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龙虎交战针法联合夹脊穴穴位注射对难治性带状疱疹后神经痛的临床疗效研究

注册号：

Registration number：

ITMCTR2025001319

最近更新日期：

Date of Last Refreshed on：

2025-07-01

注册时间：

Date of Registration：

2025-07-01

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

龙虎交战针法联合夹脊穴穴位注射对难治性带状疱疹后神经痛的临床疗效研究

Public title：

Clinical Study on the Efficacy of Dragon-Tiger Battle Acupuncture Combined with Jiaji Point Injection for Refractory Postherpetic Neuralgia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

龙虎交战针法联合夹脊穴穴位注射对难治性带状疱疹后神经痛的临床疗效研究

Scientific title：

Clinical Study on the Efficacy of Dragon-Tiger Battle Acupuncture Combined with Jiaji Point Injection for Refractory Postherpetic Neuralgia

研究课题的正式科学名称简写：

Scientific title acronym：

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：

陈伊琳

研究负责人：

王彧

Applicant：

Yilin Chen

Study leader：

Yu Wang

申请注册联系人电话：

Applicant telephone：

+86 152 0827 8296

研究负责人电话：

Study leader's telephone：

+86 138 8092 4834

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：

591426272@qq.com

研究负责人电子邮件：

Study leader's E-mail：

29733197@qq.com

申请单位网址(自愿提供)：

Study leader's 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：

四川省成都市青龙街82号

研究负责人通讯地址：

四川省成都市青龙街82号

Applicant address：

No.82 Qinglong Street Chengdu Sichuan Province

Study leader's address：

No.82 Qinglong Street Chengdu Sichuan Province

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：

成都市第三人民医院

Applicant's institution：

Chengdu Third People's Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2024-S-200

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

成都市第三人民医院医学伦理审查委员会

Name of the ethic committee：

The Third People's Hospital of Chengdu Medical Ethics Examination Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2024/6/25 0:00:00

伦理委员会联系人：

杨茜茜

Contact Name of the ethic committee：

Qianqian Yang

伦理委员会联系地址：

四川省成都市青龙街82号

Contact Address of the ethic committee：

No.82 Qinglong Street Chengdu Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 1822758678

伦理委员会联系人邮箱：

Contact email of the ethic committee：

chenyilin@stu.cdutcm.edu.cn

研究实施负责（组长）单位：

成都市第三人民医院

Primary sponsor：

Chengdu Third People's Hospital

研究实施负责（组长）单位地址：

四川省成都市青龙街82号

Primary sponsor's address：

No.82 Qinglong Street Chengdu 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

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都市第三人民医院

具体地址：

四川省成都市青龙街82号

Institution
hospital：

Chengdu Third People's Hospital

Address：

No.82 Qinglong Street Chengdu Sichuan Province

经费或物资来源：

单位自筹

Source(s) of funding：

Unit self-financing

研究疾病：

难治性带状疱疹后神经痛

研究疾病代码：

Target disease：

Refractory post-herpetic neuralgia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

本研究拟纳入常规治疗（药物、神经介入、神经调控）后仍未痊愈的难治性 PHN 患者为研究对象，将患者随机分为西药+针刺 1 组、 西药+针刺 2 组、西药组，西药+针刺 1 组进行 4 周（3 次/周）的龙虎交战针法联合夹脊穴穴位注射治疗，西药+针刺 2 组进行 4 周（3 次/周）的夹脊穴和阿是穴针刺治疗，西药组予常规药物治疗。在治疗前、治疗后、治疗后 4 周进行随访，从疼痛程度改善、红外线热成像图、情绪、睡眠等来评价疗效及安全性，探讨龙虎交战针法联合夹脊穴穴位注射对难治性 PHN 的临床疗效，为龙虎交战针法联合夹脊穴穴位注射治疗难治性 PHN 的临床疗效提供循证医学依据。

Objectives of Study：

In this study patients with refractory PHN who have not recovered after routine treatment (drugs nerve intervention nerve regulation) will be randomly divided into western medicine plus acupuncture group 1 western medicine plus acupuncture group 2 western medicine group western medicine plus acupuncture group 1 for 4 weeks (3 times/week) of dragon-tiger fighting acupuncture combined with Jiaji point injection and western medicine plus acupuncture group 2 for 4 weeks (3 times/week). Follow-up was conducted before after and 4 weeks after treatment. The efficacy and safety were evaluated from the aspects of pain improvement infrared thermography mood and sleep and the clinical efficacy of dragon-tiger engagement acupuncture combined with Jiaji point injection on refractory PHN was discussed so as to provide evidence-based medical basis for the clinical efficacy of dragon-tiger engagement acupuncture combined with Jiaji point injection on refractory PHN.

