Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492213
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a multicenter prospective observational propensity score matching cohort and assessor-blinded study designed to compare the effectiveness and safety of PRP injections combined with PRF treatment with PRF alone in patients with IONa who are responded poorly to conventional therapies and are reluctant to receive destructive therapies for seeking a better minimally invasive treatment strategy
Detailed Description:
Infraorbital neuralgia IONa is one of a rare but devastating type of facial pain and lack of current consensus on the management Previously we have proved the efficacy of pulsed radiofrequency PRF in treatment of IONa However refractory patients have not received more ideal treatment until now Platelet-rich plasma PRP as supraphysiological concentration of platelets can provide prolonged neuropathic pain relief with almost no complications To date the efficacy of PRP combined with PRF in the treatment of IONa has not yet been proved We will conduct this multicenter prospective observational propensity score matching cohort and assessor-blinded study to evaluate the efficacy and safety of PRP combined with PRF in treating refractory IONa patients who were reluctant to receive destructive therapies
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