Combining pulsed radiofrequency with platelet-rich plasma for treating trigeminal neuralgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of combining pulsed radiofrequency (PRF) with platelet-rich plasma (PRP) for patients suffering from trigeminal neuralgia (TN), a severe form of neuropathic pain. The approach aims to provide a non-destructive treatment option that may improve long-term outcomes compared to existing therapies. Patients aged 18 to 75 with TN that is not effectively managed by standard medications will be included. The study will assess pain relief and overall patient satisfaction following the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tiantan Hospital, Capital Medical University in Beijing
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.