Status:
RECRUITING
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Qinghai People's Hospital
Conditions:
Infraorbital Neuralgia
Platelet-rich Plasma
Eligibility:
All Genders
18-75 years
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 tr...
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 (PR...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06492213
Start Date
July 1 2024
End Date
July 1 2027
Last Update
February 21 2025
Active Locations (1)
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1
Fang Luo
Beijing, Beijing Municipality, China, 100070