A randomized, double blind, placebo-controlled study on the effect of 3 months treatment with the analgesic tapentadol on conditioned pain modulation (CPM) and pain relief in patients with chronic pain from fibromyalgia - FCAT

MC0 个研究点开始时间: 2015年12月17日最近更新: 2016年3月14日

研究概览

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•- Age: 18 – 75 years.
•- Sex: Either sex.
•- American Society of Anesthesiologists class 1 and 2 patients, 18 – 75 years; BMI < 40 kg/m2, and ability to give informed consent.
•Additionally patients need to have a pain score = 5 (on a scale of 0-10) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria. These criteria include a widespread pain index (WPI; 0-18 points), which defines the number of body areas in which a patient experienced pain during the last week, and a symptom severity score (SS-score; 0-12 points), which indicates the level of other core symptoms of fibromyalgia such as fatigue, un-refreshing sleep and cognitive symptoms. Inclusion criteria are:
•(1) a WPI = 7 with an SS-score = 5
•(2) a WPI of 3-6 with an SS-score = 9.
•Finally, patients need to have an absent/inactive CPM response.
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Unable to give written informed consent; medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) history of illicit drug abuse or alcohol abuse; (v) history of psychosis; (vi) epilepsy; (vii) pregnancy and/or lactation; (viii) strong opioids and benzodiazepine use.

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