ChiCTR2600126787 版本V1.0 版本创建时间2026/06/16 09:29:15 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：

ChiCTR2600126787 

最近更新日期：

Date of Last Refreshed on：

2026-06-16 09:29:00 

注册时间：

Date of Registration：

2026-06-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

粤西退变性腰椎疾病手术时机精准决策研究：动态队列支持的3T模型与湿热气候适应性体系构建

Public title：

Research on Precise Decision-making of Surgical Timing for Degenerative Lumbar Diseases in Western Guangdong: Construction of a 3T Model Supported by Dynamic Cohort and an Adaptability System for Hot and Humid Climate

注册题目简写：

English Acronym：

研究课题的正式科学名称：

粤西退变性腰椎疾病手术时机精准决策研究：动态队列支持的3T模型与湿热气候适应性体系构建

Scientific title：

Research on Precise Decision-making of Surgical Timing for Degenerative Lumbar Diseases in Western Guangdong: Construction of a ThreeT Model Supported by Dynamic Cohort and an Adaptability System for Hot and Humid Climate

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：

魏波 

研究负责人：

魏波 

Applicant：

Wei Bo 

Study leader：

Wei Bo 

申请注册联系人电话：

Applicant telephone：

+86 15218216290

研究负责人电话：

Study leader's telephone：

+86 759 2387291

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：

webjxmc@163.com

研究负责人电子邮件：

Study leader's E-mail：

webjxmc@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：

中国广东省湛江市霞山区人民大道南57号

研究负责人通讯地址：

中国广东省湛江市霞山区人民大道南57号

Applicant address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong, China

Study leader's address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong, China

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：

广东医科大学附属医院

Applicant's institution：

Affiliated Hospital of Guangdong Medical University

研究负责人所在单位：

广东医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Guangdong Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

PJKT2026-124

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：

广东医科大学附属医院临床科研伦理委员会

Name of the ethic committee：

Ethics Committee for Institutional Review Affiliated Hospitals of Guangdong Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-04-14 00:00:00

伦理委员会联系人：

王健丽

Contact Name of the ethic committee：

Wang Jianli

伦理委员会联系地址：

中国广东省湛江市霞山区人民大道南57号

Contact Address of the ethic committee：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 759 2386971

伦理委员会联系人邮箱：

Contact email of the ethic committee：

3221452@qq.com

研究实施负责（组长）单位：

广东医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guangdong Medical University

研究实施负责（组长）单位地址：

中国广东省湛江市霞山区人民大道南57号

Primary sponsor's address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong, 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)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广东医科大学附属医院

具体地址：

中国广东省湛江市霞山区人民大道南57号

Institution
hospital：

Affiliated Hospital of Guangdong Medical University

Address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

Lumbar disc herniation (LDH)Clinical symptoms: Presence of low back and leg pain, accompanied by radiating pain in the lower limbs (along the course of the sciatic nerve) which may be combined with numbness and weakness; Symptoms worsen with coughing, sneezing or bending over, and improve after lying down and resting;Physical examination: Positive straight leg raising test (angle <= 60°), or positi

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

1.构建适配粤西湿热气候特征的退变性腰椎疾病（DLSD）手术时机精准决策“3T模型”（Time - 症状持续时间、Tissue-影像退变程度、Test-血清炎症指标），明确该模型对术后12个月腰椎功能JOA评分改善率（>=50%为核心终点）及30天深部感染、脑脊液漏等并发症发生率的预测效能; 2.验证动态队列（根据患者症状恶化程度、影像退变进展动态调整随访频率）在提升手术时机判断准确性中的价值。  

Objectives of Study：

1. To construct a "3T model" (Time - duration of symptoms, Tissue - degree of degeneration on imaging, Test - serum inflammatory markers) for precise decision-making on the surgical timing of degenerative lumbar spine disease (DLSD) that is adapted to the hot and humid climate of western Guangdong, and to clarify the predictive efficacy of this model on the improvement rate of lumbar function JOA score at 12 months after surgery (>=50% as the core endpoint) and the incidence of complications such as deep infection and cerebrospinal fluid leakage within 30 days.2. To verify the value of a dynamic cohort (adjusting the follow-up frequency based on the degree of symptom deterioration and imaging degeneration progression of patients) in improving the accuracy of surgical timing judgment.

