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Follow meridian rapid acupuncture combined with 'Huoxuelishang' plaster in the treatment of blood stasis type lumbar disc herniation, a randomized single blind placebo-controlled trial

注册号：

Registration number：

ITMCTR2024000137

最近更新日期：

Date of Last Refreshed on：

2024-07-29

注册时间：

Date of Registration：

2024-07-29

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

循经快刺联合活血理伤膏治疗血瘀型腰椎间盘突出症的随机单盲安慰剂对照试验

Public title：

Follow meridian rapid acupuncture combined with 'Huoxuelishang' plaster in the treatment of blood stasis type lumbar disc herniation, a randomized single blind placebo-controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

循经快刺联合活血理伤膏治疗血瘀型腰椎间盘突出症的随机单盲安慰剂对照试验

Scientific title：

Follow meridian rapid acupuncture combined with 'Huoxuelishang' plaster in the treatment of blood stasis type lumbar disc herniation, a randomized single blind placebo-controlled trial

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：

ypzzjb1

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：

姜彬

研究负责人：

姜彬

Applicant：

jiangbin

Study leader：

jiangbin

申请注册联系人电话：

Applicant telephone：

13262280669

研究负责人电话：

Study leader's telephone：

13262280669

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：

13262280669@163.com

研究负责人电子邮件：

Study leader's E-mail：

13262280669@163.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：

杨浦区腾越路450号1号楼2层

研究负责人通讯地址：

杨浦区腾越路450号1号楼2层

Applicant address：

Doctor's Office of TCM Department, Building 1, Tengyue Road No.450, Yangpu District, Shanghai

Study leader's address：

Doctor's Office of TCM Department, Building 1, Tengyue Road No.450, Yangpu District, Shanghai

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：

同济大学附属杨浦医院中医科

Applicant's institution：

TCM Department, Yangpu Hospital, School of Medicine, Tongji University , Shanghai

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：

LL-2023-QSW-014

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

同济大学附属杨浦医院伦理委员会

Name of the ethic committee：

Ethics Committee, Yangpu Hospital, School of Medicine, Tongji University

伦理委员会批准日期：

Date of approved by ethic committee：

2023/10/9 0:00:00

伦理委员会联系人：

王佩菊

Contact Name of the ethic committee：

Wang Peiju

伦理委员会联系地址：

杨浦区腾越路450号5号楼212号办公室

Contact Address of the ethic committee：

Room 212, Building No.5, Tengyue Road No.450, Yangpu District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 2105690520

伦理委员会联系人邮箱：

Contact email of the ethic committee：

13262280669@163.com

研究实施负责（组长）单位：

同济大学附属杨浦医院中医科

Primary sponsor：

TCM Department, Yangpu Hospital, School of Medicine, Tongji University , Shanghai

研究实施负责（组长）单位地址：

上海市杨浦区腾越路450号1号楼中医科医生办公室

Primary sponsor's address：

Doctor's Office of TCM Department, Building 1, Tengyue Road No.450, Yangpu District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

杨浦区

Country：

China

Province：

Shanghai

City：

Yangpu District

单位(医院)：

同济大学附属杨浦医院中医科

具体地址：

上海市杨浦区腾越路450号1号楼中医科医生办公室

Institution
hospital：

TCM Department, Yangpu Hospital, School of Medicine, Tongji University , Shanghai

Address：

Doctor's Office of TCM Department, Building 1, Tengyue Road No.450, Yangpu District, Shanghai

经费或物资来源：

同济大学附属杨浦医院

Source(s) of funding：

Yangpu Hospital, School of Medicine, Tongji University

研究疾病：

腰椎间盘突出症

研究疾病代码：

Target disease：

Lumbar Disc Herniation (LDH)

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：

观察循经快刺配合活血理伤膏对于腰椎间盘要突出患者短期及中长期疗效，形成规范的中医特色诊疗技术。

Objectives of Study：

To observe the short and medium term curative effect of Follow meridian rapid acupuncture combined with 'Huoxuelishang' plaster on patients with lumbar disc herniation, and to form a standard TCM characteristic diagnosis and treatment technology.

