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The biomechanical mechanism based on gait analysis to explore the application and popularization value of fitness Qigong mawangdui guidance in the prevention and treatment of non-specific low

注册号：

Registration number：

ITMCTR2200005605

最近更新日期：

Date of Last Refreshed on：

2022-02-05

注册时间：

Date of Registration：

2022-02-05

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于步态分析的生物力学机制探讨健身气功·马王堆导引术引腰动作应用于非特异性下腰痛防治和推广价值

Public title：

The biomechanical mechanism based on gait analysis to explore the application and popularization value of fitness Qigong mawangdui guidance in the prevention and treatment of non-specific low

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于步态分析的生物力学机制探讨健身气功·马王堆导引术引腰动作应用于非特异性下腰痛防治和推广价值

Scientific title：

The biomechanical mechanism based on gait analysis to explore the application and popularization value of fitness Qigong mawangdui guidance in the prevention and treatment of non-specific low

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：

四川省中医药管理局课题（2021MS156）

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：

ChiCTR2200056406 ; ChiMCTR2200005605

申请注册联系人：

仉贵龙

研究负责人：

仉贵龙

Applicant：

Zhang Guilong

Study leader：

Zhang Guilong

申请注册联系人电话：

Applicant telephone：

+86 18180608848

研究负责人电话：

Study leader's telephone：

+86 18180608848

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：

zhangguilong@cdutcm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

zhangguilong@cdutcm.edu.cn

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：

四川省成都市十二桥路39号

研究负责人通讯地址：

四川省成都市十二桥路39号

Applicant address：

39 Shi-Er-Qiao Road, Chengdu, Sichuan, China

Study leader's address：

39 Shi-Er-Qiao Road, Chengdu, Sichuan, China

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：

成都中医药大学附属医院

Applicant's institution：

Hospital of Chengdu University of Traditional Chinese Medicine

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：

2021KL-126

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：

成都中医药大学附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Affiliated Hospital of Chengdu University of Traditional Chinese Medicine&

伦理委员会批准日期：

Date of approved by ethic committee：

2021/12/24 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

成都中医药大学附属医院

Primary sponsor：

Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

四川省成都市十二桥路39号

Primary sponsor's address：

39 Shi-Er-Qiao Road, Chengdu, Sichuan, China

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)：

成都

Country：

China

Province：

Sichuang

City：

Chengdu

单位(医院)：

成都中医药大学附属医院

具体地址：

十二桥路39号

Institution
hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Address：

39 Shi-Er-Qiao Road

经费或物资来源：

四川省中医药管理局课题

Source(s) of funding：

Project of Sichuan Administration of Traditional Chinese Medicine

研究疾病：

非特异性下腰痛

研究疾病代码：

Target disease：

Nonspecific low back pain

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

本次研究以 NLBP 患者为主要研究载体，依据随机对照原则，将对照组与治疗组进行组间对照以及前后对照，采用 NORAXON 步态分析系统、F-scan 足底压力分析系统结合相对应的步态测量软件以及肌骨超声对受试者行走过程中的步态运动学参数、足底压力分布以及靶肌肉相关参数进行测量、记录、分析，观察非特异性下腰痛受试者行走步态的影响，明确异常步态与 NLBP 相关性；同时探究马王堆导引术引腰动作干预 NLBP 的生物力学机制。

Objectives of Study：

In this study, PATIENTS with NLBP were taken as the main research carrier. According to the principle of randomized control, the control group and the treatment group were compared between groups as well as before and after. NORAXON gait analysis system, F - scan plantar pressure analysis system combined with the corresponding gait measurement software and musculoskeletal ultrasound for participants in the process of walking gait kinematics parameters, the plantar pressure distribution and the target muscle related parameters measurement, recording and analysis of to observe the effects of nonspecific low back pain subjects walking gait, The correlation between abnormal gait and NLBP was confirmed. At the same time, the biomechanical mechanism of mawangdui guidance lumbar movement intervention in NLBP was explored.

