中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600122883
最近更新日期： Date of Last Refreshed on：	2026-04-20 10:04:22
注册时间： Date of Registration：	2026-04-20 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	低温等离子射频消融术联合针灸睛明穴、攒竹穴针对三叉神经眼支带状疱疹相关性疼痛治疗的临床疗效观察
Public title：	Clinical Observation on the Therapeutic Effect of Low-Temperature Plasma Radiofrequency Ablation Combined with Acupuncture at Jingming (BL1) and Zanzhu (BL2) Acupoints for Ophthalmic Division Trigeminal Neuralgia Associated with Herpes Zoster
注册题目简写：
English Acronym：
研究课题的正式科学名称：	低温等离子射频消融术联合针灸睛明穴、攒竹穴针对三叉神经眼支带状疱疹相关性疼痛治疗的临床疗效观察
Scientific title：	Clinical Observation on the Therapeutic Effect of Low-Temperature Plasma Radiofrequency Ablation Combined with Acupuncture at Jingming (BL1) and Zanzhu (BL2) Acupoints for Ophthalmic Division Trigeminal Neuralgia Associated with Herpes Zoster
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	冯琳洁	研究负责人：	漆涛
Applicant：	Feng Linjie	Study leader：	Qi Tao
申请注册联系人电话： Applicant telephone：	+86 137 7815 8413	研究负责人电话： Study leader's telephone：	+86 189 8080 0287
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	454988709@qq.com	研究负责人电子邮件： Study leader's E-mail：	407176910@qq.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	四川省成都市金牛区十二桥路39-41号	研究负责人通讯地址：	四川省成都市金牛区十二桥路39-41号
Applicant address：	No. 39-41, Shi'erqiao Road, Jinniu District, Chengdu City, Sichuan Province	Study leader's address：	No. 39-41, Shi'erqiao Road, Jinniu District, Chengdu City, Sichuan Province
申请注册联系人邮政编码： Applicant postcode：	610000	研究负责人邮政编码： Study leader's postcode：	610000
申请人所在单位：	成都中医药大学附属医院
Applicant's institution：	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
研究负责人所在单位：	成都中医药大学附属医院
Affiliation of the Leader：	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2025KL-272-01	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	成都中医药大学附属医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-17 00:00:00
伦理委员会联系人：	何清
Contact Name of the ethic committee：	He Qing
伦理委员会联系地址：	四川省成都市金牛区十二桥路39-41号
Contact Address of the ethic committee：	No. 39-41, Shi'erqiao Road, Jinniu District, Chengdu City, Sichuan Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 28 8776 5900	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

成都中医药大学附属医院

Primary sponsor：

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

四川省成都市金牛区十二桥路39-41号

Primary sponsor's address：

No. 39-41, Shi'erqiao Road, Jinniu District, Chengdu City, Sichuan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	四川省	市(区县)：	成都市
Country：	China	Province：	Sichuan	City：	Chengdu
单位(医院)：	成都中医药大学附属医院	具体地址：	四川省成都市金牛区十二桥路39-41号
Institution hospital：	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Address：	No. 39-41, Shi'erqiao Road, Jinniu District, Chengdu City, Sichuan Province

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

三叉神经眼支带状疱疹相关性疼痛

Target disease：

Herpes zoster-associated pain in the ophthalmic division of the trigeminal nerve

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

本研究旨在探讨低温等离子射频消融术联合针刺在三叉神经眼支带状疱疹相关性疼痛治疗中的疗效及安全性，为临床治疗提供新的思路和方法，同时促进中西医综合治疗带状疱疹相关性疼痛的发展，研究结果可为临床提供治疗带状疱疹相关性疼痛的参考依据，为临床治疗提供更多选择和可能性，也为低温等离子射频消融术联合针刺治疗三叉神经眼支带状疱疹相关性疼痛提供临床操作规范。

Objectives of Study：

This study aims to investigate the efficacy and safety of low-temperature plasma radiofrequency ablation combined with acupuncture in the treatment of herpes zoster-associated pain involving the ophthalmic division of the trigeminal nerve, so as to provide new ideas and methods for clinical practice. Meanwhile, it will promote the development of integrated traditional Chinese and Western medicine in the treatment of herpes zoster-associated pain. The findings can offer a reference basis for clinical management, provide more options and possibilities for clinical treatment, and establish clinical practice guidelines for low-temperature plasma radiofrequency ablation combined with acupuncture in the treatment of herpes zoster-associated pain in the ophthalmic division of the trigeminal nerve.

