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Efficacy and safety of acupuncture point embedding treatment for pain caused by isolated distal deep vein thrombosis: a randomized controlled trial

注册号：

Registration number：

ITMCTR2025000672

最近更新日期：

Date of Last Refreshed on：

2025-04-07

注册时间：

Date of Registration：

2025-04-07

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

穴位埋针治疗孤立性远端深静脉血栓疼痛的疗效和安全性的随机、对照临床研究

Public title：

Efficacy and safety of acupuncture point embedding treatment for pain caused by isolated distal deep vein thrombosis: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

穴位埋针治疗孤立性远端深静脉血栓疼痛的疗效和安全性的随机、对照临床研究

Scientific title：

A randomized controlled clinical study on the efficacy and safety of acupoint embedding in the treatment of isolated distal deep vein thrombosis pain

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：

殷丹丹

研究负责人：

殷丹丹

Applicant：

Dandan-Yin

Study leader：

Dandan-Yin

申请注册联系人电话：

Applicant telephone：

18621554841

研究负责人电话：

Study leader's telephone：

18621554841

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：

859204332@qq.com

研究负责人电子邮件：

Study leader's E-mail：

859204332@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：

上海市浦东新区张衡路528号

研究负责人通讯地址：

上海市浦东新区张衡路528号

Applicant address：

No. 528 Zhangheng Road Pudong New Area Shanghai

Study leader's address：

No. 528 Zhangheng Road Pudong New Area Shanghai

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：

上海中医药大学附属曙光医院

Applicant's institution：

Shuguang Hospital Affiliated to Shanghai University 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：

2024-1534-117

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：

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/5/29 0:00:00

伦理委员会联系人：

耿希

Contact Name of the ethic committee：

Xi Geng

伦理委员会联系地址：

上海中医药大学附属曙光医院东院科教楼215

Contact Address of the ethic committee：

215 Science and Education Building Shuguang Hospital Shanghai University of Traditional Chinese Medicine

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-20256070

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sgyyllwyh@126.com

研究实施负责（组长）单位：

上海中医药大学附属曙光医院

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市浦东新区张衡路528号

Primary sponsor's address：

No. 528 Zhangheng Road Pudong New Area 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)：

浦东新区

Country：

China

Province：

Shanghai

City：

Pudong New Area

单位(医院)：

上海中医药大学附属曙光医院

具体地址：

上海市浦东新区张衡路528号

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No. 528 Zhangheng Road Pudong New Area Shanghai

经费或物资来源：

曙光医院四明基金

Source(s) of funding：

Shuguang Hospital Siming Fund

研究疾病：

孤立性远端深静脉血栓

研究疾病代码：

Target disease：

Isolated distal deep vein thrombosis.

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：

研究穴位埋针治疗孤立性远端深静脉血栓疼痛的疗效和安全性,明确其临床意义，为临床中更好的运用穴位埋针治疗孤立性远端深静脉血栓疼痛提供理论依据。

Objectives of Study：

To study the efficacy and safety of acupoint embedding in the treatment of isolated distal deep vein thrombosis pain clarify its clinical significance and provide a theoretical basis for better clinical use of acupoint embedding in the treatment of isolated distal deep vein thrombosis pain.

药物成份或治疗方案详述：

通过中医穴位埋针技术，给予孤立性远端深静脉血栓疼痛护理干预，观察患者疼痛的变化、疗效和安全性，探讨穴位埋针技术对孤立性远端深静脉血栓疼痛患者的影响，确定有改善疼痛症状的作用。选取110名受试者并随机分为两组，试验组（穴位埋针治疗组）运用抗凝治疗联合穴位埋针治疗，对照组运用抗凝治疗联合安慰针治疗。其中抗凝治疗干预6周，穴位埋针治疗干预1周，观察两组治疗前后测量数值评分量表(numeric rating scales，NRS)评价患者疼痛情况，观察并比较治疗1周，2周，6周后两组各自NRS 较基线的变化值，治疗结束后进行6周随访，重点比较6周治疗结束后6周随访期内疼痛症状复发率。研究中将同时观察并比较两组包括生命体征、体格检查及不良事件在内的安全性指标。

