中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600124000
最近更新日期： Date of Last Refreshed on：	2026-05-06 11:01:28
注册时间： Date of Registration：	2026-05-06 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	经皮穴位电刺激对老年髋部骨折手术患者术后早期疲劳的影响：一项随机对照试验的方案
Public title：	Effects of Percutaneous Electrical Acupoint Stimulation on Early Postoperative Fatigue in Elderly Patients Undergoing Hip Fracture Surgery: A Protocol for Randomized Controlled Trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	经皮穴位电刺激对老年髋部骨折手术患者术后早期疲劳的影响：一项随机对照试验
Scientific title：	Effect of Transcutaneous Electrical Acupoint Stimulation on Early Postoperative Fatigue in Elderly Patients Undergoing Hip Fracture Surgery: A Randomized Controlled Trial
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：	程晨	研究负责人：	程晨/张南南
Applicant：	Cheng Chen	Study leader：	Cheng Chen/Zhang NanNan
申请注册联系人电话： Applicant telephone：	+86 21 3829 7544	研究负责人电话： Study leader's telephone：	+86 21 3829 7544
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：	chet_0323@163.com	研究负责人电子邮件： Study leader's E-mail：	chet_0323@163.com
申请单位网址(自愿提供)： Applicant 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：	上海市徐汇区宜山路600号	研究负责人通讯地址：	上海市徐汇区宜山路600号
Applicant address：	600 Yishan Road,Xuhui District,Shanghai	Study leader's address：	600 Yishan Road,Xuhui 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：	上海市第六人民医院
Applicant's institution：	Shanghai Sixth People's Hospital
研究负责人所在单位：	上海市第六人民医院
Affiliation of the Leader：	Shanghai Sixth People's Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2026-045	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	上海市第六人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of Shanghai Sixth People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-12 00:00:00
伦理委员会联系人：	孙秀秀
Contact Name of the ethic committee：	Sun Xiuxiu
伦理委员会联系地址：	上海市徐汇区宜山路618号
Contact Address of the ethic committee：	618 Yishan Road,Xuhui District,Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 2405 6428	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：

上海市第六人民医院

Primary sponsor：

Shanghai Sixth People's Hospital

研究实施负责（组长）单位地址：

上海市徐汇区宜山路600号

Primary sponsor's address：

600 Yishan Road,Xuhui 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)：
Country：	China	Province：	ShangHai	City：
单位(医院)：	上海市第六人民医院	具体地址：	上海市徐汇区宜山路600号
Institution hospital：	Shanghai Sixth People's Hospital	Address：	600 Yishan Road,Xuhui District,Shanghai

经费或物资来源：

研究生课题

Source(s) of funding：

Postgraduate Research Project

研究疾病：

髋部骨折

Target disease：

hip fracture

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

验证围术期经皮穴位电刺激对老年髋部骨折患者早期术后疲劳的防治效果，为经皮穴位电刺激防治早期术后疲劳提供高质量证据

Objectives of Study：

To verify the preventive and therapeutic effect of perioperative percutaneous electrical acupoint stimulation on early postoperative fatigue in elderly patients with hip fracture, and to provide high-quality evidence for the application of percutaneous electrical acupoint stimulation in the prevention and treatment of early postoperative fatigue.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1.心功能 NYHA Ⅲ～Ⅳ 级；3个月内发生过急性心肌梗死、不稳定型心绞痛；室速、室颤等恶性心律失常；心胸比＞0.7的心脏扩大的患者 2.极重度慢性阻塞性肺疾病（FEV1.0＜30% 预计值）；重症哮喘急性发作期；静息状态下 PaO₂＜60mmHg 或 PaCO₂＞45mmHg；需长期有创 / 无创通气支持；严重间质性肺病、重度肺动脉高压。 3.慢性肾脏病（CKD）4～5期；尿毒症期（需血液透析 / 腹膜透析替代治疗）；急性肾损伤（AKI）3 期；血清肌酐＞2 倍正常上限且伴尿量＜0.5ml/（kg・h）持续 4h 以上。 4.多器官功能障碍综合征（MODS）或多器官功能衰竭（MOF）或严重甲状腺功能减退的患者。 5.长期服用抗惊厥药、抗抑郁药或其他精神药品 6.术前存在听、语言及认知障碍，难以进行有效沟通 7.术前有严重窦性心动过缓、病态窦房结综合征、二度Ⅱ型及以上房室传导阻滞，装有心脏起搏器 8.拟刺激部位局部皮肤过敏、破损或感染 9.近三个月内受试于其他临床研究 10.曾接受过经皮穴位电刺激疗法

Exclusion criteria：

1. Patients with NYHA functional class Ⅲ–Ⅳ; those who have suffered acute myocardial infarction or unstable angina within 3 months; patients with malignant arrhythmias such as ventricular tachycardia and ventricular fibrillation; and those with cardiomegaly with a cardiothoracic ratio > 0.7. 2. Patients with very severe chronic obstructive pulmonary disease (FEV1.0 < 30% of predicted value); severe asthma in acute exacerbation stage; resting PaO₂ < 60 mmHg or PaCO₂ > 45 mmHg; those requiring long-term invasive/non-invasive ventilatory support; patients with severe interstitial lung disease and severe pulmonary hypertension. 3. Patients with chronic kidney disease (CKD) stage 4–5; uremia requiring hemodialysis or peritoneal dialysis replacement therapy; acute kidney injury (AKI) stage 3; those with serum creatinine exceeding 2 times the upper limit of normal accompanied by urine output < 0.5 ml/(kg·h) for more than 4 consecutive hours. 4. Patients with multiple organ dysfunction syndrome (MODS), multiple organ failure (MOF), or severe hypothyroidism. 5. Long-term users of anticonvulsants, antidepressants or other psychotropic drugs. 6. Patients with preoperative hearing, speech or cognitive disorders who cannot achieve effective communication. 7. Patients with severe preoperative sinus bradycardia, sick sinus syndrome, second-degree type Ⅱ and above atrioventricular block, or those implanted with a cardiac pacemaker. 8. Those with local skin allergy, damage or infection at the intended stimulation site. 9. Participants enrolled in other clinical trials within the past three months. 10. Patients with previous treatment history of percutaneous transcutaneous electrical acupoint stimulation.

