Comparing unilateral and bilateral treatments for migraine relief
Comparison of the Efficacy of Unilateral and Bilateral Proximal Greater Occipital Nerve Pulsed Radiofrequency in the Treatment of Migraine
This study is testing whether treating migraines with one or two nerve procedures works better for people who haven't found relief from regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 2 sites (Ankara, Cankaya and 1 other locations) |
| Trial ID | NCT06894121 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of unilateral versus bilateral Greater Occipital Nerve Pulsed Radiofrequency (GON-PRF) treatments in patients suffering from migraines. The procedure is guided by ultrasound and aims to evaluate the impact of each technique on migraine symptoms, as well as any associated side effects. The study will include patients aged 18-65 who have episodic or chronic migraines and have not found relief from standard migraine prevention medications. By assessing both treatment methods, the research seeks to determine which approach may provide better outcomes for migraine relief.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with episodic or chronic migraines who have not benefited from conventional migraine prevention medications.
Not a fit: Patients with primary headaches other than migraines or those with bleeding-clotting disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from chronic migraines.
How similar studies have performed: Previous studies have shown that GON block and GON PRF are effective in treating migraines, suggesting potential success for this comparative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:Volunteers who are followed up at the Algology polyclinic of Ankara Bilkent City Hospital, between the ages of 18-65, who meet the diagnosis criteria for episodic (≥5 attacks/month) or chronic migraine according to ICHD-3 criteria, who do not benefit sufficiently from the migraine prevention medications used, who are not currently using migraine prevention medications or who have not changed their medication and/or dosage in the last 3 months, who do not have bleeding-clotting disorders and active infection in laboratory tests, who are not pregnant or suspected of being pregnant, who do not have a history of craniocervical surgery that may disrupt the anatomical structure in the intervention area, who can understand and approve the treatment and the informed consent form and who can comply with the treatment will be included in this study. Exclusion criteria for files/records/materials to be included in the study: Patients with a history of primary headache other than migraine according to ICHD-3 criteria, \<5 attacks per month, comorbid diseases that may cause headaches (such as uncontrolled hypertension, intracranial lesions), and those who have received interventional treatment, botulinum toxin injection and/or non-pharmacological treatment (acupuncture, physical therapy, ozone, cognitive behavioral therapy, etc.) for migraine within 3 months prior to GON-PRF treatment will not be included in the study. - Exclusion Criteria:The voluntary participants' request to withdraw for any reason at any stage of the study, the volunteer/legal representative's withdrawal of consent to participate in the study, failure to attend follow-up, and the emergence of any of the following criteria for not being included in the study. -
Where this trial is running
Ankara, Cankaya and 1 other locations
- Health Sciences University, Ankara Bilkent City Hospital — Ankara, Cankaya, Turkey (Recruiting)
- Health Sciences University, Ankara Bilkent City Hospital — Ankara, Cankaya, Turkey (Recruiting)
Study contacts
- Principal investigator: Sukriye Dadali, M.D. — Ankara City Hospital Bilkent
- Study coordinator: Şükriye Dadalı, M.D.
- Email: sukriyedadali@gmail.com
- Phone: +905333316636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.