ChiCTR2400093870 版本V1.0 版本创建时间2024/12/13 00:08:48 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400093870 

最近更新日期：

Date of Last Refreshed on：

2024-12-13 00:08:42 

注册时间：

Date of Registration：

2024-12-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

髋周失衡纠正性训练对慢性非特异性腰痛患者腰椎功能障碍的影响

Public title：

The effect of corrective training of peripheral hip muscle imbalance on lumbar dysfunction in patients with chronic non-specific low back pain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

髋周失衡纠正性训练对慢性非特异性腰痛患者腰椎功能障碍的影响

Scientific title：

The effect of corrective training of peripheral hip muscle imbalance on lumbar dysfunction in patients with chronic non-specific low back pain

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：

唐兰 

研究负责人：

唐兰 

Applicant：

Lan Tang 

Study leader：

Lan Tang 

申请注册联系人电话：

Applicant telephone：

+86 191 2170 7350

研究负责人电话：

Study leader's telephone：

+86 191 2170 7350

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：

tanglan1995@126.com

研究负责人电子邮件：

Study leader's E-mail：

tanglan1995@126.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：

上海市徐汇区宜山路600号

研究负责人通讯地址：

上海市徐汇区宜山路600号

Applicant address：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600Yishan Rd, Shanghai, 200233, China

Study leader's address：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600Yishan Rd, Shanghai, 200233, 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：

上海市第六人民医院

Applicant's institution：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究负责人所在单位：

上海市第六人民医院

Affiliation of the Leader：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024-199

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：

上海市第六人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Sixth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-11-08 00:00:00

伦理委员会联系人：

庞路阳

Contact Name of the ethic committee：

Luyang Pang

伦理委员会联系地址：

上海市徐汇区宜山路600号

Contact Address of the ethic committee：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600Yishan Rd, Shanghai, 200233, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 24056428

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：

上海市第六人民医院

Primary sponsor：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市徐汇区宜山路600号

Primary sponsor's address：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600Yishan Rd, Shanghai, 200233, 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)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市第六人民医院

具体地址：

上海市徐汇区宜山路600号

Institution
hospital：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600Yishan Rd, Shanghai, 200233, China

经费或物资来源：

无

Source(s) of funding：

NO

Target disease：

chronic non-specific low back pain

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1）明确慢性非特异性腰痛患者进行髋周肌群失衡纠正训练对腰椎功能障碍、疼痛程度和髋周肌群失衡的影响 （2）通过比较髋周肌群失衡纠正训练与核心稳定训练，明确慢性非特异性腰痛患者应用等速进行失衡纠正训练的可行性，为慢性非特异性腰痛的诊疗进一步提供临床依据  

Objectives of Study：

(1) To determine the effects of hip muscle imbalance correction training on lumbar dysfunction, pain degree and hip muscle imbalance in patients with chronic non-specific low back pain (2) To determine the feasibility of applying iso-velocity imbalance correction training to patients with chronic non-specific low back pain by comparing the hip muscle imbalance correction training and core stability training, and provide further clinical basis for the diagnosis and treatment of chronic non-specific low back pain

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) 位于第12肋以下和臀部以上的疼痛 2) 年龄在18-50岁之间 3) 病程大于12周，在过去3-15个月至少有1次复发性腰痛 4) 右利手 5) 经过等速肌力测试提示存在双侧髋关节同名肌肉差异性≥10% 6) 在近期3个月内进行过腰椎核磁共振检查

Inclusion criteria

1) Pain located below the 12th rib and above the hip 2) Aged between 18 and 50 3) The duration of the disease is greater than 12 weeks, and there has been at least 1 recurrent low back pain in the past 3-15 months 4) Right-handed 5) The isokinetic muscle strength test indicated that there was a bilateral hip muscle difference of the same name ≥10% 6) Lumbar MRI was performed within the last 3 months

排除标准：

1) 过去两年内有骨盆部或脊柱手术史 2) 存在任何特定的腰椎病理改变 (如脊柱肿瘤、椎体骨折、腰椎管狭窄症、腰椎滑脱、风湿性关节炎、关节僵硬等)、严重或正在进展的脊柱侧弯 3) 存在会影响髋周肌群肌力测试结果的下肢外伤或损伤 4) 存在神经根症状或向双下肢的神经放射症状 5) 因疼痛剧烈、认知功能障碍而无法完成或拒绝接受等速肌力测试、等速肌力训练与物理治疗的患者 6) 存在重要器官(如心、肺和肾脏等)的严重功能障碍 7) 存在严重的视觉或听觉障碍 8) 身体质量指数（Body Mass Index，BMI）≥30kg/m2

