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NCT06653218 | RECRUITING | Platelet-rich Plasma

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

Beijing Tia N-hospital

Information provided by (Responsible Party):

fang luo

Brief Summary:

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.

Condition or disease

Platelet-rich Plasma

Chronic Migraine

Intervention/treatment

No interventions

Not have interventions

Detailed Description:

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
Official 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
Actual Study Start Date : 2024-10-20
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age between 18 to 75 years;
  • 2. BMI between 15 and 35 kg/m2 ;
  • 3. 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);
  • 4. Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4;
  • 5. Scheduled for lidocaine acting on SGB treatment for CM；
  • 6. Signed informed consent.
Exclusion Criteria
  • 1. Previously received SGB treatment;
  • 2. Combined with other types of headaches;
  • 3. Platelet count \<105\*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
  • 4. Infection or mass near the puncture site;
  • 5. A history of other neurological disorders;
  • 6. A history of severe cardiopulmonary, hepatic or renal dysfunction;
  • 7. A history of psychological disorders;
  • 8. A history of narcotic drug abuse;
  • 9. Changes in neck anatomic structure caused by radiotherapy or surgery;
  • 10. A history of allergies to any research drugs;
  • 11. Pregnancy or lactation period.
Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine

Location Details

NCT06653218

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Locations

RECRUITING

China, Beijing Municipality

fang luo

Beijing, Beijing Municipality, China, 100070