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A randomised controlled parallel PROBE design phase 3 clinical trial of the Chinese traditional mind-body exercise Ba Duan Jin for cervical spondylosis

注册号：

Registration number：

ITMCTR2024000611

最近更新日期：

Date of Last Refreshed on：

2024-10-27

注册时间：

Date of Registration：

2024-10-27

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

中国传统身心锻炼八段锦干预颈型颈椎病随 机、对照、平行、PROBE 设计、3 期临床试验

Public title：

A randomised controlled parallel PROBE design phase 3 clinical trial of the Chinese traditional mind-body exercise Ba Duan Jin for cervical spondylosis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中国传统身心锻炼八段锦干预颈型颈椎病随 机、对照、平行、PROBE 设计、3 期临床试验

Scientific title：

A randomised controlled parallel PROBE design phase 3 clinical trial of the Chinese traditional mind-body exercise Ba Duan Jin for cervical spondylosis.

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：

张贤

研究负责人：

张贤

Applicant：

Zhang Xian

Study leader：

Zhang Xian

申请注册联系人电话：

Applicant telephone：

13616173567

研究负责人电话：

Study leader's telephone：

13616173567

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：

zhangxian0772@sina.com

研究负责人电子邮件：

Study leader's E-mail：

zhangxian0772@sina.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：

江苏省无锡市中南西路8号

研究负责人通讯地址：

江苏省无锡市中南西路8号

Applicant address：

No. 8 Zhongnan West Road Wuxi Jiangsu Province China

Study leader's address：

No. 8 Zhongnan West Road Wuxi Jiangsu Province China

申请注册联系人邮政编码：

Applicant postcode：

214071

研究负责人邮政编码：

Study leader's postcode：

214071

申请人所在单位：

无锡市中医医院

Applicant's institution：

Wuxi Hospital 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：

2024(研)-062-01

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：

无锡市中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Wuxi Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/31 0:00:00

伦理委员会联系人：

沈雁菊

Contact Name of the ethic committee：

Shen Yanju

伦理委员会联系地址：

无锡市中南西路8号,行政楼608室

Contact Address of the ethic committee：

Room 608 Administration Building No. 8 Zhongnan West Road Wuxi China

伦理委员会联系人电话：

Contact phone of the ethic committee：

0510-82703775

伦理委员会联系人邮箱：

Contact email of the ethic committee：

wxtcmirb@163.com

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine China

研究实施负责（组长）单位地址：

上海市甘河路110号　

Primary sponsor's address：

No. 110 Ganhe Road 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)：

Country：

China

Province：

Shang Hai

City：

单位(医院)：

无锡市中医医院

具体地址：

江苏省无锡市中南西路8号

Institution
hospital：

Wuxi Hospital of Traditional Chinese Medicine

Address：

No. 8 Zhongnan West Road Wuxi Jiangsu Province China

经费或物资来源：

国家中医药管理局高水平重点学科子项目

Source(s) of funding：

Sub-project of High-level Key Disciplines of the State Administration of Traditional Chinese Medicine (SATCM)

研究疾病：

颈椎病

研究疾病代码：

Target disease：

cervical spondylosis

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：

其它

Others

研究目的：

1.主要目的：评价八段锦干预颈型颈椎病临床效应。 2.次要目的：为功法干预颈型颈椎病提供高质量循证医学证据。

Objectives of Study：

1. Primary objective: to evaluate the clinical effects of Ba Duan Jin on cervical spondylosis. 2. Secondary objective: to provide high-quality evidence-based medical evidence for gongfu intervention in cervical spondylosis.

