ChiCTR2300078591 版本V1.0 版本创建时间2023/12/13 10:50:15 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2300078591 

最近更新日期：

Date of Last Refreshed on：

2023-12-13 10:50:09 

注册时间：

Date of Registration：

2023-12-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

背根神经节脉冲射频联合交感神经射频治疗急性期带状疱疹性神经痛的临床研究

Public title：

Clinical study of dorsal root ganglion pulse radiofrequency combined with sympathetic nerve radiofrequency in treatment of acute herpes zoster neuralgia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

背根神经节脉冲射频联合交感神经射频治疗急性期带状疱疹性神经痛的临床研究

Scientific title：

Clinical study of dorsal root ganglion pulse radiofrequency combined with sympathetic nerve radiofrequency in treatment of acute herpes zoster neuralgia

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：

徐平 

研究负责人：

费勇 

Applicant：

Xuping 

Study leader：

Feiyong 

申请注册联系人电话：

Applicant telephone：

+86 198 1898 5379

研究负责人电话：

Study leader's telephone：

+86 157 1263 3103

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：

Xping625@163.com

研究负责人电子邮件：

Study leader's E-mail：

Xping625@163.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：

嘉兴市第一医院

研究负责人通讯地址：

嘉兴市第一医院

Applicant address：

Jiaxing first Hospital

Study leader's address：

Jiaxing first Hospital

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

嘉兴市第一医院

Applicant's institution：

Jiaxing first Hospital

研究负责人所在单位：

嘉兴市第一医院

Affiliation of the Leader：

Jiaxing first Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023-KY-052

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：

嘉兴市第一医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Jiaxing First Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2023-02-24 00:00:00

伦理委员会联系人：

钱建萍

Contact Name of the ethic committee：

Qianjianping

伦理委员会联系地址：

嘉兴市中环南路1882号嘉兴市第一医院行政楼3楼

Contact Address of the ethic committee：

3rd Floor, Administration Building, Jiaxing First Hospital, 1882 Zhonghuan South Road, Jiaxing City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 89976378

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：

嘉兴市第一医院

Primary sponsor：

Jiaxing first Hospital

研究实施负责（组长）单位地址：

浙江省嘉兴市中环南路1882号

Primary sponsor's address：

1882 Zhonghuan South Road, Jiaxing City, Zhejiang 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)：

浙江省

市(区县)：

嘉兴市

Country：

China

Province：

Zhejiang Province

City：

Jiaxing City

单位(医院)：

嘉兴市第一医院

具体地址：

浙江省嘉兴市中环南路1882号

Institution
hospital：

Jiaxing first Hospital

Address：

1882 Zhonghuan South Road, Jiaxing City, Zhejiang Province

经费或物资来源：

浙江省医药卫生科技计划（2023KY037）

Source(s) of funding：

Zhejiang Medical and Health Technology Program (2023KY037)

Target disease：

Acute phase herpes zoster neuralgia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究将脉冲射频（PRF）和脉冲射频联合交感神经射频这两种微创介入治疗技术纳入统计，系统的评价它们对急性期带状疱疹性神经痛患者的镇痛效果、睡眠障碍指数（PSQI）、口服镇痛药物的剂量及并发症等；其次，采用感觉神经定量测试（CPT）评估患侧神经功能的修复，为急性期带状疱疹性神经痛的微创治疗效果提供依据。通过检测患者治疗前后外周血galectin-3和IL-6的水平，开发血液galectin-3和IL-6水平作为带状疱疹性神经痛患者疗效的客观评价及预后的生物学标志物。  

Objectives of Study：

In this study, two minimally invasive interventional therapy techniques of pulsed radiofrequency (PRF) and pulsed radiofrequency combined with sympathetic nerve radiofrequency were statistically included to systematically evaluate their analgesic effects, sleep disturbance index (PSQI), dosage of oral analgesic drugs and complications in patients with acute herpes zoster neuralgia. Secondly, quantitative sensory nerve test (CPT) was used to evaluate the repair of nerve function on the affected side, so as to provide a basis for the minimally invasive treatment of acute herpetic neuralgia. By measuring the levels of galectin-3 and IL-6 in peripheral blood of patients before and after treatment, to develop the blood galectin-3 and IL-6 levels as an objective evaluation of the curative effect of herpes zoster neuralgia patients and a biological marker of prognosis.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

疱疹区域为头面部、颈段、胸段或腰段神经节受累，病程≤1月，NRS评分> 3分，年龄18-85岁。

Inclusion criteria

The patients were 18-85 years old, with the disease duration ≤1 month, NRS score > 3, and herpes regions of head and face, cervical, thoracic or lumbar ganglia involvement.

