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Effect of Thunder-Fire Moxibustion for Lumbar Disc Herniation: A Randomized Controlled Trial

注册号：

Registration number：

ITMCTR2000003609

最近更新日期：

Date of Last Refreshed on：

2020-08-21

注册时间：

Date of Registration：

2020-08-21

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

雷火灸治疗腰椎间盘突出症的随机对照试验研究

Public title：

Effect of Thunder-Fire Moxibustion for Lumbar Disc Herniation: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

雷火灸治疗腰椎间盘突出症的随机对照试验研究

Scientific title：

Effect of Thunder-Fire Moxibustion for Lumbar Disc Herniation: A Randomized Controlled Trial

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：

中央级公益性科研院所基本科研业务费专项基金项目（ZZ140518）

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：

ChiCTR2000036079 ; ChiMCTR2000003609

申请注册联系人：

张佳乐

研究负责人：

王雪

Applicant：

Jiale Zhang

Study leader：

Xue Wang

申请注册联系人电话：

Applicant telephone：

+86 17812051028

研究负责人电话：

Study leader's telephone：

+86 18100502952

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：

zhang_tcm@163.com

研究负责人电子邮件：

Study leader's E-mail：

651487961@qq.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：

北京市东城区东直门内南小街中国中医科学院中医基础理论研究所619室

研究负责人通讯地址：

安徽省芜湖市南陵县南陵阳西路南陵县中医医院针灸推拿科

Applicant address：

Room 619, Institute of Basic Theory of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Dongcheng District, Beijing

Study leader's address：

Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province

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：

中国中医科学院中医基础理论研究所

Applicant's institution：

Institute of Basic Theory of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences

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：

伦研批第（007）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：

南陵县中医医院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of Nanling Hospital 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：

梁金春

Contact Name of the ethic committee：

Jinchun Liang

伦理委员会联系地址：

安徽省芜湖市南陵县南陵阳西路南陵县中医医院

Contact Address of the ethic committee：

Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu, Anhui

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

南陵县中医医院

Primary sponsor：

Nanling Hospital of traditional Chinese Medicine

研究实施负责（组长）单位地址：

安徽省芜湖市南陵县南陵阳西路

Primary sponsor's address：

Nanling Road West, Nanling County, Wuhu, Anhui

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽

市(区县)：

芜湖

Country：

China

Province：

Anhui

City：

Wuhu

单位(医院)：

南陵县中医医院

具体地址：

南陵县南陵阳西路

Institution
hospital：

Nanling Hospital of Traditional Chinese Medicine

Address：

Nanling Road West, Nanling County

经费或物资来源：

中央级公益性科研院所基本科研业务费专项基金项目（ZZ140518）

Source(s) of funding：

Fundamental Research Funds for the Central public welfare research institutes (ZZ140518)

研究疾病：

腰椎间盘突出症

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

腰椎间盘突出症(LDH)是骨科和创伤学的常见疾病之一，是由髓核突出症刺激马尾神经、神经根和椎间盘退变引起的。其临床表现为腰痛、下肢放射性疼痛、马尾神经症状，严重影响患者的生活质量。目前，口服镇痛药在临床非药物治疗中较为常用，但口服镇痛药会产生胃肠道反应等副作用。雷火艾灸是一种在我国已被广泛应用于治疗疼痛综合征的艾灸方法。本研究旨在设计雷火艾灸治疗腰椎间盘突出症的随机对照试验，探讨其是否比口服镇痛药物更安全、有效。

Objectives of Study：

Lumbar disc herniation (LDH) is one of the common diseases in orthopedics and traumatology, which is caused by nucleus pulposus herniation stimulating cauda equina nerve, nerve root, and intervertebral disc degeneration. Its clinical manifestations are low back pain, radiation pain of lower limbs, and cauda equina symptoms, which seriously affect the quality of life of patients. At present, oral analgesics are commonly used in clinical non-drug therapy for LDH, but oral analgesics will produce gastrointestinal reactions and other side effects. Thunder-fire moxibustion is one kind of moxibustion methods, which has been applied widely for treating pain syndromes in China. Our research aims to design a randomized controlled trial of thunder-fire moxibustion in the treatment of lumbar disc herniation to explore whether it is safer and effective than oral analgesic drugs.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

The operators(acupuncturists) of this experiment have more than two years of work experience and have been trained again before the test. The moxa stick is produced by Nanyang Xiancao Industry Co., Ltd. Each moxa stick is 40mm in diameter, 109g in weight, and 15cm in length. The treatment site is at the lower waist. The BL25 (Dachangshu), GV3 (Yaoyangguan), BL23 (Shenshu), and GV4 (Mingmen) will be taken during the treatment(Fig 2). The subject should be in a prone position. One moxa stick will be hold by the operator who ignites the top of the stick. Then put the moxa stick on the treatment site, and the fire head is about 3cm away from the skin. After 15 minutes of local whirling moxibustion, the contralateral acupoints will be treated with moxibustion for 15 minutes. The frequency of the treatment will be?five times for ten days, lasting for 20 days, a total of 10 times. Acetaminophen (0.65g per tablet) administered by Shanghai Johnson & Johnson Pharmaceutical Co. Ltd. will also last for 20 days, taking two tablets orally every other day. After the trial, all participants will choose to receive 6 free acupuncture treatments or health counseling as compensation.

