ChiCTR2600122766 版本V1.0 版本创建时间2026/04/17 11:15:44 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：

 ChiCTR2600122766 

最近更新日期：

Date of Last Refreshed on：

 2026-04-17 11:15:25 

注册时间：

Date of Registration：

 2026-04-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

疼痛神经科学教育联合血流限制训练对膝关节置换术后慢性疼痛患者的影响：一项随机对照试验方案

Public title：

Effects of Pain Neuroscience Education Combined With Blood Flow Restriction Training on Chronic Pain After Total Knee Arthroplasty: Protocol for a Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

疼痛神经科学教育联合血流限制训练对膝关节置换术后慢性疼痛患者的影响：一项随机对照试验方案

Scientific title：

Effects of Pain Neuroscience Education Combined With Blood Flow Restriction Training on Chronic Pain After Total Knee Arthroplasty: Protocol for 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：

徐吉鹏 

研究负责人：

徐吉鹏 

Applicant：

Jipeng Xu 

Study leader：

Jipeng Xu 

申请注册联系人电话：

Applicant telephone：

 +86 188 8182 4511

研究负责人电话：

Study leader's
telephone：

+86 188 8182 4511

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：

 1036689049@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1036689049@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：

四川省成都市东部新区环湖北路1942号

研究负责人通讯地址：

四川省成都市东部新区环湖北路1942号

Applicant address：

1942 Huanhu North Road, Eastern New District, Chengdu, Sichuan Province

Study leader's address：

1942 Huanhu North Road, Eastern New District, Chengdu, Sichuan Province

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：

成都体育学院

Applicant's institution：

Chengdu Sport University

研究负责人所在单位：

成都体育学院

Affiliation of the Leader：

Chengdu 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：

 成体伦理[2026]131号

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：

成都体育学院伦理委员会

Name of the ethic committee：

Ethics Committee of the Chengdu Sport University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-08 00:00:00

伦理委员会联系人：

廖远朋

Contact Name of the ethic committee：

Yuanpeng Liao

伦理委员会联系地址：

四川省成都市东部新区环湖北路1942号

Contact Address of the ethic committee：

No. 1942, Huanhu North Road, Eastern New District, Chengdu City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 182 0287 2188

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：

成都体育学院

Primary sponsor：

Chengdu Sport University

研究实施负责（组长）单位地址：

四川省成都市东部新区环湖北路1942号

Primary sponsor's address：

1942 Huanhu North Road, Eastern New District, Chengdu, Sichuan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都体育学院

具体地址：

四川省成都市东部新区环湖北路1942号

Institution
hospital：

Chengdu Sport University

Address：

1942 Huanhu North Road, Eastern New District, Chengdu, Sichuan Province

经费或物资来源：

自筹及学院资助

Source(s) of funding：

Self-financing and college funding

研究疾病：

膝关节置换术后慢性疼痛  

Target disease：

Chronic Pain After Total Knee Arthroplasty

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：

全膝关节置换术（Total Knee Arthroplasty, TKA）是终末期膝骨关节炎的重要治疗手段。然而，仍有相当比例患者在术后长期存在慢性疼痛及功能受限，严重影响康复效果与生活质量。既往研究表明，术后慢性疼痛的发生不仅与外周组织损伤有关，还与中枢敏化、疼痛认知异常及心理因素密切相关。 疼痛神经科学教育（Pain Neuroscience Education, PNE）通过改变患者对疼痛的认知模式，有助于降低疼痛灾难化水平并改善疼痛体验；血流限制训练（Blood Flow Restriction Training, BFRT）则可在低负荷条件下促进肌肉力量恢复，适用于术后功能受限人群。然而，目前关于PNE与BFRT联合干预在TKA术后慢性疼痛患者中的应用仍缺乏高质量随机对照研究。 因此，本研究拟通过随机对照试验设计，系统评估PNE、BFRT及其联合干预对术后慢性疼痛患者的潜在影响，为该人群的综合康复策略提供研究依据。  

