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NCT Number: NCT06753825

Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Migraine Disease

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Etlik City Hospital

Ankara, Yenimahalle, 6010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency

Device

radiofrequency treatment

flunarizine

Drug

flunarizine oral treatment

Primary outcomes

  1. Headache diary

    Time frame: 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 outcomes

  1. Pediatrik migraine disability scale PedMidas

    Time frame: 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'

Sponsors and collaborators

Lead sponsor

Damla Yürük

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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