Combining pulsed radiofrequency and platelet-rich plasma for treating facial pain
Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
This study is testing whether combining a special type of injection with a new pain treatment can help people with stubborn facial pain who haven't found relief from other methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06492213 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, observational study aims to evaluate the effectiveness and safety of combining platelet-rich plasma (PRP) injections with pulsed radiofrequency (PRF) treatment for patients suffering from refractory infraorbital neuralgia (IONa). The study focuses on individuals who have not responded well to conventional therapies and are seeking a minimally invasive treatment option. Participants will be assessed for pain relief and safety outcomes, with a particular emphasis on those reluctant to undergo more destructive therapies. The study employs a propensity score matching approach to ensure balanced comparisons between treatment groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with severe infraorbital neuralgia who have not found relief from standard treatments.
Not a fit: Patients with certain blood disorders, severe organ dysfunction, or a history of destructive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective, and minimally invasive treatment option for patients suffering from refractory infraorbital neuralgia.
How similar studies have performed: While the efficacy of pulsed radiofrequency has been previously established, the combination with platelet-rich plasma for this specific condition is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Fang Luo — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Luo Fang, M.D. — Beijing Tiantan Hospital
- Study coordinator: Lu Liu, M.D.
- Email: emmaliulu@163.com
- Phone: +8618618418228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.