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：	ChiCTR2600122013
最近更新日期： Date of Last Refreshed on：	2026-04-08 09:54:24
注册时间： Date of Registration：	2026-04-08 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	脊神经根脉冲射频联合神经阻滞治疗胸肋部带状疱疹后神经痛的有效性、安全性研究：一项随机对照临床试验
Public title：	Efficacy and Safety of Pulsed Radiofrequency Combined with Nerve Block in the Treatment of Thoracic and Costal Postherpetic Neuralgia: A Randomized Controlled Clinical Trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	脊神经根脉冲射频联合神经阻滞治疗胸肋部带状疱疹后神经痛的有效性、安全性研究：一项随机对照临床试验
Scientific title：	Efficacy and Safety of Pulsed Radiofrequency Combined with Nerve Block in the Treatment of Thoracic and Costal Postherpetic Neuralgia: A Randomized Controlled Clinical Trial
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：	钟成宇	研究负责人：	王英峰
Applicant：	Zhong Chengyu	Study leader：	Wang Yingfeng
申请注册联系人电话： Applicant telephone：	+86 173 6289 3212	研究负责人电话： Study leader's telephone：	+86 139 1991 7116
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：	17362893212@163.com	研究负责人电子邮件： Study leader's E-mail：	wyft2006@sina.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：	中国甘肃省兰州市七里河区南滨河路333号	研究负责人通讯地址：	中国甘肃省兰州市七里河区南滨河路333号
Applicant address：	No. 333 Nanbinhe Road, Qilihe District, Lanzhou City, Gansu Province, China	Study leader's address：	No. 333 Nanbinhe Road, Qilihe District, Lanzhou City, Gansu Province, China
申请注册联系人邮政编码： Applicant postcode：	730050	研究负责人邮政编码： Study leader's postcode：	730050
申请人所在单位：	中国人民解放军联勤保障部队第九四〇医院
Applicant's institution：	The 940th Hospital of Joint Logistic Support Force of Chinese People's Liberation Army
研究负责人所在单位：	中国人民解放军联勤保障部队第九四〇医院
Affiliation of the Leader：	The 940th Hospital of Joint Logistic Support Force of Chinese People's Liberation Army

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：	2026KYLL062	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：	联勤保障部队第九四〇医院科研伦理委员会
Name of the ethic committee：	Scientific Research Ethics Committee of The 940th Hospital of Joint Logistic Support Force
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-20 00:00:00
伦理委员会联系人：	陈克明
Contact Name of the ethic committee：	Chen Keming
伦理委员会联系地址：	中国甘肃省兰州市七里河区南滨河路333号
Contact Address of the ethic committee：	No. 333 Nanbinhe Road, Qilihe District, Lanzhou City, Gansu Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 931 899 4327	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：

中国人民解放军联勤保障部队第九四〇医院

Primary sponsor：

The 940th Hospital of Joint Logistic Support Force of Chinese People's Liberation Army

研究实施负责（组长）单位地址：

中国甘肃省兰州市七里河区南滨河路333号

Primary sponsor's address：

No. 333 Nanbinhe Road, Qilihe District, Lanzhou City, Gansu Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	甘肃省	市(区县)：	兰州市
Country：	China	Province：	Gansu	City：	Lanzhou
单位(医院)：	联勤保障部队第九四〇医院	具体地址：	甘肃省兰州市七里河区南滨河路333号
Institution hospital：	The 940th Hospital of the Joint Logistics Support Force	Address：	No. 333 Nanbinhe Road, Qilihe District, Lanzhou City, Gansu Province

经费或物资来源：

自筹

Source(s) of funding：

Self-funding

研究疾病：

带状疱疹后神经痛

Target disease：

Postherpetic neuralgia

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：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

本研究旨在对比分析胸脊神经根阻滞联合脊神经根脉冲射频调控与单纯脊神经根脉冲射频调控治疗带状疱疹后神经痛的临床疗效及安全性。

Objectives of Study：

This study aims to compare and analyze the clinical efficacy and safety of thoracic spinal nerve root block combined with pulsed radiofrequency versus pulsed radiofrequency alone in the treatment of postherpetic neuralgia.

