ChiCTR2600124978 版本V1.0 版本创建时间2026/05/20 09:27:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600124978 

最近更新日期：

Date of Last Refreshed on：

 2026-05-20 09:27:01 

注册时间：

Date of Registration：

 2026-05-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

重复经颅磁刺激联合经皮神经电刺激对慢性非特异性腰痛的疗效与机制研究

Public title：

A Study on the Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation Combined with Transcutaneous Electrical Nerve Stimulation in the Treatment of Chronic Nonspecific Low Back Pain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

重复经颅磁刺激联合经皮神经电刺激对慢性非特异性腰痛的疗效与机制研究

Scientific title：

A Study on the Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation Combined with Transcutaneous Electrical Nerve Stimulation in the Treatment of Chronic Nonspecific Low Back Pain

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：

黄鹏 

研究负责人：

赵浩然 

Applicant：

Huang Peng 

Study leader：

Zhao Haoran 

申请注册联系人电话：

Applicant telephone：

 +86 138 0013 8000

研究负责人电话：

Study leader's
telephone：

+86 188 4723 2965

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：

 huangp@bsu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 1791910956@qq.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：

中国北京市海淀区信息路48号

研究负责人通讯地址：

中国北京市海淀区信息路48号

Applicant address：

48 Information Road, Haidian District, Beijing, China

Study leader's address：

48 Information Road, Haidian District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

 100091

研究负责人邮政编码：

Study leader's postcode：

 100091

申请人所在单位：

北京体育大学

Applicant's institution：

Beijing Sport University

研究负责人所在单位：

北京体育大学

Affiliation of the Leader：

Beijing Sport University

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：

 2026186H

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：

北京体育大学运动科学实验伦理委员会

Name of the ethic committee：

Sports Science Experiment Ethics Committee of Beijing Sports University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-11 00:00:00

伦理委员会联系人：

梅涛

Contact Name of the ethic committee：

Mei Tao

伦理委员会联系地址：

中国北京市海淀区信息路48号

Contact Address of the ethic committee：

48 Information Road, Haidian District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 62989306

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：

北京体育大学

Primary sponsor：

Beijing Sport University

研究实施负责（组长）单位地址：

中国北京市海淀区信息路48号

Primary sponsor's address：

48 Information Road, Haidian District, Beijing, China

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)：

北京体育大学

具体地址：

中国北京市海淀区信息路48号

Institution
hospital：

Beijing Sport University

Address：

48 Information Road, Haidian District, Beijing, China

经费或物资来源：

北京体育大学运动医学与康复学院科研经费

Source(s) of funding：

Research fund of School of Sports Medicine and Rehabilitation, Beijing Sport University

研究疾病：

慢性非特异性腰痛  

Target disease：

Chronic nonspecific low back pain

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：

本研究旨在评价重复经颅磁刺激（rTMS）联合经皮神经电刺激（TENS）治疗慢性非特异性腰痛患者的临床疗效与安全性，明确联合干预方案的优势，为该康复治疗策略的临床应用提供循证依据。  

Objectives of Study：

This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) combined with transcutaneous electrical nerve stimulation (TENS) in patients with chronic nonspecific low back pain, clarify the advantages of the combined intervention regimen, and provide evidence-based support for the clinical application of this rehabilitation strategy.

