松筋整骨法治疗产后骶髂关节错位的临床研究

注册号:

Registration number:

ITMCTR2024000036

最近更新日期:

Date of Last Refreshed on:

2024-03-29

注册时间:

Date of Registration:

2024-03-29

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

松筋整骨法治疗产后骶髂关节错位的临床研究

Public title:

Clinical study on the treatment of postpartum sacroiliac joint dislocation by osteopathy and soft tissue release

注册题目简写:

English Acronym:

研究课题的正式科学名称:

松筋整骨法治疗产后骶髂关节错位的临床研究

Scientific title:

Clinical study on the treatment of postpartum sacroiliac joint dislocation by osteopathy and soft tissue release

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:

李应志

研究负责人:

李应志

Applicant:

Liyingzhi

Study leader:

Liyingzhi

申请注册联系人电话:

Applicant telephone:

18213491037

研究负责人电话:

Study leader's telephone:

18213491037

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:

tuinalyz@163.com

研究负责人电子邮件:

Study leader's E-mail:

tuinalyz@163.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:

云南省昆明市东郊路161号云南中医药大学第二附属医院

研究负责人通讯地址:

云南省昆明市东郊路161号云南中医药大学第二附属医院

Applicant address:

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, 161 Dongjiao Road, Kunming City, Yunnan Province, China

Study leader's address:

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, 161 Dongjiao Road, Kunming City, Yunnan Province, China

申请注册联系人邮政编码:

Applicant postcode:

650500

研究负责人邮政编码:

Study leader's postcode:

650500

申请人所在单位:

云南省昆明市东郊路161号云南中医药大学第二附属医院

Applicant's institution:

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, 161 Dongjiao Road, Kunming City, Yunnan Province, China

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:

2023-015

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:

云南中医药大学第二附属医院医学伦理委员会

Name of the ethic committee:

Second Affiliated Hospital of Yunnan University of Chinese Medicine Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2023/9/20 0:00:00

伦理委员会联系人:

陈柏君

Contact Name of the ethic committee:

Chenbaijun

伦理委员会联系地址:

云南省昆明市东郊路161号云南中医药大学第二附属医院

Contact Address of the ethic committee:

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, 161 Dongjiao Road, Kunming City, Yunnan Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

13888244951

伦理委员会联系人邮箱:

Contact email of the ethic committee:

chenbojunyn@163.com

研究实施负责(组长)单位:

云南中医药大学第二附属医院

Primary sponsor:

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

云南省昆明市东郊路161号

Primary sponsor's address:

161 Dongjiao Road, Kunming City, Yunnan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

云南省

市(区县):

昆明

Country:

China

Province:

Yunnan Province

City:

Kunming

单位(医院):

云南中医药大学第二附属医院

具体地址:

云南省昆明市东郊路161号

Institution
hospital:

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Address:

161 Dongjiao Road, Kunming City, Yunnan Province

经费或物资来源:

Source(s) of funding:

No source of funding

研究疾病:

骶髂关节错位

研究疾病代码:

Target disease:

Sacroiliac Joint Disorder

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:

I期临床试验

Phase I clinical trial

研究目的:

通过观察松筋整骨法和常规推拿手法治疗产后SJD的临床疗效,研究松筋整骨手法治疗该病的疗效依据,对其作用机制进行了初步探讨,以期对产后SJD的临床治疗提供治疗准确、疗效确切的方法。

Objectives of Study:

By observing the clinical efficacy of Songjin osteopathy and conventional massage in the treatment of postpartum SJD, the therapeutic basis of Songjin osteopathy in the treatment of this disease was studied, and its mechanism of action was preliminarily discussed, with a view to providing an accurate and effective method for the clinical treatment of postpartum SJD.

