ChiCTR2500109873 版本V1.0 版本创建时间2025/09/26 09:55:54 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：

 ChiCTR2500109873 

最近更新日期：

Date of Last Refreshed on：

 2025-09-26 09:55:43 

注册时间：

Date of Registration：

 2025-09-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

呼吸训练对慢性腰痛患者功能障碍改善的有效性： 一项随机双盲对照试验方案

Public title：

Effectiveness of Inspiratory Muscle Training in Improving Functional Impairment in Patients with Chronic Low Back Pain: A Protocol for a Randomized Double-Blind Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于AI的腰痛诊疗机制分析及临床一体化方案建设（结构化呼吸训练对慢性腰痛患者功能障碍改善的有效性：一项随机双盲对照试验）

Scientific title：

Analysis of AI-Based Mechanisms for Low Back Pain Diagnosis and Treatment and Development of Integrated Clinical Solutions (Effectiveness of Structured Breathing Training in Improving Functional Impairment in Patients with Chronic Low Back Pain: A Randomized Double-Blind 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：

卢旭昇 

研究负责人：

卞荣 

Applicant：

Lu Xusheng 

Study leader：

Bian Rong 

申请注册联系人电话：

Applicant telephone：

 +86 131 3963 5705

研究负责人电话：

Study leader's
telephone：

+86 139 1472 0226

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：

 649276656@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 bianrong@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：

新疆乌鲁木齐市沙依巴克区黄河路116号

研究负责人通讯地址：

新疆乌鲁木齐市沙依巴克区黄河路116号

Applicant address：

No. 116 Huanghe Road, Shayibake District, Urumqi City, Xinjiang Uygur Autonomous Region

Study leader's address：

No. 116 Huanghe Road, Shayibake District, Urumqi City, Xinjiang Uygur Autonomous Region

申请注册联系人邮政编码：

Applicant postcode：

 830000

研究负责人邮政编码：

Study leader's postcode：

 830000

申请人所在单位：

新疆医科大学附属中医医院

Applicant's institution：

Xinjiang Medical University Affiliated Hospital of Traditional Chinese Medicine

研究负责人所在单位：

新疆医科大学附属中医医院

Affiliation of the Leader：

Xinjiang Medical University Affiliated Hospital of Traditional Chinese Medicine

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：

 2025XE0183-1

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：

新疆维吾尔自治区中医医院（新疆医科大学附属中医医院）伦理委员会

Name of the ethic committee：

Ethics Committee of the Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region (Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University)

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-14 00:00:00

伦理委员会联系人：

姜广礼

Contact Name of the ethic committee：

Jiang Guangli

伦理委员会联系地址：

新疆乌鲁木齐市沙依巴克区黄河路116号

Contact Address of the ethic committee：

No. 116 Huanghe Road, Shayibake District, Urumqi City, Xinjiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 181 9973 9590

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 XJTCMIRB@163.com

研究实施负责（组长）单位：

新疆医科大学附属中医医院

Primary sponsor：

Xinjiang Medical University Affiliated Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

新疆乌鲁木齐市沙依巴克区黄河路116号

Primary sponsor's address：

No. 116 Huanghe Road, Shayibake District, Urumqi City, Xinjiang Uygur Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

新疆维吾尔自治区

市(区县)：

乌鲁木齐

Country：

China

Province：

Xinjiang Uygur Autonomous Region

City：

Urumqi City

单位(医院)：

新疆医科大学附属中医医院

具体地址：

新疆乌鲁木齐市沙依巴克区黄河路116号

Institution
hospital：

Xinjiang Medical University Affiliated Hospital of Traditional Chinese Medicine

Address：

No. 116 Huanghe Road, Shayibake District, Urumqi City, Xinjiang Uygur Autonomous Region

经费或物资来源：

单位自筹

Source(s) of funding：

Self-financed by the unit

研究疾病：

慢性腰痛  

Target disease：

Chronic 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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过随机双盲安慰剂对照试验，本研究将验证呼吸训练对CLBP患者功能障碍改善的优效性，以期为呼吸-核心联动理论提供高级别证据，并推动非药物疗法在中医康复临床的应用。  

Objectives of Study：

This randomized, double-blind, placebo-controlled trial will validate the superior efficacy of respiratory training in improving functional impairment among patients with chronic low back pain (CLBP). The study aims to provide high-level evidence supporting the respiratory-core linkage theory and advance the clinical application of non-pharmacological therapies in traditional Chinese medicine rehabilitation.

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)确诊为慢性腰痛患者 (2)年龄18-65周岁，性别不限； (3)过去1周内视觉模拟疼痛评分（VAS）＜7分； (4)近1月内未接受腰痛相关治疗方案者； (5)自愿参加本研究并签署知情同意书者。

Inclusion criteria

1. Patients diagnosed with chronic low back pain 2. Aged 18–65 years, no gender restrictions; 3. Visual Analogue Scale (VAS) pain score <7 points within the past week; 4. No low back pain-related treatment received within the past month; 5. Voluntary participation in this study and signed informed consent.

