Migraine Disease
Conditions
Brief summary
The aim of this observational study was to investigate the long-term effects of patients receiving interventional transcutaneous electrode-pulsed radiofrequency therapy versus calcium channel blockers for the treatment of childhood migraine pain. The main question to be answered was. Which of the long-term effects of interventional transcutaneous pulsed radiofrequency versus calcium channel blockers for the treatment of childhood migraine pain is more effective? Participants who have started both treatments will answer questions about their headaches in an online survey for 3 months as part of their regular medical care.
Detailed description
There are two groups in the trial. One group will receive transcutaneous pulsed radiofrequency treatment for a total of 3 weekly sessions. The other group will receive 1x 5 mg flunarizine active ingredient. Both groups will consist of 30 patients. All patients will be followed from the start of treatment and will be assessed at month 1 and month 3 using the paediatric migraine disability index, headache diaries and visual pain scale.
Interventions
DEVICERadiofrequency
radiofrequency treatment
DRUGflunarizine
flunarizine oral treatment
Sponsors
Damla Yürük
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with migraine according to ICHD-3 Migraine criteria * Being between the ages of 8-18 * Having 4 or more migraine attacks per month
Exclusion criteria
* Other primary or secondary headache diagnosis * Patient could not be reached during follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache diary | month 1 and month 3 | The headache diary : including the date, triggering event, severity (rated on a scale from 1-very mild- to 5-very severe-), type, location of the pain. Additional symptoms such as nausea, vomiting, light sensitivity, sound sensitivity, and dizziness and duration of the pain, and whether daily activities were impacted are recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatrik migraine disability scale PedMidas | month 1 and month 3 | PedMIDAS is a validated questionnaire consisting of six questions designed to assess the impact of headaches on the daily functioning of children and adolescents over the past three months. The form evaluates the extent to which headaches have affected school attendance, academic performance, ability to complete homework, and participation in family, social, and recreational activities. Respondents are asked to report the number of days missed or days when they functioned at less than half of their normal capability in these areas. A high score was associated with increased disability. If the PedMIDAS score was between 0-10, the disability was considered 'not - very mild', between 11-30 was considered 'mild', between 31-50 was considered 'moderate', 51 and above was considered 'severe' |
Countries
Turkey (Türkiye)
Outcome results
None listed