Status of Chronic Pain in Patients With Hemophilia.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
- 试验地点
- 20
- 主要终点
- Prevalence of chronic pain disorders
研究概览
简要总结
Hemophilia (A and B) are X-linked hereditary bleeding disorders whose severity depends on the level of coagulation factor (FVIII or FIX respectively). Bleeding is mainly from joints (hemarthrosis) and muscles (hematoma). Nowadays, treatment is based on preventive or curative intravenous infusion of coagulation factor concentrates. Despite these treatments, there is joint deterioration that can be responsible for hemophilic arthropathy and chronic pain. This pain may be related to excess nociception during acute bleeding, but it may also be neuropathic. There are only a few studies that have looked at pain in hemophilia, but it is accepted that the vast majority of patients (especially those with severe forms) suffer from chronic pain. Because patients have become accustomed to this pain and physicians are still not very aware of how to assess it, this pain is not treated effectively.
In order to better manage pain in hemophilia, it is therefore necessary to characterize their pain and to know the nociceptive or neuropathic component. The aim of our study is therefore to study the prevalence, the nociceptive or neuropathic profile, the chronic aspect of pain and the main locations of pain in hemophilia. In addition to raising the awareness of physicians in the centers about pain management using specific questionnaires, this survey will help to better define chronic pain in hemophilia of all severities.
详细描述
This first French assessment of chronic pain in patients with haemophilia will permit to improve and generate new data about chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.
These data will be retrieved using several questionnaires in the RedCap web plateform (eCRF).
The study will include 6 investigator centres and a minimum of 350 patients during 12 months.
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
- •Patient with haemophilia of any severity,
- •Carrier female with low levels haemophilia (< 40%),
- •≥ 18 years of age and capable of giving informed consent to participate in research.
排除标准
- •Patient's refusal to participate in the survey,
- •Patient does not understand enough French (written and spoken) to complete the survey,
- •Patient unable to complete the survey for logistical reasons (lack of internet access),
- •Patient under protective measures (guardianship),
- •Patients with known addictive comorbidities and/or cognitive disorders.
结局指标
主要结局
Prevalence of chronic pain disorders
时间窗: through study completion, an average of 1 year
Questionnaire "Brief Pain Inventory" (BPI) + History of chronic pain (≥ 3 months, Yes or No)
次要结局
- Impact of chronic pain in daily life(through study completion, an average of 1 year)
- Analgesic consumption(through study completion, an average of 1 year)
- Anxiodepressive disorders(through study completion, an average of 1 year)
- Sleep disorders(through study completion, an average of 1 year)
- Perceived injustice of chronic pain(through study completion, an average of 1 year)