ChiCTR2500113226 版本V1.0 版本创建时间2025/11/26 10:39:09 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：

 ChiCTR2500113226 

最近更新日期：

Date of Last Refreshed on：

 2025-11-26 10:38:46 

注册时间：

Date of Registration：

 2025-11-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于循经辩证理论的温通拨筋罐综合灸联合针刺在腰椎间盘突出症患者中的应用

Public title：

Application of Combined Moxibustion and Acupuncture with Warm-Through-Meridian-Based Diagnosis and Comprehensive Cupping Therapy in Patients with Lumbar Disc Herniation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于循经辩证理论的温通拨筋罐综合灸联合针刺在腰椎间盘突出症患者中的应用

Scientific title：

Application of Combined Moxibustion and Acupuncture with Warm-Through-Meridian-Based Diagnosis and Comprehensive Cupping Therapy in Patients with Lumbar Disc Herniation

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：

王金荣 

研究负责人：

王金荣 

Applicant：

Wang Jinrong 

Study leader：

Wang Jinrong 

申请注册联系人电话：

Applicant telephone：

 +86 135 6262 6836

研究负责人电话：

Study leader's
telephone：

+86 135 6262 6836

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：

 wjrwkl@126.com

研究负责人电子邮件：

Study leader's E-mail：

 wjrwkl@126.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：

山东省潍坊市奎文区虞河路2428号

研究负责人通讯地址：

山东省潍坊市奎文区虞河路2428号

Applicant address：

No. 2428, Yuhe Road, Kuiwen District, Weifang City, Shandong Province

Study leader's address：

No. 2428, Yuhe Road, Kuiwen District, Weifang City, Shandong 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：

潍坊医学院附属医院

Applicant's institution：

Weifang Medical University Affiliated Hospital

研究负责人所在单位：

潍坊医学院附属医院

Affiliation of the Leader：

Weifang Medical University Affiliated Hospital

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：

 KY-2024-M27

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：

潍坊医学院附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Weifang Medical University Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-07-18 00:00:00

伦理委员会联系人：

王树庆

Contact Name of the ethic committee：

Wang Shuqing

伦理委员会联系地址：

山东省潍坊市奎文区虞河路2428号

Contact Address of the ethic committee：

No. 2428, Yuhe Road, Kuiwen District, Weifang City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 139 5363 4596

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：

潍坊医学院附属医院

Primary sponsor：

Weifang Medical University Affiliated Hospital

研究实施负责（组长）单位地址：

山东省潍坊市奎文区虞河路2428号

Primary sponsor's address：

No. 2428, Yuhe Road, Kuiwen District, Weifang City, Shandong 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)：

山东

市(区县)：

潍坊

Country：

China

Province：

ShanDong

City：

Weifang

单位(医院)：

潍坊医学院附属医院

具体地址：

山东省潍坊市奎文区虞河路2428号

Institution
hospital：

Weifang Medical University Affiliated Hospital

Address：

No. 2428, Yuhe Road, Kuiwen District, Weifang City, Shandong Province

经费或物资来源：

潍坊市卫生健康委员会

Source(s) of funding：

Weifang Municipal Health Commission

研究疾病：

腰椎间盘突出症  

Target disease：

Lumbar Disc Herniation

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：

1、构建基于循经辩证理论的温通拨筋罐综合灸联合针刺的干预方案。 2、探讨基于循经辩证理论的温通拨筋罐综合灸联合针刺的干预方案对寒湿痹阻型腰椎间盘突出症患者的干预效果。  

Objectives of Study：

1. Developing an Integrated Intervention Protocol Combining Warm-Through Muscle-Releasing Cupping with Moxibustion and Acupuncture Based on Meridian-Based Differentiation Theory. 2. Investigating the Therapeutic Effectiveness of the Integrated Intervention Protocol Combining Warm-Through Muscle-Releasing Cupping with Moxibustion and Acupuncture Based on Meridian-Based Differentiation Theory for Patients with Lumbar Disc Herniation Due to Cold-Damp Obstruction Pattern.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄≥18岁 2.符合西医腰椎间盘突出症诊断标准及中医寒湿痹阻型辩证标准 3.入组前2个月未接受其他可影响疗效评估的治疗 4.既往无腰椎外伤史或手术史，近半年内未行创伤性腰椎检查 5.操作部位皮肤完整，无红肿、瘢痕、破损等可能影响试验结果的情况 6.知情同意并自愿参与本研究

Inclusion criteria

1. Age >= 18 years 2. Meets Western medical diagnostic criteria for lumbar disc herniation and Traditional Chinese Medicine (TCM) diagnostic criteria for cold-damp obstruction pattern. 3. No other treatments that may affect efficacy assessment within 2 months prior to enrollment. 4.No history of lumbar trauma or surgery; no traumatic lumbar examinations within the past 6 months. 5. Intact skin at the procedure site, free of redness, swelling, scars, or lesions that may affect trial results. 6. Informed consent and voluntary participation in this study.

