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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group pulsed radiofrequency | The group receiving pulsed radiofrequency therapy via transcutaneous electrodes receives 2 sessions of treatment, each lasting 8 minutes, once a week. |
| |
| group medical teratment | The group receiving 5 mg flunarizine treatment per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency | Device | radiofrequency treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Headache diary | 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. | month 1 and month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatrik migraine disability scale PedMidas | 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' |
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Inclusion Criteria:
Exclusion Criteria:
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Total 60 patients, per group 30 patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik City Hospital | Ankara | Yenimahalle | 6010 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D005444 | Flunarizine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| flunarizine |
| Drug |
flunarizine oral treatment |
|
| month 1 and month 3 |