An interventional study of Greater Occipital Nerve Pulsed Radiofrequency and Standard care in Medication Overuse Headache, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
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.
This is a single-center, prospective, adaptive randomized controlled trial evaluating the efficacy of greater occipital nerve pulsed radiofrequency (GONPRF) in patients with medication overuse headache (MOH). Although occipital nerve blocks have been investigated in MOH, randomized controlled trials evaluating GONPRF in this population are lacking. The study aims to compare different treatment strategies incorporating GONPRF in the management of MOH.
Study Design
The trial employs a two-stage adaptive randomized design.
Stage 1 - Initial Randomization
Patients diagnosed with MOH according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), are randomized in a 2:1 ratio into two groups:
Standard Treatment Group: Limitation of overused acute headache medications, lifestyle recommendations (including nutrition, hydration, physical activity, and sleep hygiene), and continuation of ongoing preventive medications without dose modification.
Primary GONPRF Group: Ultrasound-guided GONPRF applied at the C2 level in addition to standard treatment.
Stage 2 - One-Month Assessment
At one month, all patients are evaluated for predefined primary and secondary outcome measures, including monthly headache days, headache intensity, number of days requiring acute medication, Headache Impact Test (HIT-6), and Global Perceived Effect (GPE) scores.
Patients in the Standard Treatment Group who fail to achieve a ≥50% improvement in at least one primary outcome measure receive GONPRF as a second-line intervention and are classified as the Modified GONPRF Group. Patients demonstrating adequate response continue standard treatment and are classified as Standard Treatment Responders.
Patients initially randomized to the Primary GONPRF Group continue follow-up without additional intervention modifications.
Follow-Up and Data Collection
All interventions are performed on an outpatient basis. Follow-up assessments are conducted at baseline and at 1, 3, and 6 months. Patients maintain daily headache diaries documenting headache occurrence, intensity, duration, and use of acute headache medications. Diary data are supplemented by structured clinical evaluations at each follow-up visit.
Adaptive Outcome Classification
Following the one-month assessment, patients are categorized into three groups:
Standard Treatment Responders (Group A1)
Modified GONPRF Group (Group A2)
Primary GONPRF Group (Group B)
The final distribution among the three groups is anticipated to be approximately equal.
Acute Medication Protocol
Patients receive structured counseling regarding limitation of overused acute headache medications. Alternative short-acting analgesic or antimigraine medications may be used, limited to a maximum of two days per week. Preventive medications in use at baseline are continued without dose adjustment throughout the study period.
Study Purpose
The primary objective is to evaluate the clinical efficacy of GONPRF in the treatment of medication overuse headache when applied either as an early adjunctive therapy or as a second-line intervention following standard care. A secondary objective is to assess whether the timing of GONPRF initiation influences clinical outcomes.
52 studies on the registry are indexed under Headache Disorders, Secondary; 13 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 35 interventional studies indexed under Headache Disorders, Secondary.
Browse Headache Disorders, Secondary studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention Name: Standard Care Intervention Type: Other (Behavioral / Educational / Non-drug) Description: Limitation 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.
Other: Standard care
Intervention Name: Greater Occipital Nerve Pulsed Radiofrequency (GONPRF) Intervention Type: Procedure Description: GONPRF applied at C2 under ultrasound guidance in addition to standard care, starting at enrollment. Follow-up at 1, 3, and 6 months.
Procedure: Greater Occipital Nerve Pulsed Radiofrequency
Intervention Name: Greater Occipital Nerve Pulsed Radiofrequency (GONPRF) - Second Line Intervention Type: Procedure Description: Participants initially on standard care who do not achieve ≥50% improvement at 1 month receive GONPRF as a second-line intervention, alongside continued standard care, with follow-up at 3 and 6 months.
Procedure: Greater Occipital Nerve Pulsed Radiofrequency
GONPRF applied at C2 under ultrasound guidance in addition to standard care, starting at enrollment. Follow-up at 1, 3, and 6 months.
Limitation 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.
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.
Time frame: Baseline to 3 months
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.
Time frame: Baseline, 1 month, and 6 months
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.
Time frame: Baseline, 1 month, 3 months, and 6 months
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.
Time frame: Baseline, 1 month, 3 months, and 6 months
Headache Duration (hours)
Average duration of each headache attack in hours.
Time frame: Baseline, 1 month, 3 months, and 6 months
Headache Impact Test-6 (HIT-6) Score
Headache Impact Test-6 (HIT-6) total score, range 0-78, measuring the impact of headaches on daily activities, social functioning, work, and quality of life. Higher scores indicate greater headache-related disability (worse outcome).
Time frame: Baseline, 1 month, 3 months, and 6 months
Migraine Disability Assessment (MIDAS) Grade
Migraine Disability Assessment (MIDAS) evaluates headache-related disability over the past 3 months. Scores are categorized into four grades: Grade I: Minimal or infrequent disability Grade II: Mild disability Grade III: Moderate disability Grade IV: Severe disability Higher grades indicate greater disability (worse outcome). Participants will be assessed at baseline, 3 months, and 6 months.
Time frame: Baseline, 3 months, and 6 months
Global Perceived Effect (GPE) Score
Global Perceived Effect (GPE) is a 7-point Likert scale measuring overall change in the patient's main complaint and general well-being. Scores range from 1 (much worse) to 7 (much improved), with higher scores indicating greater improvement.
Time frame: Baseline, 1 month, 3 months, and 6 months
GONPRF Treatment Side (Unilateral/Bilateral)
Side of the greater occipital nerve treated during the pulsed radiofrequency procedure, recorded as left, right, or bilateral.
Time frame: During the GONPRF procedure (Day 1 of intervention)
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.
Time frame: From the time of the GONPRF procedure through study completion (up to 6 months).
Plan to share: No — IPD sharing is not planned due to national regulations regarding patient data confidentiality.
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