The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia

Launched by BEIJING TIANTAN HOSPITAL · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for trigeminal neuralgia (TN), a condition that causes severe, sharp facial pain. Researchers want to find out if combining pulsed radiofrequency (PRF) with platelet-rich plasma (PRP) is more effective than using PRF alone. PRP is derived from your own blood and contains healing properties that may help reduce pain and promote nerve repair. The trial aims to see if this combination can provide better relief for patients who have not found success with standard medications like carbamazepine or oxcarbazepine.

To participate in the trial, you should be between 18 and 75 years old and have a confirmed diagnosis of TN, experiencing significant pain that hasn't improved with usual treatments. You’ll need to agree to participate and sign a consent form. If you have certain medical conditions or a history of specific treatments or medications that might interfere with the study, you may not be eligible. Participants will receive either the combined treatment or PRF alone and will be followed for 12 months to track their pain levels and overall health. This trial is currently recruiting, and it's a chance to explore a potential new option for managing TN pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The diagnosis of TN was established according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (1).
• • 2. Aged 18 to 75 years.
• • 3. Had a score of at least 4 on a Numeric Rating Scale (NRS-11) (NRS; range, 0-10; higher scores indicate more severe pain) and could't be alleviated effectively by means of conservative medical therapy, such as carbamazepine, oxcarbazepine.
• • 4. Agreed to sign the informed consent form.
• Exclusion Criteria:
• • 1. Patients presenting classic TN or secondary TN (i.e., multiple sclerosis).
• • 2. Infection at the site of needle entry or systemic infecting.
• • 3. A history of psychiatric disease.
• • 4. Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest x-ray.
• • 5. Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (New York Heart Association grade II-III).
• • 6. A history of abuse of narcotics.
• • 7. A history of receiving CRF to the Gasserian ganglion or peripheral branches, glycerol rhizolysis, balloon compression, Gamma knife, or any other neuroablative treatments.
• • 8. A history of receiving microvascular decompression.
• • 9. Use of anticoagulants or antiplatelet agent, eg. acetylsalicylic acid.