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

Official title

The Efficacy and Safety of Pulsed Radiofrequency(PRF) Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia

Overview

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.

Interventions

• Procedure PRF+PRP, PRF
  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

Primary outcome measures

• The response rate of treatment [Time frame: After 12 months]

Secondary outcome measures (4)

• BNI scores [Time frame: day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure]
• The response rate of treatment [Time frame: 1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure]
• Anticonvulsant consumption [Time frame: 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) [Time frame: After 1, 3, 6, and 12 months following the procedure]

Eligibility criteria

Inclusion criteria

• The diagnosis of TN was established according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (1).
• Aged 18 to 75 years.
• 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.
• Agreed to sign the informed consent form.

Exclusion criteria

• Patients presenting classic TN or secondary TN (i.e., multiple sclerosis).
• Infection at the site of needle entry or systemic infecting.
• A history of psychiatric disease.
• Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest x-ray.
• Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (New York Heart Association grade II-III).
• A history of abuse of narcotics.
• A history of receiving CRF to the Gasserian ganglion or peripheral branches, glycerol rhizolysis, balloon compression, Gamma knife, or any other neuroablative treatments.
• A history of receiving microvascular decompression.
• Use of anticoagulants or antiplatelet agent, eg. acetylsalicylic acid.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Beijing Tiantan Hospital, Capital Medical University in Beijing — Beijing

Publications

• Ren H, Zhao C, Wang X, Shen Y, Meng L, Luo F. The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-Temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia: Study Protocol for a Prospective, Open-Label, Parall. Pain Physician. 2021 Jan;24(1):89-97. PMID 33400432
• Jia Y, Cheng H, Shrestha N, Ren H, Zhao C, Feng K, Luo F. Effectiveness and safety of high-voltage pulsed radiofrequency to treat patients with primary trigeminal neuralgia: a multicenter, randomized, double-blind, controlled study. J Headache Pain. 2023 Jul 18;24(1):91. doi: 10.1186/s10194-023-01629-7. PMID 37464283
• Luo F, Wang T, Shen Y, Meng L, Lu J, Ji N. High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study. Pain Physician. 2017 May;20(4):271-279. PMID 28535550
• Chong MS, Bahra A, Zakrzewska JM. Guidelines for the management of trigeminal neuralgia. Cleve Clin J Med. 2023 Jun 1;90(6):355-362. doi: 10.3949/ccjm.90a.22052. PMID 37263669
• Bendtsen L, Zakrzewska JM, Heinskou TB, Hodaie M, Leal PRL, Nurmikko T, Obermann M, Cruccu G, Maarbjerg S. Advances in diagnosis, classification, pathophysiology, and management of trigeminal neuralgia. Lancet Neurol. 2020 Sep;19(9):784-796. doi: 10.1016/S1474-4422(20)30233-7. PMID 32822636
• Fan X, Fu Z, Ma K, Tao W, Huang B, Guo G, Huang D, Liu G, Song W, Song T, Xiao L, Xia L, Liu Y. Chinese expert consensus on minimally invasive interventional treatment of trigeminal neuralgia. Front Mol Neurosci. 2022 Jul 28;15:953765. doi: 10.3389/fnmol.2022.953765. eCollection 2022. PMID 35966020
• Abd-Elsayed A, Martens JM, Fiala KJ, Izuogu A. Pulsed Radiofrequency for the Treatment of Trigeminal Neuralgia. Curr Pain Headache Rep. 2022 Dec;26(12):889-894. doi: 10.1007/s11916-022-01092-0. Epub 2022 Nov 15. PMID 36378398
• Luo F, Meng L, Wang T, Yu X, Shen Y, Ji N. Pulsed radiofrequency treatment for idiopathic trigeminal neuralgia: a retrospective analysis of the causes for ineffective pain relief. Eur J Pain. 2013 Sep;17(8):1189-92. doi: 10.1002/j.1532-2149.2012.00278.x. Epub 2013 Jan 16. PMID 23322665

Identifiers

NCT: NCT06472323 · KY2023-263-03-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