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Clinical study on treatment of cervical spondylosis with electroacupuncture combined with Danqi Tongluo decoction

注册号：

Registration number：

ITMCTR2000003677

最近更新日期：

Date of Last Refreshed on：

2020-08-24

注册时间：

Date of Registration：

2020-08-24

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

电针结合丹芪通络方治疗颈椎病的临床研究

Public title：

Clinical study on treatment of cervical spondylosis with electroacupuncture combined with Danqi Tongluo decoction

注册题目简写：

English Acronym：

研究课题的正式科学名称：

电针结合丹芪通络方治疗颈椎病的临床研究

Scientific title：

Clinical study on treatment of cervical spondylosis with electroacupuncture combined with Danqi Tongluo decoction

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：

ChiCTR2000036687 ; ChiMCTR2000003677

申请注册联系人：

孙德利

研究负责人：

孙德利

Applicant：

Sun Deli

Study leader：

Sun Deli

申请注册联系人电话：

Applicant telephone：

+86 13761536295

研究负责人电话：

Study leader's telephone：

+86 13761536295

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：

zjsdl@163.com

研究负责人电子邮件：

Study leader's E-mail：

zjsdl@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：

上海市徐汇区宛平南路725号

研究负责人通讯地址：

上海市徐汇区宛平南路725号

Applicant address：

725 Wanping Road South, Xuhui District, Shanghai

Study leader's address：

725 Wanping Road South, Xuhui District, Shanghai

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：

上海中医药大学附属龙华医院

Applicant's institution：

Longhua Hospital, Shanghai University of Traditional Chinese 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：

2020LHSB078

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：

上海中医药大学附属龙华医院医学伦理委员会

Name of the ethic committee：

Institutional Review Board Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020/8/14 0:00:00

伦理委员会联系人：

刘蕾

Contact Name of the ethic committee：

Liu Lei

伦理委员会联系地址：

上海市徐汇区宛平南路725号

Contact Address of the ethic committee：

725 Wanping Road South, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 021-64385700-1318

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：

上海中医药大学附属龙华医院

Primary sponsor：

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市徐汇区宛平南路725号

Primary sponsor's address：

725 Wanping Road South, Xuhui 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)：

上海中医药大学附属龙华医院

具体地址：

徐汇区宛平南路725号

Institution
hospital：

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Address：

725 Wanping Road South, Xuhui District

经费或物资来源：

上海申康医院发展中心

Source(s) of funding：

Shanghai Shenkang Hospital Development Center

研究疾病：

颈椎病

研究疾病代码：

Target disease：

Cervical spondylosis

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

建立电针结合丹芪通络方治疗颈椎病的临床治疗操作流程、质量控制标准和临床疗效评价，提供规范化技术操作文本。

Objectives of Study：

To establish the clinical treatment process, quality control standard and clinical effect evaluation of electroacupuncture combined with Danqi-Tongluo decoction in treating cervical spondylosis, and to provide the standardized technical operation text.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

入选病例严格按以下标准实行： 1) 诊断标准 参照国家中医药管理局《中医病症诊断疗效标准》中颈型、神经根型、椎动脉型、交感型颈椎病的诊断标准[1]选择病例。 颈椎病的诊断依据： (1)有慢性劳损或外伤史。或有颈椎先天性畸形、颈椎退行性病变。 (2)多发于40岁以上中年人，长期低头工作者或习惯于长时间看电视、录相者，往往呈慢性发病。 (3)颈、肩背疼痛，头痛头晕，颈部板硬，上肢麻木。 (4)颈部活动功能受限，病变颈椎棘突，患侧肩胛骨内上角常有压痛，可摸到条索状硬结。可有上肢肌力减弱和肌肉萎缩，臂丛牵拉试验阳性。压头试验阳性。 (5)X线正位摄片显示，钩椎关节增生，张口位可有凿状突偏歪，侧位摄片显示颈椎曲度变直，椎间隙变窄，有骨质增生或韧带钙化，斜位摄片可见椎间孔变小。CT及磁共振检查对定性定位诊断有意义。 病理分型： (1)颈型：枕颈部痛,颈活动受限,颈肌僵硬,有相应压痛点。X线片示: 颈椎生理弧度在病变节段改变。 (2)神经根型：颈痛伴上肢放射痛，颈前屈或后伸或侧屈时加重，受压神经根皮肤节段分布区感觉减弱，腱反射异常，肌萎缩，肌力减退，颈活动受限，牵拉试验、压头试验阳性。颈椎X线示：椎体增生，钩椎关节增生明显，椎间隙变窄，椎间孔变小。CT可见椎体后赘生物及神经根管变窄。 (3) 椎动脉型：头痛，眩晕，耳鸣，耳聋，视物不清，有体位性猝倒，颈椎侧弯后冲时，症状加重。X线片示：横突间距变小，钩椎关节增生。CT或MRI检查可显示左右横突孔大小不对称，一侧相对狭窄。椎动脉造影见推动脉迂曲，变细或完全梗阻。 (4) 交感型：眼睑无力，视力模糊，瞳孔扩大，眼窝胀痛，流泪，头痛，偏头痛，头晕，枕颈痛,心动过速或过缓，心前区痛，血压增高，四肢凉或手指发红发热，一侧肢体多汗或少汗等。X线片见钩椎增生，椎间孔变狭窄，颈椎生理弧度改变或有不同程度错位。椎动脉造影有受压现象。 中医证候分类： (1)风寒湿痹：颈、肩、上肢串痛麻木，以痛为主，头有沉重感，颈部僵硬，活动不利，恶寒畏风。舌淡红，苔薄白，脉弦紧。 (2)气滞血瘀：颈肩部、上肢刺痛，痛处固定，伴有肢体麻木。舌质暗，脉弦。 (3)痰湿阻络：头晕目眩，头重如裹，四肢麻木不仁，纳呆。舌暗红，苔厚腻，脉弦滑。 (4)肝肾不足：眩晕头痛，耳鸣耳聋，失眠多梦，肢体麻木，面红目赤。舌红少津，脉弦。 (5)气血亏虚：头晕目眩，面色苍白，心悸气短，四肢麻木，倦怠乏力。舌淡苔少，脉细弱。 2) 纳入标准 (1)符合颈椎病的诊断标准，且病理分型属颈型、神经根型、交感型或椎动脉型者。 (2)年龄在18—75岁之间。

