Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program - a Two-year Prospective Real-life Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 主要终点
- change in overall burden of pain NRS over a two-year period
研究概览
简要总结
Background: Prognosis of medically treated trigeminal neuralgia patients is assumed to be poor, but the evidence is lacking. Thus, prospective real-life studies of medical management of trigeminal neuralgia are warranted.
Methods: Observational study. Patients were consecutively enrolled in a structured management program at a specialist centre for facial pain. Optimisation of medical treatment, physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program. Medically intractable patients were referred for neurosurgery. Data-collection was prospective using standardised schemes and patient surveys. The aim was to describe the two-year outcome of medical treatment at the specialist centre. The primary outcome was a 50% reduction in the overall burden of pain according to a Numerical Rating Scale (NRS) after two years.
This study aimed to provide evidence concerning the real-life efficacy of medical management of trigeminal neuralgia (TN) when directed by specialists. The investigatgors hypothesised that the two-year prognosis in a group of medically managed TN patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50 % reduction of the overall burden of pain over a two-year period
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
change in overall burden of pain NRS over a two-year period
时间窗: 2 years
Defined as a good outcome, i.e number of patients who had a reduction of minimum 50% on the NRS two years after enrolment in the management program compared with baseline
次要结局
- No changes of the overall burden of pain NRS over the two-year follow-up period(2 years)
研究者
Tone Heinskou
medical doctor
Danish Headache Center