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)能满足 NLBP 诊断标准的患者； (2)18 岁及以上患者； (3)疼痛来源于躯体牵涉痛或非根性痛（膝盖以上）； (4)参与者了解本研究相关情况，本人愿意并已完善相关知情同意书者； (5)非手术绝育或育龄期女性患者，需要在研究治疗期间和研究治 疗期结束后3个月内采用一种经医学认可的避孕措施（如宫内节育器，避孕药或避孕套）；非手术绝育的育龄期女性患者在研究入组前的72h内血清或尿HCG检查必须为阴性；而且必须为非哺乳期；对于伴侣为育龄妇女的男性患者，应在试验期间采用有效方法避孕。

Inclusion criteria

245/5000 (1) patients who can meet NLBP diagnostic criteria; (2) Patients aged 18 and above; (3) pain originated from somatic referred pain or non-root pain (above the knee); (4) Participants who know the relevant information of this study and are willing and have completed the relevant informed consent; (5) Use of a medically approved contraceptive method (such as an intrauterine device, birth control pill or condom) during the study period and for 3 months after the study period for women of non-surgical sterilization or childbearing age; The serum or urine HCG test of female patients of childbearing age who were not undergoing surgical sterilization must be negative within 72 hours prior to study enrollment. And must be non lactation period; For male patients whose partners are women of reproductive age, effective methods of contraception should be used during the trial.

排除标准：

(1)18 岁以下患者； (2)特异性下腰痛（肿瘤、感染、代谢性疾病、类风湿性关节炎、骨折）； (3)脊柱畸形（脊柱滑脱、峡部裂或脊柱侧弯）； (4)膝盖以下部位疼痛； (5)脊髓外疾病（例如血管、泌尿生殖系统疾病）； (6)有腰椎手术史； (7)存在根性症状； (8)腰痛伴 2 个或以上其他部位疼痛； (9)妊娠。 (10)其他重要脏器的实质性损害患者，如严重的心、肝、肾、肺功能不全及心脑血管疾病患者； (11)易合并感染及出血者、肿瘤、术后功能障碍患者； (12)近 3 个月内接受过针灸、推拿、敷贴、熏蒸等中医特色治疗患者； (13)既往有精神疾病或长期使用镇静剂者； (14)不能完成基本治疗，依从性不好患者； (15)资料不全影响疗效判定或无法确定疗效者； (16)出现不良反应，难以耐受，自行退出者。 （注：凡符合上述任何一条的患者，即予排除）

Exclusion criteria：

(1) Patients under the age of 18; (2) specific low back pain (tumor, infection, metabolic disease, rheumatoid arthritis, fracture); (3) spinal deformity (spondylolisthesis, spondylolysis or scoliosis); (4) Pain below the knee; (5) diseases outside the spinal cord (such as vascular and urogenital diseases); (6) Have a history of lumbar surgery; (7) there are root symptoms; (8) low back pain with 2 or more other parts of the pain; (9) pregnancy. (10) Patients with substantial damage to other important organs, such as severe heart, liver, kidney, lung dysfunction and cardiovascular and cerebrovascular diseases; (11) Patients prone to infection and bleeding, tumors, and postoperative dysfunction; (12) Patients who have received traditional Chinese medicine treatment such as acupuncture, massage, application and fumigation in the past 3 months; (13) persons with previous mental illness or long-term use of sedatives; (14) Patients who cannot complete basic treatment and have poor compliance; (15) Incomplete data affect the assessment of curative effect or cannot determine curative effect; (16) Withdrawal by oneself due to adverse reactions that are difficult to tolerate. (Note: Patients meeting any of the above criteria are excluded)

