Using lidocaine and platelet-rich plasma to treat chronic migraines
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
This study is testing whether combining lidocaine with platelet-rich plasma can help people with chronic migraines feel better compared to just using lidocaine alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06653218 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, observational study aims to evaluate the effectiveness and safety of combining lidocaine with platelet-rich plasma (PRP) in treating chronic migraine through stellate ganglion block (SGB). The study will compare this combination treatment to lidocaine alone in patients diagnosed with chronic migraine. Participants will be assessed for pain relief and side effects, with a focus on those scheduled for SGB treatment. The study employs a propensity score matching design to ensure balanced comparison between the two treatment groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of chronic migraine and a high pain score.
Not a fit: Patients who have previously received SGB treatment or have other types of headaches may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and safer treatment option for patients suffering from chronic migraines.
How similar studies have performed: While previous studies have shown the efficacy of SGB with lidocaine, the combination with PRP is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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≥7; 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.
Where this trial is running
Beijing, Beijing
- Fang Luo — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Fang Luo, M.D. — Beijing Tiantan Hospital
- Study coordinator: Lu Liu, M.D.
- Email: emmaliulu@163.com
- Phone: +8618618418228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.