ChiCTR2300077021 版本V1.1 版本创建时间2024/05/07 21:11:57 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：

 ChiCTR2300077021 

最近更新日期：

Date of Last Refreshed on：

 2023-10-26 16:26:36 

注册时间：

Date of Registration：

 2023-10-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

超声引导下小针刀椎间内外孔松解治疗巨大型腰椎间盘突出症的临床研究

Public title：

Clinical study of ultrasound-guided small needle knife intervertebral foramen release in the treatment of giant lumbar disc herniation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声引导下小针刀椎间内外孔松解治疗巨大型腰椎间盘突出症的临床研究

Scientific title：

Clinical study of ultrasound-guided small needle knife intervertebral foramen release in the treatment of giant lumbar disc herniation

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：

刘金星 

研究负责人：

方伟  

Applicant：

Jinxing Liu 

Study leader：

Wei Fang 

申请注册联系人电话：

Applicant telephone：

 +86 136 9940 7372

研究负责人电话：

Study leader's
telephone：

+86 159 8331 1710

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：

 Liujinxingzy@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ms15983311710@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 成都中医药大学附属眉山医院

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：

眉山市东坡区岷东大道北段9号

研究负责人通讯地址：

眉山市东坡区岷东大道北段9号

Applicant address：

No. 9, North Section of Mindong Avenue, Dongpo District, Meishan City

Study leader's address：

No. 9, North Section of Mindong Avenue, Dongpo District, Meishan City

申请注册联系人邮政编码：

Applicant postcode：

 620010

研究负责人邮政编码：

Study leader's postcode：

 620010

申请人所在单位：

成都中医药大学附属眉山医院

Applicant's institution：

Meishan Hospital of TCM Affiliated to ChengDu University of TCM

研究负责人所在单位：

成都中医药大学附属眉山医院

Affiliation of the Leader：

Meishan Hospital of TCM Affiliated to ChengDu University of TCM

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：

 2022-055

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：

眉山市中医医院药物器械伦理委员会

Name of the ethic committee：

Drug Device Ethics Committee of Meishan Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-31 00:00:00

伦理委员会联系人：

任静雯

Contact Name of the ethic committee：

Jingwen Ren

伦理委员会联系地址：

眉山市东坡区岷东大道北段9号

Contact Address of the ethic committee：

No. 9, North Section of Mindong Avenue, Dongpo District, Meishan City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 136 9905 8853

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：

成都中医药大学附属眉山医院

Primary sponsor：

Meishan Hospital of TCM Affiliated to ChengDu University of TCM

研究实施负责（组长）单位地址：

眉山市东坡区岷东大道北段9号

Primary sponsor's address：

No. 9, North Section of Mindong Avenue, Dongpo District, Meishan City

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

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都中医药大学附属眉山医院

具体地址：

眉山市东坡区岷东大道北段9号

Institution
hospital：

Meishan Hospital of TCM Affiliated to ChengDu University of TCM

Address：

No. 9, North Section of Mindong Avenue, Dongpo District, Meishan City

经费或物资来源：

四川省中医药管理局

Source(s) of funding：

Meishan Hospital of TCM Affiliated to ChengDu University of TCM

研究疾病：

腰椎间盘突出症  

Target disease：

Lumbar disc herniation

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：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究通过一项随机临床试验，研究超声引导下小针刀椎间内外孔松解术在减轻巨大型腰椎间盘突出症（GLDH）患者疼痛和改善生活质量方面的疗效。提高临床保守治疗GLDH的治疗效果。  

Objectives of Study：

This study conducted a randomized clinical trial investigating the efficacy of ultrasound-guided small needle knife intervertebral foramen release in reducing pain and improving quality of life in patients with giant lumbar disc herniation (GLDH). Improve the therapeutic effect of clinical conservative treatment of GLDH.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准 （1）诊断为巨大型腰推间盘突出症，体格检查显示症状定位与腰椎间盘突出阶段相符合； （2）检查未发现马尾神经损伤表现，无进行性加重的神经损伤表现； （3）因本项目需要患者准确描述自身症状，年龄选在成年及以上患者，具有生活自理能力者，年龄范围在18－65岁者（包括18岁和65岁）； （4）患者知情同意，了解本项目并自愿加入，同意首选非手术方案进行治疗，同意提供精准的当前现病史及既往病史，愿意按医嘱进行治疗，并按要求完成随访； （5）治疗前1周未接受过其他治疗干预的患者。

