跳至主要内容
临床试验/NCT06472323
NCT06472323招募中不适用

The Efficacy and Safety of Pulsed Radiofrequency(PRF) Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
270
试验地点
1
主要终点
The response rate of treatment

研究概览

简要总结

Trigeminal neuralgia (TN), characterized by brief, recurrent paroxysms of lancinating pain in the distribution of 1 or more branches of the trigeminal nerve (fifth cranial nerve [CNV]), is one of the most common, severe forms of neuropathic pain. Current standard of care for TN is the sodium channel blockers such as carbamazepine or oxcarbazepine. Surgical treatments involve percutaneous procedures, stereotactic radiosurgery and open surgical treatment. Each of these treatments have drawback. In recent years, pulsed radiofrequency (PRF) has been shown to be a promising treatment option for TN. But it was reported that the long-term outcomes of PRF was not satisfactory. Thus, there is an overwhelming need for finding a safe, nondestructive treatment option that is more effective for TN. PRP releases a variety of bioactive factors and adhesion proteins, which are responsible for activating hemostatic cascade reaction, synthesizing new connective tissue and vascular reconstruction, to initiate tissue repair processes. Autologous platelet-rich plasma (PRP) is the processed liquid fraction of autologous peripheral blood with a platelet concentration above the baseline. Studies have shown that it can reduce inflammation and promote nerve repair so it has also shown broad prospects in treating neuropathic pain. In 2012, Doss AX. published a case report indicated that PRP might be effective in TN treatment. In 2023, a randomized controlled study showed that CT-guided PRF combined with PRP can effectively treat postherpetic neuralgia (PHN), and the therapeutic effect is better than that of traditional PRF combined with glucocorticoid therapy in patients with PHN, which is similar to TN in pathology. Thus, we suppose that PRF combined with PRP might show better effectiveness than PRF alone for TN and conducted a prospective trail comparing the clinical efficacy and safety of PRP combined with PRF versus PRF alone. This study is designed as a prospective cohort study, open-label study with a 12 months follow-up period, to compare the efficacy of PRF combined with PRP versus PRP alone for TN treatment.

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

入选标准

  • The diagnosis of TN was established according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (1).
  • Aged 18 to 75 years.
  • Had a score of at least 4 on a Numeric Rating Scale (NRS-11) (NRS; range, 0-10; higher scores indicate more severe pain) and could't be alleviated effectively by means of conservative medical therapy, such as carbamazepine, oxcarbazepine.
  • Agreed to sign the informed consent form.

排除标准

  • Patients presenting classic TN or secondary TN (i.e., multiple sclerosis).
  • Infection at the site of needle entry or systemic infecting.
  • A history of psychiatric disease.
  • Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest x-ray.
  • Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (New York Heart Association grade II-III).
  • A history of abuse of narcotics.
  • A history of receiving CRF to the Gasserian ganglion or peripheral branches, glycerol rhizolysis, balloon compression, Gamma knife, or any other neuroablative treatments.
  • A history of receiving microvascular decompression.
  • Use of anticoagulants or antiplatelet agent, eg. acetylsalicylic acid.

结局指标

主要结局

The response rate of treatment

时间窗: After 12 months

Patients with BNI scores of I to III were considered to respond to treatment (Table 2).

次要结局

  • Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)(After 1, 3, 6, and 12 months following the procedure)
  • BNI scores(day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure)
  • The response rate of treatment(1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure)
  • Anticonvulsant consumption(After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Luo

Director of Department of Day surgery and Pain Management Affiliation: Beijing Tiantan Hospital

Beijing Tiantan Hospital

研究点 (1)

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