Description for medicine or protocol of treatment in detail：

The nursing intervention of isolated distal deep vein thrombosis pain was given by acupoint acupuncture embedding technology of traditional Chinese medicine and the changes efficacy and safety of patients' pain were observed. The influence of acupoint acupuncture embedding technology on patients with isolated distal deep vein thrombosis pain was discussed and the effect of improving pain symptoms was confirmed. A total of 110 subjects were selected and randomly divided into two groups: the experimental group (acupoint acupuncture treatment group) was treated with anticoagulation therapy combined with acupoint acupuncture treatment and the control group was treated with anticoagulation therapy combined with comfort acupuncture treatment. The patients' pain was evaluated by numeric rating scales (NRS) before and after treatment of the two groups. The changes of NRS in the two groups compared with the baseline after 1 2 and 6 weeks of treatment were observed and compared. A 6-week follow-up was conducted after treatment. The recurrence rate of pain symptoms during the 6-week follow-up period after the 6-week treatment was compared. Safety measures including vital signs physical examinations and adverse events will be observed and compared between the two groups.

纳入标准：

(1)18至65岁，男女均可； (2)符合急性孤立性远端深静脉血栓诊断标准（首发、2周内、有小腿疼痛肿胀症状、彩超明确）； (3)受试者自愿加入本研究，并签署书面知情同意书。

Inclusion criteria

(1) Both men and women aged 18 to 65 years; (2) Meet the diagnostic criteria for acute isolated distal deep vein thrombosis (first episode within 2 weeks symptoms of calf pain and swelling clear color ultrasound); (3) Subjects voluntarily join the study and sign a written informed consent.

排除标准：

(1)患者存在任何情况的抗凝禁忌； (2)患者处于怀孕及哺乳期； (3)患者存在血小板计数<100×10⁹/L； (4)肾功能异常； (5)与凝血功能障碍和高出血风险相关的肝功能异常； (6)存在利伐沙班使用禁忌症； (7)临床怀疑或确诊PE； (8)同侧或对侧存在近端深静脉血栓； (9)存在需要长期抗凝治疗的疾病； (10)精神疾病患者； (11)预期寿命＜6个月； (12)筛选检查前3个月内曾参加过其他临床试验的患者； (13)因其它原因研究者认为不适宜参加本试验的患者。

Exclusion criteria：

(1) The patient has any anticoagulation contraindications; (2) The patient is pregnant and lactating; (3) Platelet count <100×10⁹/L; (4) Abnormal renal function; (5) Abnormal liver function associated with coagulopathy and higher blood risk; (6) There are contraindications to rivaroxaban use; (7) Clinically suspected or confirmed PE; (8) The presence of proximal deep vein thrombosis on the same or opposite side; (9) There are diseases requiring long-term anticoagulant therapy; (10) Patients with mental illness; (11) Life expectancy < 6 months; (12) Patients who had participated in other clinical trials within 3 months prior to screening; (13) Patients who were not considered suitable to participate in the study for other reasons.

研究实施时间：

Study execute time：

从From 2023-09-01

至To      2025-08-31

征募观察对象时间：

Recruiting time：

从From 2024-07-30

至To      2025-07-29

干预措施：

Interventions：

组别：

干预组

样本量：

55

Group：

Intervention group

Sample size：

干预措施：

拜瑞妥（利伐沙班片）+穴位埋针（揿针）取合谷、内关、足三里穴

干预措施代码：

Intervention：

① Anticoagulant treatment: barital (rivaroxaban tablet); ② Acupoint burying needle (press needle) take Hegu Neiguan and Zusanli points

Intervention code：

组别：

对照组

样本量：

55

Group：

Control group

Sample size：

干预措施：

拜瑞妥（利伐沙班片）+安慰针

干预措施代码：

Intervention：

① Anticoagulant treatment: barital (rivaroxaban tablet); ② Comfort needle

Intervention code：

样本总量 Total sample size ： 110

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)：

浦东新区

Country：

China

Province：

Shanghai

City：

Pudong New Area

单位(医院)：

上海中医药大学附属曙光医院

单位级别：

三级甲等

Institution/hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Class III Class A

