The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia

Официальное название

Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое No interventions
  It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.

Первичные конечные точки

• The 1-year response rate [Срок оценки: 12-month period]

Вторичные конечные точки (6)

• Response rate [Срок оценки: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
• Dosage of carbamazepine [Срок оценки: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
• Numeric rating scale (NRS) score of pain [Срок оценки: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
• Patients' quality of life (QOL) [Срок оценки: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
• Patient satisfaction scores (PSS） [Срок оценки: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation]
• Adverse events (AEs) [Срок оценки: at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fang Luo — Пекин

Идентификаторы

NCT: NCT06492213 · KY2023-263-03-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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