ChiCTR2300074648 版本V1.1 版本创建时间2023/12/26 19:57:28 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：

 ChiCTR2300074648 

最近更新日期：

Date of Last Refreshed on：

 2023-08-11 11:36:03 

注册时间：

Date of Registration：

 2023-08-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

南少林整脊手法改善脊柱侧弯患者运动协调功能的机制：基于“躯干多节段追踪模型”的研究

Public title：

Mechanism of NanShaoLin Manipulation to improve movement coordination for scoliosis: a study based on the "Multi-segment Trunk Model"

注册题目简写：

南少林手法干预脊柱侧弯的机制研究

English Acronym：

Study on the mechanism of NanShaolin manipulation intervention in scoliosis

研究课题的正式科学名称：

南少林整脊手法改善脊柱侧弯患者运动协调功能的机制：基于“躯干多节段追踪模型”的研究

Scientific title：

Mechanism of NanShaoLin Manipulation to improve movement coordination for scoliosis: a study based on the "Multi-segment Trunk Model"

研究课题代号(代码)：

Study subject ID：

 82205306

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：

苟艳芸 

研究负责人：

苟艳芸 

Applicant：

GOU Yanyun 

Study leader：

GOU Yanyun 

申请注册联系人电话：

Applicant telephone：

 +86 134 0056 4710

研究负责人电话：

Study leader's
telephone：

+86 134 0056 4710

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：

 1186890564@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1186890564@qq.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：

福建省福州市闽侯上街邱阳路1号

研究负责人通讯地址：

福建省福州市闽侯上街邱阳路1号

Applicant address：

No. 1 Qiuyang Road, Minhou Street, Fuzhou City, Fujian Province

Study leader's address：

No. 1 Qiuyang Road, Minhou Street, Fuzhou City, Fujian Province

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：

福建中医药大学

Applicant's institution：

Fujian University of Traditional Chinese Medicine

研究负责人所在单位：

福建中医药大学

Affiliation of the Leader：

Fujian 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：

 2023-kl-047

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：

福建中医药大学附属第三人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-06-06 00:00:00

伦理委员会联系人：

占璐

Contact Name of the ethic committee：

ZHAN Lu

伦理委员会联系地址：

福州市闽侯县闽侯上街国宾大道363号

Contact Address of the ethic committee：

No. 363, Minhou Street, Minhou County, Fuzhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 139 5911 4795

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：

福建中医药大学附属第三人民医院

Primary sponsor：

The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

福州市闽侯县上街镇国宾大道363号

Primary sponsor's address：

Fuzhou City Minhou County Shangshang Town, Guobin Avenue 363

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建

市(区县)：

Country：

China

Province：

Fujian

City：

单位(医院)：

福建中医药大学附属第三人民医院

具体地址：

福州市闽侯县上街镇国宾大道363号

Institution
hospital：

The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Address：

Fuzhou City Minhou County Shangshang Town, Guobin Avenue 363

国家：

中国

省(直辖市)：

福建

市(区县)：

福州

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

福建中医药大学

具体地址：

福建省福州市闽侯上街邱阳路1号

Institution
hospital：

Fujian University of Traditional Chinese Medicine

Address：

No. 1 Qiuyang Road, Minhou Street, Fuzhou City, Fujian Province

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

脊柱侧弯  

Target disease：

scoliosis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

青少年特发性脊柱侧弯（AIS）是脊柱侧弯中最常见的一种，其严重影响青少年的发育，是临床治疗难题。目前尚无最佳的功能评估手段及治疗方法。既往研究显示，高达85%的AIS患者存在运动协调障碍，改善运动协调功能对于治疗AIS至关重要。我们前期研究发现，南少林整脊手法对治疗脊柱疾病具有显著的优势。临床随机对照试验也证实南少林整脊手法可有效改善AIS患者的侧方弯曲及椎体旋转，矫正脊柱畸形，疗效显著。但是其疗效机制目前尚不十分清楚。有学者提出“躯干多节段追踪模型”实现脊柱多节段间运动协调功能的量化。本课题拟在AIS人群中，通过三维运动捕捉和表面肌电技术探讨AIS运动协调的改变，基于“躯干多节段追踪模型”进一步揭示南少林整脊手法干预AIS的疗效机制，为南少林手法的实施和推广提供科学依据。  

Objectives of Study：

Adolent idiopathic scoliosis (AIS) is the most common type of scoliosis, which seriously affects the development of adolescents. It has attracted attention from all walks of life due to the high morbidity, disability rate and medical burden. Previous studies have shown that up to 85% of patients with AIS have movement coordination dysfunction, improving movement coordination is crucial for the treatment of AIS. Randomized controlled trials have confirmed that the NanShaoLin manipulation can improve the spinal deformity of AIS. However, the mechanism of its effect is still unclear. Some authors proposed the "Multi-segment Trunk Model" to achieve the quantification of the movement coordination of the spine. We intends to explore the change of movement coordination through Three-dimensional motion capture and Surface Electromyography technology among AIS population, and further reveal the clinical effects mechanism of NanShaoLin manipulation on AIS based on the "Multi-segment Trunk Model" to provide scientific basis for the implementation and promotion of Nanshaolin techniques.

