Department of Anesthesiology and Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Anesthesiology, Beijing Sanbo Brian Hospital, Capital Medical University, Beijing, China.
BMJ Open. 2019 Mar 23;9(3):e026608. doi: 10.1136/bmjopen-2018-026608.
Single-centre reports on small groups of patients have shown that pterygopalatine ganglion pulsed radiofrequency treatment in patients with refractory cluster headache (CH) can quickly relieve pain without significant side effects. However, a randomised controlled trial is still necessary to evaluate whether pterygopalatine ganglion pulsed radiofrequency (PRF) treatment is a viable treatment option for patients with CH who are not responding to drug treatment.
This investigation is a multicentre, prospective, randomised, controlled, blinded-endpoint study. We will enrol 80 patients with CH who are not responding to medication. The enrolled patients will be randomly divided into two groups: the nerve block (NB) group and the PRF group. All patients will undergo CT-guided pterygopalatine ganglion puncture. A mixture containing steroids and local anaesthetics will be slowly injected into the patients in the NB group. The patients in the PRF group will be treated with PRF at 42°C for 360 s. After treatment, the duration of cluster periods; degree of pain during headache attacks; frequency of headache attacks; duration of each headache attack; dose of auxiliary analgesic drugs; duration of remission; degree of patient satisfaction; effectiveness rates at 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after the procedure; and intraoperative and postoperative adverse events will be compared between the two groups.
This study was approved by the institutional ethics committee of the Beijing Tiantan Hospital (approval number: KY 2018-027-02). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.
NCT03567590; Pre-results.
一些单中心的小样本研究显示，翼腭神经节脉冲射频治疗药物难治性丛集性头痛（CH）可迅速缓解疼痛，且无明显副作用。然而，仍需要随机对照试验来评估对于药物治疗无效的 CH 患者，翼腭神经节脉冲射频（PRF）治疗是否是一种可行的治疗选择。
本研究是一项多中心、前瞻性、随机、对照、盲终点研究。我们将招募 80 例药物治疗无效的 CH 患者。入组患者将随机分为神经阻滞（NB）组和 PRF 组。所有患者均行 CT 引导下翼腭神经节穿刺。NB 组缓慢注入含皮质类固醇和局麻药的混合物，PRF 组在 42°C 下治疗 360s。治疗后，比较两组患者的丛集期持续时间、头痛发作时的疼痛程度、头痛发作频率、每次头痛发作持续时间、辅助镇痛药物剂量、缓解持续时间、患者满意度、术后 1 天、3 天、1 周、2 周、1 个月、3 个月、6 个月和 1 年时的有效率；以及术中及术后不良事件。
本研究已获得首都医科大学附属北京天坛医院伦理委员会的批准（编号：KY 2018-027-02）。研究结果将发表在同行评议的期刊上，并在科学会议上展示。
NCT03567590；预注册。
