Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine

NCT06753825 | Active Not Recruiting

• 1 other identifier: childhood migraine treatment
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pediatrik migraine disability scale PedMidas

  month 1 and month 3

Study Arms (2)

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

group medical teratment

The group receiving 5 mg flunarizine treatment per day

Drug: flunarizine

Interventions

Radiofrequency DEVICE

radiofrequency treatment

group pulsed radiofrequency

flunarizine DRUG

flunarizine oral treatment

group medical teratment

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Total 60 patients, per group 30 patients

You may qualify if:

• Diagnosed with migraine according to ICHD-3 Migraine criteria
• Being between the ages of 8-18
• Having 4 or more migraine attacks per month

You may not qualify if:

• Other primary or secondary headache diagnosis
• Patient could not be reached during follow-up

Sponsors & Collaborators

• Damla Yürük: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 6010, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Flunarizine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: December 31, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 30, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)