Objectives of Study：

Total knee arthroplasty (TKA) is a key treatment for end-stage knee osteoarthritis. However, a significant proportion of patients continue to experience chronic pain and functional limitations long after surgery, which severely impacts their recovery outcomes and quality of life. Previous studies have shown that the occurrence of postoperative chronic pain is not only associated with peripheral tissue damage but is also closely linked to central sensitization, abnormal pain perception, and psychological factors. Pain Neuroscience Education (PNE) helps reduce pain catastrophizing and improve the pain experience by altering patients’ cognitive patterns regarding pain; Blood Flow Restriction Training (BFRT), on the other hand, promotes muscle strength recovery under low-load conditions and is suitable for individuals with postoperative functional limitations. However, there is currently a lack of high-quality randomized controlled trials examining the application of combined PNE and BFRT interventions in patients with chronic pain following TKA. Therefore, this study aims to use a randomized controlled trial design to systematically evaluate the potential effects of PNE, BFRT, and their combined intervention on patients with postoperative chronic pain, thereby providing a research basis for comprehensive rehabilitation strategies for this population.

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. 因膝关节骨关节炎接受初次全膝关节置换术的成人，术后时间≥12个月。 2. 目标膝关节存在持续性疼痛，且持续时间超过6个月。 3. 疼痛局限于手术部位或其对应的神经分布区域，且已排除其他可能原因 (例如假体松动、感染)。 4. 在入组前一周内，数值评分量表（NRS）的平均疼痛强度评分≥4分（0分表示无疼痛，10分表示最剧烈的疼痛，≥4分表示中度至重度疼痛）。 5. 生命体征稳定，意识清醒，且具备足够的认知和语言能力，能够评估自身的疼痛并配合完成疼痛评估量表。

Inclusion criteria

1. Adults who have undergone primary TKA for KOA with a postoperative period of >=12 months. 2. Presence of persistent pain in the target knee for a duration of >6 months. 3. Pain localized to the surgical site or its corresponding nerve distribution, with other potential causes excluded (e.g., prosthesis loosening, infection). 4. An average pain intensity score of >=4 points on the Numerical Rating Scale (NRS) over the week preceding enrollment (0 indicates no pain, 10 indicates the most severe pain, and >=4 indicates moderate to severe pain). 5. Stable vital signs, clear consciousness, and sufficient cognitive and linguistic ability to assess their own pain and cooperate in completing pain assessment scales.

排除标准：

1. 慢性疼痛的具体原因，例如假体松动或失效，这需要进行翻修手术。 2. 与类风湿性关节炎相关的继发性骨关节炎，或既往创伤的后遗症。 3. 近3个月内曾对目标膝关节进行过手术，或过去12个月内曾遭受过严重损伤。 4. 混杂性疼痛模式，定义为在基线测试期间，除目标膝关节以外的其他部位出现急性疼痛。 5. 血管系统禁忌症，包括深静脉血栓形成病史、周围血管疾病或与压缩训练不相容的活动性出血体质。 6. 正在服用其他药物或参与其他临床试验，特别是2周内使用阿片类镇痛药 或参与其他与疼痛相关的研究。 7. 因怀孕、哺乳、严重认知障碍或无法提供知情同意而导致的普遍不符合条件。

Exclusion criteria：

1. Specific reasons for chronic pain, such as loosening and failure of the prosthesis, which requires revision surgery. 2. Secondary osteoarthritis associated with rheumatoid arthritis or sequelae of previous trauma. 3. Recent surgical history involving the index knee within 3 months or significant injury within the preceding 12 months. 4. Confounding pain patterns, defined as acute pain in areas other than the index knee during baseline testing. 5. Vascular contraindications, including a history of deep vein thrombosis, peripheral vascular disease, or active bleeding diathesis incompatible with compression training. 6. Concurrent medication or trial participation, specifically the use of opioid analgesics within 2 weeks or enrollment in other pain-related studies. 7. General ineligibility due to pregnancy, lactation, severe cognitive impairment, or inability to provide informed consent.