Inclusion criteria

The selected cases were selected according to the following criteria: 1. the diagnostic criteria, the cases were selected according to the diagnostic criteria of cervical type, nerve root type, vertebral artery type and sympathetic type of cervical spondylosis in the State Administration of Traditional Chinese Medicine of Chinese medicine. The diagnosis of cervical spondylosis is based on: (1) a history of chronic strain or trauma. Or has the cervical vertebra congenital malformation, the cervical vertebra degeneration pathological change. (2) more than 40 years old in the middle-aged, long-term low-head workers or accustomed to a long time to watch television, video, often chronic disease. (3) Neck, shoulder and back pain, headache, dizziness, stiff neck, upper limb numbness. (4) the neck movement function is limited, the pathological change cervical vertebra spine process, the affected side Scapula in the upper horn often has the tenderness, may feel the cord shape Scleroma. May Have upper limb muscle weakness and muscle atrophy, brachial plexus traction test positive. Positive pressure head test. (5) the x-ray films showed that the UNCINATE joint was hyperplastic, the opening position was chisel-like, the lateral films showed that the cervical vertebral curvature became straight, the intervertebral space became narrow, there were bone hyperplasia or ligament calcification, and the oblique films showed that the intervertebral foramen became small. CT AND MRI are of significance in the qualitative and locational diagnosis. Pathological typing: (1) neck type: Occipital neck pain, limited neck movement, stiff neck muscles, corresponding tenderness point. X-ray film shows that the cervical Vertebra physiological radian changes at the pathological level. (2) radicular type: neck pain with radiating pain of upper limbs, aggravated by neck flexion or extension or lateral flexion, decreased sensation in the skin segment distribution area of the compressed nerve root, abnormal tendon reflex, muscle atrophy, decreased muscle strength, limited neck movement, positive results of traction test and head compression test. Cervical x-ray shows: Vertebral Body Hyperplasia, UNCINATE joint hyperplasia obvious, intervertebral space narrowing, intervertebral foramen smaller. CT showed posterior vegetations of vertebral body and narrowing of nerve root canal. (3) vertebral artery type: headache, Vertigo, tinnitus, deafness, blurred vision, orthostatic cataplexy, cervical scoliosis backward, symptoms aggravated. X-ray showed that the distance between the transverse processes became smaller and the UNCINATE vertebrae were hyperplastic. CT OR MRI examination can show the size of the left and right transverse foramen asymmetry, one side relatively narrow. Angiography of the vertebral artery showed tortuosity, thinning, or complete obstruction. (4) sympathetic: Eyelid weakness, blurred vision, dilated pupils, swelling of the eye socket, tears, headache, migraine, dizziness, occipitocervical pain, tachycardia or Bradycardia, precordial pain, high blood pressure, cold limbs or fingers red fever, excessive or little perspiration on one limb, etc. . X-ray films showed hyperplasia of UNCINATE Vertebra, narrowing of intervertebral foramen, physiological radian change of cervical vertebra or malposition in different degree. There was compression on the vertebral arteriography. Chinese Medicine Syndrome classification: (1) wind-cold-dampness: Neck, shoulder, upper limbs string pain numbness, mainly pain, the head has a heavy feeling, neck stiffness, adverse activities, aversion to cold wind. Tongue light red, thin white fur, pulse Taut. (2) Qi stagnation and blood stasis: Neck and shoulder, upper limb tingling, pain fixed, accompanied by limb numbness. Tongue dark, pulse stringy. (3) obstruction of collaterals due to phlegm-dampness: Dizziness, heavy head, Zombie limbs. The tongue is dark red, the fur is thick and greasy, the pulse strings are smooth. (4) deficiency of liver and Kidney: Dizziness, headache, tinnitus, deafness, insomnia, limb numbness, red eyes. The tongue is red and the pulse is stringy. (5) deficiency of Qi and blood: Dizziness, Pallor, palpitations, shortness of breath, numbness of limbs, lassitude and weakness. Light tongue with little coating and weak pulse. 2. inclusion criteria (1) meet the diagnostic criteria of cervical spondylosis, and the pathological classification is cervical, nerve root, sympathetic or vertebral artery type. (2) aged between 18 and 75 years.

