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The experimental study and clinical effect evaluation of multimodal ultrasound for plantar fasciitis

注册号：

Registration number：

ITMCTR2022000056

最近更新日期：

Date of Last Refreshed on：

2022-08-02

注册时间：

Date of Registration：

2022-06-22

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

多模态超声对足底筋膜炎针灸治疗临床效果的评价

Public title：

The experimental study and clinical effect evaluation of multimodal ultrasound for plantar fasciitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多模态超声对足底筋膜炎针灸治疗临床效果的评价

Scientific title：

The experimental study and clinical effect evaluation of multimodal ultrasound for plantar fasciitis

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：

ChiCTR2200062361 ; ChiMCTR2200006429

申请注册联系人：

项东英

研究负责人：

项东英

Applicant：

dongying xiang

Study leader：

dongying xiang

申请注册联系人电话：

Applicant telephone：

13301387201

研究负责人电话：

Study leader's telephone：

13301387201

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：

13301387201@163.com

研究负责人电子邮件：

Study leader's E-mail：

13301387201@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：

北京市西城区北线阁街5号中国中医科学院广安门医院超声科

研究负责人通讯地址：

北京市西城区北线阁街5号中国中医科学院广安门医院超声科

Applicant address：

ultrasound department，Guang'anmen Hospital China Academy of Chinese Medical Science No.5, beixiange, Xicheng District, Beijing

Study leader's address：

ultrasound department，Guang'anmen Hospital China Academy of Chinese Medical Science No.5, beixiange, Xicheng District, Beijing

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：

中国中医科学院广安门医院

Applicant's institution：

Guang'anmen Hospital China Academy of Chinese Medical Science

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：

2022-67-KY

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中国中医科学院广安门医院伦理委员会

Name of the ethic committee：

Ethics committee ofGuang’ anmen Hospital of China Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2022/4/24 0:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

jie qiao

伦理委员会联系地址：

北京市西城区北线阁街5号中国中医科学院广安门医院4号楼452

Contact Address of the ethic committee：

452 No. 4 building Guang'anmen Hospital China Academy of Chinese Medical Science No.5, beixiange, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

中国中医科学院广安门医院

Primary sponsor：

Guang'anmen Hospital China Academy of Chinese Medical Science

研究实施负责（组长）单位地址：

北京市西城区北线阁街5号中国中医科学院广安门医院超声科

Primary sponsor's address：

ultrasound department No.5, beixiange, Xicheng 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)：

Country：

china

Province：

beijing

City：

单位(医院)：

中国中医科学院广安门医院

具体地址：

北京市西城区北线阁街5号

Institution
hospital：

Guang'anmen Hospital China Academy of Chinese Medical Science

Address：

No.5, beixiange, Xicheng District, Beijing

经费或物资来源：

中国中医科学院科技创新工程

Source(s) of funding：

Scientific and technological innovation project of China Academy of Chinese Medical Sciences

研究疾病：

足底筋膜炎

研究疾病代码：

Target disease：

plantar fasciitis

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：

超声作为一种可靠的、有效的、经济的检查方法，为患者针灸治疗前提供明确诊断，并在12个月的随访期内，对针灸治疗有效性进行评估，并对复发情况进行评估。

Objectives of Study：

Ultrasound, as a reliable, effective and economical examination method, provides a definite diagnosis for patients before acupuncture treatment, and evaluates the effectiveness of acupuncture treatment and the recurrence during a 12-month follow-up period.

药物成份或治疗方案详述：

针刺治疗组： (1)取穴：阿是穴(2 处)、承山、太溪、昆仑。 (2)穴位定位：参照 2006 年中华人民共和国国家标准(GB/T 12346-2006) 《腧穴名称与定位》 (3)操作方法： 患者取俯卧位，针刺部位局部使用 75%酒精棉球擦拭消毒，然后将固定垫粘贴在穴位上，所有腧穴参照陆寿康主编《刺法灸法学》教材针刺操作，使用 0.30mm*40mm 针灸针，直刺 5mm-10mm，除阿是穴外，其余穴位局部酸胀得气，即受试者有酸、麻、胀、重等特殊感觉，施术者有针下沉紧等感觉。承山、太溪和昆仑穴每10min 行小幅度均匀捻转手法 3 次，30min 内共行手法 3 次。 出针前，稍捻针柄，待针下轻松滑利方可出针。出针时，左手持消毒棉球轻按于针刺部位，右手持针作轻微小幅度捻转并顺势将针缓缓提出，出针后按压针孔以防出血。如足跟疼痛发生在一侧，针刺一侧穴位；如疼痛发生在两侧，针刺两侧穴位，评价时选择最痛的一侧。 (4)频次、疗程及时间：每次留针 30 分钟，隔日针刺 1 次，每周治疗3次， 连续4周，共12次。 浅针刺治疗： 1)取穴：阿是穴旁、承山旁、太溪旁、昆仑旁非穴点。 定位：阿是穴旁：阿是穴水平旁开 0.5 寸(左右旁开各 1 个)；承山旁，承 山穴水平旁开 0.5 寸；太溪旁，太溪与跟腱连线中点；昆仑旁，昆仑与跟腱连线 中点。 (2)操作方法:俯卧位，皮肤常规消毒，然后将固定垫粘贴在穴位上。采 用 0.30mm*25mm钝头针针刺穿过固定垫达皮肤表面。留针期间，除阿是穴旁外，其他穴位每10min行小幅度均匀捻转手法3 次，30min内共行手法3次；留针时间、频次、疗程、出针方式均同针刺组。 常规治疗组： 该组患者在入组时，进行健康宣教，告知其避免引起足跟痛的诱发因素，在 整个试验期间，一旦出现疼痛，注意适当休息、避免加重因素，如疼痛重，患者 难以忍受，可使用研究者提供的止痛药物，并如实记录。在试验结束后，如病情 未好转，将向患者提供 4 周 12 次免费的针刺治疗(针刺方案同针刺组)。