研究实施时间：

Study execute time：

从From 2022-06-01

至To      2023-02-01

征募观察对象时间：

Recruiting time：

从From 2022-06-01

至To      2023-01-01

干预措施：

Interventions：

组别：

核心肌群稳定性训练组

样本量：

50

Group：

Core muscle stability training group

Sample size：

干预措施：

平板支撑，臀桥训练

干预措施代码：

Intervention：

Plank, hip bridge training

Intervention code：

样本总量 Total sample size ： 100

研究实施地点：

Countries of recruitment
and research settings：

测量指标：

Outcomes：

指标中文名：

肌骨超声相关参数

指标类型：

主要指标

Outcome：

Musculoskeletal ultrasound related parameters

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

足底压力相关参数

指标类型：

主要指标

Outcome：

Parameters related to plantar pressure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

步态运动学相关参数

指标类型：

主要指标

Outcome：

Gait kinematics related parameters

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：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 岁
Min age years
最大 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）：

本研究采用随机数字表法将 100 名骨科就诊患者随机分为两组。

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

In this study, 100 orthopedic patients were randomly divided into two groups using a random number table.

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）：

计算机软件CDMS 请阅读网页注册指南中关于 原始数据共享 的内容。

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

Computer software CDMS

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）建立数据库：根据病例报告表的项目采用计算机软件CDMS建立相应的录入程序，并设定录入时的逻辑审查限定条件，对数据库进行试运行，建立本试验专用的数据库系统； （2）录入前再次核查：对病例报告表的进一步检查，已经审核声明签字的病例报告表交给数据管理员，数据管理员对日期、入组标准、排除标准、脱落、缺失值等进行检查，如有疑问，可填写疑问表（query form）返回监察员，由研究者对疑问表中的问题进行书面解答并签名，交回数据管理员，疑问表应妥善保管； （3）数据录入：对数据录入员培训后进行远程数据录入，每一份病例报告表采用双份录入法，由两人独立完成； （4）数据审核：采用计算机软件中的核查功能进行逻辑检查与自动比较，查对与病例报告表不一致的结果值，然后逐项与原始病例报告表核对，予以更正。再进行病例报告表和数据库中的数据的人工比较，以确保数据库中的数据与病例报告表中的结果一致； （5）数据锁定：除进行上述的数据审核外，还要由主要研究者、统计人员、数据管理员和申办者共同进一步讨论和确认研究方案中的主要内容和统计分析计划书。进行盲态审核（blind review），确认全部数据均已录入数据库，全部疑问均已解决，分析人群已定义并做出判断后锁定数据（data locked）； （6）揭盲和数据处理：数据锁定后，由保存盲底的单位向数据管理人员提交盲底，由后者完成数据的揭盲；揭盲后的数据交统计分析人员进行分析。

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

1. establishment of database: according to the items in the case report form, the corresponding entry program was established by using the computer software CDMS, and the logic review qualification conditions during the entry were set. The trial operation of the database was conducted, and the special database system for this experiment was established; 2. to check again before entry: case report further examination, has a report on the case of audit declaration signed to the data administrator, data managers to date, the standard set, exclusion criteria, fall off, missing value, such as inspection, if in doubt, can fill in the question sheet (query form) return to inspector, the problems in the table by researchers to the question to answer in writing and signed and returned to the data administrator, doubt table should be properly kept; 3. data entry: remote data entry is carried out after the training of data entry personnel, and each case report form adopts the double entry method, which is completed by two people independently; 4. data audit: logical inspection and automatic comparison are carried out by using the verification function in the computer software to check the result values inconsistent with the case report form, and then check with the original case report form item by item and make corrections.Manual comparison between the data in the case report table and the data in the database is conducted to ensure that the data in the database are consistent with the results in the case report table. 5. data locking: in addition to the above data audit, main researchers, statisticians, data administrators and sponsors shall further discuss and confirm the main content and statistical analysis plan of the research program.Blind review was performed to confirm that all data had been entered into the database, all questions had been solved, and data locked after the analysis group was defined and judged; 6. unblinding and data processing: after data locking, the unit that saves the blind bottom shall submit the blind bottom to the data manager, who shall complete the data unblinding;After unblinding, the data were sent to statistical analysts for analysis.

数据管理委员会：

Data Managemen Committee：

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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