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NCT Number: NCT06322407

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

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.

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Key information

Conditions

Chronic Migraine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Stellate Ganglion Block (SGB)

Procedure

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)

standardized drug treatment

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Jan 17, 2025

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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