Exclusion criteria：

1) A history of pelvic or spinal surgery within the past two years 2) The presence of any specific pathological changes in the lumbar spine (such as spinal tumors, vertebral fractures, lumbar stenosis, lumbar spondylolisthesis, rheumatoid arthritis, joint stiffness, etc.), severe or progressive scoliosis 3) The presence of lower limb trauma or injury that may affect the results of the muscle strength test of the perihip muscle group 4) The presence of nerve root symptoms or nerve radiation to the lower extremities 5) Patients who are unable to complete or refuse isokinetic muscle strength tests, isokinetic muscle strength training and physical therapy due to severe pain or cognitive dysfunction 6) There is serious dysfunction of vital organs (such as heart, lungs and kidneys) 7) There is a severe visual or hearing impairment 8) Body Mass Index (BMI) ≥30kg/m2

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-01-01 00:00:00 至 To 2025-07-31 00:00:00  

干预措施：

Interventions：

组别：

失衡纠正组

样本量：

35

Group：

Hip Imbalance Correction

Sample size：

干预措施：

由评估医师采用多关节等速肌力测试系统A8-2（广州一康，中国）进行双侧髋屈伸/展收/内外旋肌群的等速肌力训练。训练时将角速度和模式设定为30、60、90、120°/s向心模式，每种速度各10次为1组，共4组，组间休息1分钟，每3天1次训练。每进行3次训练后将再次进行等速肌力测试，评估失衡程度的改善情况，以保证双侧肌群的差异度在10%以内。若再次评估后差异度仍＞10%，则继续进行当前肌群训练，最多进行12次训练。训练量及强度将根据受试者的耐受度进行适当调整，以引起肌肉适度疲劳且第二天无明显不适为宜。

干预措施代码：

Intervention：

Isokinetic muscle strength training of both hip flexion and extension/extension/internal and external rotation muscle groups will be performed by the evaluator with multi-joint isokinetic muscle strength test system A8-2 (Guangzhou Yichan, China). During the training, the angular speed and mode were set as 30, 60, 90 and 120°/s centrional mode, with 10 times of each speed as 1 group, a total of 4 groups, with 1 minute rest between groups, and 1 training every 3 days, a total of 12 training sessions. After every 3 training sessions, the isometric muscle strength test was conducted again to evaluate the improvement of the muscle imbalance to ensure that the bilateral muscle group difference is less than 10%. If the difference is still greater than 10% after re-evaluation, continue with the current muscle group training, with a maximum of 12 training sessions. The amount and intensity of training will be adjusted according to the tolerance of the subject, so as to cause moderate muscle fatigue and no obvious discomfort the next day.

Intervention code：

组别：

核心训练组

样本量：

35

Group：

Core Stabilization Exercise

Sample size：

干预措施：

根据患者病情，将由接受过专业培训的医师对患者进行核心稳定训练。核心稳定训练包括：1.呼吸训练；2.腹横肌训练；3.仰卧双桥训练；4.仰卧单桥训练；5.仰卧反桥训练；6.坐球伸腿训练；7.倚球下蹲训练。以上动作每3天1次训练，共计12次训练。训练量及强度将根据受试者的耐受度进行适当调整，以引起肌肉适度疲劳且第二天无明显不适为宜。

干预措施代码：

Intervention：

Depending on the patient's condition, the patient will be trained in core stabilization by a professionally trained physician. Core stability training includes: 1. Breathing training; 2. Transverse abdominal muscle training; 3. Supine double bridge training; 4. Supine single bridge training; 5. Supine reverse bridge training; 6. Sit with the ball and stretch your legs; 7. Lean on the ball and squat. The above exercises are performed once every 3 days for a total of 12 training sessions. The amount and intensity of training will be adjusted according to the tolerance of the subject, so as to cause moderate muscle fatigue and no obvious discomfort the next day.

Intervention code：

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)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海市第六人民医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Oswestry 功能障碍指数问卷表

指标类型：

主要指标

Outcome：

Oswestry Disability Index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉模拟评分量表

指标类型：

次要指标

Outcome：

Visual Analogue 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：

髋周肌群评估

指标类型：

次要指标

Outcome：

Assessment of perihip muscles

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腰大肌横截面积

指标类型：

次要指标

Outcome：

The cross-sectional area of the psoas major

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：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 50 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采取简单随机分组方法，患者的分配将根据计算机生成的随机表进行。

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

Using a simple randomization method, patients will be assigned according to a computer-generated randomization table.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

结局指标评估者设盲

Blinding：

The outcome measure evaluator were blinded

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

NO

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

NO

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：

采用病例记录表进行数据采集和管理

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

Data collection and management were carried out with case record form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-12-13 00:08:42