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clinical study of cervical curvature rehabilitation device combined with joint loosening manipulation to correct abnormal cervical curvature

注册号：

Registration number：

ITMCTR2000003649

最近更新日期：

Date of Last Refreshed on：

2020-08-18

注册时间：

Date of Registration：

2020-08-18

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

一种颈椎曲度康复器结合关节松动手法纠正颈椎生理曲度异常的随机对照临床研究

Public title：

clinical study of cervical curvature rehabilitation device combined with joint loosening manipulation to correct abnormal cervical curvature

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一种颈椎曲度康复器结合关节松动手法纠正颈椎生理曲度异常的随机对照临床研究

Scientific title：

clinical study of cervical curvature rehabilitation device combined with joint loosening manipulation to correct abnormal cervical curvature

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：

ChiCTR2000035834 ; ChiMCTR2000003649

申请注册联系人：

许金海

研究负责人：

叶洁

Applicant：

Jinhai Xu

Study leader：

Ye Jie

申请注册联系人电话：

Applicant telephone：

+86 18016006692

研究负责人电话：

Study leader's telephone：

+86 13300180301

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：

jinhaixu@126.com

研究负责人电子邮件：

Study leader's E-mail：

yejie1977@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：

中国上海市徐汇区宛平南路725号龙华医院11号楼9楼

研究负责人通讯地址：

中国上海市徐汇区宛平南路725号龙华医院11号楼9楼

Applicant address：

725 South Wanping Road, Xuhui District, Shanghai, China

Study leader's address：

725 South Wanping Road, Xuhui District, Shanghai, 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：

上海中医药大学

Applicant's institution：

Shanghai 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：

2020LHSB031

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：

上海中医药大学附属龙华医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020/8/14 0:00:00

伦理委员会联系人：

上海中医药大学附属龙华医院医学伦理委员会

Contact Name of the ethic committee：

Medical Ethics Committee of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会联系地址：

中国上海市徐汇区宛平南路725号龙华医院1号楼3楼

Contact Address of the ethic committee：

3rd Floor, Building 1, 725 Wanping Road South, Xuhui District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 021-64385700-1318

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：

上海中医药大学附属龙华医院

Primary sponsor：

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国上海市徐汇区宛平南路725号

Primary sponsor's address：

725 South Wanping Road, Xuhui District, Shanghai, 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)：

上海

市(区县)：

徐汇

Country：

China

Province：

Shanghai

City：

Xuhui District

单位(医院)：

上海中医药大学附属龙华医院

具体地址：

中国上海市徐汇区宛平南路725号

Institution
hospital：

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Address：

725 South Wanping Road, Xuhui District

经费或物资来源：

促进市级医院临床技能与临床创新三年行动计划（2020-2022年）重大临床研究项目

Source(s) of funding：

Major clinical research project under the three-year action plan (2020-2022) of promoting clinical skills and innovation in municipal hospitals

研究疾病：

颈椎生理曲度异常

研究疾病代码：

Target disease：

Abnormal cervical curvature

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：

建立关节松动手法结合颈椎曲度康复矫正器锻炼纠正青年型颈椎生理曲度异常的中医规范化方案，形成基于影像学测量的临床疗效评价指标。

Objectives of Study：

Objective to establish a standardized scheme of traditional Chinese medicine (TCM) to correct the abnormal physiological curvature of young type cervical spine by joint loosening manipulation combined with cervical curvature rehabilitation appliance exercise, and form the clinical efficacy evaluation index based on imaging measurement.

