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 enhances procedural safety. Emerging evidence suggests that repeated ultrasound-guided SGB may reduce headache intensity and frequency in migraine patients and may improve migraine-related disability. However, limited data exist regarding its role in highly treatment-resistant chronic migraine, particularly in patients who have not responded adequately to preventive pharmacological therapies and peripheral nerve block interventions. The primary objective of this study is to evaluate the clinical efficacy of ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary objectives include assessing changes in migraine-related disability and monitoring potential adverse events.
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 25-gauge needle is advanced using an in-plane technique, and 5 mL of 1% lidocaine is administered after confirming correct placement. For bilateral headache, alternating bilateral applications are performed with an interval between sides. The primary aim of the study is to evaluate the effect of ultrasound-guided SGB on Monthly Headache Days in patients with treatment-resistant chronic migraine. Secondary aims include evaluation of pain intensity, headache-related disability, analgesic use, patient-reported global improvement, and safety outcomes. The protocol was amended with institutional ethics committee approval prior to completion of data analysis to extend follow-up to six months and to redefine the primary outcome as change in Monthly Headache Days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
SGB is performed under sterile conditions in the operating room, with the patient's intravenous line established, monitored during the procedure, and ultrasound guidance used simultaneously. The patient is positioned supine, with the neck slightly hyperextended and the head slightly turned to the opposite side. After the skin is cleaned with an antiseptic solution and the probe is sterilized, a linear ultrasound probe is placed transversely at the level of the sixth cervical vertebra (C6). The relevant anatomical landmarks, including the internal carotid artery, internal jugular vein, thyroid tissue, longus colli muscle, prevertebral fascia, C6 transverse process (Chassaignac's tubercle), C6 nerve root, and vertebral artery, are visualized. Avoiding vascular structures and thyroid tissue, a 25-gauge 38 mm sterile needle is advanced with a lateral approach using the in-plane technique, ensuring the needle tip is just below the surface of the longus colli m
Health Sciences University, Ankara Bilkent City Hospital
Ankara, Cankaya, Turkey (Türkiye)
Change in Monthly Headache Days (MHD)
Change in the number of Monthly Headache Days from baseline to 6 months, as recorded using prospective patient headache diaries.
Time frame: Baseline to 6 months
Visual Analog Scale (VAS) pain score
The Visual Analog Scale (VAS) is a 10-cm horizontal line used to assess headache pain intensity, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants rated their average headache pain intensity at each follow-up visit.
Time frame: Baseline, 1 month, 3 months, and 6 months
Number of Days Requiring Analgesic Use
The number of days per month in which participants required analgesic medication for headache relief, recorded using patient headache diaries.
Time frame: Baseline, 1 month, 3 months, and 6 months
The Global Perceived Effect (GPE)
The Global Perceived Effect (GPE) scale is a patient-reported measure assessing overall perceived improvement compared to baseline. Participants rated their overall treatment response on a 7-point ordinal scale ranging from 1 (no improvement or worsening) to 7 (complete improvement). Treatment response was defined as a GPE score ≥6.
Time frame: 1 month, 3 months, and 6 months
Headache Impact Test (HIT-6) Score
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.
Time frame: Baseline, 1 month, 3 months, and 6 months
Migraine Disability Assessment (MIDAS) Score
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.
Time frame: Baseline, 3 months, and 6 months
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