ChiCTR2600126398 版本V1.0 版本创建时间2026/06/08 20:36:00 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：

 ChiCTR2600126398 

最近更新日期：

Date of Last Refreshed on：

 2026-06-08 20:34:53 

注册时间：

Date of Registration：

 2026-06-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

高能量激光对髋关节置换术后患者炎症水平和下肢功能的影响研究

Public title：

The effect of High-intensity laser therapy on the inflammation level and lower limb function of patients after hip joint replacement

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高能量激光对髋关节置换术后患者炎症水平和下肢功能的影响研究

Scientific title：

The effect of High-intensity laser therapy on the inflammation level and lower limb function of patients after hip joint replacement

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：

王宁 

研究负责人：

黄丽萍 

Applicant：

Wang Ning 

Study leader：

Huang Liping 

申请注册联系人电话：

Applicant telephone：

 +86 158 0153 1607

研究负责人电话：

Study leader's
telephone：

+86 133 9190 8450

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：

 wangning@plagh.cn

研究负责人电子邮件：

Study leader's E-mail：

 ping-online@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：

北京市海淀区复兴路28号中国人民解放军总医院

研究负责人通讯地址：

北京市海淀区复兴路28号中国人民解放军总医院

Applicant address：

Chinese PLA General Hospital, 28 Fuxing Road, Haidian District, Beijing, China

Study leader's address：

Chinese PLA General Hospital, 28 Fuxing Road, Haidian District, Beijing, 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：

中国人民解放军总医院康复医学科

Applicant's institution：

Department of Rehabilitation Medicine, Chinese PLA General Hospital

研究负责人所在单位：

中国人民解放军总医院康复医学科

Affiliation of the Leader：

Department of Rehabilitation Medicine, Chinese PLA General 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：

 S2025-935-02

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：

中国人民解放军总医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Chinese PLA General Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-30 00:00:00

伦理委员会联系人：

曹江

Contact Name of the ethic committee：

Cao Jang

伦理委员会联系地址：

北京市海淀区复兴路28号

Contact Address of the ethic committee：

No.28 Fuxing Road, Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6693 7166

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：

中国人民解放军总医院康复医学科

Primary sponsor：

Department of Rehabilitation Medicine, Chinese PLA General Hospital

研究实施负责（组长）单位地址：

北京市海淀区复兴路28号中国人民解放军总医院

Primary sponsor's address：

Chinese PLA General Hospital, 28 Fuxing 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)：

中国人民解放军总医院

具体地址：

北京市海淀区复兴路28号

Institution
hospital：

Chinese PLA General Hospital

Address：

Chinese PLA General Hospital, 28 Fuxing Road, Haidian District, Beijing, China

经费或物资来源：

无

Source(s) of funding：

none

研究疾病：

髋关节置换术后  

Target disease：

Post Operation of Hip Joint Replacement

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：

1. 主要目的： (1) 评估在常规康复基础上，早期应用高能量激光对髋关节置换患者术后疼痛的改善效果。 (2) 评估高能量激光对髋关节置换术后炎症标志物水平变化的影响。 (3) 评估高能量激光对髋关节置换术后髋关节功能 (活动度、行走能力、日常活动能力)恢复的影响。 2.次要目的： (1) 评估高能量激光对髋关节置换术后下肢肿胀程度的改善效果。 (2) 评估高能量激光在髋关节置换术后应用的安全性（不良事件记录）。  

Objectives of Study：

1. Primary Objectives: (1)To evaluate the effects of early application of High-Intensity Laser Therapy (HILT) on postoperative pain improvement in patients undergoing total hip arthroplasty, when used as an adjunct to conventional rehabilitation. (2)To assess the impact of HILT on the changes in the levels of postoperative inflammatory markers in patients after total hip arthroplasty. (3)To determine the efficacy of HILT in promoting the recovery of hip joint function (including range of motion, walking capacity, and activities of daily living) following total hip arthroplasty. 2. Secondary Objectives: (1)To evaluate the effect of HILT on reducing lower limb swelling after total hip arthroplasty. (2)To assess the safety of HILT application in the postoperative period of total hip arthroplasty (by recording adverse events).

