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摇拔戳手法治疗外侧踝关节扭伤的步态分析研究

注册号：

Registration number：

ITMCTR2024000064

最近更新日期：

Date of Last Refreshed on：

2024-05-19

注册时间：

Date of Registration：

2024-05-19

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

摇拔戳手法治疗外侧踝关节扭伤的步态分析研究

Public title：

Research on gait analysis of the Treatment of Lateral Ankle Joint Sprain by rotating-pulling-poking manipulation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

摇拔戳手法治疗外侧踝关节扭伤的步态分析研究

Scientific title：

Research on gait analysis of the Treatment of Lateral Ankle Joint Sprain by rotating-pulling-poking manipulation

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：

温海宝

研究负责人：

温海宝

Applicant：

Feng Minshan

Study leader：

Feng Minshan

申请注册联系人电话：

Applicant telephone：

18270757983

研究负责人电话：

Study leader's telephone：

18270757983

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：

870717325@qq.com

研究负责人电子邮件：

Study leader's E-mail：

870717325@qq.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：

北京市朝阳区望京街道中环南路6号

研究负责人通讯地址：

北京市朝阳区望京街道中环南路6号

Applicant address：

No. 6, South Zhonghuan Road, Wangjing Street, Chaoyang District, Beijing

Study leader's address：

No. 6, South Zhonghuan Road, Wangjing Street, Chaoyang District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

100102

研究负责人邮政编码：

Study leader's postcode：

100102

申请人所在单位：

中国中医科学院望京医院

Applicant's institution：

Wangjing Hospital, China Academy of Chinese Medical Sciences

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：

WJEC-YJS-2022-023-P002

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：

中国中医科学院望京医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Wangjing Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2022/11/8 0:00:00

伦理委员会联系人：

王浩

Contact Name of the ethic committee：

Wang Hao

伦理委员会联系地址：

北京市朝阳区望京街道中环南路6号

Contact Address of the ethic committee：

No. 6, South Zhonghuan Road, Wangjing Street, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 138 1012 3955

伦理委员会联系人邮箱：

Contact email of the ethic committee：

fengminshan@hotmail.com

研究实施负责（组长）单位：

中国中医科学院望京医院

Primary sponsor：

China Academy of Chinese Medical Sciences Wangjing Hospital

研究实施负责（组长）单位地址：

北京市朝阳区望京街道中环南路6号

Primary sponsor's address：

No. 6, South Zhonghuan Road, Wangjing Street, Chaoyang District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

中国

Province：

北京

City：

北京

单位(医院)：

中国中医科学院望京医院

具体地址：

北京市朝阳区望京街道中环南路6号

Institution
hospital：

China Academy of Chinese Medical Sciences Wangjing Hospital

Address：

No. 6, South Zhonghuan Road, Wangjing Street, Chaoyang District, Beijing

经费或物资来源：

自筹经费

Source(s) of funding：

self-financing

研究疾病：

外侧踝关节扭伤

研究疾病代码：

Target disease：

Lateral ankle sprain

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

比较摇拔戳手法治疗外侧踝关节扭伤治疗前后的步态参数变化，探讨该手法潜在的生物力学作用机制。

Objectives of Study：

To compare the changes in gait parameters before and after the treatment of lateral ankle sprain using the rotating-pulling-poking manipulation, and explore the potential bio-mechanical mechanism of this manipulation.