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. 符合腰椎间盘突出症、退行性腰椎滑脱症、腰椎管狭窄症任一诊断标准，症状持续>=3 个月，影像学检查满足对应分级要求（如 Pfirrmann>=III 级、Meyerding>=I 度）； 2. 经规范非手术治疗>=1 个月疗效欠佳，VAS 疼痛评分>=4 分或 ODI 腰椎功能评分<=20 分，或病情呈进展性改变； 3. 若行腰椎手术，手术时间为粤西雨季（6-9 月），且手术当日及术后 7 天内日均环境湿度>=80%（以官方气象数据为准）； 4. 意识清晰可配合完成全程随访及样本采集，无严重脏器功能障碍、凝血异常及活动性感染，能耐受腰椎手术（若需）； 5. 年龄 40-75 岁，长期（>=5 年）居住于粤西湛江、茂名、阳江等市，近 1 年有>=3 个月在年均湿度<60% 的非湿热地区居住史。 6. 与暴露组进行 1:1 倾向性匹配（年龄、性别、疾病类型、病程等），可配合随访及样本采集，无严重脏器功能障碍、凝血异常及活动性感染，能耐受腰椎手术者，且符合以下条件： (1) 符合腰椎间盘突出症、退行性腰椎滑脱症、腰椎管狭窄症任一诊断标准，症状持续>=3 个月，影像学检查满足对应分级要求（如 Pfirrmann>=III 级、Meyerding>=I 度）。 (2) 经规范非手术治疗>=1 个月疗效欠佳，VAS 疼痛评分>=4 分或 ODI 腰椎功能评分<=20 分，或病情呈进展性改变。 (3) 若行腰椎手术，手术时间为粤西旱季（10 月 - 次年 5 月），且手术当日及术后 7 天内日均环境湿度<80%（以官方气象数据为准）。

Inclusion criteria

1. Meet the diagnostic criteria for any one of lumbar disc herniation, degenerative lumbar spondylolisthesis, or lumbar spinal stenosis, with symptoms lasting >=3 months, and imaging findings meeting the corresponding grading requirements (e.g., Pfirrmann grade >=III, Meyerding grade >=I); 2. Poor response to standardized non-surgical treatment for >=1 month, with a VAS pain score >=4 points or an ODI lumbar function score <=20 points, or progressive disease; 3. If lumbar surgery is performed, the surgery takes place during the rainy season in Western Guangdong (June to September), and the average daily environmental humidity on the day of surgery and within 7 days postoperatively is >=80% (based on official meteorological data); 4. Clear consciousness, able to cooperate with full follow-up and sample collection, no severe organ dysfunction, coagulation abnormalities, or active infection, and able to tolerate lumbar surgery (if required); 5. Aged 40-75 years, long-term residence (>=5 years) in cities such as Zhanjiang, Maoming, and Yangjiang in Western Guangdong, with a history of residing for >=3 months in the past year in non-humid regions with annual average humidity <60%. 6. Undergo 1:1 propensity score matching with the exposure group (for age, gender, disease type, disease duration, etc.), able to cooperate with follow-up and sample collection, no severe organ dysfunction, coagulation abnormalities, or active infection, able to tolerate lumbar surgery, and meeting the following conditions: (1) Meet the diagnostic criteria for any one of lumbar disc herniation, degenerative lumbar spondylolisthesis, or lumbar spinal stenosis, with symptoms lasting >=3 months, and imaging findings meeting the corresponding grading requirements (e.g., Pfirrmann grade >=III, Meyerding grade >=I). (2) Poor response to standardized non-surgical treatment for >=1 month, with a VAS pain score >=4 points or an ODI lumbar function score <=20 points, or progressive disease. (3) If lumbar surgery is performed, the surgery takes place during the dry season in Western Guangdong (October to May of the following year), and the average daily environmental humidity on the day of surgery and within 7 days postoperatively is <80% (based on official meteorological data).

排除标准：

1.非退行性腰椎疾病患者，如腰椎结核、肿瘤、创伤性骨折、强直性脊柱炎、类风湿关节炎、先天性腰椎畸形（如脊柱侧弯 Cobb 角>=10°）。 2.既往有腰椎手术史（包括椎间盘切除术、椎管减压术、椎体融合术），或存在腰椎峡部裂、真性滑脱（Meyerding分级>=II度）； 3.合并严重神经系统疾病（如脑梗塞后遗症、脊髓损伤、周围神经病变）、精神疾病（如抑郁症、精神分裂症，MMSE量表评分＜24分），或认知功能障碍，无法准确反馈症状及配合随访； 4.近3个月内发生急性感染、严重创伤或接受过其他重大手术（如腹部手术、关节置换术），可能影响术后恢复及疗效评价； 5.对手术所用麻醉药物、内固定器械过敏，或存在未控制的基础疾病（如高血压收缩压>=180mmHg、糖尿病 HbA1c＞8%、严重骨质疏松症T值<=-2.5SD）且短期内无法改善； 6.随访期间计划离开粤西地区>=3个月，或因个人原因（如迁居、经济困难）无法保证完成24个月随访，预计数据缺失率>=30%； 7.参与其他同期DLSD相关临床研究，或近1个月内使用过可能影响炎症指标的药物（如糖皮质激素、免疫抑制剂）； 8.孕妇、哺乳期女性，或存在其他不适合参与研究的情况（如恶性肿瘤生存期＜2年）。

