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

Recruiting

• Conditions: Trigeminal Neuralgia, Idiopathic; PRP
• Interventions: Procedure: PRF+PRP, PRF

• Registration Number: NCT06472323
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-25
• Study Start: 2024-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PRF+PRP	PRF+PRP, PRF	The puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately 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, 2 ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve.
PRF	PRF+PRP, PRF	The puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately 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.

Primary Outcome Measures

Name	Time	Method
The response rate of treatment	After 12 months	Patients with BNI scores of I to III were considered to respond to treatment (Table 2).

Secondary Outcome Measures

Name	Time	Method
Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)	After 1, 3, 6, and 12 months following the procedure	Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
BNI scores	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
The response rate of treatment	1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure	The response rate of treatment
Anticonvulsant consumption	After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure	Dose of carbamazepine or oxcarbazepine

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University in Beijing; 🇨🇳 Beijing, Beijing, China