Combining pulsed radiofrequency with platelet-rich plasma for treating trigeminal neuralgia
The Efficacy and Safety of Pulsed Radiofrequency(PRF) Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia
This study is testing whether combining pulsed radiofrequency with platelet-rich plasma can help people with trigeminal neuralgia find better pain relief when standard medications aren't working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06472323 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of combining pulsed radiofrequency (PRF) with platelet-rich plasma (PRP) for patients suffering from trigeminal neuralgia (TN), a severe form of neuropathic pain. The approach aims to provide a non-destructive treatment option that may improve long-term outcomes compared to existing therapies. Patients aged 18 to 75 with TN that is not effectively managed by standard medications will be included. The study will assess pain relief and overall patient satisfaction following the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of trigeminal neuralgia who have not found relief from standard medications.
Not a fit: Patients with classic or secondary trigeminal neuralgia, serious systemic diseases, or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective and safer option for managing trigeminal neuralgia pain.
How similar studies have performed: While pulsed radiofrequency has shown promise in treating trigeminal neuralgia, the combination with platelet-rich plasma is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital, Capital Medical University in Beijing — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.