Beijing Tiantan Hospital, Capital Medical University in Beijing
Beijing, Beijing Municipality, China
Location status: Recruiting
NCT Number: NCT06472323
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Beijing, Beijing Municipality, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion of the patient. After puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve and PRF group only receive PRF treatment.
Time frame: After 12 months
Patients with BNI scores of I to III were considered to respond to treatment (Table 2).
Time frame: day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
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
Time frame: 1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure
The response rate of treatment
Time frame: After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure
Dose of carbamazepine or oxcarbazepine
Time frame: After 1, 3, 6, and 12 months following the procedure
Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Beijing Tiantan Hospital
Other
The Efficacy and Safety of Pulsed Radiofrequency(PRF) Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia
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