Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine

Active, not recruiting

• Conditions: Migraine Disease
• Interventions: Device: Radiofrequency; Drug: flunarizine

• Registration Number: NCT06753825
• Lead Sponsor: Damla Yürük

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.

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Study First Posted: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group pulsed radiofrequency	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	flunarizine	The group receiving 5 mg flunarizine treatment per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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'

Trial Locations

Locations (1)

Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey