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Recruiting NCT06322407

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

No phase Interventional Chronic Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stellate Ganglion Block (SGB), standardized drug treatment.
Who it may be relevant to
Registry conditions: Chronic Migraine. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • the change from baseline in mean monthly migraine days [Time frame: 6-month period]
Secondary outcome measures (8)
  • 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]
  • Total effective rate [Time frame: 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]
  • Patients satisfaction (PS) [Time frame: 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 Migraine Disability Assessment score(MIDAS) [Time frame: 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]
  • 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]

Eligibility criteria

Inclusion criteria

  • Age from 18 to 65 years;
  • Diagnosed with CM according to the International Classification of Headache Disorders, 3rd (ICHD-3) criteria \[Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211\].
  • 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

  • BMI <15 kg/m2 or >35 kg/m2；
  • Previous SGB treatment；
  • History of other neurological disorders；
  • History of severe cardiopulmonary, hepatic or renal dysfunction；
  • History of allergies to any of the study drugs；
  • Patients with chronic use of opioids；
  • Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 time normal value)；
  • Infection or mass near the puncture site；
  • Neck anatomic structural changes (caused by radiotherapy or surgery);
  • Pregnant or breast feeding;
  • Psychological disorders;
  • Refusal to sign informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06322407 · KY2023-263-03-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