研究实施时间：

Study execute time：

从 From 2026-05-11 00:00:00至 To 2027-04-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-11 00:00:00 至 To 2027-04-01 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	57
Group：	Intervention Group	Sample size：	57
干预措施：	全身麻醉后，接受合谷、内关、足三里及三阴交穴位的经皮穴位电刺激直至术毕	干预措施代码：
Intervention：	Following general anesthesia, transcutaneous electrical acupoint stimulation (TEAS) was administered at Hegu (LI4), Neiguan (PC6), Zusanli (ST36) and Sanyinjiao (SP6) until the end of surgery.	Intervention code：

组别：	对照组	样本量：	57
Group：	control group	Sample size：	57
干预措施：	全身麻醉后，在合谷、内关、足三里及三阴交穴位的黏贴经皮穴位电刺激电极贴片，连接导联线，但不打开电源，直至术毕	干预措施代码：
Intervention：	Following the induction of general anesthesia, transcutaneous electrical acupoint stimulation (TEAS) electrode pads were applied to the Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Sanyinjiao (SP6) acupoints. The electrodes were connected to the lead wires, but the power supply was kept off until the conclusion of the surgery.	Intervention code：

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)：
Country：	China	Province：	ShangHai	City：
单位(医院)：	上海市第六人民医院	单位级别：	三甲
Institution hospital：	Shanghai Sixth People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	早期术后疲劳发生率	指标类型：	主要指标
Outcome：	Incidence of early postoperative fatigue	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血清白介素 - 1β	指标类型：	次要指标
Outcome：	Serum interleukin-1β	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	超敏 C 反应蛋白	指标类型：	次要指标
Outcome：	High-sensitivity C-reactive protein (hs-CRP)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血清白介素 - 6	指标类型：	次要指标
Outcome：	Serum interleukin-6	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中性粒细胞与淋巴细胞比值	指标类型：	次要指标
Outcome：	Neutrophil-to-Lymphocyte Ratio	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	术后睡眠质量	指标类型：	次要指标
Outcome：	Postoperative sleep quality score	Type：	Secondary 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：

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	60	岁 years
最大 Max age	74	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

使用SPSS 26.0软件，由一名不参与后续干预及资料收集的研究人员使用计算机简单随机法，按1:1比例生成“干预/对照”序列。

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

This study adopted a randomized controlled trial (RCT) design with a 1:1 allocation ratio. Sequence generation was performed using SPSS 26.0 software by an independent researcher not involved in subsequent interventions or data collection, employing a computer-generated simple randomization method.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	双盲设计：① 患者盲：对照组与干预组均接受中医医生评估，接受最强电流耐受强度测试，在相同穴位标记，并黏贴电极，麻醉前均目睹操作者将相近穴位电极串联至电子针疗仪主机，分组结果及干预差异在患者诱导，失去意识后体现，干预于术毕，患者清醒前结束。患者无法区分是否接受有效干预；② 结局评估者统计分析人员盲：负责主观评分量表收集的人员为病区护理人员，干预在手术室内进行，评估人员无法区分研究对象是否接受有效干预；实验室检测的人员不参与分组和干预操作，仅获取患者编号，避免评估偏倚；受试者分组信息在统计分析结束前将被替换为无意义的编码（A组与B组），统计分析人员仅接触编码后的数据，无法关联分组属性。
Blinding：	A double-blind design was implemented throughout the study: 1. Blinding of patients: Both the intervention and control groups underwent assessment by a traditional Chinese medicine practitioner, maximum current tolerance testing, identical acupoint marking, and electrode application. Before anesthesia, all patients witnessed the operator connecting electrodes at similar acupoints to the main unit of the electronic acupuncture instrument. Group-specific interventions were initiated after patients lost consciousness during anesthesia induction and completed before they regained consciousness at the end of surgery, preventing patients from distinguishing between active and control interventions. 2. Blinding of outcome assessors and statistical analysts: Subjective scale data (e.g., VAS, AIS) were collected by ward nurses who were unaware of group assignments, as interventions were performed in the operating room. Laboratory personnel responsible for detecting serum indicators (e.g., IL-1β, hs-CRP, IL-6, NLR) only received patient numbers without access to grouping information to avoid assessment bias. Prior to statistical analysis, actual group labels were replaced with meaningless codes (Group A and Group B), and statisticians analyzed only the coded data without linking them to original group assignments. The study protocol was approved by the Ethics Committee of [Please insert the name of your affiliated hospital, e.g., Shanghai Sixth People's Hospital], and written informed consent was obtained from all participants or their legal representatives before enrollment.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	不共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not shared
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：	入组时、术前及术后3天内主观评测量表数据采用床旁面对面形式收集；术前1天及术后3天内生化数据，从住院病人管理系统电子检查报告单中提取；术后第7天主观评测量表数据采用电子问卷形式进行收集。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Subjective scale data were collected via face-to-face interviews at the bedside upon enrollment, before surgery, and within 3 days after surgery. Biochemical data one day before surgery and within 3 days after surgery were extracted from electronic examination reports in the inpatient management system. Subjective scale data on the 7th day after surgery were collected using electronic questionnaires.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-05-06 11:01:21