药物成份或治疗方案详述：

1.患者进入手术室，采取仰卧位，在患者的肩膀后放一枕头，使患者的脖子向后伸展呈45°，常规心电监护，开放上肢静脉通路，经CT扫描定位卵圆孔为等离子穿刺靶点，记号笔标记皮肤穿刺点。 2.面部常规消毒、铺无菌巾，穿刺点予注射1%盐酸利多卡因3ml局部麻醉。在CT引导下，沿定位线穿刺，右手持穿刺针经穿刺点进针，CT扫描定位显示穿刺针针尖位于卵圆孔外口处，拔出穿刺针针芯，用注射器回抽无血液及脑脊液，注入0.9%生理盐水5ml后置入等离子刀头连接主机，电凝档位为3档，行感觉测试，诱发出三叉神经第一支支配区域疼痛，表面刀头位于神经附近，再次CT定位确认穿刺针位于卵圆孔外孔，进行射频消融术，电切10 s，电凝10 s，间歇10 s，重复4次完成后拔出针头。 3.结束后将混合药液（复方倍他米松 5 mg + 1% 利多卡因+0.9%氯化钠注射液混合液）注射约 1ml，在穿刺部位加压、敷料，病人生命体征平稳，无不适主诉，瞳孔对光反射正常，安返病房。 4.针刺睛明穴、攒竹穴：病人取仰卧位，常规酒精消毒，操作者站在病人右侧，嘱病人闭眼，操作者右手持针（一次性使用无菌针灸针 0.25*25mm规格），左手轻推开患者眼球，在目内眦内上方眶内侧壁凹陷中，睛明穴所在紧靠眶缘刺入皮肤，进针约0.5寸；在眉头凹陷中，额切迹处，攒竹穴所在，向眼眶内缘斜刺0.4寸，留针10min后即轻轻拔出，嘱患者用无菌棉签轻压针刺部位片刻，防止出血。 1.患者进入手术室，采取仰卧位，在患者的肩膀后放一枕头，使患者的脖子向后伸展呈45°，常规心电监护，开放上肢静脉通路，经CT扫描定位卵圆孔为等离子穿刺靶点，记号笔标记皮肤穿刺点。 2.面部常规消毒、铺无菌巾，穿刺点予注射1%盐酸利多卡因3ml局部麻醉。在CT引导下，沿定位线穿刺，右手持穿刺针经穿刺点进针，CT扫描定位显示穿刺针针尖位于卵圆孔外口处，病人自觉麻刺感覆盖患侧三叉神经第一支分布区，停止进针，行射频仪测试，参数为50 Hz， 0.3 V，确认刺激区域并精准复制出相应神经支配区症状后予以2%的利多卡因1～2 ml，5 min后行 RFT 治疗。根据病人耐受情况缓慢升温至最高65℃ 并维持3～4 min，完成后拔出针头。 3.结束后将混合药液（复方倍他米松 5 mg + 1% 利多卡因+0.9%氯化钠注射液混合液）注射约 1ml，在穿刺部位加压、敷料，病人生命体征平稳，无不适主诉，瞳孔对光反射正常，安返病房。 4.针刺睛明穴、攒竹穴：病人取仰卧位，常规酒精消毒，操作者站在病人右侧，嘱病人闭眼，操作者右手持针（一次性使用无菌针灸针 0.25*25mm规格），左手轻推开患者眼球，在目内眦内上方眶内侧壁凹陷中，睛明穴所在紧靠眶缘刺入皮肤，进针约0.5寸；在眉头凹陷中，额切迹处，攒竹穴所在，向眼眶内缘斜刺0.4寸，留针10min后即轻轻拔出，嘱患者用无菌棉签轻压针刺部位片刻，防止出血。

