Migraine DiseaseNCT06753825
Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine
An observational study of Migraine Disease, run by Damla Yürük at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Migraine Disease
- What is being tested?
- Radiofrequency and flunarizine
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 30 May 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Total 60 patients, per group 30 patients
Who may be able to join
- Diagnosed with migraine according to ICHD-3 Migraine criteria
- Being between the ages of 8-18
- Having 4 or more migraine attacks per month
Who cannot join
- Other primary or secondary headache diagnosis
- Patient could not be reached during follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine Disease
- Being tested
- Radiofrequency, flunarizine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
radiofrequency treatment
flunarizineDrug
flunarizine oral treatment
| Study group | Role | What they receive |
|---|---|---|
| group pulsed radiofrequency | The group receiving pulsed radiofrequency therapy via transcutaneous electrodes receives 2 sessions of treatment, each lasting 8 minutes, once a week. Receives: Device: Radiofrequency | |
| group medical teratment | The group receiving 5 mg flunarizine treatment per day Receives: Drug: flunarizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 1 and month 3
Secondary outcomes (1)
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'
Measured: month 1 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Damla Yürük
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Damla Yürük, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753825
- Sponsor's protocol ID
- childhood migraine treatment
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Transcutaneous Pulsed Radiofrequency Therapy and Calcium Channel Blockers in Childhood Migraine Headache.
- ClinicalTrials.gov ID
- NCT06753825
- Acronym / sponsor ID
- childhood migraine treatment
- Conditions
- Migraine Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Damla YürükUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group pulsed radiofrequency | – | Device: RadiofrequencyThe group receiving pulsed radiofrequency therapy via transcutaneous electrodes receives 2 sessions of treatment, each lasting 8 minutes, once a week. |
| group medical teratment | – | Drug: flunarizineThe group receiving 5 mg flunarizine treatment per day |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Total 60 patients, per group 30 patients
Key inclusion criteria (3 listed)
- Diagnosed with migraine according to ICHD-3 Migraine criteria
- Being between the ages of 8-18
- Having 4 or more migraine attacks per month
Key exclusion criteria (2 listed)
- Other primary or secondary headache diagnosis
- Patient could not be reached during follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequencyradiofrequency treatment | Device | group pulsed radiofrequency |
| flunarizineflunarizine oral treatment | Drug | group medical teratment |
Primary outcome
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.
1 secondary outcome
Pediatrik migraine disability scale PedMidas
Time frame: month 1 and month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disease, run by Damla Yürük at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache diary (time frame: month 1 and month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.