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Clinical Study on the Safety and Therapeutic Efficacy of Acupuncture for Post-Arthroscopic Swelling in Meniscus Injuries

注册号：

Registration number：

ITMCTR2025000679

最近更新日期：

Date of Last Refreshed on：

2025-04-08

注册时间：

Date of Registration：

2025-04-08

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

针刺改善半月板损伤关节镜术后肿胀的安全性与临床疗效观察

Public title：

Clinical Study on the Safety and Therapeutic Efficacy of Acupuncture for Post-Arthroscopic Swelling in Meniscus Injuries

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺改善半月板损伤关节镜术后肿胀的安全性与临床疗效观察

Scientific title：

Clinical Study on the Safety and Therapeutic Efficacy of Acupuncture for Post-Arthroscopic Swelling in Meniscus Injuries

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：

张竞文

研究负责人：

李璟

Applicant：

Zhang Jingwen

Study leader：

Li Jing

申请注册联系人电话：

Applicant telephone：

15390089928

研究负责人电话：

Study leader's telephone：

18930568565

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：

hanjuan1229@163.com

研究负责人电子邮件：

Study leader's E-mail：

1971921250@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：

上海市虹口区甘河路110号

研究负责人通讯地址：

上海市虹口区甘河路110号

Applicant address：

No. 110 Ganhe Road Hongkou District Shanghai

Study leader's address：

No. 110 Ganhe Road Hongkou District 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

Applicant's institution：

Shanghai University of T.C.M

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：

2025-020

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岳阳中西医结合医院伦理委员会

Name of the ethic committee：

The Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/14 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Yin Congquan

伦理委员会联系地址：

上海市虹口区甘河路110号

Contact Address of the ethic committee：

No. 110 Ganhe Road Hongkou District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-65161782-8122

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yyyyllwyh@163.com

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号

Primary sponsor's address：

No. 110 Ganhe Road Hongkou 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)：

虹口区

Country：

China

Province：

Shanghai

City：

Hongkou

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No. 110 Ganhe Road Hongkou District Shanghai

经费或物资来源：

自筹经费

Source(s) of funding：

self-financing

研究疾病：

半月板损伤

研究疾病代码：

Target disease：

Meniscus injury

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：

探究针刺改善半月板损伤关节镜术后肿胀的临床疗效和安全性。

Objectives of Study：

To explore the clinical efficacy and safety of acupuncture in alleviating swelling in the joint after arthroscopic surgery for meniscus injury.

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）符合西医诊断标准中半月板损伤III级，且符合中医病证诊断标准气滞血瘀型； （2）年龄≥45岁且≤85岁，性别不限； （3）患膝皮肤及软组织完整，为闭合性损伤，无严重复合伤及血管神经损伤； （4）拟于本院择期进行关节镜下半月板缝合术； （5）理解、同意参加本研究并签署知情同意书。

Inclusion criteria

(1) diagnosis of grade III meniscus injury according to Western diagnostic criteria with concurrent traditional Chinese medicine (TCM) diagnosis of qi stagnation and blood stasis type; (2) age between 45 and 85 years regardless of sex; (3) intact knee skin and soft tissue without severe concomitant injuries or neurovascular damage; (4) scheduled for elective arthroscopic meniscus suture surgery at our institution; (5) willingness to participate in the study with signed informed consent.

排除标准：

（1）合并其他膝关节损伤或疾病，例如先天性盘状半月板、十字韧带断裂、侧副韧带撕裂等病症； （2）合并有下肢血管或神经功能障碍； （3）合并非常严重的各个系统等基础疾病,难以耐受手术或针刺治疗的患者； （4）从事针灸相关工作或1年内接受过针刺治疗的患者； （5）参加本研究前1个月内参加过或正在参加其他临床研究者。

Exclusion criteria：

(1) Concurrent knee injuries or pathologies such as congenital discoid meniscus cruciate ligament rupture or collateral ligament tears; (2) Comorbid lower extremity neurovascular dysfunction; (3) Severe systemic comorbidities rendering patients unfit for surgery or acupuncture therapy; (4) Individuals engaged in acupuncture-related professions or having received acupuncture treatment within the past year; (5) Participation in other clinical trials within one month prior to enrollment in this study.

研究实施时间：

Study execute time：

从From 2025-04-01

至To      2026-06-30

征募观察对象时间：

Recruiting time：

从From 2025-04-30

至To      2026-04-30

干预措施：

Interventions：

组别：

试验组

样本量：

37

Group：

Experimental group

Sample size：

干预措施：

常规治疗+针刺治疗

干预措施代码：

Intervention：

Conventional treatment + acupuncture treatment

Intervention code：

组别：

对照组

样本量：

37

Group：

Control group

Sample size：

干预措施：

常规治疗+假针刺治疗

干预措施代码：

Intervention：

Conventional treatment + sham acupuncture treatment

Intervention code：

样本总量 Total sample size ： 74

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)：

虹口区

Country：

China

Province：

Shanghai

City：

Hongkou

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

单位级别：

三级甲等

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Grade A tertiary hospital

测量指标：

Outcomes：

指标中文名：

临时镇痛药的应用总量

指标类型：

次要指标

Outcome：

Total Consumption of Rescue Analgesics

Type：

Secondary indicator

测量时间点：

镇痛药使用量数据采集截止于患者术后第7天之前

测量方法：

期间临时使用帕瑞昔布钠的应用总量记录于合并用药表中。

Measure time point of outcome：

Data collection for analgesic consumption was terminated prior to postoperative day 7.

Measure method：

The cumulative dosage of parecoxib sodium administered as rescue analgesia during the treatment period was documented in the concomitant medication records.

