超声引导下穴位埋线降低痉挛型脑瘫下肢肌张力有效层次的临床研究

注册号:

Registration number:

AMCTR-OON-18000239 

注册号获得时间:

Date of releasing the registration number:

2018/12/22 9:14:13 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

超声引导下穴位埋线降低痉挛型脑瘫下肢肌张力有效层次的临床研究 

Public title:

Ultrasound-guided acupoint embedding to reduce the effective level of muscle tension in lower limbs of spastic cerebral palsy 

研究课题的正式科学名称:

超声引导下穴位埋线降低痉挛型脑瘫下肢肌张力有效层次的临床研究 

Scientific title:

Ultrasound-guided acupoint embedding to reduce the effective level of muscle tension in lower limbs of spastic cerebral palsy 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

金炳旭 

研究负责人:

金炳旭 

Applicant:

Jin Bingxu 

Study leader:

Jin Bingxu 

申请注册联系人电话:

Applicant telephone:

13450753222 

研究负责人电话:

Study leader's telephone:

13450753222 

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:

jinbingxu80@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jinbingxu80@163.com 

申请单位网址(自愿提供):

Applicant 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:

佛山市南海区桂城街道桂平西路6号 

研究负责人通讯地址:

佛山市南海区桂城街道桂平西路6号 

Applicant address:

6 Guiping West Road, Guicheng Street, Nanhai District, Foshan City 

Study leader's address:

6 Guiping West Road, Guicheng Street, Nanhai District, Foshan City 

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:

佛山市南海区妇幼保健院(广州中医药大学附属南海妇产儿童医院) 

Applicant's institution:

Nanhai District Maternal and Child Health Hospital of Foshan City (Nanhai Maternity Children's Hospital, Guangzhou University of Traditional Chinese Medicine) 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2018-04 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

佛山市南海区妇幼保健院伦理委员会 

Name of the ethic committee:

Ethics Committee of Nanhai District Maternal and Child Health Hospital, Foshan City 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-15 

研究实施负责(组长)单位:

佛山市南海区妇幼保健院(广州中医药大学附属南海妇产儿童医院) 

Primary sponsor:

Nanhai District Maternal and Child Health Hospital of Foshan City (Nanhai Maternity Children's Hospital, Guangzhou University of Traditional Chinese Medicine) 

研究实施负责(组长)单位地址:

佛山市南海区桂城街道桂平西路6号 

Primary sponsor's address:

6 Guiping West Road, Guicheng Street, Nanhai District, Foshan City 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

佛山

Country:

china

Province:

guangdong

City:

foshan

单位(医院):

佛山市南海区妇幼保健院(广州中医药大学附属南海妇产儿童医院)

具体地址:

佛山市南海区桂城街道桂平西路6号

Institution
hospital:

Nanhai District Maternal and Child Health Hospital of Foshan City (Nanhai Maternity Children's Hospital, Guangzhou University of Traditional Chinese Medicine)

Address:

No. 6, Guiping West Road, Guicheng Street, Nanhai District, Foshan City

经费或物资来源:

佛山市南海区妇幼保健院(广州中医药大学附属南海妇产儿童医院) 

Source(s) of funding:

Nanhai District Maternal and Child Health Hospital of Foshan City (Nanhai Maternity Children's Hospital, Guangzhou University of Traditional Chinese Medicine) 

研究疾病:

脑性瘫痪 

Target disease:

Cerebral palsy 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

我国儿童痉挛型脑瘫发病率高,持续痉挛状态可致患儿运动能力下降,后期往往合并肌腱挛缩、关节畸形等表现,临床治疗较为棘手。尽管目前有关痉挛型脑瘫治疗方法的报道较多,但多数在缓解 痉挛方面疗效仍不理想,部分抗痉挛型用药因有较大不良反应而无法推广使用。近年来针刺疗法在 脑瘫康复领域得到了广泛应用,对肌张力有良好的调节作用,穴位埋线疗法是针灸学的一个重要分 支,具有“以线代针”的长效针感治疗效果。我科自 2015 年开展穴位埋线疗法,通过临床随机对 照研究,结果显示穴位埋线疗法能有效降低痉挛型脑瘫肌张力、缓解肌肉痉挛,促进运动功能康复。 目前埋线操作主要凭医生的临床经验和手下感觉进行,对于材料埋植的深度层次、方向及其与疗效 的关系并不明确,而不同层次穴位埋线会产生不同的生物学效应。因此,通过探索埋线深度层次与 肌张力调节作用的关系有利于提高临床疗效。基于此,本研究拟在超声引导下对痉挛型脑瘫分别在 浅层、中层及深层埋植线体,应用表面肌电检测、改良 Ashworth 量表、综合痉挛量表及关节被动 活动度评估不同埋线深度层次与肌张力改善程度的相关性,确定疗效最优的埋线深度层次,为穴位 埋线在痉挛型脑瘫中的靶向、精准治疗奠定基础。 

Objectives of Study:

