Clinical trial NCT02302027: Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache
Official title: Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Headache
Keywords: withdrawal therapy
oxygen therapy
Lead sponsor: Association pour la Recherche au Centre d'Urgence des Céphalées
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
timeFrame: 6th month
Secondary outcomes:
measure: number of headache days per month
timeFrame: 6th month
measure: number of session of oxygen during the 6 months
timeFrame: 6th month
measure: number of rescue medication taking on the 6 months
timeFrame: 6th month
measure: Hospital Anxiety and Depression Scale
timeFrame: 1st month, 2d month and 3rd month
measure: Headache Impact Test- 6
timeFrame: 1st, 2d and 3rd month
measure: Patient Global Impressions of Change Scale
timeFrame: 1st, 2d, 3rd, 4th, 5th and 6th month
measure: Migraine Disability Assessment Questionnaire Scale
timeFrame: 3rd and 6th month
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Urgence des Céphalées, hôpital Lariboisière
Study officials:
References:
citation: Kavuk I, Katsarava Z, Selekler M, Sayar K, Agelink MW, Limmroth V, Diener HC. Clinical features and therapy of medication overuse headache. Eur J Med Res. 2004 Dec 22;9(12):565-9.
citation: Lanteri-Minet M, Valade D, Geraud G, Chautard MH, Lucas C. Migraine and probable migraine--results of FRAMIG 3, a French nationwide survey carried out according to the 2004 IHS classification. Cephalalgia. 2005 Dec;25(12):1146-58. doi: 10.1111/j.1468-2982.2005.00977.x.
citation: Evers S, Marziniak M. Clinical features, pathophysiology, and treatment of medication-overuse headache. Lancet Neurol. 2010 Apr;9(4):391-401. doi: 10.1016/S1474-4422(10)70008-9.