Medication Overuse HeadachePRIMOGONNCT07360782
Personalized Pulsed Radiofrequency of the Greater Occipital Nerve for Medication Overuse Headache
A study testing Greater Occipital Nerve Pulsed Radiofrequency in people with Medication Overuse Headache, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medication Overuse Headache
- What is being tested?
- Greater Occipital Nerve Pulsed Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Sukriye Dadali, MD, +905333316636, sukriyedadali@gmail.com
Şükriye Dadalı, MD, +905333316636, sukriyedadali@gmail.com
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Medication Overuse Headache
- Being tested
- Greater Occipital Nerve Pulsed Radiofrequency, Standard care
- Keywords
- Medication Overuse Headache, Occipital Nerve Pulsed Radiofrequency, Headache Treatment
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greater Occipital Nerve Pulsed RadiofrequencyProcedure or 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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Greater Occipital Nerve Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 3 months, and 6 months
Headache Duration (hours)
Average duration of each headache attack in hours.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start26 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication Overuse HeadacheStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şükriye Dadalı, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360782
- Sponsor's protocol ID
- E2-25-12241
- Acronym
- PRIMOGON
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not planned due to national regulations regarding patient data confidentiality.
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.
PubMed 38816828Ashina 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.
PubMed 36732518
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Application of Occipital Nerve Pulsed Radiofrequency in Medication Overuse Headache: A Randomized Controlled Evaluation
- ClinicalTrials.gov ID
- NCT07360782
- Acronym / sponsor ID
- PRIMOGON / E2-25-12241
- Conditions
- Medication Overuse Headache
- Keywords
- Medication Overuse Headache, Occipital Nerve Pulsed Radiofrequency, Headache Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Standard Treatment (Group A1) | Experimental | Other: Standard careIntervention 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. |
| Arm 2: Primary GONPRF (Group B) | Experimental | Procedure: Greater Occipital Nerve Pulsed RadiofrequencyIntervention 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. |
| Arm 3: Modified GONPRF (Group A2) | Experimental | Procedure: Greater Occipital Nerve Pulsed RadiofrequencyIntervention 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greater Occipital Nerve Pulsed RadiofrequencyGONPRF applied at C2 under ultrasound guidance in addition to standard care, starting at enrollment. Follow-up at 1, 3, and 6 months. | Procedure or surgery | Arm 2: Primary GONPRF (Group B), Arm 3: Modified GONPRF (Group A2) |
| Standard careLimitation 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 | Arm 1- Standard Treatment (Group A1) |
Primary outcome
Change in Monthly Headache Days
Time frame: Baseline to 3 months
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.
7 secondary outcomes
Monthly Headache Days - 1 and 6 Months
Time frame: Baseline, 1 month, and 6 months
Monthly Acute Medication Use Days
Time frame: Baseline, 1 month, 3 months, and 6 months
Headache Pain Intensity (Numeric Rating Scale, NRS)
Time frame: Baseline, 1 month, 3 months, and 6 months
Headache Duration (hours)
Time frame: Baseline, 1 month, 3 months, and 6 months
Headache Impact Test-6 (HIT-6) Score
Time frame: Baseline, 1 month, 3 months, and 6 months
Migraine Disability Assessment (MIDAS) Grade
Time frame: Baseline, 3 months, and 6 months
Global Perceived Effect (GPE) Score
Time frame: Baseline, 1 month, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 38816828Gosalia 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.
- Background: PubMed 36732518Ashina 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.
- Individual participant dataSharing planned: No. IPD sharing is not planned due to national regulations regarding patient data confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greater Occipital Nerve Pulsed Radiofrequency in people with Medication Overuse Headache, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şükriye Dadalı, MD (+905333316636, sukriyedadali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Monthly Headache Days (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07360782, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.