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体外冲击波循经取穴治疗跟痛症的随机对照研究

注册号：

Registration number：

ITMCTR2025001433

最近更新日期：

Date of Last Refreshed on：

2025-07-20

注册时间：

Date of Registration：

2025-07-20

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

体外冲击波循经取穴治疗跟痛症的随机对照研究

Public title：

A randomized controlled study of extracorporeal shock wave acupoint selection along meridians in the treatment of Calcaneodynia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

体外冲击波循经取穴治疗跟痛症的随机对照研究

Scientific title：

A randomized controlled study of extracorporeal shock wave acupoint selection along meridians in the treatment of Calcaneodynia

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：

HLQ202409

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：

陈波平

研究负责人：

陈波平

Applicant：

Chen Boping

Study leader：

Chen Boping

申请注册联系人电话：

Applicant telephone：

+86 193 1023 9514

研究负责人电话：

Study leader's telephone：

+86 193 1023 9514

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：

1392310071@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1392310071@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：

上海市黄浦区复兴中路528号

研究负责人通讯地址：

上海市黄浦区复兴中路528号

Applicant address：

No.528 Fuxing Middle Road Huangpu District Shanghai

Study leader's address：

No.528 Fuxing Middle Road Huangpu District Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200020

研究负责人邮政编码：

Study leader's postcode：

200020

申请人所在单位：

上海市黄浦区香山中医医院

Applicant's institution：

Shanghai Huangpu District Xiangshan Hospital of Traditional Chinese Medicine

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：

XSE2025006

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：

上海市黄浦区香山中医医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee Xiangshan Hospital of Traditional Chinese Medicine Huangpu District Shanghai

伦理委员会批准日期：

Date of approved by ethic committee：

2025/1/22 0:00:00

伦理委员会联系人：

郁敏杰

Contact Name of the ethic committee：

Yu Minjie

伦理委员会联系地址：

上海市黄浦区复兴中路528号

Contact Address of the ethic committee：

No.528 Fuxing Middle Road Huangpu District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 5306 1730

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1392310071@qq.com

研究实施负责（组长）单位：

上海市黄浦区香山中医医院

Primary sponsor：

Shanghai Huangpu District Xiangshan Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市黄浦区复兴中路528号

Primary sponsor's address：

No.528 Fuxing Middle Road Huangpu District Shanghai

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

市(区县)：

黄浦区

Country：

China

Province：

Shanghai Municipality

City：

Huangpu District

单位(医院)：

上海市黄浦区香山中医医院

具体地址：

上海市黄浦区复兴中路528号

Institution
hospital：

Shanghai Huangpu District Xiangshan Hospital of Traditional Chinese Medicine

Address：

No.528 Fuxing Middle Road Huangpu District Shanghai

经费或物资来源：

区卫健委+本单位

Source(s) of funding：

District Health Commission + this unit

研究疾病：

跟痛症

研究疾病代码：

Target disease：

calcaneodynia

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：

其它

Others

研究目的：

探究冲击波循经取穴治疗跟痛症的疗效，以期形成一套疗效及安全性优良、可操作性及实用性强、经济和社会效益高的适宜技术并推广应用。

Objectives of Study：

To explore the therapeutic effect of shock wave meridian acupoint selection in the treatment of calcaneal pain in order to form a set of suitable techniques with good efficacy and safety strong operability and practicability and high economic and social benefits and promote its application.

药物成份或治疗方案详述：

治疗方法 1)对照组对患者足底跖筋膜痛区进行常规冲击波治疗。冲击波治疗方法：采用瑞士制造的体外冲击波治疗仪（STORZ MASTERPULS MP100 )治疗，所有患者取俯卧位，患足呈屈曲位固定，瞄准器瞄准跖筋膜痛区。冲击频率为10Hz,治疗探头直径为15mm，对照组予跖筋膜痛区冲击2000次，２次／周，２周为一个疗程。 2）试验组对患者足底跖筋膜痛区进行常规冲击波治疗，并对同侧循经取穴进行冲击波治疗。试验组予跖筋膜疼痛区冲击400次，每个穴位（涌泉穴、太溪穴、承山穴、合阳穴，标记治疗点）冲击400次， 两组均总冲击2000次。全程由同一医生操作。２次/周，２周为一个疗程。同时在入组时，均由接诊医生告知患者跟痛症患者注意事项，包括：避免负重及长时间行走，穿软底运动鞋。

