Page 95 - The clinical aspects and management of chronic migraine Judith Anne Pijpers
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during the withdrawal period. Minimal intervention consisted of a single consult of ≤15 minutes and no offer of follow-up contacts by the nurse, mainly focusing on the reprise of the withdrawal advice and education on medication overuse. Patients of both treatment groups were provided with contact details to reach the hospital at any time if needed. Patients were unaware of the existence of these two treatment arms since the study was concealed within a drug trial, studying the added effect of Botulinum toxin A (BTX) to acute withdrawal therapy in a randomized placebo controlled manner (see Figure 1, reported in detail elsewhere).15 In short, at the initiation of withdrawal, patients received either BTX (31 injections; 155 units) or placebo injections plus a low dose BTX in the forehead region to ensure blinding (24 injections with saline plus 7 injections with BTX 17.5 units). Subsequent to the 12-week withdrawal period, restricted use of acute medication was advised, and prophylactic treatment was initiated if necessary. In both treatment groups, behavioral intervention by a headache nurse was not continued after the 12-week period but regular care was provided by the treating physician. Patients who remained to have CM after successful withdrawal were offered to receive one treatment with open-label BTX. There were no differences between groups of patients treated with BTX and placebo on any of the outcome measurements in both the double blind phase (after 12 weeks) or long term, open-label phase (after 24, 36, 48 weeks).15 Study follow-up visits were planned after 12, 24 and 48 weeks. Patients kept 4-weeks diaries with daily registration of headache characteristics and use of acute headache medication during the baseline assessment period and at weeks 9-12, 21-24, 33-36 and 45-48.
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Behavioural intervention: a double blind RCT
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