Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
研究概览
简要总结
Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal .
The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use.
The aim of this study is
- verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
- use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.
It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator
Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks.
Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake).
Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months
Effective : 30 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Migrainous according to the criteria of the International Headache Society
- •Medication-overuse headaches according of the International Headache Society
- •No prophylaxis treatment or same prophylaxis treatment from more than one month
- •Signed informed consent
排除标准
- •Pregnancy
- •One or more failed withdrawal treatment
- •analgesic treatment for another reason than headache
- •Contraindication of normobaric oxygen therapy
- •Contraindication of ketoprofen (rescue therapy)
结局指标
主要结局
percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
时间窗: 6th month
次要结局
- Patient Global Impressions of Change Scale(1st, 2d, 3rd, 4th, 5th and 6th month)
- number of headache days per month(6th month)
- Hospital Anxiety and Depression Scale(1st month, 2d month and 3rd month)
- Headache Impact Test- 6(1st, 2d and 3rd month)
- number of session of oxygen during the 6 months(6th month)
- number of rescue medication taking on the 6 months(6th month)
- Migraine Disability Assessment Questionnaire Scale(3rd and 6th month)
研究者
Caroline ROOS
Medical Doctor
Association pour la Recherche au Centre d'Urgence des Céphalées