Description for medicine or protocol of treatment in detail：

Treatment method 1) The control group received conventional shock wave therapy for the pain area of plantar fascia. Shockwave therapy: The Swiss-made extracorporeal shockwave therapy apparatus (STORZ MASTERPULS MP100) was used to treat all patients in prone position the affected foot was fixed in flexion position and the sight was aimed at the plantar fascia pain area. The impact frequency was 10Hz the diameter of the treatment probe was 15mm and the control group was impacted by the plantar fascia pain area 2000 times twice a week and 2 weeks was a course of treatment. 2) In the experimental group conventional shock wave therapy was performed on the pain area of plantar fascia of the patient and shock wave therapy was performed on the ipsilateral meridian point selection. In the experimental group the pain area of plantar fascia was impacted 400 times and each acupoint (Yongquan point Taixi point Chengshan point Heyang point marked treatment point) was impacted 400 times. Both groups had a total of 2000 shocks. Same doctor all the way. 2 times/week 2 weeks for one course. At the same time at the time of enrollment patients were informed by the attending doctors about the precautions for patients with pain including: avoid bearing weight and walking for a long time and wear soft-soled sports shoes.

纳入标准：

①符合跟痛症中医诊断标准，并符合足底筋膜炎西医诊断标准；②年龄18-70周岁；③病程大＞1月；④签署知情同意书，同意接受治疗并配合随访者。

Inclusion criteria

① Meet the TCM diagnostic criteria for calcaneal pain and meet the Western diagnostic criteria for plantar fasciitis; ② Age 18-70 years old; ③ The duration of the disease was > 1 month; ④ Sign informed consent agree to receive treatment and cooperate with the interviewer.

排除标准：

①出血性疾病，凝血功能障碍可能引起局部组织出血患者，未治疗、未治愈或不能治愈的出血性疾病；②局部皮肤破损、局部或全身有炎症或感染病灶，并可能并发关节感染等患者；③合并急性外伤所导致的足踝部损伤如肌肉、肌腱断裂、骨折等；④下肢血管疾病：下肢动脉硬化和深静脉血栓；⑤合并心、脑血管严重原发性疾病；⑥痛风性关节炎；⑦跟骨骨髓炎、跟骨结核、跟骨肿瘤、跟骨骨质疏松；⑧精神病患者；⑨妊娠患者。

Exclusion criteria：

Hemorrhagic diseases patients with coagulation dysfunction that may cause local tissue bleeding untreated untreated or incurable hemorrhagic diseases; ② Patients with local skin damage local or systemic inflammation or infection and possibly joint infection; (3) Foot and ankle injuries caused by acute trauma such as muscle tendon fracture fracture etc.; (4) Lower extremity vascular diseases: lower extremity arteriosclerosis and deep vein thrombosis; ⑤ Serious primary diseases of heart and cerebrovascular; ⑥ Gouty arthritis; ⑦ Calcaneal osteomyelitis calcaneal tuberculosis calcaneal tumor calcaneal osteoporosis; ⑧ Mental patients ⑨ Pregnant patients.

研究实施时间：

Study execute time：

从From 2024-12-01

至To      2027-11-30

征募观察对象时间：

Recruiting time：

从From 2025-04-01

至To      2026-03-31

干预措施：

Interventions：

组别：

试验组

样本量：

41

Group：

Experimental group

Sample size：

干预措施：

对患者足底跖筋膜痛区进行常规冲击波治疗，并对同侧循经取穴进行冲击波治疗。试验组予跖筋膜疼痛区冲击400次，每个穴位（涌泉穴、太溪穴、承山穴、合阳穴，标记治疗点）冲击400次。

干预措施代码：

2

Intervention：

The pain area of plantar fascia of the patient was treated by conventional shock wave therapy and the point selection of ipsilateral channel was treated by shock wave therapy. In the experimental group the pain area of plantar fascia was impacted 400 times and each acupoint (Yongquan point Taixi point Chengshan point Heyang point marked treatment point) was impacted 400 times.

Intervention code：

组别：

对照组

样本量：

41

Group：

Control group

Sample size：

干预措施：

对患者患足足底跖筋膜痛区进行常规冲击波治疗2000次，２次／周，２周为一个疗程。

干预措施代码：

1

Intervention：

The patients with full plantar fascia pain were treated with conventional shock wave 2000 times, twice a week, 2 weeks as a course.