药物成份或治疗方案详述：

1、西药+针刺 1 组 （1）定位：以下腧穴穴位定位与操作方法均参照“十四五”教材《针灸学》。 （2）取穴：按 PHN 疼痛的主要部位进行经络辨证,选取相应输穴,如疼痛部位主要分布在肝经取太冲；胆经取足临泣；脾经取太白；胃经取陷谷；膀胱经取束骨；肾经取太溪。若疼痛分布在多条经络,可多个输穴同取。 夹脊穴定位：在脊柱区，第 1 胸椎至第 5 腰椎棘突下两侧，后正中线旁开 0.5 寸， 一侧 17 穴。 （3）操作：输穴用龙虎交战针法:具体操作为先大指力重速快向前左转 9 次,然后轻轻退回,再大指向后力重速快右转 6 次,然后轻轻退回,先左后右，一补一泻,每穴反复交替施术约 3 min。在疱疹皮损及疼痛区域相应夹脊穴穴位注射，选取与皮损部位相对应的夹脊穴，通常选择病变相应神经节段及上下各 1 节段。具体穴位注射操作方法如下。穴位注射方法：选取患侧与皮损部位相对应的夹脊穴(皮损相应神经节段及上下各 1 节段)，即背部后正中线棘突旁开 0.5 寸(约 1–1.5cm，颈夹脊穴为旁开 0.3 寸)，局部消毒后，用 7 号穿刺针垂直皮肤刺入，直至针尖抵达椎板（深度约 3–4cm），此时患者可有酸、麻、胀感，回抽无血后缓慢注射维生素 B12 注射液（国药集团容生制药有限公司国药准字：H41020633）1ml。 2、 西药+针刺 2 组 （1）取穴：在疱疹皮损及疼痛区域相应夹脊穴进行针刺，选取与皮损部位相对应的夹脊穴，通常选择病变相应神经节段及上下各 1 节段；再选取局部皮损及疼痛区域（阿是穴）进行针刺。 （2）操作：夹脊穴针刺可根据体型刺入 0.5-1.5 寸左右，待有麻、胀感时即停止进针；皮损四周距皮损疼痛部位 0.3cm 处进针，针尖朝向皮损中心，呈 15°角沿皮下围刺, 针距约为 2cm，围刺针数视疼痛范围大小而定，行平补平泻手法,得气后留针30 min。 受试者取健侧卧位，常规消毒后垂直进针，根据部位及体型可刺入 0.5-1.5 寸左右，待有麻、胀感时即停止进针，留针 30 分钟。操作时严格掌握进针的深度、角度，防止损伤内脏或引起外伤性气胸。 3、 西药组 只合并用药，不进行其他特殊干预。 4、 合并用药 普瑞巴林胶囊（重庆赛维，75mg/片，国药准字：H20130073）75mg，每日 2 次，共服药 4 周。若患者疼痛难以忍受可加量至 150mg，每日 2 次（300mg/日）。

