light pressure from a cotton pin radiate pain to the nearby area and exudes a motor reflex causing withdrawal of the body part related to the incision. Trigger points will be identified using ultrasound scanning.
- •Skin must be intact and dry without wounds or stripes in an area of 6 cm in diameter from the trigger point
- •A written and signed informed consent to participate in the study after having fully understood the contents of the protocol and restrictions
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Patients who cannot cooperate
- •Patients who can cooperate but do not understand or speak Danish
- •Patients with allergy to the drugs used in the study, ingredients or compo-nents in the matrix and cleansing creme*
- •Women who are not using acceptable effective contraception
- •Patients suffering from other neuropathic pain conditions.
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