Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The 1-year response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The 1-year response rate
时间窗: 12-month period
cases responding to treatment/total number of cases\*100%
次要结局
- Numeric rating scale (NRS) score of pain(at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation)
- Adverse events (AEs)(at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.)
- Response rate(at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation)
- Dosage of carbamazepine(at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation)
- Patients' quality of life (QOL)(at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation)
- Patient satisfaction scores (PSS）(at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation)
研究者
Fang Luo
Director of Department of Day surgery and Pain Management Affiliation
Beijing Tiantan Hospital