排除标准：

1.不能正常沟通的患者 2.凝血功能障碍者 3.有患肢疾病或手术史 4.与患侧对应部位有感觉异常者 5.穿刺部位有感染或肿瘤者 6.严重心血管疾病、肝肾功能障碍、出凝血功能异常的患者等。

Exclusion criteria：

1.Patients who cannot communicate properly 2.Patients with coagulation dysfunction 3.Have a history of limb disease or surgery 4.Patients with sensory abnormalities in the corresponding part of the affected side 5.Patients with infection or tumor at the puncture site 6.Patients with severe cardiovascular diseases, liver and kidney dysfunction, abnormal coagulation function, etc.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2026-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-01-01 00:00:00 至 To 2025-01-01 00:00:00  

干预措施：

Interventions：

组别：

PRF组（C组）

样本量：

39

Group：

PRF group (group C)

Sample size：

干预措施：

PRF组（C组）：患者俯卧于CT治疗床上，监护患者的生命体征，以疼痛最严重的节段为中心，且上、下各扩展1个节段，分别在3个节段实施背根神经节PRF治疗（图1-3）。CT定位选择腹侧椎间孔上缘为穿刺针点，设计穿刺路径，并进行消毒铺巾。1.0 %盐酸利多卡因局部浸润麻醉，CT下缓慢推进射频套管针（20 G，长度150 mm，活动端长度10 mm）进行穿刺。最后，针尖位于椎间孔腹侧上象限接近背根神经节时，穿刺点至疼痛分布区域时可发生根性疼痛，三维重建图明确穿刺点位于靶点位置。连接射频治疗仪（Baylis Medical Inc., Montreal, Canada），调至感觉测试模式，设置电压：0.1-0.5 V, 频率：50 Hz，如可诱发出原疼痛区域酸、胀、麻木或刺痛等不适感。运动试验采用低频电流，设置参数，电压：0.1-0.5 V, 频率：2 Hz，如复制出病变神经根区域肌纤维颤动和搏动，表明穿刺针位于靶点附近。穿刺针位置确认后，标准电压PRF组设置温度、时间、脉冲宽度和频率分别为：42 ℃，300 s，20 msec，2 Hz。脉冲射频结束后，穿刺针回抽无血、气体、液体等，注射2%盐酸利多卡因100 mg、甲钴胺注射液500 ug、倍他米松磷酸钠4 mg加0.9%生理盐水稀释至15 ml的混合液，每节段注射5 ml混合液。所有患者PRF治疗后拔针并压迫穿刺点。观察30 min，待生命体征平稳将患者送回病房。若患者在治疗期间出现剧烈疼痛或疼痛明显加重时，即刻均予盐酸曲马多缓释片0.05 g口服治疗解救。

干预措施代码：

Intervention：

PRF group (group C) : the patient was placed on the CT treatment table, and the vital signs of the patient were monitored. PRF treatment was performed in the dorsal root ganglion at three levels, with the most severe pain level as the center, and the upper and lower segments were extended by one segment, respectively (FIG. 1-3). The upper edge of the ventral intervertebral foramen was selected as the puncture needle point based on CT positioning, and the puncture path was designed and sterilized. Under local infiltration anesthesia with 1.0% lidocaine hydrochloride, the radiofrequency trocar (20 G, 150 mm in length, 10 mm in movable end) was slowly advanced under CT for puncture. Finally, when the needle tip was located in the ventral upper quadrant of the intervertebral foramen and close to the dorsal root ganglion, root pain could occur when the puncture point reached the pain distribution area. The three-dimensional reconstruction map showed that the puncture point was located at the target. Connect the radio frequency therapeutic instrument (Baylis Medical Inc., Montreal, Canada), adjust to the sensory test mode, set the voltage: 0.1-0.5 V, frequency: 50 Hz, such as can induce the original pain area acid, swelling, numbness or tingling and other discomfort. Low frequency current was used in the exercise test, and the parameters were set, voltage: 0.1-0.5 V, frequency: 2 Hz. If the muscle fibrillation and pulsation in the affected nerve root area were reproduced, the puncture needle was located near the target. After the position of the puncture needle was confirmed, the temperature, time, pulse width and frequency were set as 42 ℃, 300 s, 20 msec and 2 Hz in the standard-voltage PRF group, respectively. After the pulse radiofrequency, the needle was pulled back without blood, gas or liquid, and the mixture of 2% lidocaine hydrochloride 100 mg, mecobalamin 500 ug, betamethasone sodium phosphate 4 mg and 0.9% normal saline diluted to 15 ml was injected, and 5 ml of the mixture was injected into each segment. After PRF treatment, the needle was pulled out and the puncture point was compressed in all patients. The patients were observed for 30 min and returned to the ward when their vital signs were stable. Tramadol hydrochloride sustained-release tablets 0.05 g were given immediately to rescue the patients if severe pain or severe pain occurred during the treatment.

