The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No interventions.
- Who it may be relevant to
- Registry conditions: Infraorbital Neuralgia, Platelet-rich Plasma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
Overview
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
- Other No interventions
It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.
Primary outcome measures
- The 1-year response rate [Time frame: 12-month period]
Secondary outcome measures (6)
- Response rate [Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
- Dosage of carbamazepine [Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
- Numeric rating scale (NRS) score of pain [Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
- Patients' quality of life (QOL) [Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
- Patient satisfaction scores (PSS） [Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
- Adverse events (AEs) [Time frame: at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fang Luo — Beijing
Identifiers
NCT: NCT06492213 · KY2023-263-03-03