研究实施时间：

Study execute time：

从 From 2026-04-20 00:00:00至 To 2029-07-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-20 00:00:00 至 To 2027-07-20 00:00:00

干预措施：

Interventions：

组别：

疼痛神经科学教育组

样本量：

 44

Group：

Pain neuroscience education group (PNE)

Sample size：

干预措施：

疼痛神经科学教育组受试者将在整个干预周期内接受2次标准化PNE课程（第0周与第6周各1次，每次约60分钟），由具备疼痛神经科学教育培训资质的物理治疗师实施。首次课程主要讲解疼痛的神经生理机制，包括外周及中枢敏化、痛觉过敏，以及组织损伤与疼痛感知之间的差异，并结合全膝关节置换术后慢性疼痛（CPSP）的发生机制，采用通俗化语言及可视化材料进行患者教育；第6周课程在复习核心知识的基础上，针对受试者在前6周中遇到的疼痛相关问题进行针对性解答，并通过小组交流促进疼痛管理经验的分享，从而进一步强化其疼痛认知重建与自我管理能力。所有受试者将获得配套的PNE简明手册，未能完成全部2次课程者将被判定为依从性不足。

干预措施代码：

Intervention：

Participants in the Pain Neuroscience Education group will receive two standardized PNE sessions (one each at Week 0 and Week 6, approximately 60 minutes each) throughout the intervention period, delivered by physical therapists certified in pain neuroscience education. The first session will primarily cover the neurophysiological mechanisms of pain, including peripheral and central sensitization, hyperalgesia, and the distinction between tissue damage and pain perception. Patient education will be delivered using plain language and visual aids, with a focus on the pathogenesis of chronic pain following total knee arthroplasty (CPSP). The Week 6 session reviews core concepts and provides targeted answers to pain-related questions encountered by participants during the first 6 weeks. Group discussions facilitate the sharing of pain management experiences, thereby further strengthening participants’ ability to reframe their perception of pain and manage it independently. All participants will receive a companion PNE handbook; those who fail to complete both sessions will be deemed non-compliant.

Intervention code：

组别：

血流限制训练组

样本量：

 44

Group：

Blood flow restriction training group (BFRT)

Sample size：

干预措施：

血流限制训练组受试者将接受为期12周的低负荷血流限制抗阻训练，每周2次，共计24次训练。在正式干预前，所有受试者需完成3次间隔不少于48小时的适应性训练，以熟悉动作模式并减少学习效应。干预前采用多普勒超声设备测定个体动脉闭塞压（AOP），并在标准抗阻训练设备上评估腿举与膝关节伸展动作的1次最大重复负荷（1-RM），具体测量流程详见附录。训练采用渐进负荷模式，第1周为适应阶段，强度设定为20% 1-RM，每个动作完成4组，每组15次；自第2周起训练强度提高至30% 1-RM，第5周起每次训练组数增加至5组，组间休息时间统一为1分钟。训练过程中袖带压力设定为个体AOP的70%，于每次训练开始前充气并在最后一组完成后放气。为保证训练负荷的科学性与个体化，1-RM与AOP每4周重新评估一次并据此调整训练参数。干预期间将持续监测受试者主观感受，定期询问不适情况，并详细记录所有不良事件以确保安全性。

干预措施代码：

Intervention：

Participants in the blood flow restriction training group will undergo a 12-week program of low-load blood flow restriction resistance training, twice weekly for a total of 24 sessions. Prior to the formal intervention, all participants must complete three adaptation sessions spaced at least 48 hours apart to familiarize themselves with the movement patterns and minimize the learning effect. Prior to the intervention, individual arterial occlusion pressure (AOP) will be measured using Doppler ultrasound, and the one-repetition maximum (1-RM) for leg press and knee extension movements will be assessed on standard resistance training equipment. The specific measurement procedures are detailed in the Appendix. Training followed a progressive load protocol. Week 1 served as an adaptation phase, with intensity set at 20% of 1-RM, consisting of 4 sets of 15 repetitions per exercise. Starting from Week 2, training intensity was increased to 30% of 1-RM, and from Week 5, the number of sets per training session was increased to 5, with a uniform rest period of 1 minute between sets. During training, cuff pressure was set at 70% of the individual’s AOP, inflated before the start of each session, and deflated after completion of the final set. To ensure the scientific validity and individualization of the training load, 1-RM and AOP were reassessed every 4 weeks, and training parameters were adjusted accordingly. Throughout the intervention, participants’ subjective sensations were continuously monitored, discomfort was regularly assessed, and all adverse events were documented in detail to ensure safety.