药物成份或治疗方案详述：

患者入院后完善相关化验及检查，根据疼痛及皮损部位定位责任神经节段，常规给予普瑞巴林缓释片及甲钴胺基础药物治疗。普瑞巴林缓释片使用剂量：患者每日口服剂量为165mg，早晚各口服82.5mg，若患者耐受且疼痛缓解（VAS评分≤30分），则以此口服剂量维持。若疼痛并不缓解（VAS评分＞30分），则给予氨酚羟考酮片330mg。记录普瑞巴林缓释片及氨酚羟考酮片的用量。（1）联合组：患者平车推入手术室，俯卧于DSA床上，监测患者生命体征，胸背部皮肤充分暴露，初步查体定位目标胸椎椎体并标识，常规皮肤消毒，铺无菌巾单，标定患侧胸椎椎小关节的中点稍下方旁开棘正中线约3-4cm作为进针穿刺点，局部麻醉。采用一次性射频电极套管针穿刺，DSA透视下定位目标胸椎椎体两侧下关节突，胸脊神经节即位于该关节后方中点位置。针尖方向与X射线方向一致，对准目标胸椎关节后的中点稍内侧刺入，当刺入目标胸脊神经节时，出现患侧腰腹部放射痛。经侧位透视证实穿刺针尖位于目标胸椎椎小关节后方后，拔出穿刺针芯，反复回抽无血、脑脊液后，将15cm射频针插入工作套管件（波士顿科学神经调控公司，型号：CC151020-P、TCD-15-P），行电测试，引出皮肤异感后，行脉冲射频调控，参数：2Hz，70v，42℃，15min。脉冲射频调控结束后，沿穿刺套管针注射1ml神经阻滞药液（2%利多卡因0.75ml+地塞米松磷酸钠注射液1ml:5mg+0.9%氯化钠注射液至3ml，即0.5%利多卡因混合液，每个节段1ml）。询问患者无特殊不适主诉后拔针，穿刺点无菌纱布覆盖，送回病房。（2）PRF组：脉冲射频调控术步骤同联合组。脉冲射频调控结束后，沿穿刺套管针注射与神经阻滞药液外观相同的安慰剂1ml（0.9%氯化钠注射液3ml，每个节段1ml）。询问患者无特殊不适主诉后拔针，穿刺点无菌纱布覆盖，送回病房。