药物成份或治疗方案详述：

本研究为随机、对照、平行、PROBE 设计、3 期临床试验，本中心采用简单随机的方法，按参加单位的病例分配数（32 例）及随机比例生成随 机数字分组表。本项目各中心采用简单随机方法将纳入的患者分为对照组和试验组。对照组采用颈部常规锻炼治疗，试验组采用八段锦治疗。 1.对照组 对照组患者采用颈部常规锻炼。根据既往文献，具体操作方法如下：（1） 患者取站位。头部置于中立位。缓缓抬头至极限位，之后缓缓低头至极限位，后回至中立位。（2） 患者取站位。头部置于中立位。向左侧缓缓转动头部至极限位，之后向右侧缓缓转动头部至极限位，后回至中立位。（3） 患者取站位。头部置于中立位。向左侧缓缓侧屈，以使耳朵尽量接近左肩部，之后缓缓回至中立位并向右侧缓缓侧屈，以使耳朵尽量接近右肩部，后回至中立位。（4） 患者取站位。头部置于中立位。双手自然垂放于体侧。双手掌心向下并缓缓从身体两侧上抬至与肩同高，之后缓缓放下。（5） 患者取站位。头部置于中立位。双手自然垂放于体侧。双手掌心向下并缓缓从身体前方上抬至与肩同高，之后缓缓放下。（6） 患者取站位。头部置于中立位。将左手从体前放置于右侧肩上，缓缓上台左肘部至与肩同高，之后缓缓放下至胸前。右侧同左侧。（7） 患者取站位。头部置于中立位。耸肩以使耳朵尽量靠近肩膀。（8） 坐位俯卧撑。患者取坐位，前方放置有靠背的椅子。双手置于椅子背部，缓缓下压身体使得手肘和背部在同一平面。 颈部常规锻炼每周 3 次，每次间隔时间超过 1 日，每次 30 分钟，连续治疗12 周。 2.试验组 试验组采用八段锦功法治疗。八段锦功法的运动处方参照全国中医药高等教育“十四五”规划教材《推拿功法学》中颈部疾病“八段锦”干预方案和操作标准执行。 八段锦具体操作：（1）两手托天理三焦：自然站立，两足平开，与肩同宽，含胸收腹，腰脊放松。正头平视，口齿轻闭，宁神调息，气沉丹田。双手自体侧缓缓举至头顶，转掌心向上，用力向上托举，足跟亦随双手的托举而起落。托举六次后，双手转掌心朝下，沿体前缓缓按至小腹，还原。（2）左右开弓似射雕;自然站立，左脚向左侧横开一步，身体下蹲成骑马步，双手虚握于两髋之外侧，随后自胸前向上划弧提于与乳平高处。右手向右拉至与右乳平高，与乳距约两拳许，意如拉紧弓弦，开弓如满月；左手捏箭诀，向左侧伸出，顺势转头向左，视线通过左手食指凝视远方，意如弓箭在手，等机而射。稍作停顿后，随即将身体上起，顺势将两手向下划弧收回胸前，并同时收回左腿，还原成自然站立。此为左式，右式反之。左右调换练习六次。（3）调理脾胃须单举；自然站立，左手缓缓自体侧上举至头，翻转掌心向上，并向左外方用力举托，同时右手下按附应。举按数次后，左手沿体前缓缓下落，还原至体侧。右手举按动作同左手，惟方向相反。（4）五劳七伤往后瞧:自然站立，双脚与肩同宽，双手自然下垂，宁神调息，气沉丹田。头部微微向左转动，两眼目视左后方，稍停顿后，缓缓转正，再缓缓转向右侧，目视右后方稍停顿，转正。如此六次。（5）摇头摆尾去心火：两足横开，双膝下蹲，成"骑马步"。上体正下，稍向前探，两目平视，双手反按在膝盖上，双肘外撑。以腰为轴，头脊要正，将躯干划弧摇转至左前方，左臂弯曲，右臂绷直，肘臂外撑，臀部向右下方撑劲，目视右足尖；稍停顿后，随即向相反方向，划弧摇至右前方。反复六次。（6）两手攀足固肾腰：松静站立，两足平开，与肩同宽。两臂平举自体侧缓缓抬起至头顶上方转掌心朝上，向上作托举劲。稍停顿，两腿绷直，以腰为轴，身体前俯，双手顺势攀足，稍作停顿，将身体缓缓直起，双手右势起于头顶之上，两臂伸直，掌心向前，再自身体两侧缓缓下落于体侧。（7）攒拳怒目增气力：两足横开，两膝下蹲，呈“骑马步”。双手握拳，拳眼向下。顺势头稍向左转，两眼通过左拳凝视远方，右拳同时后拉。与左拳出击形成一种“争力”。随后，收回左拳，击出右拳，要领同前。反复六次。（8）背后七颠百病消：两足并拢，两腿直立、身体放松，两手臂自然下垂，手指并拢，掌指向前。随后双手平掌下按，顺势将两脚跟向上提起，稍作停顿，将两脚跟下落着地。反复练习六次。八段锦锻炼每周 3 次，每次间隔时间超过 1 日，每次 30 分钟，连续治疗 12周。 受试对象在首次干预前、干预 12 周后、干预结束后 12 周和 24 周共 4 个时间点进行颈部疼痛程度、颈椎功能障碍程度、情绪状态、睡眠状态、肌肉紧张程度和颈椎活动度的评估，通过比较 VAS、NDI、SF-12、HADS、PSQI、WPAI-SPH、EQ-5D 及 NPQ，观察两组干预颈型颈椎病的临床效应