药物成份或治疗方案详述：

药物成分：活血理伤膏药粉由我院中药房提供，本科医师调制。该方中的药材包括丹参、甘草 、当归 、白芷、制大黄、天花粉、生栀子、桃仁、泽兰、紫花地丁、积雪草等。骨伤活血理伤膏作过程如下：取上述药物细粉1公斤，先后加入米醋1公斤、蜂蜜1公斤、凡士林50克后调匀，装入科室治疗罐内，加盖勿令泄气，储存待用。 治疗方法： （1）快针刺组：患者取俯卧位，左手自上而下按压腰椎棘突及棘旁肌肉，寻找压痛点，右手取0.35×40mm毫针快刺压痛点，再循足太阳膀胱经快刺两侧肾俞、气海俞、关元俞，针刺方向为中心脊柱方向斜30°，深度1寸。后用芒针针刺患侧环跳，深度2寸，最后用芒针针刺患侧阳陵泉，向阴陵泉方向透刺2寸。毫针采用指切进针法进针，芒针采用双手夹持进针法，进针后施以提插捻转等手法，令受试者产生酸、麻、重、胀等得气感后拔针。每周治疗2次，治疗周期4周，共计治疗8次。嘱患者夜间将活血理伤膏敷于患侧腰部皮肤，外层用小毛巾或绷带覆盖，可加医用胶布固定，敷满8小时后早晨去除，活血理伤膏于治疗前2周每日外敷，每次1贴，每周5次，共计10次。 （2）假针刺组：患者俯卧位，采用假针快刺相同部位，并假装施行捻转手法相同时间后拔针。敷药过程相同。针刺及敷药治疗周期相同。

Description for medicine or protocol of treatment in detail：

纳入标准：

（1）符合诊断标准的患者，病情分级属于轻、中度的 LDH （2）年龄在 18-75 岁； （3）病程大于 3 个月； （4）自愿接受配合完成要求的快针刺联合活血理伤膏外用治疗。 （5）患者在接受治疗的前 4 周未口服、静脉注射、肌肉注射或软组织注射糖 皮质激素； （6）完全了解本试验后同意加入，并签署知情同意书。

Inclusion criteria

(1) Patients who met the diagnostic criteria were classified as mild or moderate LDH (2) Aged 18-75 years; (3) The duration of the disease is more than 3 months; (4) Voluntarily accept the external treatment of quick acupuncture combined with Huoxueliang ointment to complete the requirements. (5) Patients did not receive oral, intravenous, intramuscular, or soft tissue injections of sugar during the first 4 weeks of treatment Corticosteroids; (6)After fully understanding this experiment, agree to join, and sign the informed consent.

排除标准：

（1）凡不符合纳入标准者； （2）近 3 个月内参加过或正在参加其它临床研究者； （3）曾经正规的非手术疗法六个月无效者，症状加重者，或属于重度的患者； （4）短时间内肌力明显减退，肌力＜Ⅲ级者； （5）有严重腰椎创伤史和腰椎手术史者； （6）孕妇、哺乳期妇女及精神病患者； （7）过敏体质及对多种药物过敏者； （8）精神或法律上的残疾者； （9）有阿片类镇痛药、镇静催眠药及酒精滥用史者； （10）合并肝、肾、造血系统、内分泌系统、心脑血管、神经系统等严重原发性病、结核、椎体畸形、恶性肿瘤及精神病患者； （11）畏惧针刺患者

Exclusion criteria：

1) In cases where the inclusion criteria are not met; 2) Have previously participated in or are currently participating in other clinical trials within the past 3 months; 3) Patients who have failed to respond to regular non-surgical therapy for a duration of six months, patients with worsened symptoms, or patients with severe symptoms; 4) Rapid and significant decline in muscle strength, with muscle strength below level III; 5) Patients with a history of severe lumbar trauma and previous lumbar surgery; 6) Pregnant women, breastfeeding women, and individuals with mental health conditions; 7) Individuals with allergic tendencies or allergies to multiple drugs; 8) Individuals with mental or legal incapacities; 9) Individuals with a history of opioid analgesic use, sedatives and hypnotics abuse, as well as alcohol abuse; 10) Patients diagnosed with serious primary diseases affecting the liver, kidney, hematopoietic system, endocrine system cardiovascular and cerebrovascular system,nervous system,and other major systems. This includes tuberculosis infection,vertebral malformations,malignant tumors,and mental disorders. 11)Patients who fear acupuncture.

