Personalized pulsed radiofrequency treatment of the greater occipital nerve for medication overuse headache
Individualized Application of Occipital Nerve Pulsed Radiofrequency in Medication Overuse Headache: A Randomized Controlled Evaluation
This trial will try pulsed radiofrequency applied to the greater occipital nerve, given either early or after an initial month of standard care, to see if it reduces monthly headache days in adults with medication overuse headache.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07360782 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, adaptive randomized controlled trial at Ankara Bilkent City Hospital compares standard care to greater occipital nerve pulsed radiofrequency (GONPRF) in adults with medication overuse headache. Participants are randomized 2:1 to receive standard treatment alone or primary GONPRF plus standard care, and patients who do not improve after one month on standard care may receive delayed (modified) GONPRF. Outcomes include monthly headache days, headache intensity, days requiring acute medication, HIT-6, and global perceived effect, recorded by headache diaries and clinic visits over a six-month follow-up. The two-stage adaptive design allows early switching for nonresponders and aims to determine whether early or delayed GONPRF shortens the time to clinically meaningful headache reduction.
Who should consider this trial
Good fit: Adults aged 18–65 with medication overuse headache per ICHD-3 who can give informed consent, are not pregnant, and have no active infection or bleeding disorder are candidates for the study.
Not a fit: Patients with recent changes in preventive headache medications, severe systemic disease, psychiatric disorders or current antidepressant use, substance abuse, pregnancy or breastfeeding, anatomical alteration from prior craniocervical surgery, or other exclusion criteria are not eligible and unlikely to benefit from the intervention.
Why it matters
Potential benefit: If effective, GONPRF could reduce monthly headache days more rapidly and help patients stop overusing acute medications, lowering disability and medication-related harms.
How similar studies have performed: Occipital nerve blocks have shown some benefit for headache disorders, but randomized trials of pulsed radiofrequency (GONPRF) specifically for medication overuse headache are lacking, so this approach is relatively novel in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age 18-65 years * Diagnosed with Medication Overuse Headache (MOH) according to ICHD-3 criteria * No laboratory evidence of bleeding or clotting disorders * No active infection * Not pregnant and no suspicion of pregnancy * No history of craniocervical surgery that may alter anatomical structures at the intervention site * Able to understand the study procedures, provide written informed consent, and comply with treatment Exclusion Criteria * Changes in preventive treatment for migraine and/or tension-type headache within the last 3 months * Severe systemic disease (e.g., uncontrolled diabetes, serious cardiovascular disease, malignancy) * Psychiatric disorders (including current antidepressant use or psychiatric follow-up) * History of alcohol or substance abuse * Pregnancy, breastfeeding, or plans for pregnancy in the next 12 months * Concurrent use of other prophylactic headache treatments
Where this trial is running
Ankara
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Şükriye Dadalı, MD
- 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.