排除标准：

1.具备明确的手术指征需行手术治疗者。 2.重度骨质疏松，或有脊柱结核、脊柱肿瘤等病史。 3.有重大内科疾病史，如严重心脑血管疾病、严重高血压、凝血功能障碍等。 4.糖尿病末梢神经损伤或病人肢体感觉障碍。 5.怀孕、备孕、哺乳期妇女。 6.接触性过敏或艾烟过敏者。 7.伴有精神疾病或认知障碍，无法进行沟通交流。

Exclusion criteria：

1. Patients with clear surgical indications requiring surgical intervention. 2. Severe osteoporosis, or history of spinal tuberculosis, spinal tumors, etc. 3. History of major medical conditions such as severe cardiovascular disease, severe hypertension, coagulation disorders, etc. 4. Diabetic peripheral neuropathy or patients with sensory impairment in the limbs. 5. Pregnant women, women planning pregnancy, or lactating women. 6. Individuals with contact allergies or sensitivity to smoke. 7. Patients with psychiatric disorders or cognitive impairment who are unable to communicate effectively.

研究实施时间：

Study execute time：

从 From 2024-07-18 00:00:00至 To 2027-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-01 00:00:00 至 To 2024-12-26 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 40

Group：

Control group

Sample size：

干预措施：

采用普通针刺治疗（针刺以局部穴、阿是穴为主，配合循经远端取穴；主穴为相应的夹脊穴、肾俞、大肠俞、环跳、委中、阳陵泉；配穴为命门、腰阳关穴，采用毫针平补平泻法）。针刺一日一次，7天为一个疗程，共治疗两个疗程。

干预措施代码：

Intervention：

Standard acupuncture therapy was administered (primarily targeting local acupoints and Ashi points, supplemented by distal points along meridians; primary points included corresponding paravertebral points, Shenshu, Dàchángshu, Huántiào, Weizhong, and Yanglingquan; auxiliary points included Mìngmén and Yāoyángguān, using fine needles with balanced tonification and dispersion techniques). Acupuncture sessions were conducted once daily, with each course lasting 7 days, totaling two treatment courses.

Intervention code：

组别：

观察组

样本量：

 40

Group：

Observation Group

Sample size：

干预措施：

在对照组治疗基础上应用温通拨筋罐技术方案进行干预。 操作过程： 1.督脉走罐：患者俯卧位。平推法刮拭督脉，从中枢穴刮至腰俞穴。 2.足太阳经筋走罐操作：患者俯卧位。保持皮肤于罐口边缘呈10—15度，分别沿脾俞至膀胱俞，阳纲至胞肓，殷门至委中，承山至昆仑，沿一个方向重复5次，走罐结束后点拔法作用于脾俞穴、腰俞穴、膀胱俞穴、委中穴、承山穴，每穴点拔5次，以局部皮肤潮红为度。 3.足少阳经筋走罐操作：患者俯卧位。保持皮肤于罐口边缘呈10—15度，分别沿两侧环跳至风市，阳陵泉至悬钟，沿一个方向重复5次，走罐结束后点拔法作用于环跳穴、风市穴、阳陵泉穴，每穴点拔5次，以局部皮肤潮红为度。 4.足阳明经筋走罐操作：患者仰卧位。保持皮肤于罐口边缘呈10—15度，分别沿两侧滑肉门至气冲，髀关至伏兔，沿一个方向重复5次，走罐结束后点拔法作用于天枢穴、髀关穴、伏兔穴，每穴点拔5次，以局部皮肤潮红为度。 5.用点拨法刮拭腰部夹脊肌和结筋病灶点 6.用揉刮法刮拭阿是穴和委中、委阳、太溪穴。 7.刮拭结束，温通拨筋罐做灸器在命门穴悬灸10分钟。 8.施罐完成后，嘱患者避风寒，饮用温开水，4—6小时内不接触冷水等。 每次治疗约30分钟，隔日一次，7天为1个疗程，共治疗2个疗程。