Description for medicine or protocol of treatment in detail：

1. The patient was admitted to the operating room and placed in the supine position. A pillow was placed under the patient’s shoulders to extend the neck backward at 45°. Routine electrocardiographic monitoring was performed, and an upper extremity venous access was established. The foramen ovale was localized as the plasma puncture target via CT scanning, and the skin puncture site was marked with a marker pen. 2. Routine disinfection and sterile draping of the face were performed. Three milliliters of 1% lidocaine hydrochloride was injected at the puncture site for local anesthesia. Under CT guidance, puncture was performed along the localization line. The operator held the puncture needle with the right hand and advanced it through the puncture site. CT scanning confirmed that the needle tip was positioned at the outer opening of the foramen ovale. The stylet of the puncture needle was removed, and no blood or cerebrospinal fluid was aspirated with a syringe. Five milliliters of 0.9% normal saline was injected before inserting the plasma electrode tip connected to the main unit, with the electrocoagulation setting at grade 3. Sensory testing was conducted, which elicited pain in the region innervated by the first branch of the trigeminal nerve, verifying that the electrode tip was adjacent to the nerve. CT localization was repeated to confirm the needle position at the outer opening of the foramen ovale, followed by radiofrequency ablation. The procedure consisted of electrosection for 10 seconds, electrocoagulation for 10 seconds, and a 10-second interval, repeated 4 times. The needle was then withdrawn. 3. Upon completion, approximately 1 ml of a mixed solution (5 mg compound betamethasone mixed with 1% lidocaine and 0.9% sodium chloride injection) was injected. Pressure was applied to the puncture site, followed by dressing. The patient’s vital signs were stable with no complaints of discomfort, and the pupillary light reflex was normal. The patient was then transferred back to the ward safely. 4. Acupuncture at Jingming (BL1) and Zanzhu (BL2) points: The patient remained in the supine position, and routine alcohol disinfection was performed. The operator stood on the patient’s right side and instructed the patient to close their eyes. Holding a disposable sterile acupuncture needle (0.25×25 mm) with the right hand, the operator gently pushed the patient’s eyeball aside with the left hand. The needle was inserted into the skin close to the orbital margin at Jingming (BL1), located in the depression on the medial wall of the orbit superior to the inner canthus, to a depth of about 0.5 cun. At Zanzhu (BL2), situated in the depression at the medial end of the eyebrow and the frontal notch, the needle was inserted obliquely toward the inner orbital margin to a depth of 0.4 cun. The needles were retained for 10 minutes before gentle removal. The patient was instructed to press the acupuncture sites lightly with sterile cotton swabs for a short time to prevent bleeding. 1. The patient was admitted to the operating room and placed in the supine position. A pillow was placed under the patient’s shoulders to extend the neck backward at 45°. Routine electrocardiographic monitoring was performed, and an upper extremity venous access was established. The foramen ovale was localized as the puncture target via CT scanning, and the skin puncture site was marked with a marker pen. 2. Routine disinfection and sterile draping of the face were performed. Three milliliters of 1% lidocaine hydrochloride was injected at the puncture site for local anesthesia. Under CT guidance, puncture was performed along the localization line. The operator held the puncture needle with the right hand and advanced it through the puncture site. CT scanning confirmed that the needle tip was positioned at the outer opening of the foramen ovale. The patient reported a tingling sensation covering the distribution area of the first branch of the affected trigeminal nerve, and needle advancement was stopped. Radiofrequency testing was performed at parameters of 50 Hz and 0.3 V to confirm the stimulation area and accurately replicate symptoms in the corresponding nerve-innervated region. One to two milliliters of 2% lidocaine was then administered, and radiofrequency thermocoagulation (RFT) was performed 5 minutes later. The temperature was slowly increased to a maximum of 65 °C according to the patient’s tolerance and maintained for 3–4 minutes. The needle was then withdrawn. 3. Upon completion, approximately 1 ml of a mixed solution (5 mg compound betamethasone mixed with 1% lidocaine and 0.9% sodium chloride injection) was injected. Pressure was applied to the puncture site, followed by dressing. The patient’s vital signs were stable with no complaints of discomfort, and the pupillary light reflex was normal. The patient was then transferred back to the ward safely. 4. Acupuncture at Jingming (BL1) and Zanzhu (BL2) points: The patient remained in the supine position, and routine alcohol disinfection was performed. The operator stood on the patient’s right side and instructed the patient to close their eyes. Holding a disposable sterile acupuncture needle (0.25×25 mm) with the right hand, the operator gently pushed the patient’s eyeball aside with the left hand. The needle was inserted into the skin close to the orbital margin at Jingming (BL1), located in the depression on the medial wall of the orbit superior to the inner canthus, to a depth of about 0.5 cun. At Zanzhu (BL2), situated in the depression at the medial end of the eyebrow and the frontal notch, the needle was inserted obliquely toward the inner orbital margin to a depth of 0.4 cun. The needles were retained for 10 minutes before gentle removal. The patient was instructed to press the acupuncture sites lightly with sterile cotton swabs for a short time to prevent bleeding.