Intervention code：

组别：

联合干预组

样本量：

 44

Group：

Combined intervention group (PNE+BFRT)

Sample size：

干预措施：

联合干预组受试者将同时接受上述两种干预措施，其中PNE课程安排于第0周与第6周实施，BFRT训练贯穿整个12周干预周期，每周2次；在同一周同时进行两种干预时，PNE课程将安排在抗阻训练之前，以避免疲劳对教育效果产生干扰。

干预措施代码：

Intervention：

Participants in the combined intervention group will receive both of the above interventions simultaneously. The PNE sessions will be scheduled for Week 0 and Week 6, while BFRT training will be conducted twice weekly throughout the entire 12-week intervention period. When both interventions are conducted in the same week, the PNE sessions will be scheduled before resistance training to prevent fatigue from interfering with the educational outcomes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 成都体育学院 

单位级别：

 大学 

Institution
hospital：

Chengdu Sport University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

KOOS4评分

指标类型：

主要指标

Outcome：

KOOS4 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：

KOOS评分

指标类型：

次要指标

Outcome：

KOOS score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

全球感知效应量表

指标类型：

次要指标

Outcome：

Global Perceived Effect Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

数字评分量表

指标类型：

次要指标

Outcome：

Numerical Rating Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛的程度与分布

指标类型：

次要指标

Outcome：

Pain Extent and Distribution

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

医院焦虑抑郁量表

指标类型：

次要指标

Outcome：

Hospital Anxiety and Depression Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛灾难化量表

指标类型：

次要指标

Outcome：

The Pain Catastrophizing Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

40米快走测试

指标类型：

次要指标

Outcome：

40-meter Fast-Paced Walk Test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

爬梯测试

指标类型：

次要指标

Outcome：

Stair Climb Test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

30秒起立测试

指标类型：

次要指标

Outcome：

30-second Chair-Stand Test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉力量

指标类型：

次要指标

Outcome：

Muscle strength

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：

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 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）：

本研究将采用SPSS 27.0软件生成随机分配序列，由独立研究人员实施随机化过程。采用区组随机化方法，并设置随机变化的区组长度（3、6、9），以保证组间分配均衡并降低分配可预测性。

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

This study will use SPSS 27.0 software to generate a random allocation sequence, with the randomization process conducted by an independent researcher. A block randomization method will be employed, with randomly varying block sizes (3, 6, 9) to ensure balanced allocation across groups and reduce predictability of assignment.

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：

由于干预措施的性质限制，本研究无法对受试者及干预实施者实施盲法。因此，本研究拟采用单盲设计，即对结局评估者及数据分析人员设盲。 所有结局评估将由未参与随机化及干预过程的研究人员完成，且评估过程中不接触分组信息。统计分析将基于去标识化数据集进行，组别信息以编码形式呈现，以降低分析偏倚。

Blinding：

Due to the nature of the intervention, this study is unable to implement a double-blind design for participants and intervention providers. Therefore, this study will adopt a single-blind design, in which the outcome assessors and data analysts will be blinded. All outcome assessments will be conducted by researchers who were not involved in the randomization or intervention process and who will not have access to group assignment information during the assessment. Statistical analyses will be performed using de-identified datasets, with group information presented in coded form to minimize analytical bias.

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

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）：

研究结束后，通过ResMan(www.medresman.org.cn)方式共享

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

After the end of the study, it was shared by ResMan (www.medresman.org.cn).

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：

Electronic Data Capture, EDC

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

Electronic Data Capture, EDC

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：

  2026-04-17 11:15:25