Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472323
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-10
Brief Title:
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
The Efficacy and Safety of Pulsed RadiofrequencyPRF Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None