Description for medicine or protocol of treatment in detail：

1. Western medicine + acupuncture group 1 (1) Positioning: The following acupoint positioning and operation methods refer to Acupuncture and Moxibustion the 14th Five-Year Plan textbook. (2) Acupoint selection: according to the main pain site of PHN the meridian differentiation was carried out and the corresponding acupoints were selected. For example the pain site was mainly distributed in Taichong the liver meridian. The gallbladder is taken foot weeping; The spleen is too white; The stomach was taken from the valley; The bone bundle was taken from the bladder. The kidney meridian was taken from Taixi. If the pain is distributed in multiple meridians multiple acupoints can be taken together. Location of Jiaji point: in the spinal region on both sides of the first thoracic vertebra to the fifth lumbar spine under the spinous process 0.5 cun beside the posterior midline 17 points on one side. (3) Operation: the dragon-tiger fighting acupuncture method is used for acupoint shu: the specific operation is as follows: first the big finger force is heavy and fast turn forward and left for 9 times and then gently return then the big finger backward force is heavy and fast turn right for 6 times and then gently return first left and then right one reinforcing and one reducing each acupoint is repeatedly and alternately applied for about 3 minutes. The acupoint injection was performed at the corresponding Jiaji point in the herpes skin lesion and pain area and the Jiaji point corresponding to the skin lesion was selected. Usually the corresponding nerve segment and one upper and one lower segment of the lesion were selected. The specific acupoint injection method is as follows. Acupoint injection method: The Jiaji acupoint on the affected side corresponding to the lesion site (the corresponding nerve segment and the upper and lower segments of the skin lesion) was selected which was 0.5 cun (about 1-1.5 cm) next to the spinous process on the posterior midline of the back and 0.3 cun next to the cervical Jiaji acupoint. After local disinfection a 7-gauge needle was used to penetrate the skin vertically until the tip of the needle reached the lamina (about 3-4 cm in depth). At this time the patient may have a sense of acid numbness and distension and slowly inject vitamin B12 injection (Sinopharm Group Rongsheng Pharmaceutical Co. LTD. Chinese Medicine approval number: H41020633) 1ml after withdrawing blood. 2 Western medicine + acupuncture group 2 (1) Acupoint selection: acupuncture was applied to the corresponding Jiaji (EX-B) in the herpes skin lesion and pain area and the Jiaji (EX-B) corresponding to the skin lesion was selected. Usually the corresponding nerve segment 1 upper and 1 lower segment of the lesion were selected. Then the local skin lesion and pain area (ashi point) were selected for acupuncture. (2) Operation: acupuncture at Jiaji point can be inserted into about 0.5-1.5 cun according to the body type and the needle should be stopped when there is numbness or fullness. The needle was inserted 0.3cm around the lesion from the pain site of the lesion and the tip of the needle was toward the center of the lesion at an Angle of 15° along the subcutaneous circumference with a needle distance of about 2cm. The number of needles around the lesion was determined by the size of the pain range. The subjects were placed in the healthy lateral position and the needle was inserted vertically after routine disinfection. According to the location and body type the needle could be inserted 0.5-1.5 inches When there is numbness and fullness the needle should be stopped and the needle should be retained for 30 minutes. During operation the depth and Angle of the needle should be strictly controlled to prevent visceral injury or traumatic pneumothorax. 3 Western medicine group Only combined drugs no other special intervention. 4 Combined medication Pregabalin capsules (Chongqing Cervi 75mg/ tablet Chinese Medicine approval number: H20130073) 75mg twice daily for 4 weeks. If the patient's pain is unbearable the dose can be increased to 150mg twice a day (300mg/ day).

纳入标准：

参照《带状疱疹后神经痛诊疗中国专家共识》（2016 年）以及《中国带状疱疹诊疗专家共识》（2022 年）拟定 PHN 诊断标准如下： （1）有明确的带状疱疹病史且特征性皮损特征消退后遗留有疼痛并持续 1 月及以上。 （2）神经分布相关区域内皮肤有瘙痒性、刀割样、灼烧性、电击样、针刺样或搏动样疼痛，表现为间歇性和慢性疼痛。 （3）伴有情志不舒、睡眠障碍、日常生活的影响。 （4）局部有痛觉异常（痛觉过敏、痛觉减退、痛觉超敏），可见遗留瘢痕、色素沉着，局部可有汗多等自主神经紊乱表现。 （5）18-80 周岁之间，有日常生活自理能力且精神行为均正常，能够配合本次研究； （6）曾接受过药物、神经调控、神经介入治疗无效者； （7）自愿加入本次研究并签署知情同意书。 （注：同时符合以上 7 项者才能纳入本研究。）

Inclusion criteria

According to the Expert Consensus of Diagnosis and Treatment of Postherpetic Neuralgia in China (2016) and the Expert Consensus of Diagnosis and Treatment of Herpes Zoster in China (2022) the diagnostic criteria of PHN are as follows: (1) There is a clear history of herpes zoster and pain remains after the characteristic skin lesions subside and lasts for one month or more.

排除标准：

（1）哺乳期或妊娠期妇女； （2）合并有恶性肿瘤、免疫、精神或严重心、肝、肾、脑等重大疾病或凝血功能异常者； （3）已接受其他相关治疗者； （4）合并有带状疱疹其他严重并发症或有其他皮肤疾病者； （5）拒绝签署知情同意书者； （6）近半年内参加过其他临床研究，经研究者评估可能对本次研究结果评价造成干扰者，或计划在参与本研究期间参加其余临床研究者； （注：凡符合上述任何 1 条的患者即予以排除。）

Exclusion criteria：

(1) lactating or pregnant women; (2) Patients with malignant tumor immune mental or serious diseases such as heart liver kidney and brain or abnormal coagulation function; (3) Those who have received other relevant treatments; (4) Patients with other serious complications of herpes zoster or other skin diseases; (5) Refusing to sign the informed consent; (6) Participated in other clinical studies in the past six months and the results of this study may be evaluated as disruptor by the researchers or they plan to participate in other clinical researchers during their participation in this study; (Note: Patients who meet any one of the above items will be excluded. )

研究实施时间：

Study execute time：

从From 2024-06-01

至To      2026-05-31

征募观察对象时间：

Recruiting time：

从From 2024-06-26

至To      2025-12-31

干预措施：

Interventions：

组别：

西药组

样本量：

24

Group：

Western medicine group

Sample size：

干预措施：

只合并用药，不进行其他特殊干预。

干预措施代码：

Intervention：

Only combined medication, no other special intervention.

