NCT06472323 The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia
| NCT ID | NCT06472323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Trigeminal Neuralgia, Idiopathic |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2024-08-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 activating hemostatic cascade reaction, synthesizing new connective tissue and vascular reconstruction, to initiate tissue repair processes. Autologous platelet-rich plasma (PRP) is the processed liquid fraction of autologous peripheral blood with a platelet concentration above the baseline. Studies have shown that it can reduce inflammation and promote nerve repair so it has also shown broad prospects in treating neuropathic pain. In 2012, Doss AX. published a case report indicated that PRP might be effective in TN treatment. In 2023, a randomized controlled study showed that CT-guided PRF combined with PRP can effectively treat postherpetic neuralgia (PHN), and the therapeutic effect is better than that of traditional PRF combined with glucocorticoid therapy in patients with PHN, which is similar to TN in pathology. Thus, we suppose that PRF combined with PRP might show better effectiveness than PRF alone for TN and conducted a prospective trail comparing the clinical efficacy and safety of PRP combined with PRF versus PRF alone. This study is designed as a prospective cohort study, open-label study with a 12 months follow-up period, to compare the efficacy of PRF combined with PRP versus PRP alone for TN treatment.
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.
Frequently Asked Questions
Who can join the NCT06472323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Trigeminal Neuralgia, Idiopathic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06472323 currently recruiting?
Yes, NCT06472323 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Tiantan Hospital to inquire about joining.
Where is the NCT06472323 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06472323 clinical trial?
NCT06472323 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 270 participants.