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Evaluation of clinical effect of Wei's manipulation combined with transcutaneous electrical nerve stimulation (TENS) in the treatment of lumbar intervertebral disc hernia

注册号：

Registration number：

ITMCTR2024000381

最近更新日期：

Date of Last Refreshed on：

2024-09-05

注册时间：

Date of Registration：

2024-09-05

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

魏氏手法联合经皮神经电刺激（TENS）疗法治疗腰突症临床疗效评价研究

Public title：

Evaluation of clinical effect of Wei's manipulation combined with transcutaneous electrical nerve stimulation (TENS) in the treatment of lumbar intervertebral disc hernia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

魏氏手法联合经皮神经电刺激（TENS）疗法治疗腰突症临床疗效评价研究

Scientific title：

Evaluation of clinical effect of Wei's manipulation combined with transcutaneous electrical nerve stimulation (TENS) in the treatment of lumbar intervertebral disc hernia

研究课题的正式科学名称简写：

Scientific title acronym：

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：

薛彬

研究负责人：

薛彬

Applicant：

xuebin

Study leader：

xuebin

申请注册联系人电话：

Applicant telephone：

18817821387

研究负责人电话：

Study leader's telephone：

18817821387

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：

skxuebin@163.com

研究负责人电子邮件：

Study leader's E-mail：

skxuebin@163.com

申请单位网址(自愿提供)：

Study leader's 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：

上海市黄浦区瑞金二路197号

研究负责人通讯地址：

上海市黄浦区瑞金二路197号

Applicant address：

No. 197 Ruijin 2nd Road Huangpu District Shanghai

Study leader's address：

No. 197 Ruijin 2nd Road Huangpu District Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200025

研究负责人邮政编码：

Study leader's postcode：

200025

申请人所在单位：

上海交通大学医学院附属瑞金医院

Applicant's institution：

The Ruijin Hospital Afiliated to Shanghai Jiao Tong University School of Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

（2024）临伦审第（285）号

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

上海交通大学医学院附属瑞金医院伦理委员会

Name of the ethic committee：

Ethics Committee of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/8/13 0:00:00

伦理委员会联系人：

赵彦琳

Contact Name of the ethic committee：

Zhao Yanlin

伦理委员会联系地址：

上海市黄浦区瑞金二路197号35号楼2楼伦理办公室

Contact Address of the ethic committee：

London Office 2nd Floor Building 35 No. 197 Ruijin 2nd Road Huangpu District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-64370045

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ruijincrc@126.com

研究实施负责（组长）单位：

上海交通大学医学院附属瑞金医院

Primary sponsor：

The Ruijin Hospital Afiliated to Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市黄浦区瑞金二路197号

Primary sponsor's address：

No. 197 Ruijin 2nd Road Huangpu District Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

china

Province：

shanghai

City：

单位(医院)：

上海交通大学医学院附属瑞金医院

具体地址：

上海市黄浦区瑞金二路197号

Institution
hospital：

No. 197 Ruijin 2nd Road Huangpu District Shanghai

Address：

The Ruijin Hospital Afiliated to Shanghai Jiao Tong University School of Medicine

经费或物资来源：

上海市2023年度创新医疗器械应用示范项目-表面肌电图仪在腰椎间盘突出症的应用示范

Source(s) of funding：

Shanghai 2023 Innovative medical device application demonstration project - Surface electromyography in lumbar disc herniation application demonstration

研究疾病：

腰椎间盘突出

研究疾病代码：

Target disease：

lumbar disc herniation

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

主要目的： 评价魏氏手法联合TENS疗法治疗腰突症的临床疗效。 次要目的： 1、评价魏氏手法联合TENS疗法改善腰突症患者疼痛作用 2、评价魏氏手法联合TENS疗法改善腰突症患者功能障碍的作用。 3、评价魏氏手法联合TENS疗法改善腰突症患者腰部竖脊肌、多裂肌、臀中肌、腓肠肌激活程度的作用。 4、评价魏氏手法联合TENS改善腰突症患者腰部压痛点的疼痛阈值的作用。 5、探索魏氏手法联合TENS疗法改善腰突症患者疼痛的中枢镇痛效应机制。

Objectives of Study：

Objective: To evaluate the clinical effect of Wei's manipulation combined with TENS in the treatment of lumbar disc herniation. Secondary objectives: 1. To evaluate the effect of Wei's manipulation combined with TENS therapy on pain in patients with lumbar disc herniation 2. To evaluate the effect of Wei's manipulation combined with TENS therapy in improving the dysfunction of patients with lumbar disc herniation. 3. To evaluate the effect of Wei's manipulation combined with TENS therapy on the activation of lumbar erectus muscle multifidus muscle gluteus media muscle and gastrocnemius muscle in patients with lumbar disc herniation. 4. To evaluate the effect of Wei's manipulation combined with TENS in improving the pain threshold of lumbar tenderness points in patients with lumbar disc herniation. 5. To explore the central analgesic effect mechanism of Wei's manipulation combined with TENS therapy to improve pain in patients with lumbar disc herniation.