测量指标：

Outcomes：

指标中文名：

治疗后1周疼痛症状改善情况

指标类型：

主要指标

Outcome：

Pain symptoms improved 1 week after treatment

Type：

Primary indicator

测量时间点：

基线、干预后1周

测量方法：

数值评分量表

Measure time point of outcome：

Baseline, 1week after intervention

Measure method：

Numeric rating scales，NRS

指标中文名：

治疗后2周，6周疼痛症状改善情况

指标类型：

次要指标

Outcome：

Pain symptoms improved at 2 weeks and 6 weeks after treatment

Type：

Secondary indicator

测量时间点：

干预后2周、干预后6周

测量方法：

纸质问卷

Measure time point of outcome：

2 weeks after intervention and 6 weeks after intervention

Measure method：

Paper questionnaire

指标中文名：

6周随访期内疼痛症状复发率

指标类型：

次要指标

Outcome：

Recurrence rate of pain symptoms during the 6-week follow-up period

Type：

Secondary indicator

测量时间点：

干预后6周

测量方法：

纸质问卷

Measure time point of outcome：

6 weeks after intervention

Measure method：

Paper questionnaire

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

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

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 65 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）：

采用区组随机化方法，运用SAS统计软件，生成随机数字分组表，将受试者按1:1的比例随机分配到试验组和对照组。

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

The block randomization method was used to generate a random number grouping table by using SAS statistical software and the subjects were randomly assigned to the experimental group and the control group at a ratio of 1:1.

盲法：

实施者不设盲，以确保穴位埋针治疗的规范实施和细节记录。然而，为减少对结果的偏倚，受试者采用盲法，使参与者在治疗过程中不知道自己接受的是干预还是对照治疗，这样可以避免对疗效的主观影响。此外，结果评估者也是盲法设计，评估患者疼痛和其他指标时不知情。此举确保了评估过程的客观性，避免了主观偏见对结果的影响。

Blinding：

The implementer is not blind to ensure the standard implementation and detail recording of acupoint embedding therapy. However to reduce bias in the results subjects were blinded so that participants did not know during treatment whether they were receiving intervention or control treatment thus avoiding subjective influence on efficacy. In addition the outcome evaluators were also designed blind unaware of the patient's pain and other indicators. This ensures the objectivity of the evaluation process and avoids the impact of subjective bias on the results.

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）：

无

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

None

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：

在本研究中，我们将采取系统化的数据采集和管理方式，确保数据的准确性和完整性。数据采集和管理主要由两个部分构成：病例记录表（Case Record Form, CRF）和电子采集和管理系统（Electronic Data Capture, EDC）。首先，病例记录表将用于详细记录每位参试者的基本信息、治疗过程及相关评估指标。CRF将采用标准化的格式，确保每个数据项的定义清晰，以便于临床工作人员填写和审核。这一过程结合了定量和定性的评价指标，确保全面反映参试者在个体怀旧疗法干预下的认知功能及抑郁情绪变化此外，所有数据将严格遵循数据隐私和卫生伦理的相关规定，保障参试者的个人信息安全。通过这两部分的有效结合，我们将实现高效、可靠的数据采集和管理，为最终的研究分析提供坚实的数据基础。

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

In this study we will adopt systematic data collection and management methods to ensure the accuracy and integrity of data. Data acquisition and management consists of two main parts: Case Record Form (CRF) and Electronic Data Capture (EDC). First of all the case record form will be used to record in detail the basic information of each participant the treatment process and related evaluation indicators. The CRF will adopt a standardized format to ensure that each data item is clearly defined for clinical staff to fill in and review. This process combines quantitative and qualitative evaluation indicators to ensure that the cognitive function and depressive mood changes of participants under the intervention of individual nostalgia therapy are fully reflected. In addition all data will strictly follow the relevant provisions of data privacy and health ethics to ensure the security of participants' personal information. Through the effective combination of these two parts we will achieve efficient and reliable data collection and management and provide a solid data foundation for the final research and analysis.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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