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

Capital Medical University

Status: Enrolling

Conditions: Platelet-rich Plasma; Infraorbital Neuralgia

Treatments: Other: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT06492213

KY2023-263-03-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 to 75 years;
2. Paroxysmal or persistent stabbing pain in the distribution area of the infraorbital nerve and positive response to diagnostic block (1 ml of 2% lidocaine) prior to treatment;
3. NRS score≥7;
4. Scheduled for PRF treatment for IONa；
5. Signed informed consent.

Exclusion criteria

1. Platelet count <105*109/L, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders;
2. Severe cardiopulmonary or hepatorenal dysfunction;
3. Infection at the puncture site; .
4. Neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor;
5. History of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc;
6. History of mental disorders；
7. History of narcotic drug abuse;
8. Unable to cooperation.

Trial design

240 participants in 2 patient groups

PRP+PRF

Description:

PRF procedure will be performed at first. Puncture point will be identified at the surface projection point of the infraorbital foramen on the affected side, and after reach the infraorbital foramen under the guidance of thin-slice CT (2 mm/layer, Somaton, Siemens Company, Munich, Germany). The radiofrequency electrode needle (PMK-21-100; Baylis Medical Inc.) will be inserted into the trocar after removal of the the stylet and confirmation of no bleeding or air when withdrawal using a syringe. The standard PRF mode will be initially set at 42℃, then the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the treatment will be continued for 360 seconds. After PRF, the PRF electrode needle will be removed and 2 milliliter PRP will be injected into the same puncture site through the trocar needle.

Treatment:

Other: No interventions

PRF alone

Description:

Puncture point will be identified at the surface projection point of the infraorbital foramen on the affected side, and after reach the infraorbital foramen under the guidance of thin-slice CT (2 mm/layer, Somaton, Siemens Company, Munich, Germany). The radiofrequency electrode needle (PMK-21-100; Baylis Medical Inc.) will be inserted into the trocar after removal of the the stylet and confirmation of no bleeding or air when withdrawal using a syringe. The standard PRF mode will be initially set at 42℃, then the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the treatment will be continued for 360 seconds.

Treatment:

Other: No interventions