Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine

NCT ID: NCT06753825

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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group pulsed radiofrequency

The group receiving pulsed radiofrequency therapy via transcutaneous electrodes receives 2 sessions of treatment, each lasting 8 minutes, once a week.

Radiofrequency

Intervention Type DEVICE

radiofrequency treatment

group medical teratment

The group receiving 5 mg flunarizine treatment per day

flunarizine

Intervention Type DRUG

flunarizine oral treatment

Interventions

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Radiofrequency

radiofrequency treatment

Intervention Type DEVICE

flunarizine

flunarizine oral treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damla Yürük

OTHER

Sponsor Role lead

Responsible Party

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Damla Yürük

medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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childhood migraine treatment

Identifier Type: -

Identifier Source: org_study_id

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