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Landgraf, Mirjam N.; Heinen, Florian; Gerstl, Lucia; Kainz, Christine; Ruscheweyh, Ruth; Straube, Andreas; Scheidt, Jörg; Mutius, Sabine von; Obermeier, Viola and von Kries, Rüdiger (2021): Comparison of a pediatric practice-based therapy and an interdisciplinary ambulatory treatment in social pediatric centers for migraine in children: a nation-wide randomized-controlled trial in Germany: moma - modules on migraine activity. In: BMC Pediatrics, Vol. 21, No. 1, 294

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BackgroundMigraine is common in childhood, peaks in adolescents and persists into adulthood in at least 40% of patients. There is need for early interventions to improve the burden of disease and, if possible, reduce chronification. The aim of the project is to compare two types of ambulatory treatment strategies regarding their effect on headache days and quality of life in 6 to 11year old children with migraine: 1) the routine care in pediatricians' practices (intervention group A) and 2) a structured interdisciplinary multimodal intervention administered at social pediatric centers (intervention group B).MethodsThe study is a nation-wide cluster-randomized study. Based on the postal codes the regions are randomly assigned to the two intervention-strategies. Children with migraine are recruited in the pediatric practices, as common outpatient-care in the German health-care system. Parents rate headache frequency, intensity and acute medication intake at a daily basis via a digital smartphone application specifically designed for the study. Migraine-related disability and quality of life are assessed every 3months. Study duration is 9months for every participant: 3months of baseline at the pediatric practice (both groups);3months of intervention at the pediatric practice (intervention group A) or at the social pediatric center (intervention group B), respectively;3months of follow-up at the pediatric practice (both groups).DiscussionResults of the planned comparison of routine care in pediatric practices and interdisciplinary social pediatric centers will be relevant for treatment of children with migraine, both for the individual and for the health care system.Trial registrationThe study was approved by the ethics committee at the Ludwig-Maximilians-University Munich (number 18-804) and was retrospectively registered on 27 April 2021 in the WHO approved German Clinical Trials Register (number DRKS00016698).

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