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Completed

NCT Number: NCT06891118

Stellate Ganglion Blockade for Refractory Chronic Migraine

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University, Ankara Bilkent City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18- 65 years of age, diagnosed with chronic migraine in accordance with ICHD-3 criteria,
  • used migraine preventive medication drugs and
  • other interventional algologic treatments that have been applied at least three months ago with insufficient benefit are volunteer patients.

Exclusion criteria

  • Migraine according to ICHD-3 criteria has a history of primary headache other than migraine,
  • migraine preventive interventional treatment within the last 3 months and/or botulinum toxin A, nonpharmacological treatment (acupuncture, ozone, cognitive behavioral therapy, etc.),
  • injection infection at the site,
  • pregnancy or suspected pregnancy,
  • known allergy to local anesthetic drugs with a history of malignancy or cranial/cervical surgery,
  • bleeding-coagulation disorder or oral anticoagulants,
  • comorbid diseases that may cause headache (uncontrolled hypertension, intracranial lesions),
  • with diseases that may prevent compliance with treatment (psychiatric disorder, dementia) and
  • patients who did not accept the planned interventional treatment were excluded from the study will be released.

Treatment and study plan

Stellate gangion blockade %1 5 mL

Procedure

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

Primary outcomes

  1. Change in Monthly Headache Days (MHD)

    Time frame: Baseline to 6 months

    Change in the number of Monthly Headache Days from baseline to 6 months, as recorded using prospective patient headache diaries.

Secondary outcomes

  1. Visual Analog Scale (VAS) pain score

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

  2. Number of Days Requiring Analgesic Use

    Time frame: Baseline, 1 month, 3 months, and 6 months

    The number of days per month in which participants required analgesic medication for headache relief, recorded using patient headache diaries.

  3. The Global Perceived Effect (GPE)

    Time frame: 1 month, 3 months, and 6 months

    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.

  4. Headache Impact Test (HIT-6) Score

    Time frame: 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.

  5. Migraine Disability Assessment (MIDAS) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Ultrasound-Guided Stellate Ganglion Block for Refractory Chronic Migraine: A Prospective Evaluation

Acronym: SGB-RCM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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