The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
- Conditions
- Infraorbital NeuralgiaPlatelet-rich Plasma
- Interventions
- Other: No interventions
- Registration Number
- NCT06492213
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PRP+PRF No interventions 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. PRF alone No interventions 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.
- Primary Outcome Measures
Name Time Method The 1-year response rate 12-month period cases responding to treatment/total number of cases\*100%
- Secondary Outcome Measures
Name Time Method Numeric rating scale (NRS) score of pain at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation 0 representing no pain and 10 representing the most severe pain imaginable
Adverse events (AEs) at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment. such as dizziness, facial swelling, facial ecchymoma, eye injury, infection, etc
Response rate at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation cases responding to treatment/total number of cases\*100%
Dosage of carbamazepine at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation dosage of carbamazepine
Patients' quality of life (QOL) at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation 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')
Patient satisfaction scores (PSS） at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation 0 point indicates unsatisfactory, while 10 points indicate the most satisfactory
Trial Locations
- Locations (1)
Fang Luo
🇨🇳Beijing, Beijing, China