Description for medicine or protocol of treatment in detail：

Acupuncture treatment group: (1) Point selection: Ashi Point (2 places), Chengshan, Taixi and Kunlun. (2) Location of acupoints: refer to the National Standard of the People's Republic of China (GB/T 12346-2006) "Name and Location of Acupoints" (3) Operation method: Take the prone position of the patient, wipe and disinfect the acupuncture part with 75% alcohol cotton ball, and then stick the fixed pad on the acupuncture points. All the acupuncture points are operated according to the textbook Acupuncture Moxibustion Methodology edited by Lu Shoukang, using a 0.30mm*40mm acupuncture needle, stabbing 5mm-10mm straight. Except for Ashi point, the rest of the acupuncture points are sore and swollen, that is, the subjects have soreness and numbness. Chengshan, Taixi and Kunlun acupoints were subjected to small-amplitude uniform twisting manipulation for 3 times every 10 minutes, and the manipulations were performed for 3 times in 30 minutes. Twist the handle of the needle slightly before the needle goes out, and wait for the needle to slide easily before the needle goes out. When taking out the needle, gently press the sterilized cotton ball in the left hand on the acupuncture site, twist the needle slightly in the right hand and slowly lift the needle out. After taking out the needle, press the needle hole to prevent bleeding. If heel pain occurs on one side, acupuncture on one side; If the pain occurs on both sides, acupuncture points on both sides, and select the most painful side in evaluation. (4) Frequency, course of treatment and time: 30 minutes each time, acupuncture every other day, 3 times a week, for 4 consecutive weeks, totally 12 times. Shallow acupuncture treatment: 1) Acupoint selection: non-acupoints beside Ashi acupoint, Chengshan acupoint, Taixi acupoint and Kunlun acupoint. Location: Next to Ashi point: Ashi point is horizontally opened by 0.5 inches (one on the left and right sides); Beside Chengshan, the horizontal side of Chengshan point is 0.5 inches; Beside Taixi, the midpoint of the line between Taixi and Achilles tendon; Beside Kunlun, the midpoint of the line between Kunlun and Achilles tendon. (2) Operation method: lie prone, disinfect the skin routinely, and then stick the fixing pad on the acupuncture points. Use a 0.30mm*25mm blunt needle to penetrate the fixed pad and reach the skin surface. During the period of needle retention, except for Ashi point, other points were subjected to small-scale uniform twisting manipulation for 3 times every 10 minutes, and manipulations were performed for 3 times in 30 minutes. The needle retention time, frequency, course of treatment, and needle ejection mode are the same as those of the acupuncture group. Routine treatment group: When the patients in this group joined the group, they were given health education to tell them to avoid the inducing factors of heel pain. During the whole experiment, once pain occurs, they should pay attention to proper rest and avoid aggravating factors. If the pain is too heavy for the patients to bear, they can use the analgesic drugs provided by the researchers and record them truthfully. At the end of the trial, if the condition does not improve, patients will be provided with 12 free acupuncture treatments for 4 weeks (acupuncture scheme is the same as acupuncture group).