药物成份或治疗方案详述：

本研究为随机对照试验，所有受试者均接受统一的慢性腰痛健康宣教，再按分组接受不同的刺激干预，干预总周期为 4 周，每周干预 5 次，每次总时长约 40-55 分钟（含宣教与刺激操作）。具体方案如下： 一、共同干预（所有 4 组受试者均接受，内容与频次完全一致） 慢性腰痛健康宣教： 实施安排：入组基线评估时开展首次宣教，干预期间每周进行 1 次强化宣教（共 4 次），干预结束时进行随访指导，每次宣教时长 10-15 分钟。 宣教内容：① 慢性非特异性腰痛的疾病认知与科学管理原则；② 日常姿势矫正（坐、站、卧姿规范，避免久坐久站、弯腰负重）；③ 居家腰背肌功能训练指导（核心激活、脊柱牵伸练习，每日 1-2 次，每次 10 分钟）；④ 疼痛自我管理方法（热敷、肌肉放松技巧，避免不当用力）；⑤ 生活方式调整建议（体重管理、规律作息、避免久坐）。 实施方式：采用统一编写的《慢性腰痛健康宣教手册》，由经过培训的康复治疗师一对一讲解，确保所有受试者掌握核心内容；宣教内容、频次与实施人员在四组间完全一致，排除非特异性干预对疗效的影响。 二、分组刺激干预（4 组不同方案，双盲设计下受试者与评估者均不知情分组） 联合干预组（rTMS+TENS 真实刺激） rTMS 干预：采用经颅磁刺激仪，干预前测定受试者左侧初级运动皮层（M1 区）的静息运动阈值（RMT），设置参数为 10Hz、80% RMT 强度，刺激部位为左侧 M1 区，每次干预 20 分钟。 TENS 干预：采用经皮神经电刺激仪，将电极片贴于双侧 L3-L4 节段竖脊肌，设置参数为 100Hz 电流，强度为受试者可耐受的最大舒适电流，每次干预 20 分钟。 rTMS 单一组（真实 rTMS + 假 TENS） rTMS 干预：参数、操作流程与联合干预组完全一致，每次 20 分钟。 假 TENS 干预：电极片贴放位置、仪器界面设置与真实 TENS 完全相同，但仪器无电流输出，仅维持开机状态，受试者无电刺激体感反馈，每次 20 分钟。 TENS 单一组（假 rTMS + 真实 TENS） 假 rTMS 干预：将磁刺激仪线圈翻转，仅保留与真实刺激一致的声音、震动反馈，无有效磁场输出，仪器界面设置与真实 rTMS 完全相同，每次 20 分钟。 TENS 干预：参数、操作流程与联合干预组完全一致，每次 20 分钟。 假刺激对照组（假 rTMS + 假 TENS） 同时实施假 rTMS 与假 TENS 干预，仪器设置、操作流程与上述假刺激方案完全一致，无任何有效干预输出，每次总时长 40 分钟。 所有干预均由经过统一培训的康复治疗师操作，严格按照预设参数执行，确保各组干预的一致性与盲法有效性。 

Description for medicine or protocol of treatment in detail：

This study is a randomized controlled trial. All subjects receive standardized health education for chronic low back pain, followed by different stimulation interventions according to their assigned groups. The total intervention period is 4 weeks, with 5 sessions per week, and the total duration of each session is about 40-55 minutes (including health education and stimulation operation). The specific protocol is as follows: 1. Common Intervention (received by all 4 groups with identical content and frequency) Health Education for Chronic Low Back Pain: Implementation schedule: The first education is conducted at the baseline assessment, with 1 booster session per week during the intervention (4 times in total), and follow-up guidance at the end of the intervention. Each education session lasts 10-15 minutes. Education content: ① Disease cognition and scientific management principles of chronic nonspecific low back pain; ② Daily posture correction (standard sitting, standing and lying postures, avoiding prolonged sitting/standing and bending to lift heavy objects); ③ Home-based lumbar back muscle function training guidance (core activation, spinal stretching exercises, 1-2 times a day, 10 minutes each time); ④ Pain self-management methods (hot compress, muscle relaxation techniques, avoiding improper force); ⑤ Lifestyle adjustment suggestions (weight management, regular work and rest, avoiding prolonged sitting). Implementation method: Using a uniformly compiled "Chronic Low Back Pain Health Education Manual", trained rehabilitation therapists provide one-on-one explanations to ensure all subjects master the core content. The content, frequency and implementers of health education are completely consistent across the four groups to eliminate the confounding effect of non-specific interventions on efficacy. 2. Group-specific Stimulation Interventions (4 different protocols; subjects and outcome assessors are blinded to group assignment) Combined intervention group (real rTMS + real TENS) rTMS intervention: Using a repetitive transcranial magnetic stimulator, the resting motor threshold (RMT) of the left primary motor cortex (M1 area) is measured before intervention. Parameters are set to 10 Hz, 80% RMT intensity, with stimulation at the left M1 area, 20 minutes per session. TENS intervention: Using a transcutaneous electrical nerve stimulator, electrodes are attached to the bilateral erector spinae at the L3-L4 segment. Parameters are set to 100 Hz current, with intensity at the maximum comfortable current tolerable by the subject, 20 minutes per session. rTMS monotherapy group (real rTMS + sham TENS) rTMS intervention: Parameters and operation procedures are exactly the same as the combined intervention group, 20 minutes per session. Sham TENS intervention: Electrode placement and instrument interface settings are identical to real TENS, but the device has no current output and only remains powered on, with no electrical stimulation somatosensory feedback for the subject, 20 minutes per session. TENS monotherapy group (sham rTMS + real TENS) Sham rTMS intervention: The coil of the magnetic stimulator is reversed, retaining only the sound and vibration feedback consistent with real stimulation, with no effective magnetic field output. The instrument interface settings are identical to real rTMS, 20 minutes per session. TENS intervention: Parameters and operation procedures are exactly the same as the combined intervention group, 20 minutes per session. Sham stimulation control group (sham rTMS + sham TENS) Both sham rTMS and sham TENS interventions are implemented simultaneously. The instrument settings and operation procedures are identical to the above sham stimulation protocols, with no effective intervention output, and the total duration per session is 40 minutes. All interventions are performed by uniformly trained rehabilitation therapists in strict accordance with preset parameters to ensure the consistency of interventions and the effectiveness of the double-blind design. 

