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

NCT07360782 | Recruiting DMC

• 1 other identifier: E2-25-12241
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Overuse Headache

Keywords

Medication Overuse Headache; Occipital Nerve Pulsed Radiofrequency; Headache Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Monthly Headache Days - 1 and 6 Months

  Baseline, 1 month, and 6 months

• Monthly Acute Medication Use Days

  Baseline, 1 month, 3 months, and 6 months

• Headache Pain Intensity (Numeric Rating Scale, NRS)

  Baseline, 1 month, 3 months, and 6 months

• Headache Duration (hours)

  Baseline, 1 month, 3 months, and 6 months

• Headache Impact Test-6 (HIT-6) Score

  Baseline, 1 month, 3 months, and 6 months

Other Outcomes (2)

• GONPRF Treatment Side (Unilateral/Bilateral)

  During the GONPRF procedure (Day 1 of intervention)

• Adverse Events Related to GONPRF

  From the time of the GONPRF procedure through study completion (up to 6 months).

Study Arms (3)

Arm 1- Standard Treatment (Group A1)

EXPERIMENTAL

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

Arm 2: Primary GONPRF (Group B)

EXPERIMENTAL

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

Arm 3: Modified GONPRF (Group A2)

EXPERIMENTAL

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

Interventions

Standard care OTHER

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.

Arm 1- Standard Treatment (Group A1)

Greater Occipital Nerve Pulsed Radiofrequency PROCEDURE

GONPRF applied at C2 under ultrasound guidance in addition to standard care, starting at enrollment. Follow-up at 1, 3, and 6 months.

Arm 2: Primary GONPRF (Group B); Arm 3: Modified GONPRF (Group A2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 38816828 BACKGROUND

• 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.

  PMID: 36732518 BACKGROUND

MeSH Terms

Conditions

Headache Disorders, Secondary

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Şükriye Dadalı, MD

CONTACT

+905333316636; sukriyedadali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, care providers, investigators, or outcome assessors are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Medicine (Algology) specialist

Model Details: Participants are initially randomized in a parallel design to receive either standard treatment alone or standard treatment plus greater occipital nerve pulsed radiofrequency (GONPRF). An adaptive second stage is applied at the 1-month assessment, in which participants who do not respond adequately to standard treatment receive GONPRF as a second-line intervention, while follow-up continues in parallel groups.

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 22, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)