The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia
NCT Number: NCT06472323
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Trigeminal Neuralgia, Idiopathic|PRP
Interventions: PROCEDURE: PRF+PRP, PRF
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-09-30

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.

Primary Outcome Measures: The response rate of treatment, Patients with BNI scores of I to III were considered to respond to treatment (Table 2)., After 12 months
Secondary Outcome Measures: BNI scores, I No pain, off medications II Occasional pain, off medications IIIa No pain, continued use of medications IIIb Pain persists, but adequately controlled with medications IV Pain not adequately controlled with medications V No relief, day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure|The response rate of treatment, The response rate of treatment, 1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure|Anticonvulsant consumption, Dose of carbamazepine or oxcarbazepine, After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure|Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), After 1, 3, 6, and 12 months following the procedure