Intervention code：

组别：

PRF联合交感神经射频组（H组)

样本量：

39

Group：

PRF combined with sympathetic nerve radiofrequency group (group H)

Sample size：

干预措施：

PRF联合交感神经射频组（H组）：患者入院后，同时行PRF手术和交感神经射频手术，PRF具体手术步骤见上。胸交感神经射频术（以T4交感神经射频为例）的主要手术步骤为，患者俯卧 CT台上，用多功能生命检测仪实时监测患者的生命体征、脉搏血氧饱和度、末梢灌注指数和手掌温度，CT定位患侧T3-4椎间隙，CT平扫后选取最佳穿刺层面及皮肤上的穿刺点，并模拟进针深度、角度和进针点距中线的距离。对选定穿刺点完成局部浸润麻醉后，经 T3-4椎旁间隙进针越过肋横突关节至椎体后外侧T4肋骨小头上缘，调整针尖位置至测试电极尖端的周围组织电阻为 250-550 Ω，再经感觉、运动电剌激测试确认射频尖位置无误后，先设定 40 ℃给予热刺激 60 s，再将温度设定为 95 ℃，热凝持续 300 s后结束手术（图4、6）。腰交感神经射频术（以L3交感神经射频为例）的主要手术步骤为，患者取俯卧位，对患者第3腰椎椎体进行扫描，设置层厚为2 mm。避开神经、血管及脏器，选择合适的进针途径、角度以及深度。CT扫描人椎体平面在皮肤表面作金属标记，对皮肤进行消毒、铺巾和局部麻醉下持射频电极套管针缓慢进行穿刺，通过CT扫描确认针尖到达靶点（图5），回抽无脑脊液、无血后，对套管针注入２ml的造影剂，然后再进行扫描，造影剂弥散局限在锥体测前缘，确保穿刺位置正确，连接射频治疗仪，以0.3Ｖ、100 Hz进行感觉神经刺激，若患者未出现下肢或腹股沟区放射痛，腰部有酸胀感，则毁损区内无感觉神经，在进行1 V、2 Hz的运动神经刺激，下肢肌肉和臀部无抽搐现象，则毁损区内无运动神经存在，将穿刺针从42 ℃逐渐加温到95 ℃，进行300 s热凝治疗，射频治疗结束后拔针，待生命体征平稳将患者送回病房。