纳入标准：

1.符合《慢性非特异性腰痛诊断与治疗指南》诊断标准，腰痛持续时间≥12 周； 2.年龄 18~65 周岁，性别不限； 3.入组时腰痛视觉模拟评分（VAS）≥3 分； 4.能理解并签署知情同意书，自愿参与本研究并能配合完成干预及随访流程。

Inclusion criteria

1.Meet the diagnostic criteria for chronic nonspecific low back pain according to the Guidelines for the Diagnosis and Treatment of Chronic Nonspecific Low Back Pain, with low back pain lasting >=12 weeks; 2.Aged 18~65 years, regardless of gender; 3.Visual Analogue Scale (VAS) score for low back pain >=3 at enrollment; 4.Able to understand and sign the informed consent form, voluntarily participate in this study, and cooperate with the intervention and follow-up procedures.

排除标准：

1.特异性腰痛患者（如腰椎骨折、感染、肿瘤、结核、椎间盘突出伴神经根压迫症状、腰椎滑脱等）； 2.存在 rTMS 或 TENS 治疗禁忌症者：如颅内金属植入物、癫痫病史、颅内压增高、严重心脏病、心脏起搏器植入、治疗部位皮肤破损 / 感染、严重外周神经病变等； 3.近 3 个月内接受过激素、阿片类镇痛药、抗癫痫药物治疗，或参与过其他腰痛相关临床试验者； 4.妊娠、哺乳期女性，或计划在研究期间怀孕者； 5.存在认知障碍、精神疾病（如重度抑郁、精神分裂症）无法配合评估者； 6.合并严重肝肾功能不全、恶性肿瘤、严重心脑血管疾病等影响研究实施的全身性疾病； 7.有酒精或药物滥用史者。

Exclusion criteria：

1.Patients with specific low back pain (e.g., lumbar fracture, infection, tumor, tuberculosis, disc herniation with nerve root compression, lumbar spondylolisthesis, etc.); 2.Patients with contraindications to rTMS or TENS treatment: such as intracranial metal implants, history of epilepsy, increased intracranial pressure, severe heart disease, pacemaker implantation, skin damage/infection at the treatment site, severe peripheral neuropathy, etc.; 3.Patients who received hormones, opioid analgesics, or antiepileptic drugs within the past 3 months, or participated in other low back pain-related clinical trials; 4.Pregnant or lactating women, or those planning to become pregnant during the study period; 5.Patients with cognitive impairment or mental illness (such as severe depression, schizophrenia) who cannot cooperate with the assessment; 6.Patients with severe systemic diseases affecting the implementation of the study, such as severe liver and kidney dysfunction, malignant tumors, severe cardiovascular and cerebrovascular diseases; 7.Patients with a history of alcohol or drug abuse.

研究实施时间：

Study execute time：

从 From 2026-04-28 00:00:00至 To 2026-09-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-29 00:00:00 至 To 2026-06-05 00:00:00

干预措施：

Interventions：

组别：

联合干预组（rTMS+TENS）

样本量：

 18

Group：

Combined intervention group (rTMS+TENS)

Sample size：

干预措施：

健康宣教＋重复经颅磁刺激（10Hz，80% 运动阈值，左侧 M1 区，20min / 次）+ 经皮神经电刺激（100Hz，L3-L4 竖脊肌，20min / 次），每周 3 次，共 4 周

干预措施代码：

Intervention：

Repetitive transcranial magnetic stimulation (10Hz, 80% MT, left M1 area, 20min/session) + transcutaneous electrical nerve stimulation (100Hz, L3-L4 erector spinae, 20min/session), 3 times/week for 4 weeks

