Infraorbital Neuralgia, Platelet-rich Plasma
Conditions
Keywords
Infraorbital neuralgia; platelet- rich plasma
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.
Interventions
OTHERNo interventions
It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Qinghai People's Hospital
Beijing Tiantan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 1-year response rate | 12-month period | cases responding to treatment/total number of cases\*100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosage of carbamazepine | at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation | dosage of carbamazepine |
| 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 |
| 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% |
| 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 |
| 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 |
| 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') |
Countries
China
Contacts
Primary ContactLu Liu, M.D.
Outcome results
None listed