Description for medicine or protocol of treatment in detail：

This study is a randomised controlled parallel PROBE design phase 3 clinical trial. A randomised numerical grouping table was generated at our centre using a simple randomisation method based on the number of cases allocated to the participating units (32) and randomisation proportions. The centres in this project used simple randomisation method to divide the included patients into control and trial groups. The control group was treated with conventional neck exercises and the experimental group was treated with Ba Duan Jin.1. control group The patients in the control group adopt the routine exercise of the neck. According to previous literature the specific operation method is as follows: (1) The patient takes the standing position. The head is placed in the neutral position. Slowly raise the head to the limit position then slowly lower the head to the limit position and then back to the neutral position. (2) The patient is placed in the standing position. The head is placed in the neutral position. Slowly rotate the head to the left side to the limit then to the right side to the limit and then back to the neutral position. (3) The patient assumes the standing position. The head is placed in the neutral position. Slowly flex laterally to the left side to bring the ear as close as possible to the left shoulder then slowly return to the neutral position and slowly flex laterally to the right side to bring the ear as close as possible to the right shoulder then return to the neutral position. (4) The patient is placed in the standing position. The head is placed in the neutral position. Hands hang naturally at the side of the body. Palms down and slowly raise both hands from the sides of the body to shoulder height then slowly lower them. (5) The patient stands. The head is placed in a neutral position. Hands hang naturally at the side of the body. Palms down and slowly raise the hands from the front of the body to shoulder height then slowly lower them. (6) The patient stands. The head is placed in a neutral position. Place the left hand on the right shoulder from the front of the body slowly raise the left elbow to shoulder height and then slowly lower it to the chest. The right side is the same as the left side. (7) The patient takes a standing position. The head is placed in a neutral position. Shrug the shoulders so that the ears are as close to the shoulders as possible. (8) Seated push-ups. The patient sits in a seated position with a chair with a backrest in front of him. Place your hands on the back of the chair and slowly lower your body so that your elbows are in the same plane as your back.Routine neck exercises were performed 3 times per week for 30 minutes at intervals of more than 1 day for 12 weeks of continuous treatment.2. Experimental group The experimental group was treated with Baduanjin. The exercise prescription of Ba Duan Jin refers to the intervention programme and operation standard of "Ba Duan Jin" for neck diseases in the "14th Five-Year Plan" textbook of Tui Na Gong Fa" of the National Higher Education of Traditional Chinese Medicine. Specific operation of Eight-Duan-Jin: (1) Both hands hold up the sky and manage the three jiao: stand naturally with both feet flat and open shoulder width apart chest and abdomen contained and waist and spine relaxed. The head is looking at the flat mouth and teeth lightly closed tranquillity of the mind to adjust the breath the gas sinks into the dantian. Hands from the side of the body slowly raised to the top of the head turn the palm upward force upward lifting heel also with the hands of the lifting and up and down. After lifting six times turn the palms of both hands to face down slowly press along the front of the body to the abdomen restore. (2) left and right bow like shooting eagles; stand naturally left foot to the left side of the horizontal open step the body squatting into a horseback riding stance hands virtual grip on the outside of the two hips and then from the chest upward arc lifted to the level with the breast height. The right hand is pulled to the right to the right breast level and the distance between the breast is about two fists meaning as pulling the bowstring tightly open the bow like a full moon; the left hand pinch the arrow trick stretching out to the left side and then turn the head to the left and the line of sight through the left forefinger to gaze into the distance meaning as the bow and arrow in the hand and wait for the opportunity to shoot. After a short pause then the body will rise up