Chronic Migraine HeadachePhase 4NCT07763678
Efficacy of Ultrasound-Guided Combined Greater Occipital Nerve Block and Greater Auricular Nerve Block Versus Greater Occipital Nerve Block Alone in the Management of Chronic Migraine
A Phase 4 study testing greater occipital nerve block and Greater Auricular Nerve Block in people with Chronic Migraine Headache, run by Assiut University.
Trial summary
Migraine is one of the most prevalent neurological disorders worldwide and remains a leading cause of disability, particularly among individuals of working age. Chronic migraine affects approximately 1-2% of the global population and is associated with substantial impairment in quality of life, reduced work… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine Headache
- What is being tested?
- greater occipital nerve block and Greater Auricular Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Phase 4
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 aged ≥18 years.
- Diagnosis of chronic migraine according to ICHD-3 criteria (1).
- Patients free from major neurological or psychiatric disorders that may interfere with headache assessment or study participation (3,4).
- Ability to provide written informed consent and comply with study procedures.
Who cannot join
- Age <18 years.
- Medication-overuse headache according to ICHD-3 criteria .
- Acute migraine medication use within 24 hours before intervention .
- Previous trauma or surgery involving the occipital region .
- Known hypersensitivity to local anesthetic agents.
- Local skin infection, dermatological disease, or impaired occipital sensation at the injection site.
- Bleeding diathesis, anticoagulan؛t therapy, or skull defect contraindicating peripheral nerve block .
About this study
Migraine is one of the most prevalent neurological disorders worldwide and remains a leading cause of disability, particularly among individuals of working age. Chronic migraine affects approximately 1-2% of the global population and is associated with substantial impairment in quality of life, reduced work productivity, and increased healthcare utilization . Despite recent advances in migraine management, including calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies and gepants, many patients continue to experience inadequate symptom control, treatment intolerance, or limited access to these therapies . Consequently, peripheral nerve blocks have emerged as effective non-pharmacological treatment options for patients with refractory migraine and other primary headache disorders .
Among the available interventional techniques, the greater occipital nerve block (GONB) is one of the most widely used procedures for both acute and preventive treatment of migraine. The therapeutic effect of GONB is believed to result from modulation of nociceptive transmission within the trigeminocervical complex, thereby reducing central sensitization and interrupting convergence between cervical and trigeminal afferents. Several randomized clinical trials and systematic reviews have demonstrated that GONB significantly reduces headache intensity, headache frequency, analgesic consumption, and migraine-related disability while maintaining an excellent safety profile .
Read more
Migraine pain often involves overlapping sensory territories supplied by interconnected peripheral nerves. The greater auricular nerve (GAN), a superficial sensory branch of the cervical plexus arising from the C2 and C3 spinal nerves, supplies the skin over the parotid region, mastoid process, lower auricle, and angle of the mandible . Because cervical sensory afferents converge with trigeminal nociceptive pathways within the trigeminocervical complex, the GAN may contribute to peripheral nociceptive transmission involved in migraine pathophysiology . Combined blockade of multiple cervical sensory nerves may therefore provide broader interruption of peripheral nociceptive input, potentially enhancing analgesic efficacy and reducing central sensitization . Ultrasound-guided GONB has been shown to produce greater procedural accuracy and consistent clinical outcomes than landmark-guided techniques .
Despite the increasing use of peripheral nerve blocks in headache medicine, evidence regarding the additional benefit of combining a greater auricular nerve block with the standard greater occipital nerve block remains limited. To the best of our knowledge, no prospective randomized double-blind clinical trial has directly compared ultrasound-guided combined GONB and GAN block with GONB alone in patients with chronic migraine.
- Conditions
- Chronic Migraine Headache
- Being tested
- greater occipital nerve block, Greater Auricular Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
greater occipital nerve blockProcedure or surgery
The greater occipital nerve will be identified between the obliquus capitis inferior and semispinalis capitis muscles at the C2 level. An in-plane lateral-to-medial approach will be used. Following negative aspiration, the study solution will be injected around the nerve under real-time ultrasound guidance
Greater Auricular Nerve BlockProcedure or surgery
the greater auricular nerve will be identified superficially over the sternocleidomastoid muscle at the level of the cricoid cartilage. Using an in-plane approach and after negative aspiration, the study solution will be injected circumferentially around the nerve under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| GONB group | Active comparator | Patients will receive bilateral ultrasound-guided greater occipital nerve block using a standardized ultrasound-guided technique Receives: Procedure: greater occipital nerve block |
| GONB + GAN group | Active comparator | Patients will receive bilateral ultrasound-guided combined greater occipital nerve block and greater auricular nerve block. Ultrasound guidance will be used to optimize needle placement, improve local anesthetic distribution, and minimize complications Receives: Procedure: greater occipital nerve block; Procedure: Greater Auricular Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) pain score
change in Visual Analog Scale (VAS) pain score .the Visual Analogue Scale (VAS) for pain is a continuous 10-centimeter (100 mm) line with word anchors at each end. The left side reads "no pain" (0) and the right side reads "worst imaginable pain" (10 or 100). Patients make a mark on the line to show their pain level
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
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 Assiut UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Ahmed Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763678
- Sponsor's protocol ID
- GONB VS GANChronic Migraine
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No