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. 年龄 20-70 岁； 2. 初次行单侧全髋关节置换术（无论病因：OA，ONFH，RA等）； 3. 手术采用标准后外侧入路、骨水泥型股骨假体（单一手术方案）； 4. 术后生命体征平稳，意识清楚，能理解并配合研究； 5. 签署知情同意书。

Inclusion criteria

1.Aged between 20 and 70 years; 2.Have undergone primary, unilateral total hip arthroplasty (regardless of etiology, e.g., osteoarthritis (OA), osteonecrosis of the femoral head (ONFH), rheumatoid arthritis (RA), etc.); 3.The surgery was performed via a standard posterolateral approach using a cemented femoral prosthesis (single surgical protocol). 4.Stable vital signs and mentally clear postoperatively, able to understand and cooperate with the study procedures; 5.Willing to participate and having provided signed informed consent.

排除标准：

1. 术前长期使用大剂量阿片类药物或存在药物滥用史。 2. 对侧髋关节存在严重疼痛或功能障碍； 3. 存在未控制感染、严重血管神经病变、恶性肿瘤； 4. 严重认知功能障碍或精神疾病无法配合； 5. 存在光敏性疾病史或正在服用光敏性药物； 6. 已知对激光治疗过敏。

Exclusion criteria：

1.History of long-term preoperative use of high-dose opioids or substance abuse; 2.Presence of severe pain or dysfunction in the contralateral hip joint; 3.Presence of uncontrolled infections, severe vascular or neurological pathologies, or malignant tumors; 4.Severe cognitive impairment or psychiatric disorders that preclude cooperation; 5.History of photosensitivity diseases or current use of photosensitizing medications; 6.Known allergy to laser therapy.

研究实施时间：

Study execute time：

从 From 2026-06-08 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-08 00:00:00 至 To 2027-01-31 00:00:00

干预措施：

Interventions：

组别：

高能量激光组

样本量：

 15

Group：

High-intensity Laser group

Sample size：

干预措施：

采用经认证的医用高能量激光治疗仪（型号：SAT-G30）。由经过专业培训的物理治疗师按照以下规范操作：治疗师与患者均佩戴专用防护护目镜；治疗探头垂直于皮肤表面，保持非接触状态，并以2-3cm/s的速度移动扫描目标区域；避免直接照射眼睛、甲状腺及生殖器区域。每次治疗后记录患者的局部及全身反应。

干预措施代码：

Intervention：

The certified medical high-energy laser therapy device (model: SAT-G30) is adopted. The operation is carried out by professionally trained physical therapists in accordance with the following norms: Both the therapist and the patient wear special protective goggles. The treatment probe is perpendicular to the skin surface, remaining in a non-contact state, and moves to scan the target area at a speed of 2-3cm/s. Avoid direct exposure to the eyes, thyroid gland and genital area. Record the local and systemic reactions of the patient after each treatment.

Intervention code：

组别：

常规治疗组

样本量：

 15

Group：

Conventional Therapy Group

Sample size：

干预措施：

采用外观、声音及操作流程与高能量激光设备完全一致的医疗设备，该设备仅显示指示红光，不发射激光束。治疗师按照与高能量激光组相同的操作规程，照射相同部位、相同时长。患者同样佩戴专用防护护目镜。

