Actively Recruiting
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia
Led by Beijing Tiantan Hospital · Updated on 2025-04-01
270
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of trigeminal neuralgia according to International Classification of Headache Disorders, 3rd edition (ICHD-3)
- Age between 18 and 75 years
- Pain score of at least 4 on Numeric Rating Scale (NRS-11) not relieved effectively by medications such as carbamazepine or oxcarbazepine
- Signed informed consent form
You will not qualify if you...
- Having classic trigeminal neuralgia or secondary trigeminal neuralgia (e.g., due to multiple sclerosis)
- Infection at the needle entry site or systemic infection
- History of psychiatric disease
- Abnormal results in routine blood tests, liver, kidney, coagulation function, electrocardiogram, or chest x-ray
- Serious systemic diseases like uncontrolled hypertension, diabetes, or cardiac dysfunction (New York Heart Association grade II-III)
- History of narcotics abuse
- Previous neuroablative treatments to the Gasserian ganglion or nerve branches
- Previous microvascular decompression surgery
- Use of anticoagulants or antiplatelet agents such as acetylsalicylic acid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University in Beijing
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here