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

Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia

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.

Study Overview

• Status: Recruiting
• Conditions: Platelet-rich Plasma; Infraorbital Neuralgia
• Intervention / Treatment: Other: No interventions

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 Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Lu Liu, M.D.; Phone Number: +8618618418228; Email: emmaliulu@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Fang Luo
      • Contact: Fang Luo; Phone Number: 59976661; Email: 13611326978@163.com
      • Principal Investigator: Lu Liu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Power Analysis and Sample Size (PASS) V.15.0 software (NCSS Corporation, Kaysville, UT, USA) is used to compute the sample size. The results indicate that a study with a power of 80% and two-sided statistical significance level (alpha) of 0.05 would require 64 participants each group. Considering 10% loss to follow-up and an additional 40% loss after propensity score matching, the total sample size of this study will be 237 patients. And we are planning to enroll 240 patients totally considering the convenience of sample collection and statistics

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No interventions; 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.	Other: No interventions; It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 1-year response rate	cases responding to treatment/total number of cases*100%	12-month period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	cases responding to treatment/total number of cases*100%	at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Dosage of carbamazepine	dosage of carbamazepine	at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Numeric rating scale (NRS) score of pain	0 representing no pain and 10 representing the most severe pain imaginable	at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Patient satisfaction scores (PSS）	0 point indicates unsatisfactory, while 10 points indicate the most satisfactory	at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation
Adverse events (AEs)	such as dizziness, facial swelling, facial ecchymoma, eye injury, infection, etc	at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.
Patients' quality of life (QOL)	evaluated by 12-item short-form health survey (SF-12) scores,Response categories vary from 2 to 6 and can be transformed to scale scores ranging from 0 ('the worst') to 100 ('the best')	at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Wuhan Union Hospital, China; Qinghai People's Hospital
• Investigators: Principal Investigator: Luo Fang, M.D., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Infraorbital neuralgia; platelet- rich plasma
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: KY2023-263-03-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No