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：	ChiCTR2500115532
最近更新日期： Date of Last Refreshed on：	2025-12-28 21:06:23
注册时间： Date of Registration：	2025-12-28 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	超声引导下两种不同入路颈神经脉冲射频治疗颈神经痛的症状改善效果与穿刺效率比较
Public title：	Comparison of the symptom improvement effect and puncture efficiency of two different cervical nerve pulse radiofrequency approaches in the treatment of cervical neuralgia under ultrasound guidance
注册题目简写：
English Acronym：
研究课题的正式科学名称：	超声引导下两种不同入路颈神经脉冲射频治疗颈神经痛的症状改善效果与穿刺效率比较
Scientific title：	Comparison of the symptom improvement effect and puncture efficiency of two different cervical nerve pulse radiofrequency approaches in the treatment of cervical neuralgia under ultrasound guidance
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：	李春叶	研究负责人：	李春叶
Applicant：	Li Chunye	Study leader：	Li Chunye
申请注册联系人电话： Applicant telephone：	+86 132 1839 8733	研究负责人电话： Study leader's telephone：	+86 132 1839 8733
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：	372098744@qq.com	研究负责人电子邮件： Study leader's E-mail：	372098744@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：	江苏省镇江市解放路438号	研究负责人通讯地址：	江苏省镇江市解放路438号
Applicant address：	438 Jiefang Road, Zhenjiang, Jiangsu	Study leader's address：	438 Jiefang Road, Zhenjiang, Jiangsu
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：	江苏大学附属医院
Applicant's institution：	Affiliated Hospital of Jiangsu University
研究负责人所在单位：	江苏大学附属医院
Affiliation of the Leader：	Affiliated Hospital of Jiangsu University

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：	KY2025H1211-08	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：	江苏大学附属医院科学研究伦理委员会
Name of the ethic committee：	Scientific Research Ethics Committee of the Affiliated Hospital of Jiangsu University
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-18 00:00:00
伦理委员会联系人：	胡爱英
Contact Name of the ethic committee：	Hu Aiying
伦理委员会联系地址：	江苏省镇江市解放路438号
Contact Address of the ethic committee：	438 Jiefang Road, Zhenjiang, Jiangsu
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 136 5529 3227	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：

江苏大学附属医院

Primary sponsor：

Affiliated Hospital of Jiangsu University

研究实施负责（组长）单位地址：

江苏省镇江市解放路438号

Primary sponsor's address：

438 Jiefang Road, Zhenjiang, Jiangsu

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	江苏大学附属医院	具体地址：	江苏省镇江市解放路438号
Institution hospital：	Affiliated Hospital of Jiangsu University	Address：	438 Jiefang Road, Zhenjiang, Jiangsu

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

颈神经痛

Target disease：

Cervical 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：

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：

1.明确超声引导下颈椎间孔入路与横突前后结节间入路颈神经脉冲射频治疗颈神经痛的短期镇痛效果差异，以术后1天、1周、4周疼痛数字评分法（Numerical Rating Scale，NRS）为核心指标，对比两种入路对颈肩背部及上肢放射性疼痛的缓解效率。 2.评估两种入路治疗颈神经痛的长期神经功能改善效果，通过术后12周、24周颈椎功能障碍指数（Neck Disability Index，NDI）、颈椎关节活动度（ROM），分析不同入路对患者颈神经功能及日常生活能力的长期影响。 3.验证超声引导在两种入路中的安全性优势，记录术中穿刺时间、穿刺次数及术后血管损伤（如椎动脉误刺）、神经损伤等并发症发生率，明确超声实时可视化对颈椎间孔入路椎血管保护的实际价值。 4.分析两种入路疗效差异与靶点解剖位置的关联性，结合颈椎间孔邻近DRG、横突前后结节间邻近颈神经前根的解剖特征，探讨靶点距离DRG的远近对脉冲射频神经调控效应的影响机制。 5.为临床颈神经痛的微创治疗提供入路选择依据，通过综合对比短期镇痛、长期功能改善及安全性指标，筛选更优的超声引导颈神经脉冲射频治疗方案。

