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

January 15, 2025 updated by: Fang Luo, Beijing Tiantan Hospital

A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age from 18 to 65 years;
  2. Diagnosed with CM according to the International Classification of Headache Disorders, 3rd (ICHD-3) criteria [Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211].
  3. not received prior prophylactic migraine treatment or, due to lack of efficacy or tolerability, had failed or had not been suitable for up to three previous prophylactic treatments from the following: Metoprolol/propranolol, amitriptyline, and flunarizine.

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 time greater 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stellate Ganglion Block plus standardized drug treatment group
Besides orally topiramate plus ibuprofen as standardized drug treatment, patients will also receive SGBs plus standardized drug therapy; SGB will be performed once a week for 4 consecutive times in an individual series. The interval of each separate SGB procedure is 1 week. Every time patients with bilateral headache will be administered SGB alternately on each side at an interval of 40 min, and patients with unilateral headache will be administered SGB on the ipsilateral side;
Procedure: Stellate Ganglion Block (SGB)
All SGB procedures will be performed by the same experienced physicians. Patients will be positioned in a supine position with the neck slightly hyperextended and receive a SGB procedure using the B-ultrasound visualization technique (Aurora A5 Ultrasound, Risco Tech Co., Ltd.). 1% lidocaine 5mL (Shanxi Jinxin Shuanghe Pharm Co., Ltd.) will be injected below the prevertebral fascia on the surface of longus colli muscle
Other Names:
  • Ultrasound-guided Stellate Ganglion Block (SGB)
Drug: standardized drug treatment
Topiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache.
Other Names:
  • topiramate plus ibuprofen
Active Comparator: standardized drug treatment group
The patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM.
Drug: standardized drug treatment
Topiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache.
Other Names:
  • topiramate plus ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change from baseline in mean monthly migraine days
Time Frame: 6-month period
The primary outcome is the change from baseline in mean monthly (defined as 4 weeks) migraine days across 6-months follow-up period, which will be assessed by a blinded independent central review (BICR). Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A migraine day is defined as a calendar day with symptoms of a migraine attack lasting at least 30 min.
6-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieved≥50% reduction in monthly migraine days
Time Frame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Proportion of patients achieved≥50% reduction
1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Total effective rate
Time Frame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Total effective rate = cure rate + markedly effective rate + effective rate
1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The mean Numeric Rating Scale(NRS) score during headache attack
Time Frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The Numeric Rating Scale(NRS) scoring method typically uses a score range of 0-10, with 0 indicating no pain or symptoms and 10 indicating the most severe pain or symptoms.
at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Patients satisfaction (PS)
Time Frame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Patients satisfaction (PS) evaluated by PS scores, which typically uses a score range of 0-10, with 0 indicating no patient satisfaction and 10 indicating the most patient satisfaction.
1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The six item headache impact test (HIT-6)
Time Frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The six item headache impact test (HIT-6) is a self-reported questionnaire measuring the "impact that headaches have on the ability to function on the job, at school, at home, and in social situations.
at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
the Migraine Disability Assessment score(MIDAS)
Time Frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
MIDAS is a reliable and validated scale measuring migraine-related disability regarding the need for medical care.. Higher MIDAS scores indicate more days with disability
at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
PSQI is a self-administered assessment of sleep disturbances that may affect sleep quality, including sleep apnoea, with a higher score indicating more severe sleep disturbances.
at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
adverse events
Time Frame: at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Proportion of participants with adverse events (AEs) and serious adverse events
at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-263-03-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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