Intervention code：

组别：

rTMS 单一组（真实 rTMS + 假 TENS）

样本量：

 18

Group：

rTMS monotherapy group (real rTMS + sham TENS)

Sample size：

干预措施：

健康宣教＋重复经颅磁刺激（参数同上）+ 假性 TENS（无电流输出，仪器设置与真实刺激一致），每周 3 次，共 4 周

干预措施代码：

Intervention：

Repetitive transcranial magnetic stimulation (same parameters as above) + sham TENS (no current output, same instrument settings as real stimulation), 3 times/week for 4 weeks

Intervention code：

组别：

TENS 单一组（假 rTMS + 真实 TENS）

样本量：

 18

Group：

TENS monotherapy group (sham rTMS + real TENS)

Sample size：

干预措施：

健康宣教＋假性 rTMS（线圈翻转，无有效磁场输出，声音震动与真实刺激一致）+ 经皮神经电刺激（参数同上），每周 3 次，共 4 周

干预措施代码：

Intervention：

Sham rTMS (coil reversed, no effective magnetic field output, same sound and vibration as real stimulation) + transcutaneous electrical nerve stimulation (same parameters as above), 3 times/week for 4 weeks

Intervention code：

组别：

假刺激对照组（假 rTMS + 假 TENS）

样本量：

 18

Group：

Sham stimulation control group (sham rTMS + sham TENS)

Sample size：

干预措施：

健康宣教＋假性 rTMS + 假性 TENS（均无有效干预输出，仪器设置与真实刺激一致），每周 3 次，共 4 周

干预措施代码：

Intervention：

Sham rTMS + sham TENS (no effective intervention output, same instrument settings as real stimulation), 3 times/week for 4 weeks

Intervention code：

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：

Beijing

City：

单位(医院)：

 北京体育大学 

单位级别：

 大学 

Institution
hospital：

Beijing Sport University, Beijing

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

腰痛视觉模拟评分（VAS）变化值

指标类型：

主要指标

Outcome：

Change in Visual Analogue Scale (VAS) score for low back pain

Type：

Primary indicator

测量时间点：

基线、干预 2 周、干预 4 周、干预后 1 个月、3 个月

测量方法：

采用 0-10 分视觉模拟评分量表，评估受试者过去 24 小时内的腰痛程度

Measure time point of outcome：

Baseline, 2 weeks of intervention, 4 weeks of intervention, 1 month and 3 months after intervention

Measure method：

Using the 0-10 Visual Analogue Scale to assess the degree of low back pain in the past 24 hours

指标中文名：

Oswestry 功能障碍指数（ODI）变化值

指标类型：

次要指标

Outcome：

Change in Oswestry Disability Index (ODI) score

Type：

Secondary indicator

测量时间点：

基线、干预 2 周、干预 4 周、干预后 1 个月、3 个月

测量方法：

采用 Oswestry 功能障碍指数问卷，评估受试者腰痛相关日常活动功能障碍程度

Measure time point of outcome：

Baseline, 2 weeks of intervention, 4 weeks of intervention, 1 month and 3 months after intervention

Measure method：

Using the Oswestry Disability Index questionnaire to assess the degree of low back pain-related functional impairment in daily activities

指标中文名：

双侧 L3-L4 竖脊肌压力痛阈（PPT）

指标类型：

次要指标

Outcome：

Pressure Pain Threshold (PPT) of bilateral L3-L4 erector spinae

Type：

Secondary indicator

测量时间点：

基线、干预 4 周

测量方法：

采用压力测痛仪，按标准化流程测量双侧 L3-L4 竖脊肌的压力痛阈

Measure time point of outcome：

Baseline, 2 weeks of intervention, 4 weeks of intervention, 1 month and 3 months after intervention

Measure method：

Using a pressure algometer to measure the pressure pain threshold of bilateral L3-L4 erector spinae according to standardized procedures

指标中文名：

多裂肌横截面积（CSA）

指标类型：

次要指标

Outcome：

Cross-sectional Area (CSA) of multifidus muscle

Type：

Secondary indicator

测量时间点：

基线、干预 4 周

测量方法：

采用肌骨超声仪，测量受试者俯卧位时双侧 L4L5 节段多裂肌的横截面积

Measure time point of outcome：

Baseline, 2 weeks of intervention, 4 weeks of intervention, 1 month and 3 months after intervention

Measure method：

Using a musculoskeletal ultrasound device to measure the cross-sectional area of the multifidus muscle at the bilateral L4 L5 segment with the subject in the prone position