药物成份或治疗方案详述：

两组患者皆予以健康宣教：①休息：治疗期间以休息为主，尽量避免剧烈运动；②抬高患肢：使踝关节水平位与心脏齐平或高于心脏，利于消肿； （1）试验组：摇拔戳手法配合弹力绷带外固定治疗：①摇拔戳手法操作步骤(图1)如下：A)摇晃手法：操作医生两手相对，双手拇指按住外踝下缘，其余四指握住患足，将足踝摇晃转动，连续操作6次；B)拔伸手法：医生与助手进行相对拔伸，并将足跖屈内翻；C)戳按手法：再将足背伸外翻，双手拇指同时向下戳按。每周治疗2次，2周共4次治疗；②弹力绷带加压包扎外固定：采用8字缠绕法，将弹力绷带(规格：宽7.5cm x 长4.5m)从小腿外侧经踝前、足内侧、足底、足外侧缠向踝前、小腿内侧，重复缠绕6～8层。下缘平足底，上缘超内外踝10cm，调整绷带松紧度，保护骨骼突出部位，防止压疮。治疗第一天开始固定，弹力绷带3天一换，连续佩戴2周。 （2）对照组：冰敷配合弹力绷带外固定治疗：①冰敷：准备冰水混合物一袋，冰敷患处，每次15分钟，隔2小时敷1次，一天敷3次，在踝关节扭伤的前3d连续使用。②弹力绷带加压包扎外固定：包扎方法同试验组，治疗第一天开始固定，弹力绷带3天一换，连续佩戴2周。

Description for medicine or protocol of treatment in detail：

Both groups of patients were given health education: ① rest: during the treatment period, rest was the main focus, and vigorous exercise should be avoided as much as possible; ② Raising the affected limb: the patients made the ankle joint level with or above the heart, which was beneficial for reducing swelling; (1)Experimental group: The pantients were treated by rotating-pulling-poking manipulation combined with elastic bandage external fixation treatment: ① rotating-pulling-poking manipulation operation steps (Figure 1) as following: A) rotating manipulation: The doctor operated with two hands facing each other, with both thumbs pressing on the lower edge of the outer ankle, and the other four fingers gripping the affected foot, rotating the ankle for 6 consecutive operations; B) pulling manipulation: The doctor and assistant performed relative pulling, and turned the footpad inward; C) poking manipulation: The doctor and assistant extended the back of the foot and turn it outward, while simultaneously poking and pressing with both thumbs downwards.② Elastic bandage pressure binding and (2)external fixation: The doctor used the 8-shaped wrapping method with the elastic bandage (specification: 7.5cm wide x 4.5m long) from the outer side of the calf, past the front of the ankle, inside of the foot, sole, and outside of the foot, towards the front of the ankle and inside of the calf, to wrap the affected feet repeatedly for 6-8 layers.The lower edge leveled with the sole, and the upper edge exceeded the inner and outer ankles by 10cm. Tightness of the bandage was adjusted to protect the protruding parts of the bone and prevent pressure ulcers. From the first day of treatment, the elastic bandage was fixed for 3 days and replaced every 3 days for 2 consecutive weeks Control group: The patients were treated by ice compress combined with elastic bandage external fixation treatment: ① Ice compress: The doctor prepared a bag of ice water mixture to compress the affected area for 15 minutes each time, applying once every 2 hours, three times a day.And the treatment was used continuously for the first three days of ankle joint sprain. ② Elastic bandage pressure binding and external fixation: The binding method was the same as that of the experimental group. The fixation started from the first day of treatment, and the elastic bandage was changed every 3 days and worn continuously for 2 weeks[1].

纳入标准：

①符合外侧踝关节扭伤诊断标准：有明确的踝关节外伤史，出现踝关节疼痛、肿胀、皮下瘀斑、活动功能受限等症状，有踝关节局部压痛，内翻应力实验阳性等体征； ②MRI检查显示韧带未有Ⅱ度以上撕裂损伤(韧带损伤分级：Ⅰ度损伤：韧带松弛，无明显撕裂；Ⅱ度损伤：韧带部分撕裂；Ⅲ度损伤：韧带完全断裂)，内翻应力位X线摄片示距骨倾斜角＜15 °且未见骨折、脱位； ③年龄18-60岁； ④VAS评分3-7分； ⑤签署知情同意书者。

Inclusion criteria

①All participants met the diagnostic criteria for lateral ankle sprain all participants had a clear history of ankle injury, with symptoms such as ankle pain, swelling, subcutaneous ecchymosis, and limited mobility, as well as signs such as local tenderness of the ankle joint and positive varus stress test; ② MRI examination of the participants showed no degree II or higher tear damage to the ligament (ligament injury grading[16]degree I injury : ligament relaxation without obvious tearing; degreeⅡ injury: partial ligament tear; degree Ⅲ injury: complete ligament rupture), and X-ray imaging of the varus stress position showed a talus inclination angle of<15 ° and no fractures or dislocations; ③ all the participants are 18-60 years old; ④ The VAS scores of all participants were 3-7 points. ⑤ the person who signed the informed consent form.

