Assessment of Tapentadol effects on patients with pain central sensitization using functional MRI

MRI Research Unit, Radiology Department. Hospital del Mar.0 个研究点目标入组 40 人开始时间: 2017年1月4日最近更新: 2018年3月12日

适应症

试验速览

暂无简介。

•1.A diagnosis of knee OA and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
•2.Have a radiological and clinical diagnosis of knee OA based upon American College of Rheumatology (ACR) criteria (1986) affecting at least one knee of a minimum of 3 months in symptom duration prior to screening.
•3.Central sensitization as defined by a positive clinical evidence of pain central sensitization affecting the knee combined with a minimum of 2 tender points around the affected knee experimentally verified using pain thresholds (Arendt-Nielsen et al. 2010, Graven-Nielsen et al. 2010, Woolf 2011, Imamura et al. 2008, Nijs et al. 2010).
•4.Patients with Brief Pain Inventory (BPI) item 5 score of 6-10 points
•5.Subject is either male or female and at least 45 years of age.
•6.Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•7.Patients capable to be treated according to the technical specifications of summary of product characteristics (SmPC).
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

•1.A female subject is eligible to participate if she is of non-childbearing potential.
•2.Body weight >120kg.
•3.Severe or non-stable medical conditions.

发起方

MRI Research Unit, Radiology Department. Hospital del Mar.