Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine

Comparison of the Efficacy of Transcutaneous Pulsed Radiofrequency Therapy and Calcium Channel Blockers in Childhood Migraine Headache.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine Disease
• Intervention / Treatment: Device: Radiofrequency; Drug: flunarizine

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 6010
      • Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Total 60 patients, per group 30 patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group pulsed radiofrequency; The group receiving pulsed radiofrequency therapy via transcutaneous electrodes receives 2 sessions of treatment, each lasting 8 minutes, once a week.	Device: Radiofrequency; radiofrequency treatment
group medical teratment; The group receiving 5 mg flunarizine treatment per day	Drug: flunarizine; flunarizine oral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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'	month 1 and month 3

Collaborators and Investigators

• Sponsor: Damla Yürük

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Membrane Transport Modulators; Anticonvulsants; Calcium Channel Blockers; Vasodilator Agents; Histamine H1 Antagonists; Flunarizine
• Other Study ID Numbers: childhood migraine treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No