The incidence of spastic cerebral palsy in children in China is high. The persistent paralysis state can cause the children's exercise ability to decline. In the later stage, the tendon contraction and joint deformity are often combined, and the clinical treatment is more difficult. Although there are many reports on the treatment of spastic cerebral palsy, most of them are still unsatisfactory in relieving sputum. Some anti-caries drugs cannot be promoted because of large adverse reactions. In recent years, acupuncture has been widely used in the field of cerebral palsy rehabilitation, and has a good regulation effect on muscle tension. Acupoint embedding therapy is an important branch of acupuncture and moxibustion, and it has a long-acting effect of “needle-based needle”. Since 2015, our department has carried out acupoint embedding therapy. Through randomized clinical randomized study, the results show that acupoint embedding therapy can effectively reduce the sacral cerebral palsy muscle tension, relieve muscle spasm, and promote motor function recovery. At present, the embedding operation is mainly based on the doctor's clinical experience and the feeling of the hand. The relationship between the depth level, direction and the effect of the material implantation is not clear, and different levels of acupoint embedding will produce different biological effects. Therefore, it is helpful to improve the clinical efficacy by exploring the relationship between the depth of the embedding depth and the regulation of muscle tone. Based on this, this study intends to embed the sacral cerebral palsy in the superficial, middle and deep layers under ultrasound guidance, using surface electromyography, modified Ashworth scale, comprehensive sputum scale and joint passive mobility to evaluate different burial. The correlation between the depth of the line and the improvement of the muscle tension determines the optimal depth of the embedding depth, which lays a foundation for the targeted and precise treatment of acupoint embedding in the sputum sputum. 

研究设计:

无对照研究 

Study design:

Non-control study 

纳入标准:

1. 符合痉挛型脑瘫诊断标准; 2. 性别不限,年龄 1-5 岁; 3.半年内未接受过外科矫形手术及注射A型肉毒毒素治疗; 4. 无严重心肺疾患,无严重癫痫,无皮肤破损,无急性炎性反应及感染性皮 肤病等; 5. 自愿受试。 

Inclusion criteria

1. Meeting the diagnostic criteria for spastic cerebral palsy; 2. Gender is no limitation, age 1-5 years; 3. None history of surgical orthopedic surgery and injection of botulinum toxin type A; 4. No serious cardiopulmonary disease, no serious epilepsy, no skin damage , no acute inflammatory reaction and infectious skin diseases; 5. Voluntary to attend this test. 

排除标准:

1. 合并心血管、肝、肾和造血系统等原发性疾病; 2. 过敏体质及对多种药物过敏; 3. 合并癫痫发作; 4. 凝血功能障碍。 

Exclusion criteria:

1. Combined with cardiovascular, liver, kidney and hematopoietic system and other primary diseases; 2. Allergic constitution and allergies to a variety of drugs; 3. Combined with seizures; 4. Coagulation disorders. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

浅层埋线组

样本量:

30

Group:

Shallow acupoint embedding group

Sample size:

干预措施:

将PGA线体植入穴位局部的皮下组织

干预措施代码:

Intervention:

PGA line implanted into the subcutaneous tissue of the acupoint

Intervention code:

组别:

中层埋线组

样本量:

30

Group:

Middle acupoint embedding group

Sample size:

干预措施:

将PGA线体植入穴位局部的缝匠肌、股内侧肌和腓肠肌

干预措施代码:

Intervention:

PGA line implanted into the sartorius muscle, medial femoral muscle and gastrocnemius muscle

Intervention code:

组别:

深层埋线组

样本量:

30

Group:

Deep acupoint embedding group

Sample size:

干预措施:

将PGA线体植入穴位局部的长收肌、大收肌和比目鱼肌

干预措施代码:

Intervention:

PGA line implanted into the acupoints of the long adductor, adductor and soleus muscles

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

佛山 

Country:

China 

Province:

guangdong 

City:

 

单位(医院):

佛山市南海区妇幼保健院(广州中医药大学附属南海妇产儿童医院) 

单位级别:

三级甲等 

Institution
hospital:

Nanhai District Maternal and Child Health Hospital of Foshan City (Nanhai Maternity Children's Hospital, Guangzhou University of Traditional Chinese Medicine)  

Level of the institution:

Third-class A 

测量指标:

Outcomes:

指标中文名:

改良 Ashworth 量表

指标类型:

主要指标 

Outcome:

Improved Ashworth scale

Type:

Primary indicator 

指标中文名:

关节被动活动度

指标类型:

次要指标 

Outcome:

Joint passive mobility

Type:

Secondary indicator 

指标中文名:

综合痉挛量表

指标类型:

次要指标 

Outcome:

compopsite spasticity scale

Type:

Secondary indicator 

指标中文名:

不良反应

指标类型:

副作用指标 

Outcome:

Adverse Event

Type:

Adverse events 

指标中文名:

临床疗效

指标类型:

附加指标 

Outcome:

Clinical efficacy

Type:

Additional indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 5 years

随机方法(请说明由何人用什么方法产生随机序列):

佛山市南海区妇幼保健院科教科陈建宏博士应用SPSS21.0产生随机序列

性别:

男性

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

Dr. Chen Jianhong, Department of Science and Education, Nanhai District Maternal and Child Health Hospital, Foshan City, using SPSS21.0 to generate random sequences

Gender:

Male

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

实验结束1年后科通过电子邮箱联系查阅:jinbingxu80@163.com

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

After 1 year of the experiment, the department will contact you by e-mail: jinbingxu80@163.com

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

病例观察表(纸质版)

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Case report form (hard copy)

创建人:

Creater Name:

 2018-12-03
返回列表