干预措施代码：

Intervention：

The intervention involved applying the Warming and Muscle-Releasing Cupping technique on top of the standard treatment regimen. Procedure: 1. Du Meridian Cupping: Patient in prone position. Use flat scraping technique along the Du Meridian from the central point to the waist shu points. 2. Foot Taiyang Meridian Cupping: Patient in prone position. Maintain skin at a 10–15 degree angle to the cup rim. Perform along the following sequences: Yanggang to Baohuang, Yimen to Weizhong, and Chengshan to Kunlun. Repeat in one direction five times. After cupping, apply the lifting technique to the Spleen Shu, Waishu, Bladder Shu, Weizhong, and Chengshan points, lifting each point five times until local skin flushing occurs. 3. Foot Shaoyang Meridian Tendon-Cupping Technique: Patient in prone position. Maintain a 10–15 degree angle between skin and cup rim. Move along both sides from Huantiao to Fengshi, Yanglingquan to Xuanzhong, repeating 5 times in one direction. After cupping, apply tapping technique to Huantiao, Fengshi, and Yanglingquan points, tapping each 5 times until local skin flushes. 4. Foot Yangming Meridian Tendon-Cupping Technique: Patient supine. Maintain skin at a 10–15° angle to the cup rim. Perform gliding cupping along both sides from Huorumen to Qichong, and from Biguan to Futu, repeating 5 times in one direction. After cupping, apply tapping-lifting technique to Tianshu, Biguan, and Futu points, tapping-lifting 5 times per point until local skin flushes. 5. Apply the tapping method to scrape the paraspinal muscles and knotted tendon areas along the lumbar spine. 6. Use the kneading-scraping method to scrape Ashi points, Weizhong (BL40), Weiyang (BL39), and Taixi (KI3). 7. After scraping, suspend the Warming and Meridian-Activating Cupping Jar as a moxibustion device over Mingmen for 10 minutes. 8. Post-treatment instructions: Advise patient to avoid wind and cold, drink warm water, and refrain from cold water contact for 4–6 hours. Each session lasts approximately 30 minutes, administered every other day. One course comprises 7 days, with a total of 2 courses.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China

Province：

ShanDong

City：

单位(医院)：

 潍坊医学院附属医院 

单位级别：

 三甲 

Institution
hospital：

Weifang Medical University Affiliated Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

腰腿疼痛

指标类型：

主要指标

Outcome：

Back and leg pain

Type：

Primary indicator

测量时间点：

测量方法：

视觉模拟量表

Measure time point of outcome：

Measure method：

Visual Analogue Scale

指标中文名：

腰椎功能

指标类型：

主要指标

Outcome：

Lumbar function

Type：

Primary indicator

测量时间点：

测量方法：

日本骨科协会评分

Measure time point of outcome：

Measure method：

Japanese Orthopaedic Association Scores

指标中文名：

奥斯韦斯特脊椎功能障碍指数

指标类型：

主要指标

Outcome：

Oswestry Dability Index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床疗效

指标类型：

主要指标

Outcome：

Clinical efficacy

Type：

Primary 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：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 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）：

由研究小组成员按照随机数字表法将患者分为观察组和对照组。

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

Patients were randomly assigned to the observation group and the control group by members of the research team using a random number table method.

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，对研究对象隐藏分组，对评估者不隐藏

Blinding：

Single-blind: The study subjects are unaware of their group assignment, but the evaluators are aware.

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

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）：

论文发表后一年内，国家生物信息中心 https://ngdc.cncb.ac.cn/gsa

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

Within one year of publication, China Nation center for Bioinformation https://ngdc.cncb.ac.cn/gsa.

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、本研究在进行问卷调查之前，培训2名研究者关于问卷的组成、调查方法、交流技巧、填写要求等内容。2名培训合格后研究者向初入组的患者讲解本研究的目的、意义及干预内容，使用统一语言指导患者填写纸质调查问卷 2、采用EXCEl录入整理，采用SPSS 26.0软件进行分析

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

1. Prior to conducting the questionnaire survey, two researchers were trained on the questionnaire's composition, survey methodology, communication techniques, and completion requirements. After successful completion of training, these researchers explained the study's purpose, significance, and intervention content to newly enrolled patients, guiding them to complete the paper-based questionnaire using standardized language. 2. Data entry and organization were performed using Excel, with analysis conducted via SPSS 26.0 software.

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：

  2025-11-26 10:38:46