药物成份或治疗方案详述：

治疗组：颈椎曲度康复矫正器（锻炼方法：矢状位：将所述第一握把及所述第二握把转向前侧展开，拧紧活动螺栓；患者处于站立位，挺胸收腹；使所述枕托紧贴患者的头枕部，所述肩部固定装置紧贴患者肩部，所述颈带处于脖子（C3-C5）的位置；双手握住握把以水平稍偏下方的方向向体前拉握把；患者颈部用力，尽可能的将所述枕托向下压，压至极致位，维持10秒；慢慢抬头，恢复到站立位，以上动作，重复10次为一组。冠状位：将所述第一握把及所述第二握把转向前侧展开，拧紧活动螺栓；患者处于站立位，挺胸收腹；使所述枕托紧贴患者的头枕部，所述肩部固定装置紧贴患者肩部，所述颈带处于脖子（C3-C5）的位置；双手握住握把以水平稍偏下方的方向向体前拉握把；患者颈部用力，尽可能的将所述枕托向下压，压至极致位，维持住；头部再向左(右)压器械，压至极致位，维持10秒，慢慢复原；重复10次为一组。每天2次，每次3组，4周为一疗程，共治疗8周）+关节松动手法（隔日治疗1次，每周三次，4周为1个疗程，共治疗8周） 对照组：颈椎牵引者取坐位，带枕颌布兜牵引，头部向前微屈，约前倾10～15°，并以患者感觉舒适且能减轻症状为准；牵引质量从3kg开始，按0.5kg标准逐渐增加质量，最大质量不超过6kg；采用间歇牵引方式，持续40S、间歇10S，每次20min左右，隔日1次，每周3次，4周为1个疗程，共治疗8周

Description for medicine or protocol of treatment in detail：

Treatment group: cervical curvature rehabilitation appliance (exercise method: sagittal position: turn the first grip and the second grip to the front side and tighten the movable bolt; the patient is in the standing position and straightens the chest and abdomen; the pillow support is close to the patient's head and pillow, the shoulder is fixed close to the patient's shoulder, and the neck belt is at the neck (C3-C5); hold the grip with both hands Pull the grip forward in the direction slightly lower than the horizontal; press the pillow support downward as far as possible to the extreme position, and maintain for 10 seconds; slowly raise the head and return to the standing position. Repeat the above actions for 10 times as a group. Coronal position: turn the first grip and the second grip to the front side and tighten the movable bolt; the patient is in the standing position and straightens the chest and abdomen; the pillow support is close to the patient's head and pillow, the shoulder fixing device is close to the patient's shoulder, and the neck belt is at the position of neck (C3-C5); both hands hold the grip with both hands and pull the grip forward in the direction of slightly lower horizontal; the patient's neck Press the pillow support downward as far as possible to the extreme position and hold it; press the instrument to the left (right) of the head to the extreme position for 10 seconds and recover slowly; repeat 10 times as a group. The treatment group was treated with manipulation for 4 weeks, once every day for 8 weeks. The control group: the cervical vertebra traction group took the sitting position, with occipital jaw cloth pocket traction, the head forward slightly bent, about 10 ~ 15 ° forward, and according to the patient's feeling comfortable and can reduce the symptoms; the traction weight started from 3kg, gradually increased according to the standard of 0.5kg, the maximum mass was not more than 6kg; intermittent traction was used, lasting for 40s, intermittent 10s, every 20min, once every other day, three times a week, four weeks One course of treatment for 8 weeks.

纳入标准：

①知情同意并签署知情同意书； ②符合颈型颈椎病诊断标准并且符合颈椎生理曲度异常者； ③年龄在15-40岁的男性或女性； ④自愿接受配合完成要求的关节松动手法结合颈椎曲度康复矫正器锻炼； ⑤参加本试验研究期间不接受其他治疗方案。

Inclusion criteria

1. Informed consent and sign informed consent form; 2. According to the diagnostic criteria of cervical spondylosis and abnormal cervical curvature; 3. Male or female aged 15-40 years; 4. Voluntarily accept the required joint loosening manipulation combined with cervical curvature rehabilitation appliance exercise; 5. No other treatment was given during the study period.

排除标准：

①年龄小于15岁或超过40岁者； ②拒绝本课题随机分组治疗方案的患者；近3个月内参加过或正在参加其它临床研究者； ③短时间内肌力明显减退，肌力＜Ⅲ级者；曾正规非手术疗法六个月无效者 ④颈椎疼痛特别剧烈、伴有颈脊髓压迫症、伴马尾综合症、下肢行走不稳；有手术指征者； ⑤影像学检查有颈椎严重畸形、骨折、骨病、结核、肿瘤等合并疾患的患者；有颈椎严重创伤史和颈椎病手术治疗史者； ⑥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疾病、结核、椎体畸形、恶性肿瘤及精神病患者；怀疑镇静催眠药、阿片类镇痛药及酒精滥用史者；有皮肤性疾病及传染性疾病的患者； ⑦妊娠、准备妊娠或者哺乳期的女性； ⑧其他原因不宜或不能应用本治疗方法的患者； ⑨有精神障碍、语言障碍、运动功能障碍、心理疾病的患者。