药物成份或治疗方案详述：

治疗组采用魏氏二步七法手法治疗后加以TENS疗法。 对照组采用魏氏二步七法手法治疗。 手法：每周2次，每次15分钟。TENS疗法：每周两次，每次20分钟，4周为一疗程。 魏氏二步七法手法具体操作步骤如下： 1） 第一步手法。患者俯卧位，手法操作者依次按照背部点揉、腰部提拉、弹拨按揉、提腿点揉、按抖腰部、叩推腰背开展手法治疗，以上手法完毕后作为一节，连作三节。 2）第二步手法。患者取仰卧位，手法操作者主要进行“悬足压膝”手法，由低到高，逐渐加重，一般要求10次左右。以上俯卧、仰卧两个体位，共七步手法，全部手法完毕后作为一次手法治疗。 每周治疗2次，每次治疗15～20 min，共治疗4周。 TENS疗法具体操作步骤如下： 采用无线表面肌电图仪（上海诺城电气有限公司）治疗，治疗时将刺激电极分别置于竖脊肌（L4-S1）、臀中肌、腓肠肌，采用1~100 Hz 的刺激频率进行电刺激治疗。 参数为:频率20 Hz，电流 8~30mA，脉冲宽度10~200μs。治疗时根据患者情况随 时调节刺激电流强度，每增加1次，电流增加0.2 mA。 每次治疗持续20 min，每周治疗2次，4周为1个疗程。

Description for medicine or protocol of treatment in detail：

In the treatment group TENS therapy was followed by two steps and seven methods. The control group was treated with two steps and seven methods. Technique: 15 minutes twice a week. TENS therapy: 20 minutes twice a week for 4 weeks. The specific operation steps of Wei's two-step seven method are as follows: 1) The first step method. In the prone position the manipulator carried out manipulations in accordance with the back point rubbing waist lifting plucking and rubbing leg lifting point rubbing shaking the waist and tapping the waist and back. After the completion of the above manipulations the manipulations were performed for three consecutive sections. 2) The second step technique. The patient takes the supine position the manual operator mainly carries out the "hanging foot pressure knee" technique from low to high gradually increasing generally requiring about 10 times. The above prone and supine two positions a total of seven steps of manipulation all the manipulation is completed as a manipulation treatment. The patients were treated twice a week for 15 to 20 minutes each time for 4 weeks. The specific operation steps of TENS therapy are as follows: wireless surface electromyography (Shanghai Nuocheng Electric Co. LTD.) is used for treatment. During the treatment the stimulation electrodes are placed in the vertical spine muscle (L4-S1) gluteus media muscle and gastrocnemius muscle respectively and the stimulation frequency of 1~100 Hz is used for electrical stimulation therapy. The parameters are: frequency 20 Hz current 8~30mA pulse width 10~200μs. During treatment the stimulation current intensity was adjusted with time according to the patient's condition and the current was increased by 0.2mA for each increase. Each treatment lasted 20 min 2 times a week 4 weeks for 1 course.

纳入标准：

1）符合腰椎间盘突出症诊断标准，参照《腰椎间盘突出症诊疗中国疼痛专家共识》的相关内容。 2）签署带日期的知情同意书，承诺遵守研究程序，并配合实施全过程研究。 3）年龄为18-50岁。 4）症状为单侧腰痛或腰腿痛麻木患者。

Inclusion criteria

1) To meet the diagnostic criteria for lumbar disc herniation refer to the relevant contents of the "Consensus of Chinese Pain Experts on the Diagnosis and Treatment of Lumbar disc herniation". 2) Sign a dated informed consent commit to abide by the research procedures and cooperate with the implementation of the whole process of the study. 3) Aged 18-50. 4) Patients with unilateral lumbago or numbness of lumbago and leg pain.