干预措施代码：

Intervention：

Adopt medical equipment that is exactly the same in appearance, sound and operation process as high-energy laser equipment. This equipment only shows indicator red light and does not emit laser beams. The therapist irradiated the same areas and for the same duration in accordance with the same operating procedures as the high-energy laser group. The patient also wears special protective goggles. The standard postoperative rehabilitation protocol included the following components: Postoperative Pain Management: Analgesic medication was administered as prescribed by the physician. Prophylactic Anticoagulation Therapy: Standard anticoagulant medication was administered to prevent deep vein thrombosis. Standard Physical Therapy Program: Initiated on postoperative day 1, the program consisted of: Bedside/Bed-based adaptive exercises (e.g., breathing exercises, ankle pumps). Progressive muscle strengthening exercises (targeting the quadriceps, gluteal muscles, etc.). Range of motion training (using continuous passive motion (CPM) machines or active/active-assisted exercises). Transfer training (progressing from lying to sitting to standing). Gradual weight-bearing gait training (progressing from a walker to crutches, then to a cane as tolerated). Activities of daily living (ADL) instruction. The frequency and intensity of the training were determined by the physical therapist based on the patient's individual condition and standard hospital guidelines. High-Intensity Laser Therapy (HILT) Procedure HILT was administered by a trained physical therapist. Protective goggles were worn by both the therapist and the patient throughout the procedure. The laser probe was held perpendicular to the skin surface, maintained in a non-contact manner, and moved at a speed of 2-3 cm/s to scan the target area. Direct irradiation of the eyes, thyroid gland, and genitalia was strictly avoided. Patient responses were recorded after each treatment session. The specific HILT parameters were as follows: Week 1: Pulsed mode (pulse width: 25 ms, frequency: 20 Hz). A total of 5 sessions were administered with the following power settings: 5 W over the surgical incision area. 12 W over pain points. 10 W over the surrounding muscles. Week 2: Continuous mode. A total of 5 sessions were administered with the following power settings: 5 W over the surgical incision area. 12 W over pain points. 10 W over the surrounding muscles. Weeks 3 & 4: Continuous mode. A total of 6 sessions were administered with a power of 12 W applied around the pain points.

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 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国人民解放军总医院 

单位级别：

 三甲 

Institution
hospital：

Chinese PLA General Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视觉模拟评分

指标类型：

主要指标

Outcome：

Visual Analogue Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

红细胞沉降率

指标类型：

主要指标

Outcome：

Erythrocyte Sedimentation Rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

C-反应蛋白

指标类型：

主要指标

Outcome：

C-Reactive Protein

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

白介素-6

指标类型：

主要指标

Outcome：

IL-6

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

红外热成像检测的局部温度

指标类型：

主要指标

Outcome：

Local temperature detected by infrared thermal imaging

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

首次下地时间

指标类型：

主要指标

Outcome：

Time to First Walking

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

计时起立-行走测试

指标类型：

主要指标

Outcome：

Time Up and Go Test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Harris 髋关节评分

指标类型：

主要指标

Outcome：

Harris Hip Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

步态分析（步频、步速、对称性指数）

指标类型：

主要指标

Outcome：

Gait analysis (cadence, walking speed, symmetry index)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

超声检查显示的水肿程度

指标类型：

次要指标

Outcome：

The degree of edema shown by ultrasound examination

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肢体周径

指标类型：

次要指标

Outcome：

Limb Circumstance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

镇痛药剂量

指标类型：

次要指标

Outcome：

Analgesic Dose

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 20 岁 years
最大 Max age 70 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）：

采用计算机生成的随机序列，将符合纳入标准的患者按 1：1 比例随机分配至高能量激光组和常规治疗组。

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

Patients who meet the inclusion criteria were randomly assigned in a 1:1 ratio to either the high-energy laser group or the conventional treatment group using computer-generated random sequences.

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：

受试者、结局评估者及统计分析师处于盲态。治疗师因需操作设备而知晓分组，但须严格遵守研究方案，避免与受试者讨论治疗细节，且不参与结局评估。

Blinding：

The subjects, outcome evaluators and statistical analysts were in a blind state. Therapists are aware of the grouping due to the need to operate the equipment, but they must strictly adhere to the research protocol, avoid discussing treatment details with the subjects, and do not participate in the outcome assessment.

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)：

Do not share

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：

由研究者及时、准确、完整地根据原始资料填写。任何修改需划线，旁注修改后数据，签名并注明日期，不得涂改。 采用双人双份录入并校对以确保准确性。 表格需被妥善管理和存档。

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

Researchers should fill out based on original data promptly, accurately, and completely. Any modifications must be marked with a line, the revised data noted beside it, signed, and dated, with no alterations allowed. Double data entry and verification by two individuals are used to ensure accuracy. The forms need to be properly managed and archived.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-08 20:34:53