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符合本病的诊断标准； ②年龄 10-20 岁，不限性别； ③X 光筛查 Cobb 角度在 10°-30°以内（不包括 10°，不包括 30°）； ④签署知情同意书，自愿参加本试验； 符合上述各项者方可纳入。

Inclusion criteria

Meet the diagnostic criteria of the disease; Age 10-20 years old, regardless of gender; X-ray screening Cobb Angle within 10°-30° (excluding 10°, excluding 30°); Sign informed consent and participate in the experiment voluntarily; Those who meet the above criteria are eligible for inclusion.

排除标准：

①先天性、神经肌肉型、神经纤维瘤、间质病变以及创伤型脊柱侧弯； ②伴随严重的骨质疏松症及其它不适合手法治疗的疾病； ③疑有或已确诊的腰椎关节、软组织及椎管内肿瘤者； ④脊柱部位有严重皮肤损伤、出血或皮肤病者； ⑤每周运动≥3 次，每次运动量≥30min 者； ⑥双侧下肢真性腿长差超过 2cm 者； ⑦BMI＞25 者； ⑧不能按规定时间坚持接受治疗、治疗不配合者； ⑨正在参加其他临床试验者。 符合以上任何一项者即予排除。

Exclusion criteria：

① Congenital, neuromuscular, neurofibroma, interstitial disease and traumatic scoliosis; ② Accompanied by severe osteoporosis and other diseases not suitable for manual treatment; ③ Suspected or diagnosed lumbar joint, soft tissue and spinal canal tumors; ④ Severe skin injury, bleeding or skin disease in the spine; (5) Exercise ≥3 times a week, and the amount of exercise ≥30min each time; ⑥ the true leg length difference of both lower limbs is more than 2cm; ⑦BMI > 25; 8 Can not adhere to the prescribed time to receive treatment, treatment does not cooperate; ⑨ Participants in other clinical trials. Those who meet any of the above criteria are excluded.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-31 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 32

Group：

Experimental group

Sample size：

干预措施：

南少林整脊手法：a：斜扳法：患者侧卧，患者上方的膝关节置于下膝的前方，让骨盆可以旋转，使患者脊柱前屈至受累节段开始活动；保持受累节段与地面垂直，确保在胸廓(不是肱骨)和髂骨(不是大转子)上施力；保持患者适度的放松，在整脊之前通过牵拉、轻微脊柱侧屈、屈曲或伸展使受累节段锁住，治疗师双肘用力随着身体快速的往下落产生低幅的整复； b：旋转法：患者俯卧位，完全放松，治疗师触诊至脊柱受累节段，双手交叉成“蝴蝶手”，通过治疗师身体重量对脊柱产生一个后向前、内向外低幅的整复。 强度：每周 3 次，每次 30min（斜扳法 15min+旋转法 15min），治疗周期共 6 周。

干预措施代码：

Intervention：

South Shaolin spine manipulation: a: oblique manipulation: the patient lies on his side, the patient's upper knee is placed in front of the lower knee, so that the pelvis can be rotated, so that the patient's spine is bent forward to the affected segment began to move; Keep the affected segment perpendicular to the floor and ensure that force is applied to the thorax (not the humerus) and ilium (not the greater trochanter); Keeping the patient moderately relaxed, the affected segment is locked by pulling, minor scoliosis, flexion, or extension prior to the chiropractic, and the therapist uses both elbows to produce low rectification as the body falls rapidly; b: Rotation method: The patient lies in a prone position, completely relaxed, the therapist palpates to the affected section of the spine, crosses the hands into a "butterfly hand", and creates a backward forward, inward and outward low rectification of the spine through the therapist's body weight. Intensity: 30min each time, 3 times a week (15min for oblique manipulation + 15min for rotation), the treatment cycle was 6 weeks.

Intervention code：

组别：

对照组

样本量：

 32

Group：

Control group

Sample size：

干预措施：

健康宣教+等待治疗（Waiting list）：针对本疾病的自我运动训练指导及其健康生活方式教育；待试验结束后接受临床常规治疗

干预措施代码：

Intervention：

Health education + Waiting list: self-exercise training guidance and healthy living prescription for this disease Type education; After the end of the experiment, he received clinical routine treatment

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

  

Country：

China

Province：

Fujian

City：

单位(医院)：

 福建中医药大学附属第三人民医院 

单位级别：

 三甲 

Institution
hospital：

The Third People's Hospital Affiliated to Fujian University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