Intervention code：

组别：

西药+针刺2组

样本量：

24

Group：

Western medicine+acupuncture group 2

Sample size：

干预措施：

在疱疹皮损及疼痛区域相应夹脊穴进行针刺，选取与皮损部位相对应的夹脊穴，通常选择病变相应神经节段及上下各 1节段；再选取局部皮损及疼痛区域（阿是穴）进行针刺。

干预措施代码：

Intervention：

Acupuncture was performed on the corresponding Jiaji acupoints in the herpes skin lesion and pain area, and the Jiaji acupoints corresponding to the skin lesion site were selected. Usually, the corresponding nerve segment and one upper and one lower segment of the lesion were selected. Then, the local skin lesion and pain area (ashi point) were selected for acupuncture.

Intervention code：

组别：

西药+针刺1组

样本量：

24

Group：

Western medicine+acupuncture group 1

Sample size：

干预措施：

按 PHN 疼痛的主要部位选取相应输穴用龙虎交战针法；在疱疹皮损及疼痛区域相应夹脊穴穴位注射，选取与皮损部位相对应的夹脊穴，通常选择病变相应神经节段及上下各 1 节段。

干预措施代码：

Intervention：

According to the main pain site of PHN, the corresponding acupoints were selected and the dragon-tiger fighting needling method was used. The acupoint injection was performed at the corresponding Jiaji point in the herpes skin lesion and pain area, and the Jiaji point corresponding to the skin lesion was selected. Usually, the corresponding nerve segment and one upper and one lower segment of the lesion were selected.

Intervention code：

样本总量 Total sample size ： 72

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)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都市第三人民医院

单位级别：

三甲

Institution/hospital：

Chengdu Third People's Hospital

Level of the institution：

grade A tertiary hospital

测量指标：

Outcomes：

指标中文名：

焦虑状态评分

指标类型：

次要指标

Outcome：

Anxiety state 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：

疼痛评分

指标类型：

主要指标

Outcome：

visualanaloguescal

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹兹堡睡眠质量指数评分

指标类型：

次要指标

Outcome：

Pittsburgh sleep quality index 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：

抑郁状态评分

指标类型：

次要指标

Outcome：

Depressive state 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：

红外线热成像

指标类型：

次要指标

Outcome：

Infrared thermal imaging

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：

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机数字表进行随机，所有受试者按照 1：1：1 随机分为西药+针刺 1 组、西药+针刺 2 组、西药组，每组各 24 例受试者。

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

According to the random number table all subjects were randomly divided into western medication + acupuncture group 1 western medication + acupuncture group 2 and western medication group with 24 subjects in each group.

盲法：

Blinding：

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）：

http://www.medresman.org.cn/uc/index.aspx

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

http://www.medresman.org.cn/uc/index.aspx

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：

（1）试验前：数据负责人试验开展前，对涉及的研究人员进行集中培训，如受试者的纳排、剔除、脱落标准、穴位定位与操作等保持一致。本试验的操作者均具备执业资格。 （2）试验中：课题负责人定期监测试验进度，及时发现并解决问题，每周对所记录的数 据进行核实，保证其准确、真实性。严格按照评价时点，及时完成各量表评分的记录， 填充病例报告表（CRF），然后对数据进行整理、统计分析。病例报告表（CRF）作为原 始记录，严格记录且非特殊不得更改。如需更改应在原始记录旁进行批注，同时做出修 改的医师进行签名并标注日期。 （3）试验后：采集的所有数据当课题负责人进行妥善保管与数据分析，不得泄露患者任何信息。

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

(1) Before the experiment: before the experiment is carried out the data director should give centralized training to the researchers involved such as the acceptance rejection and shedding standards of the subjects acupoint positioning and operation. The operators of this experiment are all qualified to practice. (2) During the test: the project leader regularly monitors the test progress finds and solves problems in time and verifies the recorded data every week to ensure its accuracy and authenticity. In strict accordance with the evaluation time the scores of each scale were recorded in time and the case report form (CRF) was filled in and then the data were sorted out and statistically analyzed. As the original record CRF is strictly recorded and cannot be changed unless it is special. If changes are needed comments should be made next to the original records and the doctor who made the changes should sign and date them. (3) After the test: All the collected data shall be properly kept and analyzed by the project leader and no information of patients shall be disclosed.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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