ChiCTR2600118682 版本V1.0 版本创建时间2026/02/10 08:49:28 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：

ChiCTR2600118682 

最近更新日期：

Date of Last Refreshed on：

2026-02-10 08:49:22 

注册时间：

Date of Registration：

2026-02-10 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

面部康复操在三叉神痛经皮球囊压迫术后患者的应用效果

Public title：

Application of Facial Rehabilitation Exercises in Patients Following Percutaneous Balloon Compression for Trigeminal Neuralgia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于奥瑞姆理论的三叉神经球囊压迫术后患者面部康复操的应用研究

Scientific title：

A study on the application of facial rehabilitation exercises for patients after trigeminal nerve balloon compression based on the Aurum theory

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：

田海萍 

研究负责人：

陈亚平 

Applicant：

Tian Haiping 

Study leader：

Chen Yaping 

申请注册联系人电话：

Applicant telephone：

+86 185 8204 0565

研究负责人电话：

Study leader's telephone：

+86 158 2329 9412

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：

358784388@qq.com

研究负责人电子邮件：

Study leader's E-mail：

358784388@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：

中国重庆市江北区建新东路29号

研究负责人通讯地址：

中国重庆市江北区建新东路29号

Applicant address：

29 Jianxin East Road, Jiangbei District, Chongqing, China

Study leader's address：

29 Jianxin East Road, Jiangbei District, Chongqing, 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：

中国人民解放军陆军第九五八医院

Applicant's institution：

The Ninth Fifth Eighth Hospital of PLA Army

研究负责人所在单位：

中国人民解放军陆军第九五八医院

Affiliation of the Leader：

The Ninth Fifth Eighth Hospital of PLA Army

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：

ER2025KY014

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：

中国人民解放军陆军第九五八医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Ninth Five-Eight Hospital of the People's Liberation Army Ground Force

伦理委员会批准日期：

Date of approved by ethic committee：

2025-01-31 00:00:00

伦理委员会联系人：

黄金羽

Contact Name of the ethic committee：

Huang Jinyu

伦理委员会联系地址：

中国重庆市江北区建新东路29号

Contact Address of the ethic committee：

29 Jianxin East Road, Jiangbei District, Chongqing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 23762014

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：

中国人民解放军陆军第九五八医院

Primary sponsor：

The Ninth Fifth Eighth Hospital of PLA Army

研究实施负责（组长）单位地址：

中国重庆市江北区建新东路29号

Primary sponsor's address：

29 Jianxin East Road, Jiangbei District, Chongqing, 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)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

中国人民解放军陆军第九五八医院

具体地址：

中国重庆市江北区建新东路29号

Institution
hospital：

The Ninth Fifth Eighth Hospital of PLA Army

Address：

29 Jianxin East Road, Jiangbei District, Chongqing, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

Trigeminal neuralgia

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：

主要目的：评价个性化面部康复操对PBC术后患者疼痛缓解（VAS评分）和面部麻木改善（BNI分级）的效果。 次要目的：评估康复操对咀嚼无力发生率、焦虑抑郁状态（HADS评分）及睡眠质量的影响；观察术后3个月内疼痛复发率。  

Objectives of Study：

Primary Objective: To evaluate the efficacy of personalized facial rehabilitation exercises in alleviating pain (VAS score) and improving facial numbness (BNI grading) in patients following PBC surgery. Secondary Objectives: To assess the impact of rehabilitation exercises on the incidence of masticatory weakness, anxiety and depression status (HADS score), and sleep quality; to observe the recurrence rate of pain within 3 months post-surgery.

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. 诊断为三叉神经痛的患者，诊断标准参照《三叉神经痛诊疗中国专家共识》； 2. 患者接受单侧球囊压迫术治疗； 3. 年龄18~75岁，病情稳定、意识清楚能够配合康复训练与评估的患者； 4. 临床资料完备； 5. 患者及家属知情同意。

Inclusion criteria

1. Patients diagnosed with trigeminal neuralgia, with diagnostic criteria based on the Chinese Expert Consensus on the Diagnosis and Treatment of Trigeminal Neuralgia; 2. Patients undergoing unilateral balloon compression therapy; 3. Patients aged 18–75 years with stable condition, clear consciousness, and ability to cooperate with rehabilitation training and assessment; 4. Complete clinical documentation; 5. Informed consent obtained from patients and their families.