研究实施时间：

Study execute time：

从From 2024-07-01

至To      2026-12-30

征募观察对象时间：

Recruiting time：

从From 2024-08-01

至To      2026-12-01

干预措施：

Interventions：

组别：

快针刺组

样本量：

35

Group：

rapid acupuncture group

Sample size：

干预措施：

快针刺+活血理伤膏药外敷

干预措施代码：

Intervention：

rapid acupuncture + 'Huoxuelishang' plaster

Intervention code：

组别：

假针刺组

样本量：

35

Group：

sham acupuncture

Sample size：

干预措施：

假针刺+活血理伤膏药外敷

干预措施代码：

Intervention：

sham acupuncture + 'Huoxuelishang' plaster

Intervention code：

样本总量 Total sample size ： 70

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

杨浦区

Country：

China

Province：

Shanghai

City：

Yangpu District

单位(医院)：

同济大学附属杨浦医院中医科

单位级别：

三级

Institution/hospital：

TCM Department, Yangpu Hospital, School of Medicine, Tongji University , Shanghai

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

下腰痛疾患评价量表

指标类型：

次要指标

Outcome：

JOA

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

耐痛阈

指标类型：

主要指标

Outcome：

pain tolerance threshold

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

vas评分

指标类型：

次要指标

Outcome：

VAS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

痛阈值

指标类型：

主要指标

Outcome：

pain tolerance threshold

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：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 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）：

采用区组随机化采用社会科学统计软件包（Statistical Product and Service Solutions，SPSS 22.0 版）通过生成随机数字表，将患者按照 1:1 的比例随机分配至治疗组或对照组。随机化将由一名可靠的临床医生进行操作。当一位病人确定入组后，调查者将按入组顺序为这名医生提供一个数字，医生会根据随机数字表将这些病人随机分配到治疗组或对照组。所提供的数字和相应的数字表由这名医生进行专人管理和保密。所有病人的分组结果将在整个临床试验完成后才会被公开。

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

The Social science Statistical Product and Service Solutions (SPSS 22.0) software package was used to generate a table of random numbers, and patients were randomly assigned to the treatment group or the control group in a 1:1 ratio. Randomization will be performed by a trusted clinician. When a patient is enrolled, the investigator will provide the doctor with a number in the order of enrollment, and the doctor will randomly assign the patients to the treatment or control group based on a table of random numbers. The numbers provided and the corresponding tables of numbers are managed and kept confidential by the physician. The results of all patient groups will not be made public until the full clinical trial is completed.

盲法：

采用单盲的方法。患者俯卧位在腰部治疗，不知道试验分组及针刺操作真伪。

Blinding：

Single blind method was used. The patients did not know the authenticity of the trial grouping and acupuncture operation.