纳入标准：

（1）患者年龄25~80岁，性别不限； （2）符合中西医LDH诊断标准，能配合试验相关要求； （3）受试者知情，并同意签署知情同意书。

Inclusion criteria

Participants will be enrolled with the following criteria in this study: (1) The age of the patients ranges from 25 to 80 years old. (2) It meets the diagnostic criteria of LDH in criteria of diagnosis and therapeutic effect of diseases and syndromes in traditional Chinese medicine and evidence-based clinical guidelines for the diagnosis and treatment of LDH with radiculopathy. (3) The clinical manifestations and imaging findings of the patients should be consistent with lumbar disc herniation. (4) The subjects must achieve informed consent and sign the informed consent.

排除标准：

(1)严重心、脑、肝及造血系统等疾病，或其它影响其生存的其它严重疾病； (2)已知的肝肾功能不全或合并肝硬化者; (3)高热、传染性疾病患者。 (4)妊娠期或哺乳期的女性； (5)精神病患者或其他行动不能配合治疗者 (6)对本试验涉及的所有治疗过敏或可疑过敏者； (7)病情较重，需行手术治疗者； (8)自入院前3月，曾正在参加另外一项临床研究者。

Exclusion criteria：

(1) Severe heart, brain, liver, and hematopoietic system diseases, or other serious diseases that affect their survival. (2) Patients with known hepatic and renal insufficiency or cirrhosis. (3) Patients with high fever and infectious diseases. (4) Pregnant or lactating women. (5) Mental patients or other actions can not cooperate with the treatment. (6) All patients with treatment allergies or suspected allergies involve in this trial. (7) The patients with severe LDH who needs surgical treatment. (8) Patients who have been participating in another clinical study more than 3 months before admission.

研究实施时间：

Study execute time：

从From 2020-09-01

至To      2022-05-01

征募观察对象时间：

Recruiting time：

从From 2020-09-01

至To      2022-05-01

干预措施：

Interventions：

组别：

雷火灸组

样本量：

45

Group：

Thunder-Fire Moxibustion group

Sample size：

干预措施：

雷火灸治疗

干预措施代码：

Intervention：

Thunder-Fire Moxibustion

Intervention code：

组别：

口服西药组

样本量：

45

Group：

Acetaminophen group

Sample size：

干预措施：

药物治疗

干预措施代码：

Intervention：

Medical treatment

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

安徽

市(区县)：

Country：

China

Province：

Anhui

City：

单位(医院)：

南陵县中医医院

单位级别：

二级甲等

Institution/hospital：

Nanling Hospital of traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视觉模拟评分(VAS)

指标类型：

次要指标

Outcome：

Visual analogue scale (VAS)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

Incidence of adverse events

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

日本骨科协会下腰痛评分(JOA)

指标类型：

主要指标

Outcome：

Japanese Orthopaedic Association (JOA) scores

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Oswestry功能障碍指数(ODI)

指标类型：

次要指标

Outcome：

Oswestry disability index (ODI)

Type：

Secondary 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：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 25 岁
Min age years
最大 80 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）：

我们将采用一种简单的随机化方法。SPSS软件（24.0版）将用于创建随机化序列。LDH患者的参与者将被以1：1的比例随机分配到雷火灸组或对乙酰氨基酚组。

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

A simple randomization method will be used. SPSS software (version 24.0) will be used to create the randomization sequence. Participants with LDH will be randomly assigned to the group of thunder-fire moxibustion or acetaminophen in a 1:1 ratio.

盲法：

这是一项开放标签的试验；参与者和针灸师都不会设盲。所有的评估人员、数据记录者和统计学家都将独立运作；随机化的工作人员和针灸师将知道分配信息，对评估人员和统计人员设盲。每个参与者将被单独治疗，以防止任何研究信息的交换。在发生退出的情况下，研究助理将为参与者提供相关信息，其中应包括参与者的治疗分配和结果数据。

Blinding：

This is an open-label trial; neither the participants nor the acupuncturists will be blinded for the treatment. All assessors, data recorders, and statisticians will all operate independently; the randomization staff and acupuncturists will know the allocation information, while the assessor and statistician will stay blind to this information throughout the study. Each participant will be treated separately to prevent any exchange of study information. In the case that withdrawal occurs, the study research assistant will provide the relevant information for the participants, which should include the participants treatment assignment and outcome data.

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）：

试验完成后3个月内以论文发表的形式公开。

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

It will be published in the form of papers within 3 months after the completion of the experiment.

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：

以病例记录表采集数据。

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

We will use CRF to collect data.

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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