排除标准：

1. 存在意识障碍、认知障碍不能配合者； 2. 肝、肾、心等脏器功能严重障碍者； 3. 脸部皮肤有损伤。

Exclusion criteria：

1. Individuals with impaired consciousness or cognitive dysfunction who are unable to cooperate; 2. Individuals with severe dysfunction of vital organs such as the liver, kidneys, or heart; 3. Individuals with facial skin injuries.

研究实施时间：

Study execute time：

从 From 2025-02-26 00:00:00至 To 2027-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-02-26 00:00:00 至 To 2026-12-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

54

Group：

Intervention group

Sample size：

干预措施：

在对照组的基础上增加个性化面部康复操干预 1. 给患者讲解康复锻炼操的目的、意义，向患者发放康复锻炼操手册、康复锻炼操视频，指导患者及家属进行学习，告诉患者每天锻炼2次，上午及下午各进行一次，每次30分钟左右，共锻炼4周。 2. 首次练习康复锻炼操时，在病房的荧屏中打开康复锻炼操视频，并让患者打开康复锻炼操手册，指导患者根据视频和手册进行学习，及时解答患者疑惑，纠正患者错误，直至患者理解能独立完成为止。 3. 面部康复操的构建：(1) 检索国内外有关三叉神经痛患者康复锻炼的文献、指南，从中提取康复干预的内容，进行评价整合，初步确定三叉神经痛患者面部康复操的条目。之后通过对康复科、疼痛科的专家进行咨询，根据专家意见对康复操的条目进行修改，最终确定三叉神经痛患者面部康复操。(2) 面部康复操的内容和形式：将康复锻炼的内容做出图片制定成手册，并由专业人员拍摄视频，搭配舒缓轻音乐，使康复操变得具体、形象，方便练习。内容包括八部分，第一步：面颊部前后按摩；第二步：面颊部上下按摩；第三步：面颊部顺时针按摩；第四步：面颊部逆时针按摩；第五步：张口锻炼；第六步：左右摆动下颚；第七步：鼓腮；第八步：伸舌。指导患者用手放在双侧颊部进行锻炼，每个动作八个节拍。根据患者情况，进行个性化的频次锻炼。

干预措施代码：

Intervention：

In addition to the control group, implement a personalized facial rehabilitation exercise intervention: 1. Explain to the patient the purpose and significance of the rehabilitation exercises, provide the patient with a manual and video of the rehabilitation exercises, guide the patient and family members in learning, and instruct the patient to perform the exercises twice daily—once in the morning and once in the afternoon—each session lasting approximately 30 minutes, for a total of four weeks. 2. During the first practice session, play the rehabilitation exercise video on the ward screen, have the patient open the manual, and guide the patient to learn from both the video and manual, promptly answering questions and correcting errors until the patient fully understands and can perform the exercises independently. 3. Development of the facial rehabilitation exercise: (1) Search for domestic and international literature and guidelines on rehabilitation exercises for trigeminal neuralgia patients, extract rehabilitation intervention content, evaluate and integrate it to preliminarily determine the items of the facial rehabilitation exercise for trigeminal neuralgia patients. Subsequently, consult experts from rehabilitation and pain departments, revise the exercise items based on their feedback, and finally finalize the facial rehabilitation exercise for trigeminal neuralgia patients. (2) Content and format of the facial rehabilitation exercise: Convert the exercise content into illustrated manuals and have professionals film videos accompanied by soothing background music, making the exercises concrete, visual, and easy to follow. The content consists of eight steps: Step 1: Front-to-back massage of the cheeks; Step 2: Up-and-down massage of the cheeks; Step 3: Clockwise massage of the cheeks; Step 4: Counterclockwise massage of the cheeks; Step 5: Mouth-opening exercise; Step 6: Side-to-side jaw movement; Step 7: Puffing cheeks; Step 8: Tongue extension. Instruct the patient to place their hands on both sides of the cheeks during exercise, with each movement consisting of eight beats. Adjust the frequency of exercises according to the patient’s individual condition.