Description for medicine or protocol of treatment in detail：

After admission, the patient underwent relevant laboratory tests and examinations. The responsible nerve segment was localized based on the pain and skin lesion sites. Baseline pharmacological therapy with pregabalin sustained-release tablets and was routinely administered. Pregabalin sustained-release tablet dosage: The patient received a daily oral dose of 165 mg, with 82.5 mg taken in the morning and evening respectively. If the patient tolerated the medication well and experienced pain relief (VAS score <= 30), this oral dosage was maintained. If pain persisted (VAS score > 30), oxycodone and acetaminophen tablets 330 mg were administered. The consumption of pregabalin sustained-release tablets and oxycodone and acetaminophen tablets was recorded. (1) Combination Group: The patient was transported to the operating room on a stretcher and placed in prone position on the DSA table. Vital signs were monitored. The thoracodorsal skin was fully exposed. Preliminary physical examination was performed to localize the target thoracic vertebrae, which were then marked. Routine skin disinfection was performed, and sterile drapes were applied. The entry point was marked approximately 3–4 cm lateral to the midline at a point slightly below the midpoint of the ipsilateral thoracic facet joint. Local anesthesia was administered. A disposable radiofrequency electrode cannula was used for puncture. Under DSA fluoroscopy, the bilateral inferior articular processes of the target thoracic vertebrae were localized; the thoracic dorsal root ganglion is located at the midpoint posterior to this joint. The needle was advanced in the same direction as the X-ray beam, targeting the midpoint slightly medial to the posterior aspect of the target thoracic joint. When the needle penetrated the target thoracic dorsal root ganglion, ipsilateral lumbar and abdominal radiating pain was elicited. After lateral fluoroscopy confirmed that the needle tip was positioned posterior to the target thoracic facet joint, the stylet was removed. After repeated aspiration confirmed no blood or cerebrospinal fluid, a 15-cm radiofrequency needle was inserted into the working cannula (Boston Scientific Neuromodulation, Model: CC151020-P, TCD-15-P). Electrical testing was performed, and after paresthesia was elicited, pulsed radiofrequency modulation was conducted with the following parameters: 2 Hz, 70 V, 42°C, 15 min. Following pulsed radiofrequency modulation, 1 mL of nerve block solution (0.75 mL of 2% lidocaine + 1 mL dexamethasone sodium phosphate injection: 5 mg + 0.9% sodium chloride injection to 3 mL, i.e., 0.5% lidocaine mixture, 1 mL per segment) was injected through the puncture cannula. After confirming the patient had no special complaints of discomfort, the needle was removed, the puncture site was covered with sterile gauze, and the patient was returned to the ward. (2) PRF Group: The pulsed radiofrequency modulation procedure was identical to that of the Combination Group. Following pulsed radiofrequency modulation, 1 mL of placebo with the same appearance as the nerve block solution (0.9% sodium chloride injection 3 mL, 1 mL per segment) was injected through the puncture cannula. After confirming the patient had no special complaints of discomfort, the needle was removed, the puncture site was covered with sterile gauze, and the patient was returned to the ward.

纳入标准：

Inclusion criteria

排除标准：

1）严重心肺功能不全﹑严重肝肾功能不全及合并血液系统疾病者； 2）穿刺部位有皮肤损害或局部感染者； 3）糖尿病血糖控制不良者（空腹血糖≥ 10.0mmol/L）； 4）凝血功能异常情况者； 5）对本研究所使用局麻药等药物过敏或其它不适合行神经阻滞者； 6）妊娠及哺乳期妇女； 7）有精神疾病或存在认知功能障碍对研究量表不能充分理解者。

Exclusion criteria：

1) Patients with severe cardiopulmonary insufficiency, severe hepatic or renal insufficiency, or hematological disorders; 2) Patients with skin lesions or local infection at the puncture site; 3) Patients with poorly controlled diabetes (fasting blood glucose >=10.0 mmol/L); 4) Patients with abnormal coagulation function; 5) Patients with allergy to local anesthetics or other drugs used in this study, or those otherwise unsuitable for nerve block; 6) Pregnant or lactating women; 7) Patients with psychiatric disorders or cognitive dysfunction who cannot adequately understand the study assessment scales.

研究实施时间：

Study execute time：

从 From 2025-10-01 00:00:00至 To 2027-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-10 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	51
Group：	Intervention group	Sample size：	51
干预措施：	胸脊神经根阻滞联合脉冲射频调控	干预措施代码：
Intervention：	Thoracic spinal nerve root block combined with pulsed radiofrequency modulation	Intervention code：

组别：	对照组	样本量：	51
Group：	Control group	Sample size：	51
干预措施：	单纯脉冲射频调控	干预措施代码：
Intervention：	Pulsed radiofrequency modulation alone	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	甘肃省	市(区县)：	兰州市
Country：	China	Province：	gansu	City：	lanzhou
单位(医院)：	中国人民解放军联勤保障部队第九四〇医院	单位级别：	三甲
Institution hospital：	The 940th Hospital of Joint Logistic Support Force of Chinese People's Liberation Army	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	术后1月疼痛VAS评分	指标类型：	主要指标
Outcome：	Postoperative pain VAS score at 1 month	Type：	Primary indicator
测量时间点：	术后1月	测量方法：
Measure time point of outcome：	postoperative 1 month	Measure method：

