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临床试验/EUCTR2020-001022-57-DK
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.

研究者

发起方
Wojciech Zbigniew Pawlak

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