Objectives of Study：

1. To clarify the difference in short-term analgesic effect between ultrasound-guided cervical intervertebral foraminal approach and transverse anterior and posterior inter-nodal approach of cervical nerve pulsed radiofrequency treatment for cervical neuralgia, and to compare the efficacy of the two approaches in relieving radiating pain of neck, shoulder, back and upper limb by using Numerical Rating Scale (NRS) of pain at 1 day, 1 week, and 4 weeks after the operation as the core index. 2. Evaluate the long-term neurological function improvement effect of the two approaches in treating cervical neuralgia, and analyse the long-term effects of the different approaches on the cervical nerve function and daily life ability of the patients through the Neck Disability Index (NDI) and the cervical spine joint mobility (ROM) at 12 and 24 weeks after the operation. 3. Verify the safety advantages of ultrasound guidance in the two approaches, record the intraoperative puncture time, the number of punctures, and the incidence of postoperative vascular injuries (e.g., vertebral artery mispuncture), nerve injuries and other complications, so as to clarify the real-time ultrasound visualisation's actual value for the protection of vertebral blood vessels in cervical foraminal approach. 4. Analyse the correlation between the efficacy of the two approaches and the anatomical location of the target point, combine the anatomical characteristics of the cervical intervertebral foramen adjacent to the DRG and the anterior and posterior transverse processes of the anterior and posterior cervical nerves, and explore the mechanism of the influence of the distance of the target point from the DRG on the effect of pulsed radiofrequency neuromodulation. 5. To provide a basis for the selection of access routes for the minimally invasive treatment of cervical neuralgia, and to screen for better ultrasound-guided cervical nerve pulsed radiofrequency treatment options by comparing the short-term analgesia, long-term functional improvement and safety indicators.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Meet the diagnostic criteria of cervical neuralgia: manifested as pain in the upper back of the neck and shoulders with radiating pain in the upper limbs (involving the C₄~C₇ innervation area), with or without mild hypesthesia of the upper limbs, and cervical spine MRI/CT confirms the existence of cervical nerve root compression, intervertebral foraminal stenosis, or peri-nerve root inflammation.
2. Duration of the disease >= 1 month: no significant pain relief after >= 2 weeks of standardised conservative treatment (including oral non-steroidal anti-inflammatory drugs, neurotrophic drugs, physiotherapy, etc.), which is in line with the timing of minimally invasive therapeutic intervention.
3. Pain level up to the standard: NRS>=4 points, and pain affects daily life (such as sleep, daily activities are limited), with a clear need for analgesic treatment.
4. Age 18-90 years old: taking into account the safety and efficacy of treatment for adult patients, excluding the immature development of the cervical spine in minors and the lack of tolerance in elderly patients (>90 years old).
5. Imaging assessment is suitable for puncture: ultrasound and MRI/CT examination of the cervical spine show clear anatomical structures of the anterior and posterior cervical transverse processes and intervertebral foramina, with no serious bony deformities (e.g., severe scoliosis, vertebral compression fracture), and no abnormal variations of vertebral vascular routes to ensure that the two approaches are feasible for puncture operation.
6. Normal cognition and cooperation ability: no mental disease or cognitive impairment, able to clearly express pain perception and treatment response, and able to cooperate with preoperative assessment, intraoperative stimulation test and postoperative follow-up.

