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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara City Hospital Bilkent

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Greater Occipital Nerve Pulsed Radiofrequency

    Procedure/Surgery

    GONPRF 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 intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Arm 1- Standard Treatment (Group A1)Experimental treatment 1 intervention
Group B: Arm 2: Primary GONPRF (Group B)Experimental treatment 1 intervention
Group C: Arm 3: Modified GONPRF (Group A2)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline to 3 months

Secondary outcomes

1

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
2

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
3

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
4

Headache Duration (hours)

Average duration of each headache attack in hours.

Time frame
Baseline, 1 month, 3 months, and 6 months

Other outcomes

1

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)
2

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).

Sponsors and contacts

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