排除标准：

1）不能配合完成资料收集者或资料不全者； 2）合并腰椎骨折，或有结核、肿瘤等局部骨病患者； 3）合并有心血管、肝肾或造血系统等严重原发性疾患者。有其他自身免疫性疾病、变态反应性疾病和急、慢性感染者； 4）精神病患者，或有严重更年期症状的女性患者； 5）妊娠期或哺乳期妇女； 6）2周内正在进行其他本疾病疗法的实验研究

Exclusion criteria：

1）noncooperate with the completion of data collection or incomplete data 2) Patients with lumbar spine fracture or local bone diseases such as tuberculosis and tumor 3) Patients with serious primary diseases such as cardiovascular liver kidney or hematopoietic system. Other autoimmune diseases allergic diseases acute and chronic infections 4) Mental patients or female patients with severe menopausal symptoms 5) Pregnant or lactating women 6) Experimental studies of other treatments for this disease are being conducted within 2 weeks

研究实施时间：

Study execute time：

从From 2024-09-01

至To      2026-07-31

征募观察对象时间：

Recruiting time：

从From 2024-09-30

至To      2026-12-31

干预措施：

Interventions：

组别：

治疗组

样本量：

85

Group：

Treatment group;

Sample size：

干预措施：

魏氏手法加经皮神经电刺激疗法

干预措施代码：

Intervention：

wei's manipulation and Transcutaneous electrical nerve stimulation therapy

Intervention code：

组别：

对照组

样本量：

85

Group：

control group

Sample size：

干预措施：

魏氏手法疗法

干预措施代码：

Intervention：

wei's manipulation treatment

Intervention code：

样本总量 Total sample size ： 170

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

china

Province：

shanghai

City：

单位(医院)：

上海交通大学医学院附属瑞金医院

单位级别：

三级甲等综合性医院

Institution/hospital：

The Ruijin Hospital Afiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary general hospital

测量指标：

Outcomes：

指标中文名：

压痛点评估

指标类型：

次要指标

Outcome：

Tender point assessment

Type：

Secondary indicator

测量时间点：

治疗1周；治疗4周；治疗3个月后；治疗6个月后

测量方法：

检测与记录程序： a.按Power键打开电源，系统自检； b.按Unit键选择单位：磅、公斤、牛； c.在需要测量的肌肉表面垂直、缓慢按压，当患者感觉到疼痛，患者立即按下遥控开关，系统可以记录下测试数据； d.如果测量数据准确，按Record记录。如果测试过程中存在位置、按压不准确等问题，可以按Reset取消上一次测试数据； e.如无误，开始第二次测试，步骤与第一次测试相同； f.完成三次测量后，按Record显示三次测试平均值，该平均值代表了当前部位肌肉疼痛阈值。

Measure time point of outcome：

Treatment for 1 week; Treatment for 4 weeks; 3 months after treatment; Six months after treatment

Measure method：

Test and record program: a. Press the Power key to open the power supply system self-test; b. Press the Unit key to select the unit: pound kilogram ox; c. Press vertically and slowly on the muscle surface to be measured. When the patient feels pain the patient can press the remote control switch immediately and the system can record the test data; d. If the measurement data is accurate Record it according to record.

指标中文名：

Oswestry功能障碍指数量表

指标类型：

次要指标

Outcome：

ODI

Type：

Secondary indicator

测量时间点：

治疗1周；治疗4周；治疗3个月后；治疗6个月后

测量方法：

采用Oswestry功能障碍指数量表评定腰突症患者功能障碍情况，评估内容包括疼痛、单项功能和个人综合功能3个方面10项内容

Measure time point of outcome：

Treatment for 1 week; Treatment for 4 weeks; 3 months after treatment; Six months after treatment

Measure method：

Oswestry Disability Index was used to assess the functional impairment of patients with lumbago. The assessment included 10 items in 3 aspects: pain individual function and individual comprehensive function

指标中文名：

日本骨科协会评估治疗分数

指标类型：

次要指标

Outcome：

Japanese Orthopaedic Association ScoresJOA

Type：

Secondary indicator

测量时间点：

治疗1周；治疗4周；治疗3个月后；治疗6个月后

测量方法：

JOA评分包括主观症状(下腰痛,腿痛,步态),临床体征(直腿抬高,感觉障碍,运动障碍),日常活动受限度和膀胱功能四个部分,总分29分，分数越低表明功能障碍越明显。

Measure time point of outcome：

Treatment for 1 week; Treatment for 4 weeks; 3 months after treatment; Six months after treatment

Measure method：

The JOA score includes four components: subjective symptoms (low back pain leg pain gait) clinical signs (straight leg elevation sensory impairment motor impairment) limited daily activities and bladder function with a total score of 29 with lower scores indicating greater dysfunction.