Intervention code：

组别：

对照组

样本量：

54

Group：

Control Group

Sample size：

干预措施：

1. 基础护理：(1) 病室空气清新，温湿度适宜；(2) 患者床单位舒适、整洁；(3) 遵医嘱用药，观察患者用药反应及病情状况。 2. 健康指导：给患者及家属讲解疾病有关知识。 3. 饮食护理：饮食应清淡，不吃刺激性食物，多吃蔬菜水果，适当摄入蛋白质丰富的食物。 4. 术后康复指导：(1) 咀嚼肌锻炼：1) 每天做扣齿锻炼，上下牙齿一张一合；2) 咀嚼口香糖；3) 术后3天在手术侧吃饭，锻炼咀嚼功能；4) 按摩面部。 (2) 防止烫伤：手术后术侧面部感觉减退，进食不能过热。 (3) 注意眼部卫生，防止角膜溃疡：术后角膜感觉减退，眼部摩擦感，可以滴玻璃酸钠滴眼液润滑一下，不能用手或毛巾揉搓眼睛。 (4) 复视：复视期间术侧眼睛戴眼罩，注意安全。 (5) 术后随访，若有不适，请及时复诊。

干预措施代码：

Intervention：

1. Basic nursing: (1) The ward air is fresh with appropriate temperature and humidity; (2) The patient’s bed unit is comfortable and tidy; (3) Administer medications as prescribed and monitor the patient’s response to medication and condition. 2. Health education: Provide patients and their families with information about the disease. 3. Dietary care: Diet should be light, avoiding spicy or irritating foods; increase intake of vegetables and fruits, and consume adequate protein-rich foods. 4. Postoperative rehabilitation guidance: (1) Chewing muscle exercise: 1) Perform tooth-clacking exercises daily, opening and closing the teeth; 2) Chew gum; 3) Eat meals on the surgical side starting three days postoperatively to exercise chewing function; 4) Massage the face. (2) Prevent burns: Facial sensation is reduced on the surgical side after surgery; avoid consuming food that is too hot. (3) Maintain ocular hygiene to prevent corneal ulceration: Corneal sensation is reduced postoperatively, causing a gritty sensation; instill sodium hyaluronate eye drops for lubrication, and avoid rubbing the eyes with hands or towels. (4) Diplopia: Wear an eye patch on the surgical side during the period of diplopia and pay attention to safety. (5) Follow-up postoperatively; seek prompt medical attention if any discomfort occurs.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China 

Province：

ChongQing 

City：

 

单位(医院)：

中国人民解放军陆军第九五八医院 

单位级别：

三甲 

Institution
hospital：

The Ninth Fifth Eighth Hospital of PLA Army

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛程度

指标类型：

主要指标

Outcome：

Degree of pain

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

面部麻木

指标类型：

主要指标

Outcome：

Barrow neurological institute

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑抑郁

指标类型：

次要指标

Outcome：

Anxiety and Depression

Type：

Secondary indicator

测量时间点：

测量方法：

医院焦虑抑郁量表

Measure time point of outcome：

Measure method：

Hospital Anxiety and Depression Scale

指标中文名：

咀嚼无力发生率

指标类型：

副作用指标

Outcome：

Incidence of chewing weakness

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后复发率

指标类型：

次要指标

Outcome：

Postoperative recurrence rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

睡眠质量

指标类型：

次要指标

Outcome：

Sleep quality

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：

N/A

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

采用计算机生成随机数字序列，将合格受试者按1:1比例分为观察组（康复操+常规护理）与对照组（常规护理）。随机分配方案由独立研究助理密封保存，入组时按顺序拆封，确保分配隐藏。

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

A computer-generated random number sequence was used to assign eligible subjects in a 1:1 ratio to either the observation group (rehabilitation exercises plus routine care) or the control group (routine care only). The random allocation plan was sealed and stored by an independent research assistant, with sequential opening at the time of enrollment to ensure allocation concealment.

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：

由于干预措施特性，患者与干预实施者（护士）无法设盲。结局评估者（负责收集VAS、BNI、HADS等数据的研究人员）与数据分析人员对分组信息设盲。

Blinding：

Due to the nature of the intervention, blinding of patients and intervention providers (nurses) was not feasible. Outcome assessors (researchers responsible for collecting data such as VAS, BNI, and HADS) and data analysts were blinded to group assignment information.

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）：

ResMan平台；研究结束半年

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

ResMan platform; Half a year after the research ended

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：

数据管理：采用双人独立录入，逻辑核查，保证数据准确。

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

Data Management: Implemented through dual independent data entry and logical verification to ensure data accuracy.

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：

  2026-02-10 08:49:22