The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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；
Disqualifiers
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;
Trial design
Treatments tested in this trial
- No interventions
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Qinghai People's Hospital
Collaborator
Source ClinicalTrials.gov