Optimization of External Treatment for Knee Osteoarthritis: a Randomized and Controlled Clinical Trial

注册号:

Registration number:

ITMCTR2000003283

最近更新日期:

Date of Last Refreshed on:

2020-05-07

注册时间:

Date of Registration:

2020-05-07

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

膝骨性关节炎中医外治法方案优化研究—一项随机、对照的临床试验研究

Public title:

Optimization of External Treatment for Knee Osteoarthritis: a Randomized and Controlled Clinical Trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

膝骨性关节炎中医外治法方案优化研究—一项随机、对照的临床试验研究

Scientific title:

Optimization of External Treatment for Knee Osteoarthritis: a Randomized and Controlled Clinical 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:

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:

ChiCTR2000032710 ; ChiMCTR2000003283

申请注册联系人:

康武林

研究负责人:

袁普卫

Applicant:

Kang Wulin

Study leader:

Yuan Puwei

申请注册联系人电话:

Applicant telephone:

+86 15706028935

研究负责人电话:

Study leader's telephone:

+86 13892010780

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:

2031443565@qq.com

研究负责人电子邮件:

Study leader's E-mail:

spine_surgeon@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:

陕西省咸阳市渭阳西路副2号

研究负责人通讯地址:

陕西省咸阳市渭阳西路副2号

Applicant address:

Plus 2, Weiyang Road West, Xianyang City, Shannxi Provice, PR. China

Study leader's address:

Plus 2, Weiyang Road West, Xianyang, Shannxi, China

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:

陕西中医药大学附属医院

Applicant's institution:

Affiliated Hospital of Shaanxi 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:

SZFYIEC-PJ-2019年第31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:

陕西中医药大学附属医院伦理委员会

Name of the ethic committee:

IEC of Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2019/11/20 0:00:00

伦理委员会联系人:

吉娜

Contact Name of the ethic committee:

Ji Na

伦理委员会联系地址:

陕西省咸阳市渭阳西路副2号

Contact Address of the ethic committee:

Plus 2, Weiyang Road West, Xianyang, Shaanxi, China

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:

陕西中医药大学附属医院

Primary sponsor:

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

陕西省咸阳市渭阳西路副2号

Primary sponsor's address:

Plus 2, Weiyang Road West, Xianyang, Shaanxi, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

陕西

市(区县):

咸阳

Country:

China

Province:

Shaanxi

City:

Xianyang

单位(医院):

陕西中医药大学附属医院

具体地址:

渭阳西路副2号

Institution
hospital:

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Address:

Plus 2, Weiyang Road West

经费或物资来源:

陕西省科学技术厅

Source(s) of funding:

Department of science and technology of Shaanxi Province

研究疾病:

膝骨性关节炎

研究疾病代码:

Target disease:

Knee Osteoarthritis

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:

比较联合疗法(针灸、中药熏洗、中药蜡疗3种疗法同时治疗)与单纯针灸治疗膝骨性关节炎的有效性和安全性。

Objectives of Study:

To compare the efficacy and safety of combined therapy (Acupuncture, Chinese herbal fumigation, Chinese herbal wax therapy) and acupuncture in the treatment of knee osteoarthritis.

药物成份或治疗方案详述:

