Chronic Migraine HeadacheGONBLOCK-RCTNCT07497646
Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache
A study testing Bupivacaine, Normal Saline (0.9% NaCl) and Greater occipital nerve blockade in people with Chronic Migraine Headache and Chronic Tension-type Headache, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine Headache, Chronic Tension-type Headache
- What is being tested?
- Bupivacaine, Normal Saline (0.9% NaCl) and Greater occipital nerve blockade
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Diagnosis of chronic migraine or chronic tension-type headache according to International Classification of Headache Disorders (ICHD-3) criteria
- History of headache for at least 3 months prior to enrollment
- Ability to provide written informed consent
- Willingness to comply with study procedures and follow-up visits
Who cannot join
- Secondary headache disorders
- Previous greater occipital nerve blockade within the last 3 months
- Known allergy or contraindication to bupivacaine
- Local infection at the injection site
- Coagulation disorders or ongoing anticoagulant therapy that contraindicates injection procedures
- Severe uncontrolled systemic disease
- Pregnancy or breastfeeding
- Participation in another clinical trial within the previous 30 days
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Research and Training Hospital
Istanbul, Istanbul
About this study
Official title: Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited.
Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period.
The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited.
Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period.
The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
- Being tested
- Bupivacaine, Normal Saline (0.9% NaCl), Greater occipital nerve blockade
- Keywords
- Chronic Tension-Type Headache, Greater Occipital Nerve Block, Chronic Headache, Bupivacaine, Migraine Treatment, Peripheral Nerve Block
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Bupivacaine hydrochloride, 0.5% bupivacaine
0.5% bupivacaine administered as bilateral greater occipital nerve blockade. Injections were performed using 1.5 mL per side (total 3 mL per session). The procedure was repeated weekly during the first month and monthly during the following two months, resulting in a total of six injections.
Normal Saline (0.9% NaCl)Drug
Also called Sodium chloride, Normal saline, 0.9% NaCl
0.9% sodium chloride (normal saline) administered as placebo injections for bilateral greater occipital nerve blockade using the same injection volume (1.5 mL per side, total 3 mL) and schedule as the active treatment group.
Greater occipital nerve blockadeProcedure or surgery
Bilateral greater occipital nerve blockade performed using the standard injection technique described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine GON Blockade | Experimental | Participants received bilateral greater occipital nerve blockade with 0.5% bupivacaine (1.5 mL per side). Injections were administered weekly during the first month and monthly during the following two months, resulting in six injections over a three-month period. Receives: Drug: Bupivacaine; Procedure: Greater occipital nerve blockade |
| Placebo GON Blockade | Placebo comparator | Participants received bilateral greater occipital nerve blockade with placebo injections consisting of 0.9% normal saline (1.5 mL per side), following the same injection schedule as the active treatment group. Receives: Drug: Normal Saline (0.9% NaCl); Procedure: Greater occipital nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in monthly number of headache days assessed using patient-reported daily headache diary
Change from baseline in the number of monthly headache days recorded using a patient-reported daily headache diary. A headache day is defined as any calendar day with headache lasting ≥4 hours or requiring acute medication.
Measured: Baseline and Month 1
Secondary outcomes (4)
Change from baseline in pain intensity measured using the Visual Analog Scale (VAS) for pain
Change from baseline in pain intensity measured using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: Baseline and Month 3
Change from baseline in total monthly headache duration (hours) assessed using patient-reported daily headache diary
Change from baseline in total monthly headache duration (hours), calculated from patient-reported daily headache diaries as the cumulative number of hours with headache per month.
Measured: Baseline and Month 3
Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire
Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire. Scores range from 0 to 270, with higher scores indicating greater disability.
Measured: Baseline and Month 3
Incidence of treatment-emergent adverse events (TEAEs)
The number and proportion of participants experiencing treatment-emergent adverse events (TEAEs), assessed through clinical evaluation and patient self-report. Adverse events were categorized by severity and relationship to the intervention.