干预措施代码：

Intervention：

PRF combined with sympathetic radiofrequency group (group H) : patients were treated with PRF and sympathetic radiofrequency surgery at the same time after admission, and the specific surgical procedures of PRF are described above. The main surgical steps of thoracic sympathetic radiofrequency (taking T4 sympathetic radiofrequency as an example) are as follow: the patient is placed on the CT table in the prone position, and the vital signs, pulse oxygen saturation, peripheral perfusion index and palm temperature of the patient are monitored in real time by multi-function vital detector. The T3-4 intervertebral space on the affected side is located by CT, and the best puncture level and puncture point on the skin are selected after CT scan. The depth, Angle and distance between the insertion point and the midline were simulated. After local infiltration anesthesia was completed at the selected puncture point, a needle was inserted through the T3-4 paraspinal space across the costotransverse joint to the lateral edge of the rib at T4, and the position of the needle tip was adjusted to the tissue resistance around the tip of the test electrode, which was 250-550 Ω. After sensory and motor electrical stimulation tests were performed to confirm the correct position of the radiofrequency tip. First, the temperature was set to 40 ℃ for 60 s, and then the temperature was set to 95 ℃. The operation was completed after 300 s of thermal coagulation (FIG. 4 and 6). The main surgical steps of lumbar sympathetic radiofrequency (taking L3 sympathetic radiofrequency as an example) were as follow: the patient was placed in the prone position, the third lumbar vertebra of the patient was scanned, and the slice thickness was set to 2 mm. Avoid nerves, blood vessels and organs, and choose the appropriate way, Angle and depth of needle insertion. After skin disinfection, drape, and slow puncture with radiofrequency electrode trocar under local anesthesia, CT scan was used to confirm that the needle tip reached the target (FIG. 5). After withdrawal of cerebrospinal fluid and blood, 2ml of contrast agent was injected into the trocar, and then scanning was performed. If the patient did not have radiating pain in the lower limbs or groin area and had soreness in the waist, there was no sensory nerve in the damaged area. When the motor nerve stimulation was performed at 1 V and 2 Hz, there was no convulsion in the lower limbs muscles and buttock, there was no motor nerve in the damaged area. The needle was gradually heated from 42 ℃ to 95 ℃ for 300 s of thermal coagulation. After the end of radiofrequency treatment, the needle was pulled out, and the patient was sent back to the ward when the vital signs were stable.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 嘉兴市 

Country：

China 

Province：

Zhejiang Province 

City：

Jiaxing City 

单位(医院)：

嘉兴市第一医院 

单位级别：

三甲 

Institution
hospital：

Jiaxing first Hospital

Level of the institution：

trimethylate

测量指标：

Outcomes：

指标中文名：

NRS评分

指标类型：

主要指标

Outcome：

NRS score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PHN的发生率

指标类型：

主要指标

Outcome：

The incidence of PHN

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PSQI评分

指标类型：

次要指标

Outcome：

PSQI score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

口服加吧喷丁胶囊和盐酸曲马多缓释片的剂量

指标类型：

次要指标

Outcome：

Oral dosage of gabapentin capsules and Tramadol hydrochloride sustained-release tablets

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

感觉神经定量测试评估患侧神经功能的修复

指标类型：

次要指标

Outcome：

Quantitative sensory nerve test to assess the repair of affected nerve function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血液gal-3、IL-6的水平

指标类型：

次要指标

Outcome：

Blood levels of gal-3 and IL-6

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

并发症的发生率

指标类型：

副作用指标

Outcome：

Incidence of complications

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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 18 岁 years
最大 Max age 85 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）：

由研究者用spss软件，设置固定值为默认模式，使用RV.UNIFORM函数生成随机数字序列（random number sequence），产生的随机数字为1分配到C组，随机数字是2分配到H组。随机分配表严密保存，由课题负责人保管。

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

The researchers used spss software to set fixed values as the default mode, and used RV.UNIFORM function to generate a random number sequence. The resulting random numbers were 1 assigned to group C, and random numbers were 2 assigned to group H. The random assignment table is kept strictly by the subject leader.

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：

本研究采用单盲法，仅对患者设盲。使用SPSS统计软件包以1:1的比例生成随机编号。将入组患者分为PRF组（C组）、PRF联合交感神经射频组（H组），产生的随机数字为1分配到C组，随机数字是2分配到H组。随机分配表严密保存，由课题负责人保管。研究结束后，即最后一名纳入组的患者进行治疗后1年的随访后，可向患者破盲。

Blinding：

In this study, only patients were blinded by single blind method. The SPSS statistical package was used to generate random numbers at a 1:1 ratio. The enrolled patients were divided into PRF group (group C) and PRF combined with sympathetic radiofrequency group (group H). The random number generated was 1 assigned to group C, and the random number was 2 assigned to group H. The random assignment table is kept strictly by the subject leader. At the end of the study, that is, after 1 year of follow-up after treatment for the last enrolled patient, the patient can be blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

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）：

不共享数据

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Unshared data

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：

通过病例记录表进行数据采集，用excel建立数据库进行数据管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The data were collected through the case record table, and the database was established by excel for data management.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-12-13 10:50:09