Influenza Vaccination in Patients Suffering From Fibromyalgia
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- proportion of patients who achieve a titer of antibodies above 1/40, against each of the antigens included in the vaccine
研究概览
简要总结
Fibromyalgia is a clinical syndrome characterized by the presence of chronic widespread pain accompanied by tenderness and fatigue. Central sensitization is considered to be a major pathogenetic feature of fibromyalgia. While the etiology of fibromyalgia is incompletely understood, it is generally considered to result from the interaction between an appropriate genetic background and the exposure of a susceptible individual to various inciting "triggers". These have included among others physical trauma, infection, stress etc.
The possible role of vaccination in causing or exacerbating fibromyalgia has been previously raised. Thus, gulf war syndrome, an entity with considerable clinical overlap with fibromyalgia, has been considered to have a possible link with the exposure to multiple vaccinations. More recently a theory has been advanced regarding the possibility that vaccination - related adjuvants may induce a multisystem disorder characterized by symptoms such as fatigue, cognitive impairment and arthralgia (the so called ASIA syndrome).
The investigators have previously established the safety and efficacy of influenza vaccination in Rheumatoid arthritis patients.
In view of this background it is of considerable clinical importance to ascertain both the efficacy and safety of vaccination in patients suffering from fibromyalgia.
详细描述
Fifty patients with fibromyalgia and 30 healthy, age - matched controls will participate in the study.
The classification of fibromyalgia will be performed by applying the 1990 ACR criteria.
After signing informed consent, all subjects will be vaccinated with the inactivated split virion vaccine, recommended by the WHO this fall.
Patients will be evaluated at weeks 0 and 6 weeks later. Clinical evaluation will be based on the Fibromyalgia Impact Questionnaire and the 2010 Fibromyalgia Severity Scale.
ESR and CRP Blood will be collected on the day of vaccination and 6 weeks later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients >18 year old age
- •Capable to sign a informed consent
- •Suffering from fibromyalgia (ACR criteria)
排除标准
- •Known allergy to influenza vaccine
- •Allergy to eggs
结局指标
主要结局
proportion of patients who achieve a titer of antibodies above 1/40, against each of the antigens included in the vaccine
时间窗: Six weeks
次要结局
- Number of adverse events(Six weeks)
- Clinical changes post - vaccination(Six weeks)