Personalized Pulsed Radiofrequency of the Greater Occipital Nerve for Medication Overuse Headache (PRIMOGON)

Individualized Application of Occipital Nerve Pulsed Radiofrequency in Medication Overuse Headache: A Randomized Controlled Evaluation

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.

Study Overview

• Status: Recruiting
• Conditions: Medication Overuse Headache
• Intervention / Treatment: Other: Standard care; Procedure: Greater Occipital Nerve Pulsed Radiofrequency

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Şükriye Dadalı, MD; Phone Number: +905333316636; Email: sukriyedadali@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Recruiting
    • Ankara Bilkent City Hospital
    • Contact: Sukriye Dadali, MD; Phone Number: +905333316636; Email: sukriyedadali@gmail.com
    • Contact: Şükriye Dadalı, MD; Phone Number: +905333316636; Email: sukriyedadali@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1- Standard Treatment (Group A1); 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; 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.
Experimental: Arm 2: Primary GONPRF (Group B); 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; GONPRF applied at C2 under ultrasound guidance in addition to standard care, starting at enrollment. Follow-up at 1, 3, and 6 months.
Experimental: Arm 3: Modified GONPRF (Group A2); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 1 month, 3 months, and 6 months
Headache Duration (hours)	Average duration of each headache attack in hours.	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).	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.	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.	Baseline, 1 month, 3 months, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GONPRF Treatment Side (Unilateral/Bilateral)	Side of the greater occipital nerve treated during the pulsed radiofrequency procedure, recorded as left, right, or bilateral.	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.	From the time of the GONPRF procedure through study completion (up to 6 months).

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Gosalia H, Moreno-Ajona D, Goadsby PJ. Medication-overuse headache: a narrative review. J Headache Pain. 2024 May 31;25(1):89. doi: 10.1186/s10194-024-01755-w.
• Ashina S, Terwindt GM, Steiner TJ, Lee MJ, Porreca F, Tassorelli C, Schwedt TJ, Jensen RH, Diener HC, Lipton RB. Medication overuse headache. Nat Rev Dis Primers. 2023 Feb 2;9(1):5. doi: 10.1038/s41572-022-00415-0.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 10, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Medication Overuse Headache; Occipital Nerve Pulsed Radiofrequency; Headache Treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: E2-25-12241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing is not planned due to national regulations regarding patient data confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No