排除标准：

1.存在穿刺相关禁忌证：包括凝血功能异常（凝血酶原时间延长、血小板计数 <80×10⁹/L）、穿刺部位皮肤或软组织感染、全身活动性感染；合并严重心肺功能障碍（如心力衰竭、慢性阻塞性肺疾病急性加重期）、肝肾功能衰竭，无法耐受介入操作。 2.颈椎解剖异常或严重病变：存在颈椎肿瘤、结核、颈椎不稳（如Ⅱ度以上腰椎滑脱），或椎间孔重度狭窄（前后径<4mm）。 3.神经功能严重受损：合并脊髓损伤（如肌力<=3级）、严重周围神经病变（如糖尿病周围神经病变累及上肢）。 4.特殊人群：妊娠或哺乳期女性；对局部麻醉药、射频治疗相关材料过敏；长期服用抗凝药物（如华法林、新型口服抗凝药）且停药<7天（增加出血风险）。 5.既往颈神经介入治疗史：曾接受过颈神经根射频、神经阻滞或脊髓电刺激治疗，可能残留治疗效应，干扰本研究两种入路的疗效对比。 6.疼痛部位仅为肌筋膜炎：疼痛区域诊断为单纯肌肉筋膜炎症，不符合影像学诊断的颈神经累及节段。

Exclusion criteria：

1. Contraindications related to puncture: including abnormal coagulation function (prolonged prothrombin time, platelet count <80×10⁹/L), skin or soft tissue infection at the puncture site, active systemic infection; combined with severe cardiopulmonary dysfunction (such as heart failure, acute exacerbation of chronic obstructive pulmonary disease), liver and kidney failure, and inability to tolerate interventional procedures. 2. Cervical anatomical abnormalities or serious lesions: cervical spine tumors, tuberculosis, cervical spine instability (such as lumbar spondylolisthesis above grade II), or severe stenosis of the intervertebral foramen (anterior and posterior diameter <4mm). 3. Severe impairment of neurological function: combined with spinal cord injury (such as muscle strength <=grade 3), severe peripheral neuropathy (such as diabetic peripheral neuropathy involving the upper limbs). 4. Special groups: Pregnant or lactating women; allergic to local anesthetics and materials related to radiofrequency treatment; long-term use of anticoagulants (such as warfarin, new oral anticoagulants) with discontinuation of <7 days (increased risk of bleeding). 5. Previous cervical nerve interventional treatment history: Have received cervical nerve root radiofrequency, nerve block or spinal cord electrical stimulation treatment, which may have residual treatment effects and interfere with the comparison of the efficacy of the two approaches in this study. 6. The painful area is only myofasciitis: The painful area is diagnosed as simple myofascial inflammation, and the cervical nerve involvement segment does not meet the imaging diagnosis.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	35
Group：	Control group	Sample size：	35
干预措施：	超声引导+横突前后结节间入路	干预措施代码：
Intervention：	Ultrasound guidance + transverse process anterior and posterior intertubercular approach	Intervention code：

组别：	试验组	样本量：	35
Group：	Test grou	Sample size：	35
干预措施：	超声引导+椎间孔入路	干预措施代码：
Intervention：	Ultrasound guidance + intervertebral foraminal approach	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	江苏大学附属医院	单位级别：	三甲
Institution hospital：	Affiliated Hospital of Jiangsu University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	NRS评分变化	指标类型：	主要指标
Outcome：	NRS score changes	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	NDI评分变化	指标类型：	主要指标
Outcome：	NDI score changes	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	定位时间	指标类型：	主要指标
Outcome：	Positioning time	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	穿刺次数	指标类型：	主要指标
Outcome：	Number of punctures	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量表评分	指标类型：	次要指标
Outcome：	PSQI (Pittsburgh Sleep Quality Inde)scale 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：	Odom标准分级	指标类型：	次要指标
Outcome：	Odom's Criteria grading	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良反应发生率	指标类型：	次要指标
Outcome：	Incidence of adverse reactions	Type：	Secondary indicator
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：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	90	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）：

随机对照研究：负责招募受试者的研究人员根据计算机生成的随机数序列，将受试者随机分为试验组和对照组。

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

Randomized controlled study: The researcher responsible for recruiting subjects randomly divides the subjects into an experimental group and a control group based on a computer-generated random number sequence.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	单盲：患者不知晓
Blinding：	Single-blind: patient does not know

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）：	无
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：	CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-12-28 21:06:18