跳至主要内容
临床试验/NCT04339335
NCT04339335Unknown不适用

Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.

Attikon Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月1日最近更新:
适应症

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

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

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chrysanthi Batistaki

Associate Professor of Anaesthesiology

Attikon Hospital

研究点 (1)

Loading locations...

相似试验