针灸治疗: 1)取穴:基础取穴+辨证取穴。基础取穴:阿是穴、血海、梁丘、阳陵泉、膝眼、大杼。辨证取穴:气滞血瘀型配膈俞;寒湿痹阻型配阴陵泉、足三里。 2)体位:根据取穴点确定受试者体位,坐位、仰卧位或者侧卧位。 3)定点、定穴:根据骨度分寸法等,用手揣摸按压欲针之处,确定穴位。 4)消毒:医者手指消毒:针刺前,用肥皂水将手指洗干净,再用75%乙醇棉球擦拭后,尽量避免手指直接接触针身。针刺部位消毒:用75%乙醇棉球从腧穴部位的中心点向外绕圈消毒。 5)操作:采用苏州产华陀牌一次性管针(0.30mm×25mm),直刺入穴位,针刺时,力争微痛或无痛刺入,同时需要注意确定针刺角度、方向和深度。进针深度按照选穴部位和受试者体型设定为10~20mm,各穴均运针采取平补平泻法,得气(酸麻胀重)为宜,留针20min。出针后用消毒棉球轻压针孔片刻,防治出血或针孔疼痛。 6)频率:1次/日,4次/周,共治疗3 周。 中药熏洗: 1)药方:气滞血瘀型:红花12g、川芎15g、赤芍15g、桂枝10g、细辛6g、威灵仙20g、刘寄奴20g、艾叶30g、花椒15g。寒湿痹阻型:制川乌10g、制草乌10g、威灵仙20g、细辛6g、艾叶30g、花椒15g、透骨草15g、海桐皮15g、独活12g、羌活12g、干姜12g、苍术12g。 2)制备:首先将诸药用纱布包好放置于药锅内,浸泡15min后用武火煎煮至沸腾,5 min后将武火改为文火再煎煮20 min,离火另加 100 ml陈醋,将上述药液倒于药浴桶中,加热水1500ml备用。以上制备过程均由同一人操作。 3)体位:嘱受试者将患膝置于药浴桶上先利用蒸汽进行熏蒸,待其自觉不烫皮肤时,直接在药浴桶内浸洗局部。 4)频率:每次40分钟,1次/日,4次/周,共治疗3 周。 中药蜡疗: 1)蜡饼制备:先用恒温蜡疗仪将固体石蜡融化,再用专用蜡盘将石蜡冷却凝结成饼(表面 45~50℃),其厚度为3-4cm为宜,将切好的柔软石蜡用透油布装好。 2)中药药液制备:药液组成:气滞血瘀型:威灵仙20g、土鳖虫10g、血竭15g、透骨草15g、三棱15g、细辛6g、制川乌10g、制草乌19g、冰片10g、花椒15g。寒湿痹阻型:独活15g、牛膝12g、防己15g、制草乌10g、干姜6g、麻黄6g、细辛6g、桂枝15g。用75%酒精将上述药物浸泡1周时间,取浸泡液的上层用于患者使用。经过辨证施治后选取适合患者的方药进行煎煮,冷却至约45 ℃后留置待用。 3)体位:受试者取舒适体位,暴露治疗部位,将含有中药的药液均匀涂擦于膝关节周围,再将表面罩有透油布的蜡饼敷于治疗部位,尽量保证蜡饼能全面的接触治疗部位,用保温棉布进行包裹,防止散热;再用弹力绷带绑紧蜡块及患部即可;20min后取下,将石蜡倒回保温箱进行清洗消毒后备用。治疗过程中注意蜡饼的温度,防止烫伤。 4)频率:每次40分钟,1次/日,4次/周,共治疗3 周。

Description for medicine or protocol of treatment in detail:

Acupuncture treatment: 1) Acupuncture treatment was conducted by inserting needles into essential acupoints and additional acupoints as appropriate. The essential acupoints included six acupoints which were Ashi, Xuehai, Liangqiu, Yanglingquan, Xiyan, and Dashu. additional acupoints depended on that if Participants were differentiated as Qizhixueyu type then acupoint selection was Geyu, and if Hanshizubi type then Yanglingquan and Zusanli. 2) According to various acupoints, we decided the patient's postures differently Sitting, supine or lateral. 3) Locating acupoints: According to the measurement of Chinese medicine (measured by the unit of Cun, one Cun was about two centimeters), the corresponding acupoints were located by the acupuncturist. 4) Disinfection: the acupuncturist hand was disinfected by washing soap water firstly and wiping fingers with 75% alcohol. disinfection of participates' acupoint site was also used by 75% alcohol with wiping from center to outward. 5) Hwato brand disposable acupuncture needles (size 0.30 x 75 mm) was used. Needle insertion followed an angle of 90°in an inferomedial direction acupoints. Following needle insertion, small, equal manipulations of twirling, lifting and thrusting were performed on all needles to reach de qi (a composite of sensations including soreness, numbness, distention, heaviness, and other sensations), which is believed to be an essential component for acupuncture efficacy. 6) Frequency: once/day, four times/week, total treatment time was 3 weeks. Herbal fumigation: 1) Herbal prescription: Qizhixueyu type (Honghua 12g, Chuanqiong 15g, Chishao 15g, Guizhi 10g, Xixin 6g, Weilinxian 20g, Liujinu 20g, Aiye 30g, Huajiao 15g). Hanshibizu type (Zhichuanwu 10g, Zhicaowu 10g, Weilinxian 20g, Xixin 6g, Aiye 30g, Huajiao 15g, Tougucao 15g, Haitongpi 15g, Duhuo 12g, Qianghuo 12g, Ganjiang 12g, Cangzhu 12g). 2) Medicine Preparation: First, wrap all the medicinal gauze in the medicine pot, soak it for 15 minutes, then boil it with the fire till it boils, then change the fire to the gentle fire for another 20 minutes after 5 minutes, add another 100 ml vinegar from the fire, pour the above medicine solution into the medicine bath barrel, and heat the water for 1500 ml for standby. The above preparation process is operated by the same person. 3) Body position: ask the subject to put the knee on the medicine bath bucket and use the steam to fumigate first. When the subject does not burn the skin consciously, wash the part directly in the medicine bath bucket. 4) Frequency: once(40 minutes)/day, four times/week, total treatment time was 3 weeks. Traditional Chinese medicine wax therapy: Wax cake preparation: First, melt the solid paraffin with the constant temperature wax therapy instrument, then cool and condense the paraffin into a cake (surface 45-50 degrees C) with a special wax pan, the thickness of which is 3-4cm, and then pack the cut soft paraffin with a tarpaulin. Preparation of liquid of herbal: Qizhixueyu type (Weilinxian 20g, Tubiechong 10g, Xuejie 15g, Tougucao 15g, Sanlin 15g, Xixin 6g, Zhichuanwu 10g, Zhicaowu 19g, Bingpian 10g, Huajiao 15g). Hanshibizu type (Duhuo 15g, Niuxi 12g, Fangji 15g, Zhicaowu 10g, Ganjiang 6g, Mahuang 6g, Xixin 6g, Guizhi 15g). The above drugs were soaked with 75% alcohol for one week, and the upper layer of the soaking solution was used for patients. After syndrome differentiation and treatment, select the appropriate prescription for patients to decoct, cool to about 45 degrees C, and then leave it for use. Body position: The subjects took a comfortable position, exposed the treatment site, evenly applied the liquid containing traditional Chinese medicine around the knee joint, and then applied the wax cake covered with a tarpaulin on the treatment site, Try to ensure that the wax cake can fully contact the treatment part, wrap it with heat preservation cotton cloth to prevent heat dissipation; then tie the wax block and the affected part with an elastic bandage; take it off 20 minutes later, and return the wax to the heat preservation box for cleaning and disinfection before standby. During the treatment, pay attention to the temperature of wax cake to prevent scalding. 6) Frequency: once (40 minutes)/day, four times/week, total treatment time was 3 weeks.