指标中文名：

竖脊肌 / 多裂肌张力肌动图（TMG）指标（Dm、Tr、Ts）

指标类型：

次要指标

Outcome：

Tensiomyography (TMG) parameters of erector spinae/multifidus muscle (Dm, Tr, Ts)

Type：

Secondary indicator

测量时间点：

基线、干预 4 周

测量方法：

采用张力肌动图（TMG）仪，在标准体位下对双侧 L3-L4 节段竖脊肌 / 多裂肌进行电刺激，记录肌肉收缩位移（Dm）、收缩时间（Tr）、张力发展时间（Ts），评估肌肉弹性与收缩功能

Measure time point of outcome：

Baseline, 4 weeks of intervention

Measure method：

Using a tensiomyography (TMG) device, electrical stimulation was applied to the bilateral L3-L4 erector spinae/multifidus muscle in a standard position. Muscle contraction displacement (Dm), contraction time (Tr), and tension development time (Ts) were recorded to assess muscle elasticity and contractile function.

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

 其它  

说明

Fate of sample：

0thers  

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 18 岁 years
最大 Max age 65 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）：

本研究采用区组随机化方法。由不参与受试者招募、评估及干预实施的第三方统计人员，使用 SPSS 26.0 统计软件生成区组随机序列，区组长度设为 4，按 1:1:1:1 的分配比例，将受试者随机分配至联合干预组、rTMS 单一组、TENS 单一组及假刺激对照组。

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

This study adopts a block randomization method. A third-party statistician not involved in subject recruitment, assessment or intervention implementation uses SPSS 26.0 to generate a block random sequence with a block length of 4. Subjects are randomly assigned to the combined intervention group, rTMS monotherapy group, TENS monotherapy group and sham stimulation control group at a ratio of 1:1:1:1.

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：

本研究采用双盲设计，即受试者和结局评估者均设盲。 受试者设盲：通过假刺激实现盲法。rTMS 假刺激采用线圈翻转的方式，仪器声音、震动反馈与真实刺激一致，但无有效磁场输出；TENS 假刺激采用无电流输出设置，界面与真实刺激完全相同，受试者无法区分分组。 结局评估者设盲：结局评估人员不参与任何干预操作，不获知受试者分组信息，仅按标准化流程在规定时间点采集数据。 干预实施者不设盲：为保证干预参数设置的准确性，由经过培训的康复治疗师实施干预，不设盲。

Blinding：

This study adopts a double-blind design, in which both subjects and outcome assessors are blinded. Subjects blinding: Blinding is achieved through sham stimulation. The rTMS sham stimulation uses a reversed coil, with the same sound and vibration feedback as real stimulation but no effective magnetic field output. The TENS sham stimulation uses a no-current output setting, with the same interface as real stimulation, so subjects cannot distinguish groups. Outcome assessors blinding: Outcome assessors do not participate in any intervention operations, do not know the subject's group information, and only collect data according to standardized procedures at specified time points. Intervention implementers are not blinded: To ensure the accuracy of intervention parameter settings, interventions are performed by trained rehabilitation therapists who are not blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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：

本研究采用标准化病例报告表（CRF）结合电子数据采集（EDC）的方式进行数据管理。 1.所有受试者数据均由经过统一培训的研究人员采集，使用纸质 CRF 记录，确保数据真实、完整、准确。 2.采用双人双录入方式，将纸质 CRF 数据录入 Excel 电子数据库，录入完成后进行交叉核对，不一致的数据需查阅原始 CRF 核实修正。 3.原始 CRF 由专人归档保存，电子数据存储于加密电脑中，每周进行一次数据备份，防止数据丢失。 4.数据修改需记录修改人、修改时间及原因，修改痕迹永久保留，研究结束后由研究负责人确认数据无误并锁定数据库。

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

This study adopts a combination of standardized Case Report Form (CRF) and Electronic Data Capture (EDC) for data management. 1.All subject data are collected by uniformly trained researchers using paper CRFs to ensure the authenticity, completeness and accuracy of the data. 2.A double-entry method is used to input paper CRF data into an Excel electronic database. Cross-checking is performed after data entry, and inconsistent data must be verified and corrected by referring to the original CRF. 3.Original CRFs are archived and stored by dedicated personnel, and electronic data are stored in an encrypted computer with weekly data backups to prevent data loss. 4.Data modifications must record the modifier, modification time and reason, and modification traces are permanently retained. After the study, the principal investigator confirms the data is correct and locks the database.

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：

  2026-05-20 09:27:01