ChiCTR2300073325 版本V1.1 版本创建时间2023/08/29 20:32:45 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：

ChiCTR2300073325 

最近更新日期：

Date of Last Refreshed on：

2023-07-06 18:21:18 

注册时间：

Date of Registration：

2023-07-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

浮针配合再灌注治疗改善腰肌劳损患者临床疗效观察方案

Public title：

Observation of clinical effect of Fu’s subcutaneous needling(FSN) combined with reperfusion therapy on patients with nonspecific low back pain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

浮针配合再灌注治疗改善腰肌劳损患者临床疗效观察方案

Scientific title：

Observation of clinical effect of Fu’s subcutaneous needling(FSN) combined with reperfusion therapy on patients with nonspecific low back pain

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：

卢晶晶 

研究负责人：

郑谅 

Applicant：

Jingjing Lu 

Study leader：

Liang Zheng 

申请注册联系人电话：

Applicant telephone：

+86 185 2021 5013

研究负责人电话：

Study leader's telephone：

+86 138 0253 3166

申请注册联系人传真 ：

Applicant Fax：

+86 18520215013

研究负责人传真：

Study leader's fax：

+86 138 0253 3166

申请注册联系人电子邮件：

Applicant E-mail：

262596210@qq.com

研究负责人电子邮件：

Study leader's E-mail：

zhliang66@aliyun.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：

中国广东省广州机场路16号大院

研究负责人通讯地址：

中国广东省广州机场路16号大院

Applicant address：

No.16 Airport Road, Guangzhou, Guangdong Province, China

Study leader's address：

No.16 Airport Road, Guangzhou, Guangdong Province, China

申请注册联系人邮政编码：

Applicant postcode：

510405

研究负责人邮政编码：

Study leader's postcode：

510405

申请人所在单位：

广州中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

研究负责人所在单位：

广州中医药大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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：

IIT2022-40

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：

广州中医药大学第一附属医院临床研究专家委员会

Name of the ethic committee：

Clinical Research Expert Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023-04-25 00:00:00

伦理委员会联系人：

黄纯美

Contact Name of the ethic committee：

Huang Chunmei

伦理委员会联系地址：

广东省广州市白云区机场路12号广州中医药大学综合楼11楼1115号室

Contact Address of the ethic committee：

Room 1115, 11th Floor, Comprehensive Building, Guangzhou University of Chinese Medicine, 12 Airport Road, Baiyun District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 3658 5411

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：

广州中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

研究实施负责（组长）单位地址：

中国广东省广州机场路16号大院

Primary sponsor's address：

No.16 Airport Road, Guangzhou, Guangdong Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中华人民共和国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州中医药大学第一附属医院

具体地址：

中国广东省广州机场路16号大院

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address：

No.16 Airport Road, Guangzhou, Guangdong Province, China

经费或物资来源：

广东省中医针灸重点实验室开放基金项目

Source(s) of funding：

Supported by Guangdong Key Laboratory of Acupuncture and Moxibustion

Target disease：

nonspecific low back pain

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：

浮针医学研究表明浮针疗法（FSN）能影响患者的肌肉和血管，缓解患者的疼痛，其中“患肌”是治疗的第一靶标，但浮针对于“患肌”的干预效应仍处于理论推导阶段，尚缺少高质量的具体形态结构证据支持“患肌”论点。本课题成员长期从事浮针的临床研究，致力于验证浮针干预腰肌劳损的显著疗效，提供高质量的临床试验结论。另外，我们希望运用肌骨超声观察FSN对腰肌劳损患者患肌横截面积的影响，并分析其与患者疼痛程度的相关性，以进一步阐释浮针的取效机制。  

Objectives of Study：

Lots of medical studies have shown that Fu’s subcutaneous needling (FSN) can affect the muscles and blood vessels of patients and relieve their pain, among which the "affected muscle" is the first target of treatment. However, the intervention effect of floating needle on the "affected muscle" is still in the stage of theoretical derivation, and there is still a lack of high-quality concrete morphological and structural evidence to support the argument of "affected muscle". Members of this project have been engaged in clinical research of FSN for years, committed to verifying the significant efficacy of FSN in the intervention of nonspecific low back pain, and providing high-quality clinical trial conclusions. In addition, we hope to use musculoskeletal ultrasound to observe the influence of FSN on the cross-sectional area of the affected muscle in patients with nonspecific low back pain, and analyze the correlation between the cross-sectional area of the affected muscle and the pain degree of patients, so as to further explain the effect mechanism of FSN.