排除标准：

(1)既往有或疑似有腰椎重大疾病，如骨折、肿瘤、结核、感染、骨质疏松、马尾综合征等引起的腰痛； (2)严重肺部疾病：气胸、肺大泡、慢性阻肺、其他呼吸道感染疾病症状未消失的患者 (3)合并有严重的心、肝、肾、神经系统疾病；； (4)有严重精神系统疾病（如精神分裂、双相情感障碍、重度抑郁等）； (5)孕妇或哺乳期妇女； (6)无法配合完成各项检查。

Exclusion criteria：

1. History of or suspected major lumbar spine conditions causing low back pain, such as fractures, tumors, tuberculosis, infections, osteoporosis, or cauda equina syndrome; 2. Severe pulmonary diseases: pneumothorax, pulmonary bullae, chronic obstructive pulmonary disease (COPD), or other respiratory infections with persistent symptoms; 3. Concurrent severe cardiac, hepatic, renal, or neurological disorders; 4. Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depressive disorder); 5. Pregnant or lactating women; 6. Inability to cooperate with all required examinations.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2027-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-10-15 00:00:00 至 To 2026-08-31 00:00:00

干预措施：

Interventions：

组别：

呼吸训练组

样本量：

 70

Group：

Breathing Training Group

Sample size：

干预措施：

①　体位准备：受试者取仰卧位，双脚平放于墙面调整髋关节、膝关节均保持90°屈曲，臀部贴合床面，腰部自然放松，双臂置于身体两侧。 ②　佩戴医用硅胶鼻夹：在呼吸训练的整个过程中，需要患者全程佩戴医用硅胶鼻夹。干预人员协助受试者将鼻夹中央弹簧部分对准鼻梁，两侧软垫贴合鼻翼，轻压固定以完全阻断鼻腔通气，避免因鼻腔通气影响吸气强度的准确性及抗阻呼吸效果。单次训练结束后，由受试者自行取下鼻夹，干预人员记录鼻夹佩戴的贴合度。 ③　训练方法：仪器采用中国江苏苏云医疗器材有限公司生产的呼吸训练器（医疗器械生产许可证编号：苏药监械生产许20010234号）。首先指导受试者进行自然腹式呼吸（时长3分钟），逐步适应体位，避免腰部肌肉紧张。基于干预前测定的MIP，通过压力阈值装置将吸气强度固定为其50%，患者吸气、呼气均通过呼吸训练器。连续呼吸30次，每次呼吸吸气时间：呼气时间=1:2。中间不能漏气，然后进入休息阶段。患者恢复自然腹式呼吸，干预人员询问受试者腰部及胸部不适情况，记录主观感受。每天早晚各一次，每次30次呼吸，持续4周，其中在第二周随访时根据前期训练结果，再次检测MIP，以50%MIP的强度对抗阻呼吸阈值进行动态调整。

干预措施代码：

Intervention：

1. Positioning: The subject lies supine with feet flat against the wall, adjusting the hips and knees to maintain 90° flexion. The buttocks should be flat against the bed surface, the lumbar region naturally relaxed, and arms resting at the sides. 2. Application of Medical Silicone Nose Clip: The subject must wear a medical silicone nose clip throughout the entire respiratory training session. The intervention staff assists the subject in positioning the central spring section of the clip over the bridge of the nose, with the soft pads on both sides fitting snugly against the nostrils. Apply gentle pressure to secure it, completely blocking nasal airflow to prevent nasal ventilation from affecting the accuracy of inspiratory strength measurements and the effectiveness of resistance breathing. After each training session, the subject removes the clip independently, and the intervention staff records the fit of the clip during wear. 3. Training Method: The device used is a respiratory trainer manufactured by Jiangsu Suyun Medical Equipment Co., Ltd. (Medical Device Production License No.: Su Ya Jian Xie Sheng Xu 20010234). Participants were first instructed to perform natural abdominal breathing (for 3 minutes) to gradually adapt to the position and avoid tension in the lumbar muscles. Based on the pre-intervention measured MIP, the inspiratory intensity was fixed at 50% of MIP using a pressure threshold device. Patients performed both inhalation and exhalation through the respiratory trainer. Thirty consecutive breaths were performed, with an inhalation-to-exhalation ratio of 1:2. No air leakage was permitted during the exercise, followed by a rest period. Patients resumed natural abdominal breathing, and the intervention staff inquired about any discomfort in the waist or chest, recording subjective experiences. The regimen was performed once daily in the morning and evening, with 30 breaths per session, for 4 weeks. During the second-week follow-up, MIP was reassessed based on initial training results. The dynamic adjustment of the resistance breathing threshold was then performed at 50% of the MIP intensity.