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.年龄为18~45岁之间的产后女性患者; 2.符合上述产后SJD的诊断标准的前后旋错位型患者; 3.产后相关实验室检查结果未见明显异常,排除其他因素干扰; 4.病人本身的沟通能力和文化程度能够和研究人员进行正常的沟通; 5.分娩6周(约42天)后的产妇[22]; 6.自愿参加的受试者(患者)签署知情同意书(见附录1)

Inclusion criteria

1. Postpartum female patients aged between 18 and 45 years; 2. Patients with anteroposteric dislocation who meet the above diagnostic criteria for postpartum SJD; 3. Postpartum related laboratory examination results showed no obvious abnormalities, excluding other factors; 4. The patient's communication ability and educational level can communicate with the researchers normally; 5.Women after 6 weeks of delivery (about 42 days) [22]; 6. Voluntary subjects (patients) sign informed consent (see Appendix 1)

排除标准:

1.非产后女性患者; 2.年龄范围在18岁以下和45岁以上者; 3.不符合产后SJD诊断标准者; 4.合并有心脑血管疾病、肝脏疾病、肾脏疾病等严重的原发性疾病,骨质疏松、骨质增生以及精神病患者; 5.子痫、羊水栓塞、急性胎膜早破、胎儿宫内窘迫、子宫破裂等严重产科并发症、耻骨联合严重损伤、尿路感染等; 6.骨盆骨折、骨盆先天发育畸形、腰椎结核、强直性脊柱炎、脊髓肿瘤、腰椎滑脱、腰椎间盘突出症等; 7.剖腹产术后半年内患者; 8.无法配合完成病历资料收集者; 9.治疗过程中,出现严重的并发病或病情恶化者。

Exclusion criteria:

1. Non-postpartum female patients; 2.persons under the age of 18 and over the age of 45; 3.Those who do not meet the diagnostic criteria for postpartum SJD; 4.Patients with cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases and other serious primary diseases, osteoporosis, bone hyperplasia and mental illness; 5. Eclampsia, amniotic fluid embolism, acute premature rupture of membranes, fetal distress, uterine rupture and other serious obstetric complications, serious injury of pubic symphysis, urinary tract infection, etc. 6. Pelvic fracture, congenital developmental deformity of pelvis, tuberculosis of lumbar spine, ankylosing spondylitis, spinal cord tumor, lumbar spondylolisthesis, lumbar disc herniation, etc.; 7. Patients within half a year after caesarean section; 8. Unable to cooperate with the completion of medical record data collection; 9.In the course of treatment, there are serious co-morbidity or deterioration of the condition.

研究实施时间:

Study execute time:

From 2024-03-01

To      2025-03-01

征募观察对象时间:

Recruiting time:

From 2024-04-15

To      2024-10-15

干预措施:

Interventions:

组别:

试验组

样本量:

36

Group:

treatment group

Sample size:

干预措施:

松筋整骨法

干预措施代码:

Intervention:

Traditional release technique and MET

Intervention code:

组别:

对照组

样本量:

36

Group:

control group

Sample size:

干预措施:

常规推拿手法

干预措施代码:

Intervention:

Routine massage method

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):

云南省

市(区县):

昆明市

Country:

China

Province:

Yunnan Province

City:

Kunming

单位(医院):

云南中医药大学第二附属医院

单位级别:

三级甲等

Institution/hospital:

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Level of the institution:

Grade 3 A

测量指标:

Outcomes:

指标中文名:

改良日本骨科协会评分

指标类型:

主要指标

Outcome:

M-JOA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分

指标类型:

主要指标

Outcome:

VAS

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:

组织:

Sample Name:

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 18
Min age years
最大 45
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

将符合产后SJD纳入标准的72例患者,从1号开始进行编号直到72号(表1-1中第1行)﹔随后从随机数字表中的第5行第3列开始逐渐进行编号,依次从左往右读取两位数作为一个随机数录入编号下面(表1-1中第2行)﹔随后将选出的全部随机数按照从小到大的顺序进行编号(随机数相同的按照其先后顺序进行编号),记录在表1-1中第3行。规定序号1~36为A组(试验组),序号37~72为B组(对照组)。

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

The 72 patients who met the inclusion criteria for postpartum SJD were numbered from No. 1 to No. 72 (Row 1 in Table 1-1). Then the number is gradually numbered from the fifth row and third column in the random number table, and two digits are read from left to right successively as a random number to enter the number below (row 2 in Table 1-1); All selected random numbers are numbered in ascending order (those with the same random numbers are numbered in their sequence) and recorded in row 3 of Table 1-1. The serial number 1~36 is group A (experimental group), and the serial number 37~72 is group B (control group).

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

暂无

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

There is currently no way to share raw data

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:

暂缺

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

No data collection and management for the time being

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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