药物成份或治疗方案详述：

①浮针组：患者取俯卧位，确定L3-L5的患肌位置后用龙胆紫记号笔做一标记，行进针部位及进针器的消毒。然后选用一次性浮针(型号：FSN5.0，国家发明专利申请号：CN201520373588.5，公开号：CN204932248U，直径0.6mm，长度52mm)。确定包装完整无损后取其安置于进针器上备用。先选取患侧L3-L5疼痛区域周围为进针点，局部及医者手指常规消毒后右手夹持浮针进针器紧贴于进针点，针尖朝向“患肌”，左手放置于进针器前方并将进针点处的皮肤用拇指及食指、中指稍向上捏起，以保证顺利进针，减轻疼痛。按压进针器的针以垂直于提捏皮肤的角度射入皮下约0.2cm。针尖进入皮下，平放针身，再让针尖微向上翘起，保持针体与肌肉层平行，轻柔缓慢地将剩余针身推进皮下层。针体进入皮下组织后，将针芯退出至凹槽卡住，此时针尖与软管齐平。右手拇指、食指及中指合力固定于针座处，以拇指及中指为中点，食指及无名指居左右两侧，行前后摆动似跷跷板样扇形扫散，扫散时间约2min，频率为100次/min。进行腰部浮针扫散过程中，让患者同时配合以小飞燕为主的再灌注活动，行3次再灌注活动，每次10s。若患者改善不明显，可再配合3次外展髋关节抗阻或左右扭腰臀为主的再灌注动作，结束后退针，棉签止血后贴上创口贴，治疗完成。 ②假浮针组：患者会被要求进入一个单独的治疗室，佩戴好眼罩，直到治疗结束才能取下。术者操作时使用进针器仅模拟进针瞬间对患肌施术，在皮外停留 10 秒钟以模拟手法的时间，但不会给患者做任何有创手法。同时配合使用扶他林软膏外用患处。我们要求患者之间不得沟通治疗的具体情况。此外，其他相关的研究人员都不能了解试验的内容，如疗效评估者、统计分析者等。 ③扶他林组：采用扶他林软膏 (双氯芬酸二乙胺乳胶剂, 由北京诺华制药公司生产, 国药准字H19990291, 规格为每支20g) , 扶他林软膏外敷腰部肌肉10min。外敷过程中涂抹均匀即可，勿加力按压。 

Description for medicine or protocol of treatment in detail：

①FSN Group The patient was placed in prone position, the location of the affected muscle of L3-L5 was determined, a mark was made with Gentian purple marker, and the needle site and needle injector were disinfected. Then, disposable floating needle (Model: FSN5.0, National Invention patent application number: CN201520373588.5, public number: CN204932248U, diameter: 0.6mm, length: 52mm) is selected. After making sure that the package is intact, it is placed on the needle feeder for reserve. First, the area around the pain area of L3-L5 on the affected side was selected as the needle insertion point. After routine disinfection of the local area and the doctor's fingers, the right hand held the floating needle insertion device cling to the needle insertion point, and the needle tip was toward the "affected muscle". The left hand was placed in front of the needle insertion device and the skin at the needle insertion point was slightly upward with the thumb, index finger and middle finger to ensure smooth needle insertion and relieve the pain. The needle pressed into the syringe is injected into the subcutaneous area about 0.2cm,at perpendicular to the Pinched skin. Insert the needle tip into the subcutaneous layer, lay the needle body flat, and then let the needle tip slightly upward, keeping the needle body parallel to the muscle layer, gently and slowly push the remaining needle body into the subcutaneous layer. After the needle body enters the subcutaneous tissue, withdraw the needle core to the groove and get stuck. At this time, the tip of the needle is flush with the hose. The thumb, index finger and middle finger of the right hand were fixed at the pin base, with the thumb and middle finger as the middle point, and the index finger and ring finger at the left and right sides. They were moved back and forth like seesaw fan-like sweeping. The sweeping time was about 2min and the frequency was 100 times /min. In the process of lumbar floating needle sweeping-out, the patient was asked to cooperate with the reperfusion activity dominated by flying-swallow-like exercises at the same time, three reperfusion activities were performed, 10s each time. If the patient's improvement is not obvious, the patient can be combined with three times of abductive hip joint resistance or left and right waist and hip rotation reperfusion, the end of the receding needle, cotton swab to stop bleeding, then apply a band-aid, the treatment is complete. ②sham FSN group Patients are asked to go into a separate treatment room, wear a eye mask, and can't take it off until the treatment is over. The operator uses the needle injector to simulate the operation of the affected muscle only at the moment of injection, and stays outside the skin for 10 seconds to simulate the time of manipulation, but does not perform any invasive manipulation on the patient. At the same time with the use of voltaren ointment for external use on the affected area. We forbid patients to communicate with each other about their treatment. What’s more, the content of the trial is not accessible to other relevant investigators, such as efficacy evaluators, statistical analysts, etc. ③Voltaren group Voltaren ointment (diclofenac diethylamine emulgel, produced by Produced by Novartis, a pharmaceutical company in Beijing, national medicine approval number H19990291, the specification is 20g each) was applied to the waist muscle for 10min. Apply evenly in the process of external application, do not press. 