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）：

于中国临床试验注册中心、临床试验公共管理平台ResMan (www.medresman.org)公开

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

sharing on Chinese Clinical Trial Registry website

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.登记编号 （1）对所有前来咨询本研究的患者进行基本信息登记，并按照咨询顺序给予筛选号，详细询问病史后如果该患者符合标准，即可纳入本研究并按照入组先后顺序分配入组号，另外通过随机数字表根据入组号对患者进行分组，并填写相应的治疗编号，不符合标准的患者，仅分配筛选号后即可排除，不予入组。如研究者张小毛筛选的第五位受试者，是第四位成功入组的病人，随机分配为对照组，则筛选号-入组号为 005-004，治疗编号为 002。 （2） 记录参与者的姓名和拼音缩写、家庭住址、联系电话及记录时间，以年月日格式填写，如 2023 年 01 月 20 日。 2.基本信息填写（CRF 表） （1）根据受试者描述，填写信息采集表中人口学特征： 性别、年龄、出生年月； （2）LDH 患者根据主诉完成病史、治疗史及合并其他疾病情况填写； （3）研究者按诊断学要求对患者进行系统体格检查，将异常状况记录，如遇不确定异常表现，经 3 个以上科研人员讨论后，不会对研究结果产生影响，则进入下一环节筛选，否则终止筛选； 3.治疗前后数据采集： （1）测量针灸前后最敏感椎体的痛阈及耐痛阈：使用压力测痛仪（仪器：Wagner Instruments,Greenwich,CT-USA）进行测量，进行客观疼痛疗效评估。 （2）视觉模拟量表（Visual Analog Scale，VAS）：记录VAS疼痛评分，进行主观疼痛疗效评估。 （3）JOA评分： 通过问诊记录患者治疗前后下腰痛功能量表内容。 分别在治疗1月（即治疗周期结束时）、3月、6月后进行，对受试者的痛阈、压痛阈、VAS 评分、JOA评分综合评定。 数据管理: 本研究采用SPSS 22.0软件统计分析。计量资料用均值±标准差形式表示，组内比较时先检验正态性和方差齐性，两者符合的情况下采用重复测量的方差分析，结果先经球形检验，若符合球形检验，则采用主体内效应检验，若不符合，则参考多变量检验结果。对不符合正态性的计量资料，以及等级资料组间比较用秩和检验，以p＜0.05作为差异有统计学意义。

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

1. Registration number (1) All patients who came to consult this study were registered with basic information and given a screening number according to the consultation order. After detailed medical history inquiry, if the patient meets the criteria, he can be included in this study and assigned an enrollment number according to the enrollment order. In addition, patients were grouped according to the enrollment number through a random number table and corresponding treatment number was filled in. After assigning a screening number, it can be excluded and not included in the group. If the fifth subject screened by researcher Zhang Xiaomao is the fourth successfully enrolled patient and randomly assigned to the control group, the screening number - enrollment number is 005-004, and the treatment number is 002. (2) Record the participant's name and pinyin abbreviation, home address, contact phone number and record time in the format of year month, such as January 20, 2023. 2. Fill in basic information (CRF form) (1) According to the description of the subject, fill in the demographic characteristics in the information collection form: gender, age, date of birth; (2) LDH patients complete the medical history, treatment history and other diseases according to the chief complaint; (3) Researchers conduct systematic physical examination of patients according to diagnostic requirements and record abnormal conditions. In case of uncertain abnormal manifestations and no impact on research results after discussion by more than three researchers, the screening will proceed to the next step; otherwise, the screening will be terminated; 3. Data collection before and after treatment: (1) The pain threshold and pain tolerance threshold of the most sensitive vertebra before and after acupuncture were measured by a pressure pain meter (Wagner Instruments,Greenwich,CT-USA) for objective evaluation of pain efficacy. (2) Visual Analog Scale (VAS) : The VAS pain score was recorded to evaluate the subjective pain efficacy. (3) JOA score: The contents of the low back pain function scale before and after treatment were recorded through consultation. After 1 month of treatment (i.e., at the end of the treatment cycle), 3 months and 6 months, the subjects' pain threshold, tenderness threshold, VAS score and JOA score were comprehensively evaluated. Data Management: SPSS 22.0 software was used for statistical analysis. The measurement data were expressed in the form of mean ± standard deviation, and the normality and homogeneity of variance were tested first during the intra-group comparison. If they met the spherical test, the results were tested by repeated measurement ANOVA. If they met the spherical test, the in-subject effect test was used; if they did not meet the multivariate test results were referred to. The rank sum test was used to compare the measurement data that did not conform to normality, and the difference was statistically significant with p < 0.05.

数据管理委员会：

Data Managemen Committee：

有

Yes

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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