Exclusion criteria：

1.Patients with non-hereditary lumbar spine diseases, such as lumbar tuberculosis, tumors, traumatic fractures, ankylosing spondylitis, rheumatoid arthritis, and congenital lumbar deformities (such as spinal curvature with a Cobb angle of >=10°). 2. Has a history of previous lumbar surgery (including discectomy, spinal canal decompression, and vertebral fusion), or has a lumbar pars defect or true spondylolisthesis (Meyerding grade >= II). 3. Patients with severe neurological disorders (such as post-embolism sequelae, spinal cord injury, peripheral nerve lesion), mental disorders (such as depression, schizophrenia, with MMSE score less than 24), or cognitive dysfunction, who are unable to accurately report symptoms and cooperate with follow-up; 4. Within the past 3 months, there has been an acute infection, severe trauma, or any other major surgery (such as abdominal surgery or joint replacement surgery), which may affect postoperative recovery and the evaluation of therapeutic efficacy; 5. Allergic to the anesthetic drugs used during the surgery, or having uncontrolled underlying diseases (such as hypertension with systolic blood pressure >= 180 mmHg, diabetes with HbA1c > 8%, severe osteoporosis with T value <= -2.5SD) that cannot be improved in the short term; 6. During the follow-up period, if one plans to leave the western Guangdong region for more than 3 months, or if for personal reasons (such as moving, financial difficulties) they are unable to complete the 24-month follow-up, the expected rate of data loss is >= 30%. 7. Participated in other concurrent clinical studies related to DLSD, or used drugs that might affect inflammatory indicators within the past 1 month (such as glucocorticoids, immunosuppressants); 8. Pregnant women, lactating women, or those with other conditions that make them unsuitable for participating in the study (such as a survival period of less than 2 years for a malignant tumor).

研究实施时间：

Study execute time：

从 From 2026-04-10 00:00:00至 To 2029-04-10 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-10-10 00:00:00 至 To 2029-02-10 00:00:00  

干预措施：

Interventions：

组别：

暴露组

样本量：

261

Group：

Exposure group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

非暴露组

样本量：

261

Group：

The non-exposure group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

广东医科大学附属医院 

单位级别：

三级甲等 

Institution
hospital：

Affiliated Hospital of Guangdong Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

JOA评分

指标类型：

主要指标

Outcome：

JOA score

Type：

Primary indicator

测量时间点：

术后2周、4周、8周、16周、24周随访

测量方法：

术后JOA（日本骨科协会）评分改善率，评估腰椎功能恢复程度，JOA评分涵盖主观症状（腰腿痛、麻木）、临床体征（直腿抬高试验、肌力）、日常活动受限程度（翻身、行走），满分29分（分数越高功能越好）；改善率 =（术后 12个月JOA评分 - 术前JOA评分）/（29 - 术前JOA评分）×100%。评价标准：优：改善率>=50%（核心终点，用于验证“3T模型”预测效能）；良：改善率30%-49%；

Measure time point of outcome：

Postoperative follow-ups at 2 weeks, 4 weeks, 8 weeks, 16 weeks, and 24 weeks

Measure method：

The improvement rate of the JOA (Japanese Orthopaedic Association) score after surgery was used to assess the degree of recovery of lumbar function. The JOA score covered subjective symptoms (low back and leg pain, numbness), clinical signs (straight leg raising test, muscle strength), and the degree of limitation in daily activities (turning over, walking). The maximum score was 29 points (the higher the score, the better the function). The improvement rate = ((JOA score at 12 months after surg

指标中文名：

VAS评分

指标类型：

次要指标

Outcome：

VAS score

Type：

Secondary indicator

测量时间点：

术后2周、4周、8周、16周、24周随访

测量方法：

疼痛视觉模拟评分（Visual analog score，VAS），1-3 分为轻度疼痛。 4-6 为中度疼痛，7-10 为重度疼痛。

Measure time point of outcome：

Postoperative follow-ups at 2 weeks, 4 weeks, 8 weeks, 16 weeks, and 24 weeks

Measure method：

Pain visual analog score (VAS), a score of 1-3 indicates mild pain. 4-6 represents moderate pain, and 7-10 indicates severe pain.

指标中文名：

暴露组（手术日为 6-9 月，日均湿度>=80%） 与（手术日为 10-5 月，日均湿度＜80%）的 30 天深部手术部位感染率

指标类型：

主要指标

Outcome：

30-day deep surgical site infection rate in the exposure group (surgery performed from June to September with average daily humidity >=80%) versus the control group (surgery performed from October to May with average daily humidity <80%)

Type：

Primary 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：

无

组织：

Sample Name：

NA

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 25 岁 years
最大 Max age 90 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

本研究数据将在我院公告数据平台公开共享。

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

The data from this study will be publicly shared on our hospital's data announcement platform.

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：

按照每人每份的病例表收集病人信息，后纳入我院病人电子信息管理平台严格管理。

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

The patient information was collected based on the case form for each individual, and then was strictly managed within our hospital's electronic patient information management system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-16 09:29:00