RecruitingNCT06492213

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


Sponsor

Beijing Tiantan Hospital

Enrollment

240 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

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Interventions

OTHERNo interventions

It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.


Locations(1)

Fang Luo

Beijing, Beijing Municipality, China

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NCT06492213