[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553909":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":53,"collaborators":55,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PRP+PRF",null,"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\u002Flayer, 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.",[13],"Other: No interventions",{"label":15,"type":10,"description":16,"interventionNames":17},"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\u002Flayer, 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.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"No interventions","It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.",[15,9],[24],{"name":25,"affiliation":5,"role":26},"Luo Fang, M.D.","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Lu Liu, M.D.","CONTACT","+8618618418228","emmaliulu@163.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fang Luo","RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49,52],{"name":35,"role":30,"phone":50,"phoneExt":10,"email":51},"59976661","13611326978@163.com",{"name":29,"role":26,"phone":10,"phoneExt":10,"email":10},{"type":26,"investigatorFullName":35,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Director of Department of Day surgery and Pain Management Affiliation",[56,58],{"name":57,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":59,"class":6},"Qinghai People's Hospital","100553909","the-efficacy-and-safety-of-pulsed-radiofrequency-combined-with-platelet-rich-plasma-for-infraorbital-neuralgia-100553909",false,"NCT06492213","The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia","Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia","Inclusion Criteria:\n\n1. Age between 18 to 75 years;\n2. 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;\n3. NRS score≥7;\n4. Scheduled for PRF treatment for IONa；\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. Platelet count \\\u003C105\\*109\u002FL, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders;\n2. Severe cardiopulmonary or hepatorenal dysfunction;\n3. Infection at the puncture site; .\n4. Neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor;\n5. History of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc;\n6. History of mental disorders；\n7. History of narcotic drug abuse;\n8. Unable to cooperation.","ALL","18 Years","75 Years",{"count":71,"type":72},240,"ESTIMATED","OBSERVATIONAL","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.",[76,77],"Infraorbital Neuralgia","Platelet-rich Plasma",[79],"Infraorbital neuralgia; platelet- rich plasma","2025-02-19",{"date":82,"type":83},"2025-02-21","ACTUAL",{"date":85,"type":83},"2024-07-01",{"date":87,"type":72},"2027-07-01",{"name":5,"class":6},1]