排除标准：

①伴有骨关节感染、骨折、肿瘤、结核等； ②踝关节局部有皮肤破损或皮肤病者； ③有踝关节手术史； ④不适合参与临床研究的特殊人群(盲、聋、哑、智力或精神障碍等)； ⑤踝关节韧带Ⅲ度损伤。

Exclusion criteria：

① The cases accompanied by bone and joint infections, fractures, tumors, tuberculosis, etc.; ② Individuals with local skin damage or skin disorders in the ankle joint; ③ Individuals with a history of ankle surgery; ④ Special populations who were not suitable for clinical research (blind, deaf, mute, intellectual or mental disorders, etc.). ⑤ third degree ankle ligament injury

研究实施时间：

Study execute time：

从From 2022-11-16

至To      2023-12-31

征募观察对象时间：

Recruiting time：

从From 2022-11-30

至To      2022-12-31

干预措施：

Interventions：

组别：

治疗组

样本量：

20

Group：

therapy group

Sample size：

干预措施：

摇拔戳手法+弹力绷带外固定治疗：（1）手法疗程2周，每周2次；（2）弹力绷带固定2周

干预措施代码：

Intervention：

Shake and poke technique + elastic bandage external fixation treatment: (1) manual treatment for 2 weeks, twice a week, (2) elastic bandage fixation for 2 weeks

Intervention code：

组别：

对照组

样本量：

20

Group：

control group

Sample size：

干预措施：

冰敷+弹力绷带外固定治疗：（1）冰敷治疗3天，每天冰敷3次；（2）弹力绷带固定2周

干预措施代码：

Intervention：

Ice + elastic bandage external fixation: (1) ice treatment for 3 days, ice 3 times a day, (2) elastic bandage fixation for 2 weeks

Intervention code：

样本总量 Total sample size ： 40

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

中国

Province：

北京

City：

北京

单位(医院)：

中国中医科学院望京医院

单位级别：

三甲

Institution/hospital：

China Academy of Chinese Medical Sciences Wangjing Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

力学参数：垂直轴、矢状轴、冠状轴的足跟着地(第1峰值）、足尖蹬地（第2峰值）产生的分力峰值。

指标类型：

主要指标

Outcome：

Mechanical parameters: the peak force of the heel (peak 1) and the toe push (peak 2) of the vertical axis, the sagittal axis and the coronal axis.

Type：

Primary indicator

测量时间点：

治疗前、治疗后

测量方法：

步态力学测力板系统测量

Measure time point of outcome：

Before and after treatment

Measure method：

Gait mechanics force plate system measurements

指标中文名：

运动学参数：步行周期、步速、步频、跨步长、步宽、支撑时间、摆动时间、跖屈峰值，背伸峰值

指标类型：

主要指标

Outcome：

Kinematic parameters: walking cycle, pace, cadence, stride length, stride width, support time, swing time, peak plantar flexion, peak dorsal extension

Type：

Primary indicator

测量时间点：

治疗前、治疗后

测量方法：

动态捕捉步态系统测量

Measure time point of outcome：

Before and after treatment

Measure method：

Dynamic capture of gait system measurements

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

无

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

结束

Completed

年龄范围：

最小 18 岁
Min age years
最大 60 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）：

随机数字表法

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

Random number table method

盲法：

Blinding：

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）：

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)：

presented paper

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：

数据采集经过病例记录表记录

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

Data collection was recorded through a case record form

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）：

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

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