Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Days with headache
研究概览
简要总结
Pulsed radiofrequency of the occipital nerves (greater and lesser) for primary headache management.
详细描述
Patients participating suffered from primary headaches (migraine, cluster, and tension headache) and occipital neuralgia were enrolled in the study. They have all received in the past the standard systemic pharmacotherapy prophylaxis for headache management (with topiramate or amitriptylline) as well as tryptanes for rescue treatment, and were scheduled for a diagnostic nerve block of the occipital nerves in cases of intractable pain. Inclusion criteria included: not adequate response to systemic pharmacotherapy, pain over crises of >4/10, occipital tenderness bilaterally or unilaterally, and days with headache of more than 10/month. Exclusion criteria were age<18 years old, pregnancy or lactation, presence of cardiac pacemaker, previous therapy with PRF, severe psychiatric disorder and patient refusal. In cases of a positive response to the diagnostic nerve block with local anesthetic, with >50% pain relief they were scheduled for pulsed radiofrequency of GON and LON bilaterally.
Primary outcome measure was the days with headache per month, before and after treatment. In addition, pain during headache crisis (with Visual Analogue Scale, VAS, 0-10), the analgesic consumption (number per month) and the quality of life (measured with EQ6D) were studied. All measurements were performed before treatment, as well as after 1, 3, 6, and 12 months. All patients completed the Brief Pain Inventory questionnaire in Greek language and signed an informed consent prior treatment. All measurements were accomplished by an independed (blinded) researcher of the pain unit. All complications and side effects were also recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •not adequate response to systemic pharmacotherapy
- •pain over crises of >4/10
- •occipital tenderness bilaterally or unilaterally,
- •days with headache of more than 10/month.
排除标准
- •age<18 years old,
- •pregnancy or lactation
- •presence of cardiac pacemaker
- •previous therapy with PRF
- •severe psychiatric disorder
- •severe coagulopathy
- •patient refusal
结局指标
主要结局
Days with headache
时间窗: 12 months
days with headache per month
次要结局
- pain during crisis(12 months)
- analgesics consumption(12 months)
- quality of life(12 months)
研究者
Chrysanthi Batistaki
Associate Professor of Anaesthesiology
Attikon Hospital
