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A prospective, randomized controlled clinical study on the combination of spinal adjustment surgery and strong muscle and waist exercises in the three-stage syndrome differentiation treatment of lumbar disc herniation

注册号：

Registration number：

ITMCTR2024000376

最近更新日期：

Date of Last Refreshed on：

2024-09-04

注册时间：

Date of Registration：

2024-09-04

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

调脊术配合强筋健腰功法在腰椎间盘突出症三期辨证治疗的前瞻性、随机性对照临床研究

Public title：

A prospective, randomized controlled clinical study on the combination of spinal adjustment surgery and strong muscle and waist exercises in the three-stage syndrome differentiation treatment of lumbar disc herniation

注册题目简写：

调脊术配合强筋健腰功法治疗腰椎间盘突出症

English Acronym：

Spinal adjustment surgery combined with strong muscle and waist exercises for the treatment of lumbar disc herniation

研究课题的正式科学名称：

调脊术配合强筋健腰功法在腰椎间盘突出症三期辨证治疗的前瞻性、随机性对照临床研究

Scientific title：

A prospective randomized controlled clinical study on the combination of spinal adjustment surgery and strong muscle and waist exercises in the three-stage syndrome differentiation treatment of lumbar disc herniation

研究课题的正式科学名称简写：

调脊术配合强筋健腰功法治疗腰椎间盘突出症

Scientific title acronym：

Spinal adjustment surgery combined with strong muscle and waist exercises for the treatment of lumbar disc herniation

研究课题代号(代码)：

Study subject ID：

2024-3-7131

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：

白金山

研究负责人：

白金山

Applicant：

Bai Jinshan

Study leader：

Bai Jinshan

申请注册联系人电话：

Applicant telephone：

13911221990

研究负责人电话：

Study leader's telephone：

13911221990

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：

bjs8005@126.com

研究负责人电子邮件：

Study leader's E-mail：

bjs8005@126.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：

北京市平谷区平翔路6号

研究负责人通讯地址：

北京市平谷区平翔路6号

Applicant address：

No. 6 Pingxiang Road, Pinggu District, Beijing

Study leader's address：

No. 6 Pingxiang Road, Pinggu District, Beijing

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：

北京市平谷区中医医院

Applicant's institution：

Beijing Pinggu District Traditional Chinese Medicine 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-sfkt-02

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：

北京市平谷区中医医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Pinggu District Traditional Chinese Medicine Hospital, Beijing

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/10 0:00:00

伦理委员会联系人：

刘惠杰

Contact Name of the ethic committee：

liu huijie

伦理委员会联系地址：

北京市平谷区平翔路6号

Contact Address of the ethic committee：

No. 6 Pingxiang Road, Pinggu District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

13401149969

伦理委员会联系人邮箱：

Contact email of the ethic committee：

kjc651@bjpg.gov.cn

研究实施负责（组长）单位：

北京市平谷区中医医院

Primary sponsor：

Beijing Pinggu District Traditional Chinese Medicine Hospital

研究实施负责（组长）单位地址：

北京市平谷区平翔路6号

Primary sponsor's address：

No. 6 Pingxiang Road, Pinggu District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

平谷区

Country：

china

Province：

beijing

City：

pinggu

单位(医院)：

北京市平谷区中医医院

具体地址：

北京市平谷区平翔路6号

Institution
hospital：

Beijing Pinggu District Traditional Chinese Medicine Hospital

Address：

No. 6 Pingxiang Road, Pinggu District, Beijing

经费或物资来源：

北京市卫生健康委

Source(s) of funding：

Beijing Municipal Health Commission

研究疾病：

腰椎间盘突出症

研究疾病代码：

Target disease：

Lumbar disc herniation

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：

评价调脊术配合强筋健腰功法治疗腰椎间盘突出症（LDH）临床疗效

Objectives of Study：

Evaluate the clinical efficacy of Manual skills of Spinal Tuina Therapy combined with strong muscle and waist exercises in the treatment of lumbar disc herniation (LDH)

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符合腰椎间盘突出症患者；②年龄16～60岁；③签署知情同意书；④可配合治疗并按时定期接受随访。

Inclusion criteria

① patients with lumbar disc herniation; ② Age ranged from 16 to 60 years; ③ Sign the informed consent form; ④ Patients who can cooperate with treatment and receive regular follow-up on time.