指标中文名：	术后1天、1周、1月、3月疼痛变化情况	指标类型：	次要指标
Outcome：	Changes in pain at 1 day, 1 week, 1 month, and 3 months postoperatively	Type：	Secondary indicator
测量时间点：	术后1天、1周、1月、3月	测量方法：
Measure time point of outcome：	Postoperative 1 day, 1 week, 1 month and 3 month	Measure method：

指标中文名：	炎症指标	指标类型：	次要指标
Outcome：	Inflammatory indicators	Type：	Secondary indicator
测量时间点：	术前、术后	测量方法：
Measure time point of outcome：	Preoperative, Postoperative	Measure method：

指标中文名：	失眠严重程度指数	指标类型：	次要指标
Outcome：	Insomnia Severity Index, ISI	Type：	Secondary indicator
测量时间点：	术前及术后1天、1周、1月、3月	测量方法：
Measure time point of outcome：	Preoperatively and at 1 day, 1 week, 1 month, and 3 months postoperatively	Measure method：

指标中文名：	抑郁症筛查量表	指标类型：	次要指标
Outcome：	Patient Health Questionnaire-9, PHQ-9	Type：	Secondary indicator
测量时间点：	术前及术后1天、1周、1月、3月	测量方法：
Measure time point of outcome：	Preoperatively and at 1 day, 1 week, 1 month, and 3 months postoperatively	Measure method：

指标中文名：	广泛性焦虑自评量表	指标类型：	次要指标
Outcome：	Generalized Anxiety Disorder-7, GAD-7	Type：	Secondary indicator
测量时间点：	术前及术后1天、1周、1月、3月	测量方法：
Measure time point of outcome：	Preoperatively and at 1 day, 1 week, 1 month, and 3 months postoperatively	Measure method：

指标中文名：	术后并发症及不良反应	指标类型：	次要指标
Outcome：	Postoperative complications and adverse reactions	Type：	Secondary indicator
测量时间点：	治疗及随访期间	测量方法：
Measure time point of outcome：	During treatment and follow-up period	Measure method：

指标中文名：	镇痛药物使用量及补救用药情况	指标类型：	次要指标
Outcome：	Dosage of analgesic drugs and remedial drugs	Type：	Secondary indicator
测量时间点：	术后3月	测量方法：
Measure time point of outcome：	Postoperative 3 month	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：

尚未开始

Not yet 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）：

本研究采用区组随机的方法进行随机分组，动态区组大小设为2和4，随机结果采用SAS软件生成，并将随机化结果密封至不透光的信封，患者入组后拆开信封确定患者分组信息。

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

This study employed block randomization for group allocation, with dynamic block sizes set at 2 and 4. The randomization sequence was generated using SAS software, and the randomization results were sealed in opaque envelopes. The envelopes were opened to determine patient randomization after patient enrollment was confirmed.

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：	双盲。对患者、家属、治疗医护人员、随访人员及数据分析人员设盲；研究期间仅研究人员A知道患者具体分组及负责在单独场地配制神经阻滞所需的药液。
Blinding：	Blinding was applied to patients, family members, treating medical staff, follow-up personnel, and data analysts. During the study period, only Researcher A was aware of the specific group allocation and was responsible for preparing the nerve block solution in a separate area.
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	否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）：	否
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	研究者将受试者治疗期间和随访期间的试验数据及时、准确的记录在病例报告表（CRF）中，并将所有数据录入至Epidata软件进行管理，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Investigators recorded trial data from subjects during treatment and follow-up in a timely and accurate manner on a case report form (CRF), and entered all data into Epidata software for management, with multiple backups saved on different disks or recording media for proper storage and prevention of damage.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-04-08 09:54:17