and in the process the two hands will arc downward to recover the chest and at the same time to recover the left leg restored to natural standing. This is the left form the right form and vice versa. Left and right switch practice six times. (3) To regulate the spleen and stomach must be single lift; stand naturally the left hand slowly from the side of the body up to the head turn the palm up and to the left side of the force to lift support while the right hand down the press should be attached. After lifting and pressing several times the left hand slowly descends along the front of the body and is restored to the side of the body. The right hand lifts and presses the same action as the left hand but in the opposite direction. (4) Five Labours and Seven Injuries: Stand naturally with feet shoulder-width apart hands naturally hanging down tranquillising the mind and regulating the breath and sinking the qi into the dantian. Head slightly turned to the left eyes on the left rear after a short pause slowly turn right and then slowly turn to the right side eyes on the right rear a short pause turn right. Do this six times. (5) Swinging the head and tail to the heart fire: two feet horizontally open knees squatting into a "horseback riding". The upper body is under slightly forward probe two eyes flat hands against the knees elbows outside the support. With the waist as the axis the head and spine should be positive the torso will arc to the left front the left arm is bent the right arm is taut the elbow and arm support the hips to the right lower support the eye on the right foot tip; after a short pause then to the opposite direction arc to the right front. Repeat six times. (6) Climbing the feet with both hands to strengthen the kidney and waist: stand in a loose and quiet position with both feet flat and open shoulder width apart. Raise both arms from the side of the body slowly to the top of the head above the palm facing up up for lifting strength. A short pause both legs straight to the waist as an axis the body bent forward both hands follow the trend to climb the foot a short pause the body slowly straight up both hands right above the top of the head both arms straight palms forward and then from both sides of the body slowly down on the side of the body. (7) Save the fist and eyes to increase the power: two feet open horizontally two knees squatting was "riding a horse step". Make a fist with both hands eyes down. Turn your head slightly to the left gaze into the distance with your eyes through your left fist and pull your right fist back at the same time. The right fist is pulled back at the same time. This creates a kind of "contention" with the left fist. Afterwards take back the left fist and strike the right fist with the same principles as before. Repeat six times. (8) Behind the seven upside down elimination of all diseases: two feet together two legs upright body relaxation two arms naturally down fingers together palm pointing forward. Then press the flat palms of both hands down and then lift both heels upwards pause for a while and drop both heels to the ground. Repeat the exercise six times. The Ba Duan Jin exercise was performed 3 times a week for 30 minutes at intervals of more than 1 day for 12 consecutive weeks of treatment. The degree of neck pain cervical spine dysfunction emotional state sleep state muscle tension and cervical spine mobility were assessed at 4 time points before the first intervention 12 weeks after the intervention 12 weeks and 24 weeks after the end of the intervention and were compared with the VAS NDI SF-12 HADS PSQI WPAI-SPH EQ-5D and NPQ. Clinical effects of the intervention of cervical cervical spondylosis in two groups

纳入标准：

（1）年龄≥20 周岁且≤50 周岁，性别不限；（2）满足 2014 年《加拿大整脊治疗成人颈痛循证指南》中慢性非特异性颈 痛诊断标准：颈部疼痛持续至少 3 个月，疼痛局限于颈部、枕部或肩胛后部，颈项部肌肉痉挛，颈部牵张试验、Spurling 颈部压迫试验和 Adson 试验结果阴性；（3）VAS 评分≥3 分；（4）自愿参加本研究并签署知情同意书。

Inclusion criteria

(1) aged ≥20 years and ≤50 years regardless of gender; (2) fulfilled the diagnostic criteria for chronic non-specific neck pain in the 2014 Canadian Evidence-Based Guidelines for Chiropractic Treatment of Neck Pain in Adults: neck pain lasting at least 3 months pain confined to the cervical occipital or posterior scapular region cervical muscle spasm and negative results of the cervical distraction test the Spurling cervical pressure test and the Adson test; (3) had a VAS score of ≥3; (4) voluntarily signed an informed consent for this study; and (5) had a VAS score of ≥3. Negative; (3) VAS score ≥3; (4) Voluntary participation in the study and signing the informed consent form.

