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”

DOI: https://doi.org/10.1186/s12887-021-02757-2

Abstract-Summary 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 chil- dren with migraine: (1) the routine care in pediatricians’ practices (intervention group A) and (2) a structured interdisciplinary multimodal intervention adminis- tered at social pediatric centers (intervention group B).

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 out-

patient-care in the German health- care system.

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).

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.

Extended: The aim of the presented study is to evaluate if an early intervention in young children at the time migraine has just started leads to a reduction of headache days and headache intensity as well as to a lower intake of analgesics and to an amelioration of quality of life.

Children with migraine have a shorter migraine history and less comorbidities, such as other pain syndromes or psychiatric disorders, than adult migraine patients. Children with migraine are treated in pediatric practices and social pediatric cen-

ters in Germany.

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The same model is used for analysis of the secondary outcome parameters.

Background Social pediatric centers are regional neuropediatric centers offering interdisciplin- ary treatment for children with chronic diseases.

It has repeatedly been shown that interdisciplinary treatment is effective in adult patients with migraine: e.g., in one study 42.5% of patients achieved a reduction of headache days of more than 50% even in the long term [635] and in another study, the number of headache days was significantly reduced from 13.8  ±  7.6 to 8.2 ± 6.2 [636].

Studies about the efficacy of multimodal treatment in young children with

migraine do not exist so far.

An early interdisciplinary multimodal treatment in young children may lead to an even better outcome in comparison to adults and may prevent the establishing of co-morbidities in the long term.

We designed an interdisciplinary multimodal intervention for treatment of pedi- atric migraine in social pediatric centers and a randomized controlled study to eval- uate its effectiveness compared with standard basic pediatric care over a 9 months interval (elements of the interdisciplinary intervention: see 2.3.

Methods/Design In both groups, children are diagnosed with migraine by their pediatrician in prac- tice, included in the study and, if they have at least 3 days of headache in the base- line phase (week −12 to 0), go on to the intervention phase (week 0–12).

On-treatment analysis (“per protocol set“) Patients who additionally completed all 4 study visits at the pediatric practices and (only in the intervention group) the three visits at the social pediatric centers and provided electronic headache diary data with less than 33% of the days missing during the intervention and follow-up phase are included in the per protocol analysis.

Discussion Only the data necessary for study conduction and analysis is obtained via the smart- phone app (from the parents) and via the moma website (from the pediatricians in practice and from the social pediatric centers).

The presented intervention study is of high interest not only for the young patients but also for the pediatric and scientific communities as well as for the health systems worldwide.

We plan to publish the results of the multimodal intervention study in interna- tional scientific medical journals with a high distribution rate among pediatricians and neuropediatricians.

The first strength of the study is the possible positive impact of the results for the

participating child with migraine and its family.

The third strength is the clinical and political importance of the study subject: interdisciplinary intervention programs for children with migraine are mandated but efficacy studies in this age group are lacking.

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Acknowledgement A machine generated summary based on the work of Landgraf, Mirjam N.; Heinen, Florian; Gerstl, Lucia; Kainz, Christine; Ruscheweyh, Ruth; Straube, Andreas; Scheidt, Joerg; von Mutius, Sabine; Obermeier, Viola; von Kries, Ruediger. 2021 in BMC Pediatrics.

Treatment of disabling headache with greater occipital nerve injections in a large population of childhood and adolescent patients: a service evaluation