Inclusion criteria

(1) Diagnosed as giant lumbar disc herniation, physical examination showed that the symptom localization was consistent with the stage of lumbar disc herniation; (2) No cauda equina nerve injury was found in the examination, and there was no progressive aggravation of nerve injury; (3) Because this project requires patients to accurately describe their symptoms, the age is selected as adult and above, those with self-care ability, and those aged 18-65 (including 18-65 years old); (4) The patient has informed consent, understands the program and voluntarily joins, agrees to prefer non-surgical treatment for treatment, agrees to provide accurate current and past medical history, is willing to treat according to medical advice, and completes follow-up as required; (5) Patients who have not received other therapeutic interventions in the 1 week before treatment.

排除标准：

排除标准 （1）患者存在马尾综合征表现或具有进行性运动神经损伤症状和体征的患者； （2）孕妇、处于哺乳期或准备怀孕的女性； （3）存在严重器质性疾病或精神异常的患者； （4）存在椎间盘脱出、椎间盘退行性不稳定、脊柱结核、肿瘤、骨折或严重骨质疏松症患者； （5）患有严重内科疾病且未予以控制者。具有出血倾向或凝血功能不全者； （6）术区皮肤脓肿、溃烂、水泡或其他皮肤病者； （7）正在接受其他临床试验的患者；

Exclusion criteria：

Exclusion criteria (1) Patients with cauda equina syndrome manifestations or patients with symptoms and signs of progressive motor nerve injury; (2) Pregnant women, breastfeeding or women planning to become pregnant; (3) Patients with severe organic diseases or mental abnormalities; (4) Patients with intervertebral disc herniation, intervertebral disc degenerative instability, spinal tuberculosis, tumors, fractures or severe osteoporosis; (5) Those who suffer from serious internal medicine diseases and are not controlled. Those with bleeding tendency or coagulation insufficiency; (6) Skin abscess, ulceration, blisters or other skin diseases in the surgical area; (7) Patients undergoing other clinical trials;

研究实施时间：

Study execute time：

从 From 2023-11-01 00:00:00至 To 2024-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-11-01 00:00:00 至 To 2024-11-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 45

Group：

Control group

Sample size：

干预措施：

常规保守治疗方案：参考《腰椎间盘突出症诊疗中国疼痛专家共识》制定，包括物理疗法及口服药物治疗。 （1）卧床休息2周 （2）中医电针治疗 电针操作均在眉山市中医医院骨伤一科操作完成。操作医师均为有一年及以上操作经验的执业中医师。穴位定位参照《腧穴名称与定位》(GB/T12346~2006)。 操作：选取患者阿是穴及双侧腰夹脊穴、肾俞、大肠俞、环跳、委中、阳陵泉、承山、悬钟、昆仑。患者俯卧位，暴露腰腿部，放松，调匀呼吸，医者常规消毒，诸穴常规针刺，行平补平泻手法。环跳穴，针感以沿腰腿部向下放射为佳。电针选取腰夹脊穴，两侧各接一组线，疏密波，10HZ，强度以患者耐受为度，30min/次。出针后处理：棉签按压针孔数秒。休息 5min 无不适后离开。每周6次，共治疗2周。 （3）每名患者都将接受康复治疗师的康复评定，并在评定结果的基础上制定专门的康复治疗计划。 （4）散射式红外偏振光治疗，30min/次，每日一次 （5）电脑中频电治疗，30min/次，每日一次。 （6）对于急性期发作后1-2周，患者疼痛未缓解者，允许患者口服塞来昔布0.2 g，每日1次。 对于接受进入对照组接受保守治疗的患者，将于试验结束后按照患者意愿提供补偿性超声引导下小针刀椎间内外孔松解术治疗，每周2次共两周4次。

