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循经取穴脊柱振动治疗结合“脊柱平衡导引术”治疗退行性脊柱侧凸的临床研究

注册号：

Registration number：

ITMCTR2024000271

最近更新日期：

Date of Last Refreshed on：

2024-08-20

注册时间：

Date of Registration：

2024-08-20

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

循经取穴脊柱振动治疗结合“脊柱平衡导引术”治疗退行性脊柱侧凸的临床研究

Public title：

Clinical study on the treatment of degenerative scoliosis by meridian acupoint spinal vibration therapy combined with'spinal balancing and guiding technique'

注册题目简写：

English Acronym：

研究课题的正式科学名称：

循经取穴脊柱振动治疗结合“脊柱平衡导引术”治疗退行性脊柱侧凸的临床研究

Scientific title：

Clinical study on the treatment of degenerative scoliosis by meridian acupoint spinal vibration therapy combined with'spinal balancing and guiding technique'

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：

2023LCSY074 ;

申请注册联系人：

景柳青

研究负责人：

沈琪幸

Applicant：

liu-qing jing

Study leader：

qi-xin shen

申请注册联系人电话：

Applicant telephone：

17521293579

研究负责人电话：

Study leader's telephone：

13761035717

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：

jlqshzyydx@126.com

研究负责人电子邮件：

Study leader's E-mail：

qixin_shen@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：

上海市徐汇区宛平南路725号

研究负责人通讯地址：

上海市徐汇区宛平南路725号

Applicant address：

No.725, Wanping South Road, Xuhui District, Shanghai, China

Study leader's address：

No.725, Wanping South Road, Xuhui District, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

200032

研究负责人邮政编码：

Study leader's postcode：

200032

申请人所在单位：

上海中医药大学附属龙华医院

Applicant's institution：

Longhua Hospital, 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：

2023LCSY074

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

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, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, China

伦理委员会批准日期：

Date of approved by ethic committee：

2023/10/26 0:00:00

伦理委员会联系人：

肖臻

Contact Name of the ethic committee：

Zhen Xiao

伦理委员会联系地址：

上海市徐汇区宛平南路725号

Contact Address of the ethic committee：

No.725, Wanping South Road, Xuhui District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-64385700-11318

伦理委员会联系人邮箱：

Contact email of the ethic committee：

lhtcmirb@sina.cn

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：

上海市徐汇区宛平南路725号

Primary sponsor's address：

No.725, Wanping South 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

市(区县)：

上海市

Country：

China

Province：

shanghai

City：

shanghai

单位(医院)：

上海中医药大学附属龙华医院

具体地址：

上海市徐汇区宛平南路725号

Institution
hospital：

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Address：

No.725, Wanping South Road, Xuhui District, Shanghai, China

经费或物资来源：

龙华医院第三批优秀青年人才临床能力提升计划

Source(s) of funding：

The Third Batch of Outstanding Young Talents Clinical Competence Enhancement Programme of Longhua Hospital

研究疾病：

退行性脊柱侧凸

研究疾病代码：

Target disease：

degenerative scoliosis

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：

1、退行性脊柱侧凸症是目前骨伤科治疗难点，复发率高。将适宜技术“脊柱平衡导引术”，配合循经取穴脊柱振动治疗运用于退行性脊柱侧凸的治疗,分析并探讨退行性脊柱侧凸的治疗效果。 2、干预目的是为了缓解疼痛，改善老年人生活质量，手术治疗往往耐受性差、费用高、并发症多。 3、影像学资料及脊柱振动治疗仪固定成像技术（CFI) 的研究意义： 3.1 X线测量骨盆矢状位失衡参数，并与性别、年龄、BMI、骨折情况、饮酒、吸烟、饮食习惯、疼痛等情况、特别是临床症状及体征的相关性进行分析。 3.2 目前还没有大量的临床数据研究CFI检测和X线分析结果的相关性。CFI 产生的是一个间接图像，可以更好的描述反映深部肌肉骨骼结构，不失为一种好的骨科测量辅助手段。分析脊柱X线和计算机固定成像CFI测量结果的异同。

Objectives of Study：

1. Degenerative scoliosis is a difficult problem in orthopaedic treatment and has a high recurrence rate. We apply the appropriate technology spinal balance guiding technique, together with the spinal vibration therapy of meridian point extraction, to the treatment of degenerative scoliosis, and analyse and discuss the therapeutic effect of degenerative scoliosis. The purpose of the intervention is to relieve pain and improve the quality of life of the elderly. Surgical treatment is often poorly tolerated, expensive and has many complications. 3、Imaging data and the significance of the study of spinal vibration therapeutic instrumentation fixed imaging (CFI): 3.1 Pelvic sagittal imbalance parameters were measured on X-ray and analysed for correlation with gender, age, BMI, fracture status, alcohol consumption, smoking, dietary habits, pain, and especially clinical signs and symptoms. 3.2 There is no extensive clinical data on the correlation between the results of CFI and X-ray analyses.CFI produces an indirect image that better describes and reflects deep musculoskeletal structures and is a good orthopaedic measurement aid. The similarities and differences between spinal X-ray and computerised fixed imaging CFI measurements were analysed.

