About this trial
This study evaluates a novel treatment approach for medication overuse headache (MOH) using greater occipital nerve pulsed radiofrequency (GONPRF).
Three treatment strategies are compared:
Standard Treatment: Limitation of overused acute headache medications, lifestyle counseling, and continuation of existing preventive medications.
Primary GONPRF: GONPRF administered in addition to standard treatment.
Modified GONPRF: GONPRF administered as a second-line intervention in individuals who do not respond adequately to standard treatment alone.
The study assesses whether GONPRF, when applied early or after an initial period of standard care, reduces monthly headache days more rapidly and effectively than standard treatment alone. Outcomes are evaluated over a 6-month follow-up period using headache diaries and scheduled clinical assessments.
This is a randomized controlled trial designed to systematically evaluate the clinical benefit of GONPRF in patients with medication overuse headache.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Greater Occipital Nerve Pulsed Radiofrequency
Procedure/SurgeryGONPRF applied at C2 under ultrasound guidance in addition to standard care, starting at enrollment. Follow-up at 1, 3, and 6 months.
Standard care
Other interventionLimitation of overused acute headache medications, lifestyle advice (nutrition, hydration, activity, sleep), and continuation of preventive medications. Participants who respond at 1 month continue standard care.
Treatment groups
Trial outcomes
Primary outcomes
Change in Monthly Headache Days
Number of headache days per month, defined as days with headache lasting ≥4 hours and/or requiring acute headache treatment, recorded using patient headache diaries. The primary analysis compares the change from baseline to 3 months.
Secondary outcomes
Monthly Headache Days - 1 and 6 Months
Number of headache days per month assessed at early and longer-term follow-up time points to evaluate short- and long-term treatment effects.
Monthly Acute Medication Use Days
Number of days per month on which acute headache medications (paracetamol, nonsteroidal anti-inflammatory drugs, triptans, ergot derivatives, or opioids) are used, as recorded in headache diaries.
Headache Pain Intensity (Numeric Rating Scale, NRS)
Average and maximum headache pain intensity per attack measured using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain severity.
Headache Duration (hours)
Average duration of each headache attack in hours.
Other outcomes
GONPRF Treatment Side (Unilateral/Bilateral)
Side of the greater occipital nerve treated during the pulsed radiofrequency procedure, recorded as left, right, or bilateral.
Adverse Events Related to GONPRF
All procedure-related adverse events (e.g., injection site pain, infection, vasovagal reaction) will be recorded, including type, severity, and duration.
Sponsors and contacts
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