干预措施代码：

Intervention：

Conventional conservative treatment plan: formulated with reference to the "Chinese Expert Consensus on the Diagnosis and Treatment of Lumbar Disc Herniation", including physical therapy and oral drug therapy. (1) Bed rest for 2 weeks (2) Traditional Chinese medicine electroacupuncture treatment The electroacupuncture operations were all performed in the Department of Bone Injury of Meishan Traditional Chinese Medicine Hospital. The operating physicians are all practicing TCM physicians with one year or more of operating experience. Acupoint positioning refers to "Acupoint Name and Positioning" (GB/T12346~2006). Operation: Select the patient's Ah is acupoint and bilateral lumbar clamp ridge point, kidney Yu, large intestine Yu, Huan jump, Weizhong, Yanglingquan, Chengshan, Hanging Bell, Kunlun. The patient lies prone position, exposes the waist and legs, relaxes, adjusts the breathing, the doctor routinely disinfects, the acupoints are routinely pricked, and the technique of flattening and flattening is performed. Ring jumping point, the needle sensation is preferably radiating down the waist and legs. The electroacupuncture selects the waist clamp ridge point, and a set of lines is connected on both sides, loose wave, 10HZ, the intensity is tolerated by the patient, 30min/time. Post-needle treatment: Cotton swab presses the pinhole for a few seconds. Rest for 5 minutes without discomfort and leave. 6 times a week for 2 weeks. (3) Each patient will receive a rehabilitation assessment by a rehabilitation therapist and develop a special rehabilitation treatment plan based on the assessment results. (4) Scattered infrared polarized light treatment, 30min/time, once a day (5) Computer intermediate frequency electrical therapy, 30min / time, once a day. (6) For patients whose pain is not relieved 1-2 weeks after the onset of the acute stage, patients are allowed to take oral celecoxib 0.2 g, once a day. For patients admitted to the control group for conservative treatment, compensatory ultrasound-guided small needle knife intervertebral foraminal and extraforaminal release will be provided twice a week for two weeks after the end of the trial.

Intervention code：

组别：

针刀组

样本量：

 45

Group：

Needle knife group

Sample size：

干预措施：

针刀组治疗方案：超声引导下小针刀椎间内外孔松解术+常规保守治疗 3.3.2.1超声引导下小针刀椎间内外孔松解术操作步骤： （1）定位：患者俯卧位，腰下垫枕，充分暴露，找到痛点或结节病灶点，记号笔标记。再次定位腰椎病变节段的关节突关节、椎体横突尖端等体表的投影，标记出椎间外孔及内孔进针点。 （2）操作前准备：①常规消毒；②备物：准备两支 5ml 无菌注射器，一支抽取适量利多卡因注射液（利多卡因：生理盐水按 1:3 比例稀释），连接 0.7*80TWLB 无菌注射针头， 无菌小针刀数根；无菌纱布、干棉球数枚； 置于一次性无菌消毒包内备用；③无菌 US 探头：医师带无菌手套，US 探头处均匀涂抹耦合剂，置于事先标记好的标记线处，微调探头位置，使治疗部位成像于屏幕中央。 （3）操作过程：取稀释好的利多卡因注射液，以平面内进针方式于标记点处沿 US 探头纵轴进针，边进针边回抽，逐层浸润麻醉。动态观察超声显示屏中针体路线，注意避开神经、血管，针尖到达病变区深筋膜处时，缓慢注射局麻药 1ml，以原路线送入小针刀，待针尖到达椎间外孔，顺神经根走行方向剥离切割 2-3 刀，松解黏连组织，待行针无明显阻力后出针；从棘突间隙斜向外侧进针，到达椎间内孔，平行于神经根走行方向剥离切割 2-3 刀，松解黏连组织，待行针无明显阻力后出针。操作结束后于穿刺点给予无菌棉球压迫止血，无菌敷贴覆盖。 （4）术后：保持伤口清洁，48 h内避免沾水。 超声引导下小针刀椎间内外孔松解术均由具有手术操作资质且有5年以上操作经验的副主任以上医师实施。超声引导下小针刀椎间内外孔松解术每周治疗2次，共治疗2周。

