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.