纳入标准：

1) 足底筋膜炎病程大于6个月 2) 足底筋膜近端跟骨止点处疼痛； 3) 晨起或休息一段时间后患足负重时疼痛加重； 4) 疼痛持续时间超过3个月； 5) 视觉模拟评分（VAS）4~10分； 6) 患者没有经过皮质激素注射或冲击波治疗或手术治疗或X线证实无跟骨骨刺。

Inclusion criteria

1) The course of plantar fasciitis is longer than 6 months. 2) Pain at the proximal calcaneus stop of plantar fascia; 3) The pain is aggravated when you get up in the morning or have a rest for a period of time; 4) The pain lasts more than 3 months; 5) Visual analogue scale (VAS)4~10 points; 6) The patient has no calcaneal spur after corticosteroid injection or shock wave therapy or surgical treatment or X-ray.1) The course of plantar fasciitis is longer than 6 months. 2) Pain at the proximal calcaneus stop of plantar fascia; 3) The pain is aggravated when you get up in the morning or have a rest for a period of time; 4) The pain lasts more than 3 months; 5) Visual analogue scale (VAS)4~10 points; 6) The patient has no calcaneal spur after corticosteroid injection or shock wave therapy or surgical treatment or X-ray.

排除标准：

1) 前期接受过局部治疗（如拉伸、类固醇注射、体外冲击波治疗和离子电渗疗法）； 2) 患有银屑病、痛风、血清阴性脊柱关节炎等系统性疾病，以及牛皮癣、指甲营养不良等足部相关疾病。

Exclusion criteria：

1) Having received local treatment in the early stage (such as stretching, steroid injection, extracorporeal shock wave therapy and iontophoresis); 2) Suffering from systemic diseases such as psoriasis, gout, serum-negative spinal arthritis, and foot-related diseases such as psoriasis and nail malnutrition.

研究实施时间：

Study execute time：

从From 2021-10-01

至To      2024-10-01

征募观察对象时间：

Recruiting time：

从From 2022-07-19

至To      2024-04-01

干预措施：

Interventions：

组别：

浅针刺组

样本量：

30

Group：

Shallow acupuncture group

Sample size：

干预措施：

阿是穴旁、承山旁、太溪旁、昆仑旁非穴点

干预措施代码：

Intervention：

acupuncture besides Ashi, Chengshan, Taixi, and Kunlun

Intervention code：

组别：

针刺组

样本量：

60

Group：

Acupuncture group

Sample size：

干预措施：

针刺阿是穴(2 处)、承山、太溪、昆仑

干预措施代码：

Intervention：

Acupuncture at Ashi (2 places), Chengshan, Taixi and Kunlun.

Intervention code：

组别：

常规治疗组

样本量：

30

Group：

Conventional treatment group

Sample size：

干预措施：

该组患者在入组时，进行健康宣教，告知其避免引起足跟痛的诱发因素

干预措施代码：

Intervention：

Patients in this group were given health education when they joined the group, telling them to avoid the inducing factors of heel pain.

Intervention code：

样本总量 Total sample size ： 120

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)：

Country：

China

Province：

beijng

City：

单位(医院)：

中国中医科学院广安门医院

单位级别：

所级

Institution/hospital：

Guang'anmen Hospital China Academy of Chinese Medical Science

Level of the institution：

institute level

测量指标：

Outcomes：

指标中文名：

足底筋膜厚度

指标类型：

主要指标

Outcome：

Plantar fascia thickness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

足底筋膜弹性指标

指标类型：

主要指标

Outcome：

elasticity index of Plantar fascia

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：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 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）：

1．试验设计 采用三臂、前瞻性、随机的方法进行的随机对照试验。试验中心：中国中医科学院广安门医院、烟台市中医院。 采用简单随机化方法。使用 PROC PLAN of SAS 9.4( SAS Institute Inc ., Cary , NC , USA ）生成随机号，将患者按照2:1:1的比例分配到针刺组、浅针刺组和常规治疗组。按照试验患者入组顺序将研究对象编为1-120号，得出与纳入顺序相应的随机分配组别，即针刺组60例，浅针刺组和常规治疗组各30例。随机方案事先由不参与本课题研究的人员设计好随机分组信封，纳入顺序号贴在信封表面，将随机数字及组别密封于不透光的信封内进行随机分配隐藏。随机信封和分配由不参与治疗和评价的专人负责。 盲法设计与实施：①对针刺组和浅针刺组患者施盲，常规治疗组则为开放性试验；②评价者盲法：观察过程中疗效评价由不知分组情况的专职评价者（研究护士或研究生）负责：③统计者盲法：由东直门医院教育部中医内科学重点实验室统计专家负责。

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

1. experimental design Randomized controlled trial with three-arm, prospective and random method. Test Center: Guang 'anmen Hospital, Chinese Academy of Traditional Chinese Medicine, Yantai Chinese Medicine Hospital. A simple randomization method was used. Proc Plan of SAS 9.4 (SAS Institute Inc., Cary, NC, USA) was used

盲法：

Blinding：

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）：

2024.10.1 Excel或word 数据资料

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

2024.10.1 Excel or word 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：

病例记录表 excel 病例管理表

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

Case record form excel Case management table

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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