Chronic Headache
Conditions
Keywords
withdrawal therapy, oxygen therapy
Brief summary
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 1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator 2. 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
Interventions
DEVICEplatinium IRC9LXO2AWQ
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 \* 67 \* 36 cm
Sponsors
Association pour la Recherche au Centre d'Urgence des Céphalées
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Pregnancy * One or more failed withdrawal treatment * analgesic treatment for another reason than headache * Contraindication of normobaric oxygen therapy * Contraindication of ketoprofen (rescue therapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases | 6th month |
Secondary
| Measure | Time frame |
|---|---|
| number of session of oxygen during the 6 months | 6th month |
| number of rescue medication taking on the 6 months | 6th month |
| Hospital Anxiety and Depression Scale | 1st month, 2d month and 3rd month |
| number of headache days per month | 6th month |
| Patient Global Impressions of Change Scale | 1st, 2d, 3rd, 4th, 5th and 6th month |
| Migraine Disability Assessment Questionnaire Scale | 3rd and 6th month |
| Headache Impact Test- 6 | 1st, 2d and 3rd month |
Countries
France
Contacts
Primary ContactCaroline Roos, MD
Outcome results
None listed