排除标准：

（1）颈部外观异常者，如疤痕、色素沉着、丘疹等；（2）有颈部外伤史及手术史者；（3）有严重器质性疾病或精神疾病者；（4）在入组前三个月内参与过其他临床试验者；（5）妊娠期、哺乳期女性；（6）有明显传染病史、遗传病史者；（7）有智力或精神障碍无法进行问卷填写及检查者；（8）酗酒和（或）精神情志异常、药物滥用和药物依赖者（含镇痛药）；（9）既往长期习练或在过去 3 个月内习练过八段锦、气功或瑜伽者；（10）接受本疗法前 1 个月内接受包括西药、中药、针灸、推拿等治疗。

Exclusion criteria：

(1) People with abnormal neck appearance such as scars hyperpigmentation pimples etc.; (2) People with history of neck trauma and surgery; (3) People with serious organic diseases or mental illness; (4) People who have participated in other clinical trials within three months prior to enrolment; (5) Pregnant and breastfeeding women; (6) People with history of obvious infectious diseases and genetic diseases; (7) People with intellectual or mental disabilities who are unable to fill out the questionnaire and (7) Those who have intellectual or mental disabilities and are unable to complete the questionnaire and examination; (8) Alcoholism and/or mental abnormality drug abuse and drug dependence (including analgesics); (9) Those who have practiced Baduanjin Qigong or yoga for a long period of time in the past or have done so in the past 3 months; (10) Those who have received treatment including western medicines traditional Chinese medicines acupuncture tuina and so on in the past month prior to receiving the therapy.

研究实施时间：

Study execute time：

从From 2024-07-31

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2024-08-01

至To      2024-12-31

干预措施：

Interventions：

组别：

试验组

样本量：

16

Group：

test group

Sample size：

干预措施：

八段锦

干预措施代码：

Intervention：

Baduanjin

Intervention code：

组别：

对照组

样本量：

16

Group：

control subjects

Sample size：

干预措施：

常规颈椎操

干预措施代码：

Intervention：

Routine Cervical Exercises

Intervention code：

样本总量 Total sample size ： 32

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

无锡市

Country：

China

Province：

Jiang Su

City：

Wu XI

单位(医院)：

无锡市中医医院

单位级别：

市级

Institution/hospital：

Wuxi Hospital of Traditional Chinese Medicine

Level of the institution：

municipal

测量指标：

Outcomes：

指标中文名：

医院焦虑抑郁量表

指标类型：

次要指标

Outcome：

Hospital Anxiety and Depression Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

针对特定健康问题的工作效率和活动障碍问卷

指标类型：

次要指标

Outcome：

（Work Productivity and Activity Impairment Questionnaire: Specific Health Problem

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

EuroQOL-5 维度问卷

指标类型：

次要指标

Outcome：

EuroQoL 5-dimension (EQ-5D) questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉模拟疼痛评分

指标类型：

主要指标

Outcome：

Visual Analog Scale

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

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

颈椎功能障碍评分

指标类型：

次要指标

Outcome：

Neck Disability Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命质量调查量表

指标类型：

次要指标

Outcome：

12-item health survey

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

诺斯维克公园颈痛量表

指标类型：

次要指标

Outcome：

Northwick Park Neck Pain questionnaire， NPQ)

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：

无

组织：

Sample Name：

nothing

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 20 岁
Min age years
最大 50 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）：

简单随机 由研究人员采用随机数字表法产生随机数列

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

Researchers use random number table to get random sequence.

盲法：

Blinding：

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）：

学术论文发表

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

Publication of academic papers

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：

数据采集和管理由两部分组成，一为病例记录表(Case Record Form,CR)，二为电子采集和管理系统(Electronic Data Capture,EDC)

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

Data capture and management consists of two components the Case Record Form (CR) and the Electronic Data Capture (EDC) system.

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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