干预措施代码：

Intervention：

Treatment regimen of acupuncture group: ultrasound-guided small needle knife intervertebral foramen release + conventional conservative treatment 3.3.2.1 Ultrasound-guided small needle knife intervertebral and external foramen release operation steps: (1) Positioning: the patient is prone position, lumbar pillow, fully exposed, find pain points or nodular lesions, marker marks. The projection of the body surface such as the articular joint and the tip of the transverse process of the vertebral body was relocated in the lumbar spine-lesion segment, and the needle entry points of the external foramen and the internal foramen were marked. (2) Preparation before operation: (1) routine disinfection; (2) Preparation: prepare two 5ml sterile syringes, one to extract an appropriate amount of lidocaine injection (lidocaine: normal saline diluted in a ratio of 1:3), connect 0.7*80TWLB sterile injection needles, and several sterile small needle knives; several sterile gauze and dry cotton balls; Place in a disposable sterile sterilization package for later use; (3) Sterile US probe: The physician wears sterile gloves, evenly applies couplant at the US probe, places it at the pre-marked marker line, fine-tunes the probe position, and imprints the treatment site in the center of the screen. (3) Operation process: take the diluted lidocaine injection, insert the needle along the longitudinal axis of the US probe at the marked point by means of in-plane needle injection, withdraw it while entering the needle, and infiltrate anesthesia layer by layer. Dynamically observe the needle body route in the ultrasound display, pay attention to avoid nerves and blood vessels, when the needle tip reaches the deep fascia of the lesion area, slowly inject 1ml of local anesthetic, send a small needle knife to the original route, wait for the needle tip to reach the external intervertebral foramen, peel and cut 2-3 knives in the direction of nerve root, release the adhesion tissue, and wait for the needle to be performed without obvious resistance before the needle is discharged; The needle is inserted obliquely from the spinous process space to the outside to reach the intervertebral internal foramen, peel and cut 2-3 knives parallel to the direction of nerve root, release the adhesion tissue, and wait for the needle to be released after no obvious resistance. After the operation, a sterile cotton ball is applied to the puncture point to stop bleeding, and the sterile compress is covered. (4) Postoperative: keep the wound clean and avoid water within 48 h. Ultrasound-guided small needle knife intervertebral and external foramen release is performed by a deputy chief physician or above with surgical qualifications and more than 5 years of operation experience. Ultrasound-guided small needle knife intervertebral foramen release is performed twice a week for a total of 2 weeks.

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)：

 眉山市 

Country：

China

Province：

Sichuan

City：

Meishan

单位(医院)：

 成都中医药大学附属眉山医院 

单位级别：

 三甲 

Institution
hospital：

Meishan Hospital of TCM Affiliated to ChengDu University of TCM

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

程继伟改良Oswestry功能障碍指数

指标类型：

主要指标

Outcome：

Oswestry disability index,ODI

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

健康状况调查问卷SF-36

指标类型：

次要指标

Outcome：

The Short Form-36 Health Survey, SF-36

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：

The Hospital Anxiety and Depression Scale,HADS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中文版腰背痛恐惧-回避信念问卷(FABQ)

指标类型：

次要指标

Outcome：

Chinese version of the Low Back Pain Fear-Avoidance Belief Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛视觉模拟量表

指标类型：

主要指标

Outcome：

visualanaloguescale,VAS

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术发生率

指标类型：

主要指标

Outcome：

Incidence of surgery

Type：

Primary 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：

正在进行

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）：

本实验采用简单随机分组的方法，运用SPSS.25.0软件生成90位随机数字，取中位数45，前45位数字归为针刀组，后45位数字归为对照组。

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

In this experiment, a simple random group method was adopted, and 90 random numbers were generated by SPSS.25.0 software, the median was 45, the first 45 digits were classified as needle knife group, and the last 45 digits were classified as control group.

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：

None

Blinding：

None

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：

研究采用CRF表的形式采集数据

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

This research collected data in the form of a CRF table

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：

  2023-10-26 16:26:06