Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult

Last updated: January 15, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Migraine (Adult)

Oral Facial Pain

Migraine And Cluster Headaches

Treatment

Stellate Ganglion Block (SGB)

standardized drug treatment

Clinical Study ID

NCT06322407
KY2023-263-03-02
  • Ages 18-65
  • All Genders

Study Summary

To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age from 18 to 65 years;

  2. Diagnosed with CM according to the International Classification of HeadacheDisorders, 3rd (ICHD-3) criteria [Headache Classification Committee of theInternational Headache Society (IHS). The International Classification of HeadacheDisorders, 3rd edition. Cephalalgia. 2018;38:1-211].

  3. not received prior prophylactic migraine treatment or, due to lack of efficacy ortolerability, had failed or had not been suitable for up to three previousprophylactic treatments from the following: Metoprolol/propranolol, amitriptyline,and flunarizine.

Exclusion

Exclusion Criteria:

  1. BMI <15 kg/m2 or >35 kg/m2;

  2. Previous SGB treatment;

  3. History of other neurological disorders;

  4. History of severe cardiopulmonary, hepatic or renal dysfunction;

  5. History of allergies to any of the study drugs;

  6. Patients with chronic use of opioids;

  7. Preoperative coagulation abnormalities (activated partial thromboplastin timegreater than 1.5 time normal value);

  8. Infection or mass near the puncture site;

  9. Neck anatomic structural changes (caused by radiotherapy or surgery);

  10. Pregnant or breast feeding;

  11. Psychological disorders;

  12. Refusal to sign informed consent.

Study Design

Total Participants: 206
Treatment Group(s): 2
Primary Treatment: Stellate Ganglion Block (SGB)
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
December 01, 2025

Study Description

The investigators aim to investigate whether the stellate ganglion block(SGB) is better than traditional medication treatment and provides medical evidence for the clinical application and promotion of SGB to provide a minimally invasive, safe, and effective treatment for patients with chronic migraine(CM) who failed to receive standardized drug treatment.

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, Beijing 100050
    China

    Active - Recruiting

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