指标中文名：

膝关节活动度

指标类型：

次要指标

Outcome：

Knee Range of Motion (ROM)

Type：

Secondary indicator

测量时间点：

在术前、术后24h、术后72h、术后第 5天测定。

测量方法：

放松平卧，暴露患膝，伸膝位为 0°。抬高患肢，固定股骨，以股骨外侧髁为轴点，小腿主动屈曲至最大角度，使用量角器测量其伸直状态及最大屈曲状态的角度，取差值。测量 3 次求平均数并取整数。

Measure time point of outcome：

Assessments were conducted preoperatively and at 24 hours 72 hours and 5 days postoperatively.

Measure method：

With the patient supine and relaxed the affected knee was exposed. Starting from 0° in full extension the femur was stabilized while the lower leg actively flexed to maximum capacity using the lateral femoral condyle as the pivot point. A goniometer measured angles at full extension and maximum flexion with the difference calculated as ROM. Three measurements were averaged and rounded to the nearest integer.

指标中文名：

疼痛视觉模拟评分

指标类型：

次要指标

Outcome：

Visual analogue scale

Type：

Secondary indicator

测量时间点：

术前、术后24h、术后72h、术后第 5天进行的VAS评分。并在术后2周进行随访

测量方法：

通过VAS评分对肩关节急性疼痛程度进行量化评分,评分从0(无痛)到10(最痛),取决于病人在数字评价量化表上所作的选择。

Measure time point of outcome：

Collected VAS scores preoperatively at 24 hours 72 hours and 5 days postoperatively with additional follow-up conducted at 2 weeks post-surgery.

Measure method：

Acute shoulder pain was quantified using the Visual Analog Scale (VAS) with scores ranging from 0 (no pain) to 10 (worst possible pain) based on patient-reported responses.

指标中文名：

Lysholm 功能评分表

指标类型：

次要指标

Outcome：

Lysholm Knee Scoring Scale

Type：

Secondary indicator

测量时间点：

在术前、术后72h、术后第 5天测定。并在术后2周进行随访。

测量方法：

最高总评分 100，跛行(5～0 分)、需要支撑物(5～0 分)、交锁(15～0 分)、关节不稳(25～0 分)、疼痛(25～0 分）、肿胀(10～0 分)、上下楼梯困难(10～0 分)、下蹲困难(5～0 分)，各项合计，评分越高，则关节功能越好。

Measure time point of outcome：

Assessments were performed preoperatively at 72 hours and 5 days postoperatively with additional follow-up at 2 weeks post-surgery.

Measure method：

The Lysholm scale (maximum score = 100) evaluated knee function across eight domains: limping (5-0 points) need for support (5-0 points) locking (15-0 points) instability (25-0 points) pain (25-0 points) swelling (10-0 points) stair-climbing difficulty (10-0 points) and squatting difficulty (5-0 points). Higher composite scores indicated better joint function

指标中文名：

膝关节肿胀程度

指标类型：

主要指标

Outcome：

Degree of knee swelling

Type：

Primary indicator

测量时间点：

在术前、术后24h、术后72h、术后第 5天的下午 16:00进行。以术后第5天的膝关节肿胀程度作为主要评价指标。

测量方法：

双侧膝关节暴露，围度测量软尺分别测量两侧膝关节髌骨上缘 4 厘米和髌骨下缘4厘米处的周长，取两者之和的平均数，患侧周长平均数减去健侧周长平均数即为患膝关节肿胀程度，3 次测量求平均值。

Measure time point of outcome：

Assessments were performed preoperatively and at 24 hours 72 hours and 5 days postoperatively (at 16:00 each day). The primary outcome measure was the knee swelling degree on postoperative day 5.

Measure method：

With bilateral knee joints exposed a flexible measuring tape was used to determine the circumference at 4 cm above and 4 cm below the patellar margin for both knees. The mean value of these two measurements was calculated for each knee. The swelling degree of the affected knee was defined as the difference between the mean circumference of the affected side and the unaffected side with the average of three measurements recorded.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

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：

尚未开始

Not yet recruiting

年龄范围：

最小 45 岁
Min age years
最大 85 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SPSS 25.0软件生成随机数字序列，将受试者按1:1比例随机分配到试验组和对照组。随机分配结果密封于不透光的信封中，信封外标注受试者的唯一编号，信封内详细记录该受试者的组别及对应的治疗方案。当符合纳入标准的受试者进入研究时，按照其入组顺序拆开对应编号的信封，获取随机分配结果并实施相应的治疗方案。

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

Using SPSS 25.0 software a random number sequence was generated to allocate participants at a 1:1 ratio into either the experimental or control group. The randomization results were sealed in opaque envelopes each labeled externally with the participant's unique identification number. Inside each envelope detailed records specified the assigned group and corresponding treatment protocol. Upon enrollment of eligible participants the sequentially numbered envelope matching their entry order was opened to reveal the randomization outcome and initiate the designated treatment regimen.

盲法：

盲法实施上，采用盲法疗效评价以及盲法统计分析，由不知分组的第三方完成，研究受试者和评估者均不知道受试者被分配到的组别实行操作者、统计者双分离。

Blinding：

A double-blind design was implemented where both efficacy evaluations and statistical analyses were conducted by an independent third party unaware of group allocations. This approach ensured blinding of both study participants and assessors to treatment assignments while maintaining separation between operators and statisticians throughout the trial.

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）：

试验完成后即时公开，采用O-Trial +网络平台公开，https://plus.o-trial.com/web/login

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

Upon study completion, results shall be immediately disclosed through the O-Trial+ web platform (https://plus.o-trial.com/web/login) in compliance with transparency requirements

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：

病例记录表和电子采集和管理系统

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

Case Record Form and Electronic Data Capture

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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