柯布角

指标类型：

主要指标

Outcome：

Cobb angle

Type：

Primary indicator

测量时间点：

干预前后

测量方法：

采用X-Ray 测量Cobb角，取患者站立正位 X 线片评估冠状面畸形程度，确定侧弯脊柱的上下两端椎体，头端椎体上缘的垂线与尾端椎体下缘的垂线的交角即为 Cobb 角。若椎体的上下缘不清楚，可取椎弓根上下缘的连线，然后取其垂线的交角[3]；取患者站立侧位 X 线片评估失状面畸形程度，取骶骨平面与水平面的交角为腰骶角，取L5椎体下缘与L1椎体上缘交角为腰椎生理曲度，取T12椎体下缘与T4椎体下缘交角为胸椎生理曲度

Measure time point of outcome：

pre/post intervention

Measure method：

The Cobb Angle was measured by X-Ray, and the degree of coronal deformity was evaluated by taking the patient's standing upright X-ray film. The upper and lower ends of the scoliosis spine were determined. The intersection Angle between the vertical line of the upper edge of the cephalic vertebra and the vertical line of the lower edge of the caudal vertebra was called Cobb Angle. If the upper and lower edges of the vertebral body are not clear, the line between the upper and lower edges of the

指标中文名：

脊柱外观问卷

指标类型：

次要指标

Outcome：

spinal appearance questionnaire

Type：

Secondary indicator

测量时间点：

干预前后

测量方法：

SAQ通过使用标准的图画和问题来评估患者和家属对其脊柱畸形情况的认知。包括8个维度：总体、躯干弯曲、背部隆起、躯干移位、腰部、双肩水平、后凸畸形、胸部畸形以及若干调查患者最关心的问题，整个问卷由表示不同畸形程度的图像与患者对外观预期的文字表述2部分组成

Measure time point of outcome：

pre/post intervention

Measure method：

SAQ assesses the patient's and family's perception of their spinal deformity by using standard drawings and questions. The questionnaire included 8 dimensions: total body, trunk curvature, back bulge, trunk displacement, waist, shoulder level, kyphosis, chest deformity and some of the most concerned questions of the patients. The whole questionnaire consisted of two parts: images indicating different degrees of deformity and words describing the patients' expectations of appearance

指标中文名：

脊柱侧弯研究学会-22

指标类型：

次要指标

Outcome：

Scoliosis Research Society-22

Type：

Secondary indicator

测量时间点：

干预前后

测量方法：

广泛应用于评估脊柱侧弯的影响和治疗效果，是脊柱侧弯研究学会在全球重点推荐使用的量表。主要包括功能/活动（Function/activity）、疼痛（Pain）、自我印象(Self-image/appearance）、心理健康(Mental health) 、治疗满意度(Satisfaction of management)等5个方面的评估。

Measure time point of outcome：

pre/post intervention

Measure method：

Widely used to assess the impact and treatment of scoliosis, it is the scale recommended by the scoliosis Research Society worldwide. It mainly includes Function/activity, Pain, Self-image/appearance, Mental health, and Satisfaction of treatment management) and other five aspects of evaluation.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 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）：

随机化序列产生方法：简单随机分组方法-随机数字分组：从随机数字表中任意一个数开始，沿同一方向顺序获取每个实验单位一个随机数字，将研究对象随机分为试验组、对照组；

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

Random sequence generation method: Simple random grouping method - Random number grouping: any number from the random number table At first, a random number was obtained from each experimental unit in the same direction, and the subjects were randomly divided into experimental group and control group.

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：

未说明

Blinding：

Not stated

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

否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）：

NA

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

NA

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：

制定详细的研究手册，规范受试者招募流程、青少年特发性脊柱侧弯临床筛查流程、纳入标准及排除标准、干预手段的实施细则、评估流程细则、实验操作流程规范、病历记录表填写规范、受试者数据采集任务细则等，保证参与研究的所有人员熟悉所有流程及细则. 由经过专业培训的物理治疗专业人员对受试者进行结局指标的评价，为保证测量结果的准确性，进行重测信度法（Test-Retest），对与之匹配的同年龄段健康人群 10 人进行测试，一周后由同一个人进行第二次测试，对两次数据进行统计分析，计算其相关系数。本实验结局指标评价均由一人完成，保证实验数据的准确性及可信性；评定人员每次测试后在病历记录表签字保证数据的真实性.

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

Formulate a detailed study manual to standardize the process of subject recruitment, clinical screening process for adolescent idiopathic scoliosis, inclusion criteria and exclusion criteria, implementation rules of intervention means, evaluation process rules, experimental procedure rules, medical record form filling criteria, and subject data collection task rules, etc., to ensure that all participants in the study are familiar with all procedures and rules. Professionally trained physiotherapy professionals evaluated the outcome indicators of the subjects. In order to ensure the accuracy of the measurement results, a test-retest was performed on 10 matched healthy people of the same age group. A week later, the same person conducted a second Test, and statistical analysis was conducted on the two data. The correlation coefficient was calculated. The outcome indexes of this experiment were all evaluated by one person to ensure the accuracy and credibility of the experimental data. The evaluator will sign the medical record form after each test to ensure the authenticity of the data.

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：

  2023-08-11 11:35:12