药物成份或治疗方案详述：

本研究遵循临床研究设计原则,将循经取穴脊柱振动治疗结合“脊柱平衡导引术”中医特色功能锻炼方法运用于退行性脊柱侧凸的治疗,分析并探讨退行性脊柱侧凸的治疗效果。 治疗组为循经取穴脊柱振动治疗+脊柱平衡导引术，对照组为脊柱平衡导引术。治疗前、治疗后2周、4周、12周观察记录SF-36 评分、VAS评分，测量CFI(凸侧节段测量值)；入组治疗前检测脊柱全长X线片。 利用X线放射检查及计算机固定成像技术对患者进行检测,得出两种检查方法作为客观评价疗效的关系及区别,为临床研究及治疗提供新的疗效评判依据；分析骨盆矢状位失衡参数（X线测量）与性别、年龄、BMI、骨折情况、饮酒、吸烟、饮食习惯、疼痛等情况、临床症状及体征的相关性。

Description for medicine or protocol of treatment in detail：

In this study, we followed the principles of clinical research design, and applied the Chinese medicine functional exercise method of spinal vibration therapy combined with ‘spinal balancing and guiding’ to the treatment of degenerative scoliosis, to analyse and explore the treatment effect of degenerative scoliosis. The treatment group was treated with spinal vibration therapy based on meridian acupoints and spinal balancing and guiding technique, while the control group was treated with spinal balancing and guiding technique. The SF-36 score, VAS score, and CFI (convex lateral segment measurement) were recorded before, 2 weeks, 4 weeks, and 12 weeks after the treatment; full-length X-ray films of the spine were examined before entering the group. X-ray radiography and computerized fixed imaging were used to examine the patients, and the relationship and difference between the two methods of examination as an objective evaluation of the efficacy of treatment were obtained, providing a new basis for clinical research and treatment; the correlation between the pelvic sagittal imbalance parameters (measured by X-ray) and the gender, age, BMI, fracture status, alcohol consumption, smoking, dietary habits, pain and other conditions, clinical signs and symptoms were analysed.

纳入标准：

1、符合诊断标准:（参考：胥少汀，葛宝丰，徐印土坎主编.实用骨科学第3版[M].北京：人民军医出版社,2005.03.） 1.1、见于 40 周岁以上中老年人； 1.2、腰痛特点为“姿势性腰痛”,长时间端坐、行走及劳累后疼痛加重。疼痛通常出现在畸形最严重的部位； 1.3、下肢症状表现为各种疼痛、麻木，可出现股神经牵拉试验或直腿抬高试验阳性； 1.4、x 线片可见脊柱侧弯，冠状位Cobb角 >10°。 2、x 线片冠状位 Cobb 角在 10°－30°； 3、年龄 40-80周岁； 4、既往无侧凸病史，成人以后出现的侧凸； 5、过去3 个月内没有接受过任何药物治疗； 6、知情同意并签署知情同意书。

Inclusion criteria

1.Meet the diagnostic criteria: (Reference: Xu Shao-Ting Ge Bao-Feng Xu Yin-Tu-Kan eds. Practical Orthopaedics 3rd edition [M]. Beijing: People's Military Medical Press2005.03.) 1.1. It is found in middle-aged and elderly people over 40 years old; 1.2 Lumbar pain is characterised by postural lumbar pain which is aggravated by prolonged sitting walking and exertion. The pain usually occurs in the area where the deformity is most severe; 1.3 The symptoms of lower limbs are various pains and numbness and the femoral nerve pulling test or straight leg raising test may be positive; 1.4. Scoliosis with a coronal Cobb's angle >10° is seen on radiographs. 2. Coronal Cobb angle of 10°-30° on x-ray film; 3. Age: 40-80 years old; 4. No previous history of scoliosis scoliosis that occurs after adulthood; 5. Have not received any medication in the past 3 months; 6. Informed consent and signing the informed consent form.

