New combo shot may cut migraine days in half
NCT ID NCT06653218
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether injecting lidocaine plus platelet-rich plasma into a nerve cluster in the neck works better than lidocaine alone for chronic migraine. 200 adults with frequent migraines took part. The main goal was to see if the combo reduced monthly headache days more than the standard treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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200 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
We speculate that the reduction value in monthly headache days after PRP combined lidocaine acting on SGB is expected to 2.0, and the standard deviation (SD) for the PRP group is 9.0. Assuming a 20% rate of loss to follow-up and an additional 40% loss after PSM, a total of 200 participants will provide 90% power to use a 0.05 two tailed alpha to detect the significant difference in the monthly headache days. Three participating centers will compete to enroll patients.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fang Luo
Beijing, Beijing Municipality, 100070, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Migraine relief may sharpen the mind: study investigates cognitive benefits of preventive therapies