Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- oxidative balance
研究概览
简要总结
The oxidative - antioxidative balance is the crucial mechanism of opioid-induced immunomodulation. Additionally, impairement of cognitive function during opioid therapy is another important side- effect. This phenomenon was clearly described in opioids abuse. This is interesting to evaluate the importance of this subjects in chronic pain patients. The aim of the study was to investigate the oxidative - antioxidative homeostasis and cognitive functions using serum total oxidative capacity (TOC) and total antioxidative capacity (TAC) tests and Brain Derivered Neutrophic Factor (BDNF) in patient with chronic non-cancer pain treated with opioids.
详细描述
The project was approved in Ethical Committee and supported by Medical University of Bialystok (Poland). The serum TOC and TAC measurements were performed in total group of 50 adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group - 14 patients, healthy volunteers. In Study Group anthropometric parameters, duration in opioid therapy, type of opioid, total dose, and form of application were registered.TOC, TAC, and BDNF measurements were performed using ImAnOx, PerOx, BDNF tests (Immundiagnostik, Germany).Data were analyzed using non-parametric tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •minimally, 6 months opioid therapy in chronic Low- Back Pain
排除标准
- •depression, steroids- local or systemic administration
研究组 & 干预措施
Study Group
Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy
干预措施: biochemical measurements (Diagnostic Test)
Control Group
Control Group - 14 patients, healthy volunteers.
干预措施: biochemical measurements (Diagnostic Test)
结局指标
主要结局
oxidative balance
时间窗: 6 months of opioids therapy
measurements of total oxidative capacity and total antioxidative capacity
cognitive state
时间窗: 6 months of opioids therapy
measurements of Brain-derived Neurotrophic Function
次要结局
未报告次要终点