Abstract
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 11 year 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 3 months. Study duration is 9 months for every participant: 3 months of baseline at the pediatric practice (both groups); 3 months of intervention at the pediatric practice (intervention group A) or at the social pediatric center (intervention group B), respectively; 3 months 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).
Highlights
Migraine is common in childhood, peaks in adolescents and persists into adulthood in at least 40% of patients
Results 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
We developed the patientcentered, structured, interdisciplinary multimodal intervention “moma – modules on migraine activity”, presented in this protocol
Summary
Migraine is common in childhood, peaks in adolescents and persists into adulthood in at least 40% of patients. The Barmer health insurance company dataset, which is covering 11% of all German policyholders, showed that in 2015 approximately 1% of all children received a diagnosis of migraine already at the age of primary school (6 to 11 years of age) [1]. In patients with migraine diagnosed at the age of 7 years, migraine persists into adulthood in 65% of the affected females and 21% of the affected males [2]. The Barmer insurance data reveal that only half of the primary school children diagnosed with migraine got appropriate medication e.g. NSAID, but 2.1% were at least once in inpatient treatment for migraine. Social pediatric centers are regional neuropediatric centers offering interdisciplinary treatment for children with chronic diseases. They belong to the customary care institutions in Germany
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