NL-OMON26947招募中不适用
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 low back pain
eiden University Medical Center (LUMC)0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •American Society of Anesthesiologists class 1 and 2 patients, 18 – 75 years; BMI < 40 kg/m2, and ability to give informed consent. Chronic Low Back Pain for > 3-months with a pain score of 5 or more on a numerical rating scale ranging from 0 (= no pain) to 10 (= most extreme pain imaginable).
- •To be enrolled in the study, patients need to have an absent/inactive CPM response.
排除标准
- •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; (ix) previous extensive spinal surgery or spinal surgery in the past 6 months; (x) serious spinal pathology and (xi) diagnosed neurological disease.
- •Patients are not allowed to continue co-analgesics that target CPM.
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