排除标准：

1. 脊髓型颈椎病; 胸廓出口综合征、肩周炎、腕管综合征等； 2. X线片示椎间孔横径正常者；X线片示骨质增生非常严重形成骨桥者； 4. 伴有先天性畸形或脊柱侧弯畸形；患有骨肿瘤或结核；伴有高血压病、冠心病及其它严重内脏疾病。

Exclusion criteria：

1. cervical spondylotic myelopathy; Thoracic Outlet Syndrome, scapulohumeral periarthritis, carpal tunnel syndrome, etc.; 2. x-ray film showed normal transverse diameter of intervertebral foramen. 3. with congenital malformation or Scoliosis of the column; with Bone Tumor or tuberculosis. Accompanied by hypertension, coronary heart disease and other serious visceral diseases.

研究实施时间：

Study execute time：

从From 2020-10-01

至To      1990-01-01

征募观察对象时间：

Recruiting time：

从From 2020-10-01

至To      1990-01-01

干预措施：

Interventions：

组别：

电针药物治疗组

样本量：

150

Group：

Electroacupuncture and drug therapy group

Sample size：

干预措施：

电针+拔罐+TDP+丹芪通络方

干预措施代码：

Intervention：

Electroacupuncture + cupping therapy + TDP + Danqi-Tongluo decoction

Intervention code：

组别：

电针对照组

样本量：

150

Group：

Electroacupuncture control group

Sample size：

干预措施：

电针+拔罐+TDP

干预措施代码：

Intervention：

Electroacupuncture + cupping therapy+ TDP

Intervention code：

样本总量 Total sample size ： 300

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)：

上海中医药大学附属龙华医院

单位级别：

三级甲等

Institution/hospital：

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市宝山区中西医结合医院

单位级别：

三级甲等

Institution/hospital：

Shanghai Baoshan District Hospital of Traditional Chinese and Western medicine

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市光华中西医结合医院

单位级别：

三级甲等

Institution/hospital：

Shanghai Guanghua Hospital of Traditional Chinese and Western medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

颈椎功能障碍指数（NDI）调查问卷

指标类型：

主要指标

Outcome：

Cervical spine dysfunction index (Ndi) questionnaire

Type：

Primary indicator

测量时间点：

治疗前及治疗后4周、8周、4个月及6个月后随访

测量方法：

Measure time point of outcome：

Follow-up before treatment and 4,8,16 and 24 weeks after treatment

Measure method：

指标中文名：

肝肾功能

指标类型：

副作用指标

Outcome：

Liver and kidney function

Type：

Adverse events

测量时间点：

治疗前与治疗8周后

测量方法：

Measure time point of outcome：

Before and after 8 weeks of treatment

Measure method：

指标中文名：

颈椎CT或MRI

指标类型：

次要指标

Outcome：

CT or MRI of the cervical spine

Type：

Secondary indicator

测量时间点：

治疗前

测量方法：

Measure time point of outcome：

治疗前 6/5000 Before treatment

Measure method：

指标中文名：

临床疗效评价

指标类型：

主要指标

Outcome：

Evaluation of clinical efficacy

Type：

Primary indicator

测量时间点：

治疗前及治疗后4周、8周、4个月及6个月后随访

测量方法：

Measure time point of outcome：

Follow-up before treatment and 4,8,16 and 24 weeks after treatment

Measure method：

指标中文名：

视觉模拟评分法

指标类型：

主要指标

Outcome：

VAS

Type：

Primary indicator

测量时间点：

治疗前及治疗后4周、8周、4个月及6个月后随访

测量方法：

Measure time point of outcome：

Follow-up before treatment and 4,8,16 and 24 weeks after treatment

Measure method：

指标中文名：

TCD检查

指标类型：

主要指标

Outcome：

TCD

Type：

Primary indicator

测量时间点：

治疗前和治疗后1月

测量方法：

Measure time point of outcome：

Before treatment and 1 month after treatment

Measure method：

指标中文名：

颈椎病临床症状体征记分法

指标类型：

主要指标

Outcome：

Scoring method for clinical symptoms and signs of cervical spondylosis

Type：

Primary indicator

测量时间点：

治疗前及治疗后4周、8周、4个月及6个月后随访

测量方法：

Measure time point of outcome：

Follow-up before treatment and 4,8,16 and 24 weeks after treatment

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

静脉血

组织：

Sample Name：

Venous blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 岁
Min age years
最大 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）：

SPSS 21.0统计软件产生随机序列

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

SPSS 21.0 statistical software produces random sequences

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

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）：

依托学校及医院科研平台进行共享

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

Relying on the scientific research platform of schools and hospitals for sharing

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：

数据通过手写记录及电子保存、整理、归纳，并按时填写患者病例报告表。

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

The data are saved, sorted and summarized by hand-written record and electronic record, and the patient case report form is filled out on time.

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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