Exclusion criteria：

1. The patients who refused the treatment plan randomly divided into two groups, and those who had participated in or were participating in other clinical researches in the past three months; 2. The muscle strength decreased significantly in a short period of time, and the muscle strength was lower than grade III. The patients who had been treated with regular non-surgical therapy for six months had no effect; 3. Patients with severe cervical pain, cervical spinal cord compression, cauda equina syndrome and unstable lower limb walking were found; 4. The patients with serious cervical deformity, fracture, osteopathy, tuberculosis, tumor and other complicated diseases by imaging examination, and those with severe cervical trauma history and cervical spondylosis surgery treatment history; 5. Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardio cerebrovascular system, nervous system, tuberculosis, vertebral malformation, malignant tumor and psychosis; patients suspected of sedative hypnotics, opioid analgesics and alcohol abuse; patients with skin diseases and infectious diseases; patients with severe primary diseases such as liver, kidney, hematopoiesis, endocrine system, cardiovascular and cerebrovascular diseases, and psychiatric patients; 6. Pregnant woman, or ready for pregnancy or lactation; 7. Patients who are not suitable or unable to use this treatment method for other reasons; 8. Patients with mental disorders, language disorders, motor dysfunction, mental illness.

研究实施时间：

Study execute time：

从From 2020-10-01

至To      2022-09-30

征募观察对象时间：

Recruiting time：

从From 2021-01-01

至To      2021-02-28

干预措施：

Interventions：

组别：

治疗组

样本量：

96

Group：

Treatment group

Sample size：

干预措施：

颈椎曲度康复矫正锻炼+关节松动手法

干预措施代码：

Intervention：

Rehabilitation training of cervical curvature + Joint Mobilization

Intervention code：

组别：

对照组

样本量：

96

Group：

Control group

Sample size：

干预措施：

牵引

干预措施代码：

Intervention：

tow

Intervention code：

样本总量 Total sample size ： 192

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

青浦

Country：

China

Province：

Shanghai

City：

Qingpu District

单位(医院)：

上海市青浦区中医医院

单位级别：

二级甲等

Institution/hospital：

Shanghai Qingpu District Hospital of traditional Chinese Medicine

Level of the institution：

Second A Hospita

国家：

中国

省(直辖市)：

上海

市(区县)：

奉贤

Country：

China

Province：

Shanghai

City：

Fengxian District

单位(医院)：

上海市奉贤区中医院

单位级别：

二级甲等

Institution/hospital：

Shanghai Fengxian District Hospital of traditional Chinese Medicine

Level of the institution：

Second A Hospita

国家：

中国

省(直辖市)：

上海

市(区县)：

长宁

Country：

China

Province：

Shanghai

City：

Changning District

单位(医院)：

上海市长宁区天山中医医院

单位级别：

二级甲等

Institution/hospital：

Shanghai Changning Tianshan Hospital of traditional Chinese Medicine

Level of the institution：

Second A Hospita

国家：

中国

省(直辖市)：

上海

市(区县)：

徐汇

Country：

China

Province：

Shanghai

City：

Xuhui District

单位(医院)：

上海中医药大学附属龙华医院

单位级别：

三级甲等

Institution/hospital：

Shanghai TCM-Integrated Hospital, Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

NDI评分

指标类型：

主要指标

Outcome：

NDI score

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：

主要指标

Outcome：

VAS score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

X线

指标类型：

主要指标

Outcome：

X-ray

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：

影像学资料

组织：

Sample Name：

Imaging data

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：

尚未开始

Not yet recruiting

年龄范围：

最小 15 岁
Min age years
最大 40 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）：

随机化由独立的统计学家负责。将采用完全随机分组。随机序列将由专业的统计学软件产生。

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

Randomization is done by independent statisticians. Complete randomization will be used. Random sequences will be generated by professional statistical software.

盲法：

未说明

Blinding：

Not stated

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）：

2023/3/31

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

2023/3/31

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：

病例记录表进行登记

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

use Case Record Form, CRF

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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