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

Recruitingn/aAges 18 Years - 75 YearsAllBeijing Tiantan Hospital
NCT06472323 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Trigeminal neuralgia (TN), characterized by brief, recurrent paroxysms of lancinating pain in the distribution of 1 or more branches of the trigeminal nerve (fifth cranial nerve \[CNV\]), is one of the most common, severe forms of neuropathic pain. Current standard of care for TN is the sodium channel blockers such as carbamazepine or oxcarbazepine. Surgical treatments involve percutaneous procedures, stereotactic radiosurgery and open surgical treatment. Each of these treatments have drawback. In recent years, pulsed radiofrequency (PRF) has been shown to be a promising treatment option for TN. But it was reported that the long-term outcomes of PRF was not satisfactory. Thus, there is an overwhelming need for finding a safe, nondestructive treatment option that is more effective for TN. PRP releases a variety of bioactive factors and adhesion proteins, which are responsible for activati

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📋 Eligibility rules (as published)
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.
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What it tests

  • PRF+PRP, PRF
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Where

1 site
Beijing Tiantan Hospital, Capital Medical University in Beijing
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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