排除标准：

①年龄<16或者>60岁②游离型或重度椎间盘突出，压迫马尾神经而出现鞍区症状者；③严重椎管狭窄；④弓崩裂和重度骨质疏松者；⑤腰部局部有较大面积皮肤破损者；⑥合并精神疾患患者；⑦孕妇及妇女月经期；⑧合并肝肾疾病、呼吸系统、脊椎结核、肿瘤、糖尿病、严重心脑血管疾病或极度衰弱者等情况。

Exclusion criteria：

① age < 16 or > 60 years old; ② free or severe disc herniation compression of cauda equina and saddle area symptoms; ③ Severe spinal stenosis; ④ Patients with arch fracture and severe osteoporosis; ⑤ There is a large area of skin damage in the waist; ⑥ Patients with mental disorders; All landowners pregnant women and women's menstrual period; ⑧ Patients with liver and kidney diseases respiratory system spinal tuberculosis tumor diabetes serious cardiovascular and cerebrovascular diseases or extremely weak etc.

研究实施时间：

Study execute time：

从From 2024-01-01

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2024-09-30

至To      2026-08-31

干预措施：

Interventions：

组别：

试验组

样本量：

48

Group：

Experimental Group

Sample size：

干预措施：

调脊术+强筋腱腰功法

干预措施代码：

Intervention：

Manual skills of Spinal Tuina Therapy by realigning the small joints subluxation of the spinal vertebrae + strengthening tendon and waist exercise

Intervention code：

组别：

对照组

样本量：

48

Group：

Control Group

Sample size：

干预措施：

口服非甾体抗炎药+强筋健腰功法

干预措施代码：

Intervention：

Oral non-steroidal anti-inflammatory drugs + strengthening tendon and waist exercise

Intervention code：

样本总量 Total sample size ： 96

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

市(区县)：

平谷区

Country：

china

Province：

beijing

City：

pinggu

单位(医院)：

北京市平谷区夏各庄社区卫生服务中心

单位级别：

一级

Institution/hospital：

Xiagezhuang Community Health Service Center, Pinggu District, Beijing

Level of the institution：

First level hospital

国家：

中国

省(直辖市)：

北京市

市(区县)：

平谷区

Country：

china

Province：

beijing

City：

pinggu

单位(医院)：

北京市平谷区中医医院

单位级别：

三级甲等医院

Institution/hospital：

Beijing Pinggu District Traditional Chinese Medicine Hospital

Level of the institution：

class A tertiary hospital

国家：

中国

省(直辖市)：

北京市

市(区县)：

平谷区

Country：

china

Province：

beijing

City：

pinggu

单位(医院)：

北京市平谷区平谷镇滨河社区卫生服务中心

单位级别：

一级

Institution/hospital：

Binhe Community Health Service Center, Pinggu Town, Pinggu District, Beijing

Level of the institution：

First level hospital

测量指标：

Outcomes：

指标中文名：

总体治疗有效率疗效评价，参照2012年国家中医药 管理局发布的《中医病证诊断疗效标准》中LDH的疗效标准。主要来源于下面三个评分表的量化数据，反映治疗前后患者自觉疼痛、查体体征、生活功能方面的变化情况。

指标类型：

主要指标

Outcome：

For the overall treatment efficiency and curative effect evaluation, refer to the curative effect standard of LDH in the Diagnostic Efficacy Standard of TCM Diseases and Syndrome issued by state administration of traditional chinese medicine in 2012. It mainly comes from the quantitative data of the following three scales, which reflects the changes of patients' conscious pain, physical examination and living function before and after treatment.

Type：

Primary indicator

测量时间点：

0、0.5月、1月、3个月、6个月

测量方法：

Japanese orthopaedic association, JOA评分；Oswestry disability index,ODI 评分；VAS疼痛评分

Measure time point of outcome：

0, 0.5 month, 1 month, 3 month and 6 month

Measure method：

JOA；ODI； VAS；

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 16 岁
Min age years
最大 60 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）：

本研究分为三个中心，采用多中心随机分组模式。将三个中心分别以字母A、B、C代表。A代表北京市平谷区中医医院，拟收入患者n=56例；B代表北京市平谷区夏各庄镇社区卫生服务中心，拟收患者数n=20例；C代表北京市平谷区平谷镇滨河社区卫生服务中心，拟收患者数n=20例.按照拟收患者人数分别进行随机分组。以A组拟收56例为例：利用EXCEL表格，函数F（X）==RAND()*100，取其整数部分，得到若干1-100之间的随机数字，令产生100*100数字表，从第5行第5列作为起点，向下依次获取56个随机数字，将入组患者按就诊顺序从A01-A56进行编号并与随机数字对应，规定单数进入治疗组，双数进入对照组；如果分组例数不相等则进行调整，调整方法：查原随机数字表，将取数行（列）紧邻的下一个数字除以较多人数组之人数，余数即为较多人数组需要调整的入组顺序号，调整后例数仍不相等则再次依法调整，直到两组患者均为28例。