Intervention code：

组别：

安慰剂组

样本量：

 70

Group：

Placebo group

Sample size：

干预措施：

采用与呼吸训练组完全一致的仰卧屈髋屈膝体位，全程佩戴鼻夹，仅在抗阻呼吸阈值上实施假干预。呼吸训练器拆除呼吸阻力阀。呼吸动作流程同呼吸训练组，每天早晚各一次，每次30次呼吸，持续4周。该强度仅模拟呼吸训练形式，不产生针对性激活核心肌群及呼吸-核心协同功能的作用。

干预措施代码：

Intervention：

Participants adopted the same supine position with flexed hips and knees as the respiratory training group, wore a nose clip throughout the entire session, and received sham intervention only at the respiratory resistance threshold. The respiratory resistance valve was removed from the respiratory trainer. The breathing protocol mirrored that of the respiratory training group: 30 breaths twice daily (morning and evening) for 4 weeks. This intensity merely mimicked the form of respiratory training without producing targeted activation of core muscles or respiratory-core coordination.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 新疆维吾尔自治区 

市(区县)：

 乌鲁木齐 

Country：

China

Province：

Xinjiang Uygur Autonomous Region

City：

Urumqi City

单位(医院)：

 新疆医科大学附属中医医院 

单位级别：

 三甲 

Institution
hospital：

Xinjiang Medical University Affiliated Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Oswestry功能障碍指数

指标类型：

主要指标

Outcome：

Oswestry Dability Index

Type：

Primary indicator

测量时间点：

在治疗前、干预后第2周、干预后第4周评估指标。

测量方法：

治疗室现场评估

Measure time point of outcome：

Assessment metrics at baseline, 2 weeks post-intervention, and 4 weeks post-intervention.

Measure method：

On-site Assessment in the Treatment Room

指标中文名：

呼吸肌功能

指标类型：

次要指标

Outcome：

Respiratory muscle function

Type：

Secondary indicator

测量时间点：

在治疗前、干预后第2周、干预后第4周评估指标。

测量方法：

治疗室现场评估

Measure time point of outcome：

Assessment metrics at baseline, 2 weeks post-intervention, and 4 weeks post-intervention.

Measure method：

On-site Assessment in the Treatment Room

指标中文名：

核心肌群厚度变化率

指标类型：

次要指标

Outcome：

Rate of Change in Core Muscle Thickness

Type：

Secondary indicator

测量时间点：

在治疗前、干预后第2周、干预后第4周评估指标。

测量方法：

治疗室现场评估

Measure time point of outcome：

Assessment metrics at baseline, 2 weeks post-intervention, and 4 weeks post-intervention.

Measure method：

On-site Assessment in the Treatment Room

指标中文名：

非甾体抗炎药使用量

指标类型：

次要指标

Outcome：

Nonsteroidal anti-inflammatory drug usage

Type：

Secondary indicator

测量时间点：

在治疗前、干预后第2周、干预后第4周评估指标。

测量方法：

治疗室现场评估

Measure time point of outcome：

Assessment metrics at baseline, 2 weeks post-intervention, and 4 weeks post-intervention.

Measure method：

On-site Assessment in the Treatment Room

指标中文名：

起立-行走计时

指标类型：

次要指标

Outcome：

Timed Up and Go

Type：

Secondary indicator

测量时间点：

在治疗前、干预后第2周、干预后第4周评估指标。

测量方法：

治疗室现场评估

Measure time point of outcome：

Assessment metrics at baseline, 2 weeks post-intervention, and 4 weeks post-intervention.

Measure method：

On-site Assessment in the Treatment Room

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

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）：

本试验采用随机、双盲、1:1安慰剂对照、优效性设计，随机序列由统计人员使用SPSS26.0统计软件生成1:1比例的简单随机数字序列。

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

This trial employed a randomized, double-blind, 1:1 placebo-controlled, superiority design. The randomization sequence was generated by a statistician using SPSS 26.0 statistical software to produce a simple random number sequence in a 1:1 ratio.

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：

试验对受试者及数据评估者设盲。生成随机序列的人员不参与随机分配。固定1-2名研究者作为评估者，负责对患者的疗效指标相关量表进行评价，且每名受试者的基线和各访视评估需由同一研究者完成，以保证评估一致性。进行疗效评估的研究者不得作为呼吸训练的指导医师，同时受试者需避免向评估者泄露自身接受的治疗方式，以维持盲态。

Blinding：

The trial is blinded for both subjects and data evaluators. Personnel generating the random sequence do not participate in random assignment. Two to three fixed investigators served as evaluators responsible for assessing patients' efficacy-related scales. Each investigator consistently evaluated the same subject's baseline and all follow-up assessments to ensure consistency. Investigators conducting efficacy evaluations were prohibited from serving as respiratory training instructors. Subjects were instructed to avoid disclosing their treatment assignment to evaluators to maintain blinding.

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：

由课题组经过培训的研究者使用新疆维吾尔自治区中医院伦理委员会会审核通过的病例报告表进行填写，填写完成后进行封存。

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

Researchers trained by the project team completed the case report forms approved by the Ethics Committee of Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine. Upon completion, the forms were sealed and stored.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-09-26 09:55:43