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

NCT ID: NCT06492213

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-07-01

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.

Conditions

Infraorbital Neuralgia; Platelet-rich Plasma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PRP+PRF

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.

No interventions

Intervention Type: OTHER

It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.

PRF alone

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.

No interventions

Intervention Type: OTHER

It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.

Interventions

No interventions

It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Qinghai People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director of Department of Day surgery and Pain Management Affiliation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luo Fang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Fang Luo

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Liu, M.D.

Role: CONTACT

emmaliulu@163.com

+8618618418228

Facility Contacts

Fang Luo

Role: primary

13611326978@163.com

59976661

Other Identifiers

KY2023-263-03-03

Identifier Type: -

Identifier Source: org_study_id