纳入标准：

①属于腰肌劳损引起的慢性非特异性腰痛患者。（参照2020 年北美脊柱协会 （NASS）腰肌劳损的循证医学指南：18 岁及以上患者；疼痛来源于躯体牵涉痛或非根性痛。) ②年龄18 ～ 60 岁，性别不限。 ③病程持续12周以上，VAS评分≥4分。 ④支持本研究，签署知情同意书，可协助医师完成整个研究过程。 ⑤未使用其他治疗方案治疗腰痛。

Inclusion criteria

①Patients with chronic non-specific low back pain. (Refer to the 2020 North American Spine Association (NASS) Evidence-Based Medicine guidelines for nonspecific low back pain: Patients 18 years of age and older; Pain comes from referred or non-root pain.) ②Age ranges from 18 to 60 years old and gender is not limited. ③ The course of the disease lasted more than 12 weeks, and the VAS score was ≥4 points. ④ Supporting this study and signing informed consent, assisting physicians to complete the whole study process. ⑤ No other treatment was used for lumbago.

排除标准：

① 妊娠； ② 特异性腰痛（肿瘤、感染、代谢性疾病、类风湿性关节炎、骨折）； ③ 脊柱畸形（脊柱滑脱、峡 部裂或脊柱侧弯）； ④ 膝盖以下部位疼痛； ⑤ 脊髓外疾病（例如血管、泌尿生殖系统疾病）； ⑥ 有腰椎手术史； ⑦ “腰椎间盘突出症”、“腰椎管狭窄症”等根性疼痛； ⑧ 腰痛伴2个或以上其他部位疼痛； ⑨ 试验近1个月接受过针刺治疗者。

Exclusion criteria：

① pregnancy; ② Specific low back pain (tumor, infection, metabolic disease, rheumatoid arthritis, fracture); ③ Spinal deformity (spondylolishesis , spondylolysis or scoliosis); ④ Pain below the knee; ⑤ Extra-spinal diseases (such as vascular and genitourinary diseases); ⑥ History of lumbar surgery; ⑦ "lumbar disc herniation", "lumbar spinal stenosis" and other root pain; ⑧Lumbago with ≥2 other areas of pain ⑨ Patients who received acupuncture treatment in the past 1 month of the experiment.

研究实施时间：

Study execute time：

从 From 2022-06-01 00:00:00至 To 2024-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-07-07 00:00:00 至 To 2024-04-26 00:00:00  

干预措施：

Interventions：

组别：

浮针组

样本量：

45

Group：

Fu’s subcutaneous needling(FSN) group

Sample size：

干预措施：

浮针治疗

干预措施代码：

Intervention：

Fu’s subcutaneous needling therapy

Intervention code：

组别：

假浮针组（假浮针+扶他林外用）

样本量：

45

Group：

sham FSN group （sham FSN+ voltaren external use）

Sample size：

干预措施：

假浮针+扶他林外用

干预措施代码：

Intervention：

sham FSN+ voltaren external use

Intervention code：

组别：

药物组（扶他林外用）

样本量：

45

Group：

voltaren external use

Sample size：

干预措施：

扶他林外用

干预措施代码：

Intervention：

voltaren external use

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中华人民共和国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guangdong 

City：

Guangzhou 

单位(医院)：

广州中医药大学第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛视觉模拟评分 (VAS)

指标类型：

主要指标

Outcome：

Visual analog pain scale (VAS)

Type：

Primary indicator

测量时间点：

治疗前，第一次治疗后，第三次治疗后

测量方法：

Measure time point of outcome：

Before treatment, after the first treatment, after the third treatment

Measure method：

指标中文名：

肌肉横断面积（CSA）

指标类型：

次要指标

Outcome：

Muscle cross-sectional area (CSA)

Type：

Secondary indicator

测量时间点：

治疗前，第一次治疗后，第三次治疗后

测量方法：

肌骨超声

Measure time point of outcome：

Before treatment, after the first treatment, after the third treatment

Measure method：

Musculoskeletal ultrasound

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 60 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）：

为了保证组间基线的可比性、避免选择性偏倚，卢晶晶使用区组随机化的随机方法。

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

In order to ensure the comparability of baseline between groups and avoid selective bias, the block randomization was used by Jingjing Lu.

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：

无，因本次研究涉及不同的用药及针刺方法，故患者及研究者、评分人员、统计人员无法设盲。我们禁止患者之间沟通具体治疗经过。此外，其他相关的研究人员都不能了解试验的内容，如疗效评估者、统计分析者等。

Blinding：

None. As different medication and acupuncture methods were involved in this study, patients, researchers, raters and statisticians could not be blinded. We forbid patients to communicate with each other about their treatment. What’s more, the content of the trial is not accessible to other relevant investigators, such as efficacy evaluators, statistical analysts, etc.

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

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）：

https://www.chictr.org.cn

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

https://www.chictr.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：

无

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

none

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：

  2023-07-06 18:21:12