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

NCT06492213 | Recruiting

• 1 other identifier: KY2023-263-03-03
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Infraorbital Neuralgia; Platelet-rich Plasma

Keywords

Infraorbital neuralgia; platelet- rich plasma

Outcome Measures

Primary Outcomes (1)

• The 1-year response rate

  cases responding to treatment/total number of cases\*100%

  12-month period

Secondary Outcomes (6)

• Response rate

  at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

• 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

  at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

• Patients' quality of life (QOL)

  at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

• Patient satisfaction scores (PSS）

  at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

Study Arms (2)

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

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

Interventions

No interventions OTHER

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

PRF alone; PRP+PRF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age between 18 to 75 years;
• 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;
• NRS score≥7;
• Scheduled for PRF treatment for IONa；
• Signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Qinghai People's Hospital: collaborator

Study Sites (1)

Fang Luo

Beijing, Beijing Municipality, 100070, China

RECRUITING

Study Officials

• Luo Fang, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Liu, M.D.

CONTACT

+8618618418228; emmaliulu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day surgery and Pain Management Affiliation

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)