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NCT Number: NCT06653218

Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine

This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fang Luo

Beijing, Beijing Municipality, 100070, China

About this study

Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 to 75 years;
  • BMI between 15 and 35 kg/m2 ;
  • Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211);
  • Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4;
  • Scheduled for lidocaine acting on SGB treatment for CM;
  • Signed informed consent.

Exclusion criteria

  • Previously received SGB treatment;
  • Combined with other types of headaches;
  • Platelet count <105*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
  • Infection or mass near the puncture site;
  • A history of other neurological disorders;
  • A history of severe cardiopulmonary, hepatic or renal dysfunction;
  • A history of psychological disorders;
  • A history of narcotic drug abuse;
  • Changes in neck anatomic structure caused by radiotherapy or surgery;
  • A history of allergies to any research drugs;
  • Pregnancy or lactation period.

Treatment and study plan

No interventions

Other

It is a observational study

Not have interventions

Other

It is a observational study

Primary outcomes

  1. the change from baseline in mean headache days across the 1-month follow-up period.

    Time frame: 1-month period

    the change from baseline in mean headache days across the 1-month follow-up period.

Secondary outcomes

  1. 50% responder rate

    Time frame: at weeks 4, 8, 12.

    the proportion of patients who achieved a ≥50% reduction in monthly headache days.

  2. Mean VAS score during headache attack

    Time frame: at baseline and weeks 4, 8, 12.

    evaluation of the average severity of headache days

  3. Analgesic consumption

    Time frame: at baseline and weeks 4, 8, 12.

    including the number of days, the specific drug used, and the dose of drugs.

  4. Patient satisfaction (PS) scores

    Time frame: at weeks 4, 8, 12.

    It ranges from 0 to 10 points, and 0 indicates unsatisfactory, while 10 points indicate very satisfactory.A higher scores mean a better satisfaction

  5. Headache impact test version 6 (HIT-6)

    Time frame: at baseline and weeks 4, 8,12.

    a six-item survey that assesses the adverse impact of headaches on social, role and cognitive functioning, vitality, and psychological distress.A larger score reflects a greater adverse impact. It ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent

  6. Migraine disability assessment (MIDAS) scores

    Time frame: at baseline and weeks 4, 8, 12.

    to evaluate headache-related disability using 4-week recall, and is associated with headache frequency and average pain score.The score ranges from 0 to 270. Higher scores indicate greater disability caused by headaches with scores of 21 or greater considered severe.

  7. Hospital anxiety and depression scale (HADS) scores

    Time frame: at baseline and weeks 4, 8, 12.

    a 14-item self-report instrument used to screen for anxiety and depression separately.The range of the scale is 0 to 21, with scores of 8 to 10 being indicative of a probable risk of anxiety or depression, whereas scores of 11 to 21 indicate a high risk of anxiety or depression

  8. Pittsburgh sleep quality index (PSQI) scores

    Time frame: at baseline and weeks 4, 8, 12

    a 19-item self-report instrument that comprises 7 components used to assess quality of sleep. The range of the scale is 0 to 21,with a higher score indicating more severe sleep disturbances.

  9. Adverse events

    Time frame: at day 0, 1, weeks 1, 4, 8, 12

    • including SGB-related complication and medication-related complication.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Qinghai People's Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine: a Protocol of a Multi-center, Prospective, Propensity Score-matched, Cohort Analysis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Feb 12, 2026

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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