Stellate Ganglion Blockade for Refractory Chronic Migraine

NCT06891118 | Completed DMC

• 1 other identifier: TABED-2-24-33
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Migraine Headache; Headache, Migraine

Keywords

Migraine, Stellate Ganglion, Nerve Blockade; ultrasonography guided

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 months

Secondary Outcomes (5)

• Visual Analog Scale (VAS) pain score

  Baseline, 1 month, 3 months, and 6 months

• Number of Days Requiring Analgesic Use

  Baseline, 1 month, 3 months, and 6 months

• The Global Perceived Effect (GPE)

  1 month, 3 months, and 6 months

• Headache Impact Test (HIT-6) Score

  Baseline, 1 month, 3 months, and 6 months

• Migraine Disability Assessment (MIDAS) Score

  Baseline, 3 months, and 6 months

Study Arms (1)

SGB blockade patients

EXPERIMENTAL

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.

Procedure: Stellate gangion blockade %1 5 mL

Interventions

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

SGB blockade patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Health Sciences University, Ankara Bilkent City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Related Links

• Yu B, Zhang W, Zhao C, Xing Y, Meng L, Luo F. Effectiveness, safety, and predictors of response to ultrasound-guided stellate ganglion blockades for the treatment of patients with chronic migraine: A retrospective and observational study. Pain Pract.2023
• Yu B, Hou S, Xing Y, Jia Z, Luo F. Ultrasound-guided stellate ganglion block for the treatment of migraine in elderly patients: A retrospective and observational study. Headache. 2023; 63:763-770. doi:10.1111/head.14537.

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: A single-center, prospective, cross-sectional observational study

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 24, 2025
• Study Start: March 6, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)