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

This study is divided into three centers and adopts the multi-center random grouping mode. The three centers are represented by letters a b and c respectively. A stands for Pinggu District Hospital of Traditional Chinese Medicine in Beijing with n=56 patients to be admitted; B represents the community health service center of Xiagezhuang Town Pinggu District Beijing and the number of patients to be admitted is n=20; C stands for Binhe Community Health Service Center in Pinggu Town Pinggu District Beijing. The number of patients to be admitted is n=20. They are randomly divided according to the number of patients to be admitted. Take 56 cases in group A as an example: use EXCEL table function F(X)==RAND()*100 take its integer part and get a number of random numbers between 1 and 100 so as to generate a table of 100*100 numbers. From the fifth row and the fifth column as the starting point get 56 random numbers in turn and number the patients in the group from A01 to A56 according to the order of treatment. If the number of grouped cases is not equal adjust it. The adjustment method is as follows: check the original random number table divide the next number next to the row (column) of data access by the number of people in the larger group and the remainder is the grouping sequence number that needs to be adjusted in the larger group. If the adjusted number of cases is still not equal adjust it again according to law until there are 28 patients in both groups.

盲法：

本研究由于干预措施不能对患者社盲，故在纳入病例及随访评估方面对相应研究人员设盲，尽量减小信息偏移。由于三个中心分别纳入患者，各自接诊医师纳入患者入组时不知道随机数字表编号方式，也不知道纳入的顺序号，只有负责信封的专人知道纳入的顺序号，只有打开信封揭盲后才知道患者的组别。管理药物、指导功法、手法治疗的研究人员进行各自操作，治疗前后由观察表填写医师，进行表格填写，并由非治疗与非功法人员进行数据录入及数据分析。接诊、功法指导、手法治疗人员、随访人员、数据分析人员不知道分组名单；信封管理人员不接触患者；功法指导人员不填写评估报告；填写报告表的医师不进行治疗及指导。

Blinding：

In this study because the intervention measures can't be blind to the patients' society we should be blind to the corresponding researchers in the aspects of case inclusion and follow-up evaluation so as to minimize the information deviation. As patients are included in the three centers respectively the attending doctors do not know the numbering method of the random number table or the sequence number when they are included in the group. Only the person in charge of the envelope knows the sequence number and the group of patients is not known until the envelope is opened. The researchers who manage drugs instruct manual therapy and manual therapy perform their own operations. Before and after treatment the observation form is filled in by doctors the form is filled in and the data is entered and analyzed by non-therapeutic and non-manual therapy personnel. Reception exercise guidance manual therapy personnel follow-up personnel and data analysis personnel do not know the grouping list; Envelope managers do not touch patients; The instructor does not fill in the evaluation report; Doctors who fill in the report form do not give treatment and guidance.

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）：

不公开

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

not published

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、基本要求 建立数据库与数据录入：建立病例观察表，填写病例观察表，建立EXCEL数据库，全部数据均录入数据库。 2、保障措施 2.1团队成员分工明确，以科学严谨的态度记录客观数据，并登记好，安排责任强的医师负责监督管理，每月进行数据汇总统计。 2.2加强技术培训，做好技术规范的讲解，耐心、细心记录好每个受试患者的各项数据采集，有问题及时修正。 2.3加强医德培训，做好患者的病情交代，保证技术过关，对待患者有责任心。 3、数据管理 3.1研究者对原始材料要仔细核对信息，保证材料的完整性，做到定期审核。 3.2数据录入要准确，仔细核对，对CRF表保存完整。 3.3记录医师要做好签名，防止漏项。

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

1. Basic requirements Database establishment and data entry: establish case observation table, fill in case observation table, establish EXCEL database, and all data are entered into the database. 2. Safeguard measures 2.1 team members have a clear division of labor, record objective data with a scientific and rigorous attitude, register them well, arrange doctors with strong responsibilities to be responsible for supervision and management, and conduct monthly data summary statistics. 2.2 Strengthen technical training, explain the technical specifications, patiently and carefully record the data collection of each patient, and correct the problems in time. 2.3 Strengthen the training of medical ethics, explain the patient's condition, ensure the technical pass, and treat patients with a sense of responsibility. 3. Data management 3.1 The researcher should carefully check the information of the original materials, ensure the integrity of the materials, and audit them regularly. 3.2 Data entry should be accurate and carefully checked, and CRF tables should be kept intact. 3.3 The recording physician shall sign it well to prevent any omission.

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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