指标中文名：

视觉模拟评分量表

指标类型：

次要指标

Outcome：

Visual analog rating scale

Type：

Secondary indicator

测量时间点：

治疗1周；治疗4周；治疗3个月后；治疗6个月后

测量方法：

使用一条长约10cm的游动标尺，一面标有10个刻度，两端分别为“0”分端和“10”分端，0分表示无痛，10分代表难以忍受的最剧烈的疼痛。

Measure time point of outcome：

Treatment for 1 week; Treatment for 4 weeks; 3 months after treatment; Six months after treatment

Measure method：

Use a walking scale about 10cm long one side marked with 10 scales the two ends of the "0" end and "10" end 0 indicates no pain 10 indicates the most unbearable pain.

指标中文名：

有效性评价

指标类型：

主要指标

Outcome：

Effectiveness evaluation

Type：

Primary indicator

测量时间点：

治疗1周；治疗4周；治疗3个月后；治疗6个月后

测量方法：

计算方法参照《中药新药临床研究指导原则》，干预前后主要结局指标症状量表积分改善率计算方法（尼莫地平法）:积分改善率=［（治疗前评分－治疗后评分）/治疗前评分］× 100% 。临床痊愈: 症状积分改善率≥95% ；显效:症状积分改善率 ≥70%，＜ 95% ；有效: 症状积分改善率 ≥30%，＜70%；无效:症状积分改善率＜30%。 总有效率 =（治愈例+显效例+有效例）/本组总病例。疗效判定标准参照国家中医药管理局发布《中医病证诊断疗效标准》中腰椎间盘突出症之疗效标准进行评定，结合治疗前后相关量表等临床疗效评价指标的变化情况，综合疗效评价是以症状记分、病期加权或主要评价观察指标的总积分计算出疗效率，分4级判定。

Measure time point of outcome：

Treatment for 1 week; Treatment for 4 weeks; 3 months after treatment; Six months after treatment

Measure method：

According to the Guiding Principles for Clinical Research of New Chinese Medicines the score improvement rate of symptom scale the main outcome indicator before and after intervention was calculated (Nimodipine method) : score improvement rate = [(pre-treatment score - post-treatment score)/pre-treatment score] × 100%. Clinical recovery: symptom score improvement rate ≥95%; Obvious effect: symptom score improvement rate ≥70% < 95%; Effective:

指标中文名：

肌肉组织状态评估

指标类型：

次要指标

Outcome：

Assessment of muscle tissue status

Type：

Secondary indicator

测量时间点：

治疗1周；治疗4周；治疗3个月后；治疗6个月后

测量方法：

检测设备：肌肉状况快速测定系统（日本伊藤超短波株式会社，OE-220）。 竖脊肌状态评估方案： a.患者俯卧，手放松放在身体两侧；检查者站其一侧；触诊手放在两侧竖脊肌外侧缘； b.令患者微微抬起上身，垂直肌纤维方向触摸竖脊肌的紧张收缩程度并双侧对比； c.整个竖脊肌位置确定后令患者放松，触诊其基础张力。 检测点标定：竖脊肌：双髂后上嵴连线标定腰4-5椎间隙。向上及向下标定腰3-4及腰5骶1间隙，平对间隙旁开1.5cm处标定竖脊肌测定点，每侧各3个。

Measure time point of outcome：

Treatment for 1 week; Treatment for 4 weeks; 3 months after treatment; Six months after treatment

Measure method：

Testing equipment: Rapid muscle condition measurement system (OE-220 ITO Ultrashave Co. LTD.). Assessment of the status of the erector spine muscle: a. The patient lay on his stomach with hands relaxed at his sides; The inspector stands to one side; Palpation hand placed on lateral margin of vertical spinalis muscle on both sides; b. Ask the patient to slightly lift the upper body touch the tension and contraction degree of the vertical spinal

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 50 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

简单随机，统计师用Sas9.2的proc plan 过程产生

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

Simple random generated by the statistician using Sas9.2's proc plan process

盲法：

Blinding：

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）：

病例报告表

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

Case report form

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：

病例记录表

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

Case report form

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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