National Neuropathic Pain Database Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 789
- 试验地点
- 1
- 主要终点
- To establish the infrastructure for a national Neuropathic Pain Database.
研究概览
简要总结
To establish the infrastructure for a national neuropathic pain database.
To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability, and quality of life.
详细描述
The database will provide standard information on demographics, diagnosis, treatment interventions and outcome modeled on guidelines from the expert panel on initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT)(Turk et al.,Pain 2003;106:337-345) The IMMPACT panel determined that patients should be evaluated according to six core domains as follows: Pain, physical functioning, emotional functioning, subject rating of global satisfaction with treatment, symptoms and adverse events and subject disposition.
The database will allow us to examine outcomes based on single (eg. pregabalin) and multiple (e.g tricyclic antidepressants and gabalin) therapeutic interventions. Standard guidelines for management of neuropathic pain acknowledge that polypharmacy is appropriate when individual first line treatments fail to provide adequate pain relief (Gilron I et al., CMAJ 2006; 175: 265-275; Attal N et al., European Journal of Neurology 2006; 13: 1153-1169)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primarily Neuropathic Pain
- •Able to give informed consent
- •Estimated Life Expectancy of 2 years
排除标准
- •Not primarily neuropathic pain
- •Declined participation- too much traveling
- •Declined participation- Unknown
- •Declined participation- Other, specify
- •Considered unreliable- personality disorder
- •Considered unreliable- cognitive impairment
- •Considered unreliable- substance abuse
- •Considered unreliable- Other
- •Language barrier
- •Exceeded quarterly quota
- •Presentation with progressive or recurrent cancer, fibromyalgia, perineal pain of unknown etiology
- •Other, specify
结局指标
主要结局
To establish the infrastructure for a national Neuropathic Pain Database.
时间窗: 2 years
To establish the infrastructure for a National Neuropathic Pain Database, with a composite primary outcome measure in average pain intensity (based on average pain intensity of BPI) and reduction in disability (based on Interference Scale Score of BPI))
次要结局
- To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life.(2 years)