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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Paris, Francia, 75010
- Reclutamento
- Centre d'Urgence des Céphalées, hôpital Lariboisière
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Contatto:
- Caroline Roos, MD
- Numero di telefono: 00 33 1 49 95 89 53
- Email: caroline.roos@aphp.fr
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Sub-investigatore:
- Dominique Valade, MD
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Investigatore principale:
- Caroline ROOS, MD
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Sub-investigatore:
- Cecilia Burcin, MD
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Sub-investigatore:
- Jérome MAWET, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
Lasso di tempo: 6th month
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6th month
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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number of headache days per month
Lasso di tempo: 6th month
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6th month
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number of session of oxygen during the 6 months
Lasso di tempo: 6th month
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6th month
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number of rescue medication taking on the 6 months
Lasso di tempo: 6th month
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6th month
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Hospital Anxiety and Depression Scale
Lasso di tempo: 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
Lasso di tempo: 1st, 2d and 3rd month
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1st, 2d and 3rd month
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Patient Global Impressions of Change Scale
Lasso di tempo: 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
Lasso di tempo: 3rd and 6th month
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3rd and 6th month
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ARCUC
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