G43 G44
Conditions
Interventions
Group 1: Children and adolescents aged 6-17 years who have received at least one trial treatment with rNMS as part of the multimodal treatment of their primary headache disorder according to ICHD-3.
Sponsors
LMU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: Primary or secondary headache disorder according to the International Classification of Headache Disorders (ICHD-3)
Exclusion criteria
Exclusion criteria: - Diagnosis of epilepsy - Implanted shunt systems (VP, VA, etc.; magnetically adjustable valve) - Implanted biomedical devices (e.g. cochlear implant, drug pump, cardiac or brain pacemaker) - Metal parts on/in the body (e.g. piercings, intrauterine spirals, vascular clips) - Malignant disorder - Other chronic or chronic inflammatory diseases - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients and spectrum of indications: How many patients received rNMS of the neck muscles during multimodal treatment of what kind of headache disorder. Data collected by review of the patients' medical charts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness: Clinical effects of rNMS: headache-related variables (such as frequency of headache episodes, headache days per month, use of medication, etc collected in headache calendars.) and muscular variables (pain in the shoulder and neck area reported in questionnaires, physiotherapeutic findings including algometry to assess for pain pressure thresholds reported in the therapists' documentation) are analyzed. Treatment goal: Has the treatment goal previously set by the headache specialist team together with the parents been achieved? Review of patients' medical charts. Treatment setting: Which stimulation parameters were selected and how was the general treatment setting organised? Review of treatment documentation. Adherence: How many patients have completed all scheduled rNMS sessions? Review of patients' medical charts. Safety: Frequency and spectrum of adverse effects during the period of treatment. Analysis of costumized questionnaires. Satisfaction: How satisfied were the patients and their relatives with the treatment? Analysis of costumized questionnaires. Exploratory group analyses: How do the different groups of patients (e.g. patients with and without mTrP, treatment(s) once, twice to six times per week) differ from each other in terms of subjective assessment of treatment success and headache-related variables (e.g. frequency and intensity)? How do these variables differ after a first and second treatment block (One block means 6 sessions of rNMS in 2 to 3 weeks)? | — |
Countries
Germany
Contacts
Public ContactMichaela V. Bonfert
LMU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner
Outcome results
None listed