纳入标准：

Inclusion criteria

排除标准：

1.颅内占位或合并其他可能加重疼痛的疾病者； 2.严重感染； 3.妊娠或哺乳期的妇女； 4.凝血功能障碍者，血糖、血压未控制稳定或合并严重的心血管、脑血管、肝、肾、造血系统等疾病，或患有免疫缺陷性疾病、精神类疾病及血液病者； 5.瘢痕及高敏体质者； 6.无法耐受手术体位或无法配合操作治疗者。

Exclusion criteria：

1. Patients with intracranial space-occupying lesions or other diseases that may aggravate pain; 2. Patients with severe infection; 3. Pregnant or lactating women; 4. Patients with coagulation disorders, uncontrolled blood glucose or blood pressure, severe cardiovascular, cerebrovascular, hepatic, renal or hematopoietic diseases, immunodeficiency diseases, mental disorders, or hematological diseases; 5. Patients with scar constitution or hypersensitivity constitution; 6. Patients unable to tolerate the surgical position or cooperate with the operation and treatment.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2027-04-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-20 00:00:00 至 To 2026-12-01 00:00:00

干预措施：

Interventions：

组别：	治疗组	样本量：	30
Group：	Treatment Group	Sample size：	30
干预措施：	低温等离子射频消融联合针刺睛明穴、攒竹穴	干预措施代码：
Intervention：	Low-temperature plasma radiofrequency ablation combined with acupuncture at Jingming (BL1) and Zanzhu (BL2) acupoints	Intervention code：

组别：	对照组	样本量：	30
Group：	Control Group	Sample size：	30
干预措施：	射频热凝术联合针刺睛明穴、攒竹穴	干预措施代码：
Intervention：	Radiofrequency Thermocoagulation combined with acupuncture at Jingming (BL1) and Zanzhu (BL2) acupoints	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	四川省	市(区县)：	成都市
Country：	China	Province：	Sichuan	City：	Chengdu
单位(医院)：	成都中医药大学附属医院	单位级别：	三甲
Institution hospital：	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	视觉模拟疼痛评分	指标类型：	主要指标
Outcome：	Visual Analogue Scale for Pain	Type：	Primary indicator
测量时间点：	治疗后1d，7d，14d，30d，90d	测量方法：
Measure time point of outcome：	1d, 7d, 14d, 30d, 90d after treatment	Measure method：

指标中文名：	每日睡眠干扰评分	指标类型：	次要指标
Outcome：	Daily Sleep Interference Score	Type：	Secondary indicator
测量时间点：	治疗后1d，7d，14d，30d，90d	测量方法：
Measure time point of outcome：	1d, 7d, 14d, 30d, 90d after treatment	Measure method：

指标中文名：	眼部症候评分	指标类型：	次要指标
Outcome：	Ocular Symptom Score	Type：	Secondary indicator
测量时间点：	治疗后1d，7d，14d，30d，90d	测量方法：
Measure time point of outcome：	1d, 7d, 14d, 30d, 90d after treatment	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：	无
Sample Name：	no	Tissue：	no
人体标本去向	使用后销毁	说明	无
Fate of sample：	Destruction after use	Note：	no

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	40	岁 years
最大 Max age	80	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用区组随机化方法，区组长度为6，由独立统计师使用SAS 9.4软件生成随机序列，按1∶1比例分配至治疗组及对照组组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

A block randomization method was adopted with a block length of 6. The random sequence was generated by an independent statistician using SAS 9.4 software, and patients were randomly assigned to the treatment group and the control group at a ratio of 1:1.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	单盲
Blinding：	single-blind
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	日期：2027.4.1，邮箱：454988709@qq.com
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	DATE:2027.4.1,Email:454988709@qq.com
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	病历记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-04-20 10:04:02