排除标准：

1、近3个月内参加过或正在参加其他临床研究者，近3个月内接受过或正在接受其他影响疗效判定治疗方法者； 2、有手术指征的患者 (有明显的腰痛及根性症状，治疗不能缓解，cobb 角大于30°－40°，侧方滑脱大于6mm，侧凸角度进展大于10° )； 3、有严重胸腰椎创伤史和胸腰椎手术史、骨折或骨折术后放置钢板、骨折不愈； 4、继发于脊柱骨或软组织器质性病变如肿瘤、创伤、结核，佩吉特病等原因引起的侧凸； 5、有阿片类镇痛药、镇静催眠药及酒精滥用史者； 6、合并有高热、感染性疾病（如关节盘炎、骨髓炎、化脓性关节炎）、出血性疾病、严重心脑血管功能障碍、多发性神经病、皮肤溃疡或过敏、开放性创伤、服用抗凝药期间、安装心脏起搏器、心脏搭桥、血管内支架、精神疾患及其他特殊体质者； 7、先天性脊柱侧凸或未被发现的青少年特发性脊柱侧凸； 8、合并有风湿免疫性关节炎 (强直性脊柱炎、类风湿关节炎等)； 9、软骨发育不全、严重的骨质疏松症、因病理原因骨头无法承受躯体重量、头颅和面部缝合者；

Exclusion criteria：

1.Those who have participated or are participating in other clinical studies in the last 3 months and those who have received or are receiving other treatments that affect the determination of efficacy in the last 3 months; 2. Patients with surgical indication (with obvious low back pain and radicular symptoms that cannot be relieved by treatment cobb angle greater than 30°-40° lateral slip greater than 6mm and progression of scoliosis angle greater than 10° ); 3. History of severe thoracolumbar spine trauma and thoracolumbar spine surgery fracture or placement of plate after fracture surgery and non-healing fracture; 4. Scoliosis secondary to organic spinal bone or soft tissue lesions such as tumours trauma tuberculosis Paget's disease and other causes; 5. History of opioid analgesics sedative-hypnotics and alcohol abuse; 6. Combined with high fever infectious diseases (such as arthritis discitis osteomyelitis septic arthritis) haemorrhagic disease severe cardiovascular and cerebrovascular dysfunction polyneuropathy skin ulcers or allergies open trauma during the period of anticoagulant medication installation of cardiac pacemaker cardiac bypass grafting intravascular stents mental disorders and other special physical conditions; 7. Congenital scoliosis or undetected adolescent idiopathic scoliosis; 8. Combined rheumatoid arthritis (ankylosing spondylitis rheumatoid arthritis etc.); 9. chondrodysplasia severe osteoporosis pathological inability of bones to bear the weight of the body cranial and facial sutures;

研究实施时间：

Study execute time：

从From 2023-10-27

至To      2024-10-25

征募观察对象时间：

Recruiting time：

从From 2023-10-27

至To      2024-10-25

干预措施：

Interventions：

组别：

对照组

样本量：

36

Group：

control group

Sample size：

干预措施：

脊柱平衡导引术

干预措施代码：

Intervention：

Spinal Balance Guiding Technique

Intervention code：

组别：

试验组

样本量：

36

Group：

experimental group

Sample size：

干预措施：

循经取穴脊柱振动治疗结合“脊柱平衡导引术”

干预措施代码：

Intervention：

Meridian-based spinal vibration therapy combined with ‘Spinal Balance Guiding Technique’

Intervention code：

样本总量 Total sample size ： 72

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)：

上海市

Country：

China

Province：

shanghai

City：

shanghai

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：

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Level of the institution：

grade 3A

测量指标：

Outcomes：

指标中文名：

健康调查简表-36

指标类型：

主要指标

Outcome：

SF-36

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

计算机固定成像

指标类型：

次要指标

Outcome：

CFI

Type：

Secondary indicator

测量时间点：

测量方法：

pulstarG3 impulse

Measure time point of outcome：

Measure method：

指标中文名：

疼痛视觉模拟评分

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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

no

Tissue：

no

人体标本去向

其它

说明

no

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 40 岁
Min age years
最大 80 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）：

景柳青使用SPSS 25.0软件实现完全随机化分组

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

liu-qing jing use SPSS 25.0 software to achieve completely randomised groupings

盲法：

第三方盲法（对资料管理与统计分析人员设置盲法）

Blinding：

Third-party blinding (blinding of data management and statistical analysts)

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）：

ResMan临床试验公共管理平台“http://www.medresman.org.cn/uc/index.aspx”

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

ResMan Public Management Platform for Clinical Trials ‘http://www.medresman.org.cn/uc/index.aspx’

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、临床医师负责合格病例的筛选依据分组分别给予病人不同方案治疗。同时负责临床数据的收集，填写病例报告表（CRF）。 2、观察报告表由研究人员如实填写，尽量不涂改 如填写错误，修改时不得涂黑，只在填写错误之处划一条线，临床观察者在涂 改处附近签名并注明日期和原因。 3、采用 Excel录入数据。

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

1. Clinicians are responsible for screening qualified cases and treating patients with different programmes based on grouping. At the same time, they were responsible for the collection of clinical data and filling in the case report form (CRF). 2. The observation report form was filled in by the researchers honestly, and as far as possible, it was not altered. If it was filled in incorrectly, it should not be blacked out, but only a line was drawn at the place of filling in the error, and the observer of the clinic signed near the place of alteration, and indicated the date and the reason. 3. Excel was used for the entry of the data.

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）：

暂无发表

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

No publication

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