Measured: Up to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2025
- Primary completion30 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- The study was conducted as a double-blind trial. Participants, treating physicians, investigators, and outcome assessors were blinded to treatment allocation. Active and placebo injections were prepared in identical syringes to maintain blinding.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Neurological Society
- Responsible party
- Principal investigator, NAZLI GAMZE BÜLBÜL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497646
- Sponsor's protocol ID
- GON-RCT-2022
- Acronym
- GONBLOCK-RCT
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07497646
- Acronym / sponsor ID
- GONBLOCK-RCT / GON-RCT-2022
- Keywords
- Chronic Tension-Type Headache, Greater Occipital Nerve Block, Chronic Headache, Bupivacaine, Migraine Treatment, Peripheral Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Turkish Neurological Society
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 27 Mar 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 multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited.
Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period.
The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited.
Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period.
The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was conducted as a double-blind trial. Participants, treating physicians, investigators, and outcome assessors were blinded to treatment allocation. Active and placebo injections were prepared in identical syringes to maintain blinding.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine GON Blockade | Experimental | Drug: Bupivacaine, Procedure: Greater occipital nerve blockadeParticipants received bilateral greater occipital nerve blockade with 0.5% bupivacaine (1.5 mL per side). Injections were administered weekly during the first month and monthly during the following two months, resulting in six injections over a three-month period. |
| Placebo GON Blockade | Placebo comparator | Drug: Normal Saline (0.9% NaCl), Procedure: Greater occipital nerve blockadeParticipants received bilateral greater occipital nerve blockade with placebo injections consisting of 0.9% normal saline (1.5 mL per side), following the same injection schedule as the active treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years or older
- Diagnosis of chronic migraine or chronic tension-type headache according to International Classification of Headache Disorders (ICHD-3) criteria
- History of headache for at least 3 months prior to enrollment
- Ability to provide written informed consent
- Willingness to comply with study procedures and follow-up visits
Key exclusion criteria (8 listed)
- Secondary headache disorders
- Previous greater occipital nerve blockade within the last 3 months
- Known allergy or contraindication to bupivacaine
- Local infection at the injection site
- Coagulation disorders or ongoing anticoagulant therapy that contraindicates injection procedures
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 |
|---|---|---|
| BupivacaineAlso: Bupivacaine hydrochloride, 0.5% bupivacaine0.5% bupivacaine administered as bilateral greater occipital nerve blockade. Injections were performed using 1.5 mL per side (total 3 mL per session). The procedure was repeated weekly during the first month and monthly during the following two months, resulting in a total of six injections. | Drug | Bupivacaine GON Blockade |
| Normal Saline (0.9% NaCl)Also: Sodium chloride, Normal saline, 0.9% NaCl0.9% sodium chloride (normal saline) administered as placebo injections for bilateral greater occipital nerve blockade using the same injection volume (1.5 mL per side, total 3 mL) and schedule as the active treatment group. | Drug | Placebo GON Blockade |
| Greater occipital nerve blockadeBilateral greater occipital nerve blockade performed using the standard injection technique described in the protocol. | Procedure or surgery | Bupivacaine GON Blockade, Placebo GON Blockade |
Primary outcome
Change from baseline in monthly number of headache days assessed using patient-reported daily headache diary
Time frame: Baseline and Month 1
Change from baseline in the number of monthly headache days recorded using a patient-reported daily headache diary. A headache day is defined as any calendar day with headache lasting ≥4 hours or requiring acute medication.
4 secondary outcomes
Change from baseline in pain intensity measured using the Visual Analog Scale (VAS) for pain
Time frame: Baseline and Month 3
Change from baseline in total monthly headache duration (hours) assessed using patient-reported daily headache diary
Time frame: Baseline and Month 3
Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire
Time frame: Baseline and Month 3
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Normal Saline (0.9% NaCl) and Greater occipital nerve blockade in people with Chronic Migraine Headache and Chronic Tension-type Headache, run by Saglik Bilimleri Universitesi 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Mar 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in monthly number of headache days assessed using patient-reported daily headache diary (time frame: Baseline and Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.