Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache (O214)
Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Paris, Francia, 75010
- Reclutamiento
- Centre d'Urgence des Céphalées, hôpital Lariboisière
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Contacto:
- Caroline Roos, MD
- Número de teléfono: 00 33 1 49 95 89 53
- Correo electrónico: caroline.roos@aphp.fr
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Sub-Investigador:
- Dominique Valade, MD
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Investigador principal:
- Caroline ROOS, MD
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Sub-Investigador:
- Cecilia Burcin, MD
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Sub-Investigador:
- Jérome MAWET, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: platinium IRC9LXO2AWQ
Normobaric oxygen therapy with high flow concentrator to treat headaches attacks, 30 minutes of oxygene inhalation with mask, 9l/minute, no frequency limitation
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high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
Periodo de tiempo: 6th month
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6th month
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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number of headache days per month
Periodo de tiempo: 6th month
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6th month
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number of session of oxygen during the 6 months
Periodo de tiempo: 6th month
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6th month
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number of rescue medication taking on the 6 months
Periodo de tiempo: 6th month
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6th month
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Hospital Anxiety and Depression Scale
Periodo de tiempo: 1st month, 2d month and 3rd month
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1st month, 2d month and 3rd month
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Headache Impact Test- 6
Periodo de tiempo: 1st, 2d and 3rd month
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1st, 2d and 3rd month
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Patient Global Impressions of Change Scale
Periodo de tiempo: 1st, 2d, 3rd, 4th, 5th and 6th month
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1st, 2d, 3rd, 4th, 5th and 6th month
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Migraine Disability Assessment Questionnaire Scale
Periodo de tiempo: 3rd and 6th month
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3rd and 6th month
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ARCUC
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