Chronic Migraine Headache, Headache, Migraine
Conditions
Keywords
Migraine, Stellate Ganglion, Nerve Blockade, ultrasonography guided
Brief summary
Stellate Ganglion Block (SGB) is an interventional anesthetic technique used to treat pain conditions affecting the head, face, neck, and upper extremities by temporarily blocking sympathetic nerve output. Ultrasound guidance improves anatomical visualization and facilitates accurate needle placement. Emerging evidence suggests that repeated ultrasound-guided SGB may be associated with reductions in headache intensity and frequency in patients with migraine and with improvement in migraine-related disability. However, limited data exist regarding its use in highly treatment-resistant chronic migraine, particularly in patients who have not responded adequately to preventive pharmacological therapies and prior interventional treatments. The primary objective of this study is to evaluate 6-month clinical outcomes following ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary objectives include assessing changes in pain intensity, migraine-related disability, analgesic use, patient-reported global improvement, and treatment tolerability.
Detailed description
Migraine is a common neurological disorder, and approximately 8% of patients develop chronic migraine (CM), defined as headache occurring on 15 or more days per month for more than three months, with at least 8 days fulfilling migraine criteria. Chronic migraine is associated with substantial disability and reduced quality of life. In patients who do not respond adequately to preventive pharmacological therapies, interventional procedures such as greater occipital nerve blocks, sphenopalatine ganglion blocks, pulsed radiofrequency procedures, and botulinum toxin injections may be considered. However, a subset of patients continues to experience persistent and disabling symptoms despite these interventions. The stellate ganglion is formed by the fusion of the inferior cervical and first thoracic sympathetic ganglia and plays a key role in cervical sympathetic outflow. Stellate ganglion block (SGB) involves the injection of local anesthetic around the stellate ganglion to temporarily inhibit sympathetic activity. Ultrasound guidance allows real-time visualization of anatomical structures, reduces the risk of vascular injury, and avoids radiation exposure. In this study, SGB is performed under sterile conditions with continuous monitoring and real-time ultrasound guidance. A linear ultrasound probe is positioned at the level of the sixth cervical vertebra to identify relevant anatomical structures. A 22-gauge, 90-mm needle is advanced using an in-plane technique, and 5 mL of 1% lidocaine is administered after confirming correct placement. For participants with bilateral headache distribution, bilateral blocks were performed sequentially with a minimum 60-minute interval between sides. The primary aim of the study is to evaluate 6-month clinical outcomes following ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary aims include evaluation of pain intensity, headache-related disability, analgesic use, patient-reported global improvement, and tolerability outcomes. The original study protocol was approved on 6 March 2024 (TABED 2-24-33) and initially specified follow-up through 3 months. The study was retrospectively registered at ClinicalTrials.gov (NCT06891118); the initial registration was submitted on 6 March 2025 and first posted on 24 March 2025. A formal protocol amendment was submitted on 30 October 2025, while follow-up data collection was ongoing and before statistical analysis, to extend follow-up from 3 to 6 months and to define the final assessment time points as months 1, 3, and 6. The amendment was approved by the institutional ethics committee on 26 November 2025 (TABED 2-25-1653). The ClinicalTrials.gov record was subsequently updated to reflect the approved 6-month follow-up and the primary outcome, defined as change in Monthly Headache Days from baseline to 6 months.
Interventions
PROCEDUREProcedure/Surgery: Ultrasound-Guided Stellate Ganglion Block
Ultrasound-guided SGB was performed under sterile conditions with intravenous access and continuous monitoring. With the patient in the supine position, a linear ultrasound probe was placed transversely at the C6 level to identify the longus colli muscle, prevertebral fascia, carotid artery, internal jugular vein, thyroid gland, and adjacent vascular structures. A 22-gauge, 90-mm needle was advanced using an in-plane lateral-to-medial approach toward the prevertebral fascia anterior to the longus colli muscle. After negative aspiration and confirmation of needle position, 5 mL of 1% lidocaine was administered. For bilateral headache distribution, bilateral blocks were performed sequentially with a minimum 60-minute interval between sides.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-center, prospective, uncontrolled, single-group interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years. * Diagnosis of chronic migraine according to ICHD-3 criteria. * Insufficient clinical response to prior preventive migraine treatment. * Prior interventional headache treatment performed at least 3 months before enrollment, with insufficient clinical benefit. * Willingness and ability to participate in the study, comply with follow-up, and undergo the planned interventional treatment.
Exclusion criteria
* History of a primary headache disorder other than migraine. * Migraine-related interventional treatment, botulinum toxin A treatment, or nonpharmacological headache treatment (e.g., acupuncture, ozone therapy, or cognitive behavioral therapy) within the previous 3 months. * Infection at the planned injection site. * Pregnancy or suspected pregnancy. * Known allergy to local anesthetic agents. * History of malignancy or cranial/cervical surgery. * Bleeding or coagulation disorder, or current oral anticoagulant therapy. * Comorbid conditions that could contribute to headache, such as uncontrolled hypertension or intracranial lesions. * Conditions that could impair adherence to the treatment or follow-up protocol, such as significant psychiatric disease or dementia. * Unwillingness to undergo the planned interventional treatment or to continue the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Monthly Headache Days (MHD) | Baseline to 6 months | Change in the number of Monthly Headache Days from baseline to 6 months. A headache day was defined as a calendar day on which headache lasted continuously for at least 4 hours and reached at least moderate intensity, or on which acute medication was used to treat headache regardless of headache duration or intensity. Monthly headache information was collected using patient headache follow-up forms and structured patient-reported information obtained at scheduled follow-up visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) pain score | Baseline, 1 month, 3 months, and 6 months | The Visual Analog Scale (VAS) was used to assess headache pain intensity on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants reported both average and peak headache pain intensity at each assessment. |
| Number of Days Requiring Analgesic Use | Baseline, 1 month, 3 months, and 6 months | The number of days per month in which participants used analgesic medication for headache relief. Analgesic-use information was collected using patient headache follow-up forms and structured patient-reported information obtained at scheduled follow-up visits. |
| The Global Perceived Effect (GPE) | 1 month, 3 months, and 6 months | The Global Perceived Effect (GPE) scale is a patient-reported measure assessing overall perceived change compared with baseline. Participants rated their overall treatment response on a 7-point ordinal scale ranging from 1 (very much worsened) to 7 (very much improved). Clinically meaningful improvement was defined as a GPE score ≥6. |
| Headache Impact Test (HIT-6) Score | Baseline, 1 month, 3 months, and 6 months | The Headache Impact Test (HIT-6) is a validated 6-item questionnaire assessing the impact of headache on daily functioning. Total scores range from 36 to 78, with higher scores indicating greater headache-related disability. Changes in HIT-6 scores over time were evaluated. |
| Migraine Disability Assessment (MIDAS) Score | Baseline, 3 months, and 6 months | The Migraine Disability Assessment (MIDAS) questionnaire evaluates headache-related disability over the preceding three months. Higher scores indicate greater disability. Changes in MIDAS scores over time were assessed. |
Countries
Turkey (Türkiye)
Outcome results
None listed