Intervention code：

样本总量 Total sample size ： 82

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

黄浦区

Country：

China

Province：

Shanghai Municipality

City：

Huangpu District

单位(医院)：

上海市黄浦区香山中医医院

单位级别：

二级

Institution/hospital：

Shanghai Huangpu District Xiangshan Hospital of Traditional Chinese Medicine

Level of the institution：

Second level

测量指标：

Outcomes：

指标中文名：

AOFAS踝-后足评分

指标类型：

次要指标

Outcome：

AOFAS ankle-hind foot score

Type：

Secondary indicator

测量时间点：

治疗前、1周后（第2次治疗后）、2周后（第4次治疗后）、6周后（治疗结束后1月）、14周后（治疗结束后3月）

测量方法：

AOFAS踝-后足评分量表

Measure time point of outcome：

Before treatment 1 week after treatment (after the second treatment) 2 weeks after treatment (after the fourth treatment) 6 weeks after treatment (1 month after treatment) 14 weeks after treatment (3 months after treatment)

Measure method：

AOFAS ankle-hind foot score rating scale

指标中文名：

疼痛视觉模拟评分

指标类型：

主要指标

Outcome：

Visual analogue pain score

Type：

Primary indicator

测量时间点：

治疗前、1周后（第2次治疗后）、2周后（第4次治疗后）、6周后（治疗结束后1月）、14周后（治疗结束后3月）

测量方法：

VAS评分量表

Measure time point of outcome：

Before treatment 1 week after treatment (after the second treatment) 2 weeks after treatment (after the fourth treatment) 6 weeks after treatment (1 month after treatment) 14 weeks after treatment (3 months after treatment)

Measure method：

VAS rating scale

指标中文名：

SF-36健康调查简表评分系统

指标类型：

次要指标

Outcome：

SF-36 Health Survey Summary Form scoring system

Type：

Secondary indicator

测量时间点：

治疗前、1周后（第2次治疗后）、2周后（第4次治疗后）、6周后（治疗结束后1月）、14周后（治疗结束后3月）

测量方法：

SF-36健康调查简表评分量表

Measure time point of outcome：

Before treatment 1 week after treatment (after the second treatment) 2 weeks after treatment (after the fourth treatment) 6 weeks after treatment (1 month after treatment) 14 weeks after treatment (3 months after treatment)

Measure method：

SF-36 Health Survey Summary Scale

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 70 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）：

将纳入的受试者按照入组先后顺序排序，排序编号为01~82。再由一位独立的研究人员使用SPSS24.0统计软件进行随机分组。

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

The included subjects were sorted in the order of enrollment with the sorting numbers ranging from 01 to 82. Then an independent researcher randomly grouped them using SPSS24.0 statistical software.

盲法：

单盲（对受试者隐藏分组)，对评估者隐藏分组

Blinding：

Single-blind (hidden grouping for subjects) hidden grouping for evaluators

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）：

经过合理的申请，符合科研需求，经过课题负责人同意，可以获取本课题原始数据。

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

After a reasonable application, in line with the needs of scientific research, through the consent of the subject leader, the original data of the subject can be obtained.

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：使用病例记录表记录受试者入组后的数据。 数据管理：对纳入研究的所有跟痛症患者录入数据库，临床实施过程进行动态管理，强化对临床病例资料的分析、总结。 统计处理：数据描述：计数资料采用构成比描述，计量资料采用均数±标准差描述，非正态分布资料采用中位数、百分位数描述。②疗效组间比较采用全分析集（Full analysis set, FAS），尽可能按意向性治疗(intention to treatment,ITT)分析原则。计数资料两组比较采用卡方检验；正态分布的计量资料采用成组t检验；非正态分布的计量资料采用非参数检验。 统计分析数据集的定义与选择 ①全分析数据集（full analysis set，FAS):包括所有随机入组、至少治疗一次、并至少有一次访视记录的全部受试者，用全分析数据集进行意向性分析（Intention-to-treat，ITT）。 ②符合方案数据分析（Per-Protocol populations，PPS）：包括遵守试验方案、基线资料没有缺失、主要结局可以测定、没有对试验方案有重大违反的全部受试者。 ③数据集的选择：本试验的疗效评价，同时采用FAS 分析和PPS 分析

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

Data collection: The data after enrollment were recorded using the medical record form. Data management: All patients with calcanardynia included in the study were recorded into the database the clinical implementation process was dynamically managed and the analysis and summary of clinical case data were strengthened. Statistical processing: Data description: Counting data was described by composition ratio measurement data was described by mean ± standard deviation and non-normal distribution data was described by median and percentile. (2) The Full analysis set (FAS) was used to compare the efficacy between groups and the intention to treatment (ITT) analysis principle was adopted as far as possible. Chi-square test was used to compare the two groups of counting data. The measurement data of normal distribution were tested by group t test. The measurement data with non-normal distribution were tested by non-parametric test. Definition and selection of statistical analysis data sets ① full analysis set (FAS): Including all subjects who were randomly enrolled treated at least once and had at least one visit record Intention-to-treat (ITT) was performed with the full analysis data set. (2) Per-Protocol populations (PPS) : including all subjects who comply with the test protocol have no missing baseline data can determine the main outcome and have no major violations of the test protocol. ③ Selection of data sets: FAS analysis and PPS analysis were used to evaluate the efficacy of this trial

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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