纳入标准:

1)符合上述西医诊断标准及《膝骨关节炎中医诊疗专家共识(2015年版)》气滞血瘀、寒湿痹阻型膝骨关节炎患者; 2)年龄≥40周岁,性别不限; 3)研究膝骨关节炎的X 线证据为0—Ⅲ级(Kellgren Lawrence 放射学评分); 4)体重指数(BMI)≤35kg/m2;体质指数(BMI)=体重(kg)/身高 (m)^2 5)WOMAC评分中疼痛子量表的5个问题中至少有1个问题的得分为40分或更高。 6)2周内未经过膝骨关节炎系统治疗的患者,且能按计划坚持完成治疗,并能够配合临床观察者及随访。 7)受试者在完全了解本研究的性质,本人疾病的性质,受试药物的特性,相关的治疗方法和参加本研究可能需承担的风险后,能理解并签署知情同意书。

Inclusion criteria

1) According to the above diagnosis standards of Western medicine and the consensus of experts on traditional Chinese medicine diagnosis and treatment of knee osteoarthritis (2015 Edition), patients with knee osteoarthritis of qi stagnation and blood stasis, cold dampness obstruction type; 2) Aged >= 40 years, male or female; 3) The X-ray evidence of knee osteoarthritis was grade 0-III (Kellgren Lawrence rating); 4) BMI <= 35kg / m2; BMI = weight (kg) / height (m) ^2; 5) At least one of the five questions on the pain subscale in the WOMAC score scored 40 or higher. 6) Patients who have not been treated with knee osteoarthritis system within 2 weeks can complete the treatment according to the plan and can cooperate with clinical observers and follow-up. 7) After the subjects fully understand the nature of the study, the nature of their disease, the characteristics of the test drug, the relevant treatment methods and the possible risks to be borne by participating in the study, they can understand and sign the informed consent.

排除标准:

1)膝关节其它炎性疼痛性疾病:风湿/类风湿性关节炎、牛皮癣性关节炎、痛风、血友病性关节炎、感染性关节炎等。 2)膝骨关节炎以外的膝关节疼痛性伤病,如关节内肿瘤、绒毛结节性滑膜炎、急性关节创伤(半月板撕裂、韧带损伤、骨软骨挫伤及骨折)等。 3)怀孕和哺乳期妇女。 4)有严重心脑血管(近6月内突发脑梗且有后遗症者、近6 月内突发心梗者)、肝脏(ALT、AST 为正常值上限2 倍及以上者)、肾脏疾病(血肌酐超过正常值上限者)、糖尿病需胰岛素注射者或血糖控制欠佳者(空腹血糖≥10mmol/L)、凝血功能障碍者(血小板减少,血友病等)。 5)患侧膝关节周围有皮肤缺损或溃疡者。 6)膝内翻>10°、膝外翻>20°畸形及关节间隙消失者。 7)在本次试验前1月内服用过糖皮质激素类药物或参加过其他药物的临床试验的患者。 8)在本次试验前3个月内进行过关节腔内治疗的患者,包括关节内用药,关节腔冲洗,关节镜手术。 9)已知对本试验相关药物成分过敏者。 10)其他经研究者判断不适合入选试验者。

Exclusion criteria:

1) Other inflammatory and painful diseases of the knee joint: rheumatism / rheumatoid arthritis, psoriasis arthritis, gout, hemophilic arthritis, infectious arthritis, etc. 2) Pain injury of knee joint other than osteoarthritis of the knee, such as an intraarticular tumor, villonodular synovitis, acute joint trauma (meniscus tear, ligament injury, bone cartilage contusion, and fracture), etc. 3) Pregnant and lactating women. 4) There are severe cardio cerebral vessels (cerebral infarction and sequelae in recent 6 months, myocardial infarction in recent 6 months), liver (alt, AST are the upper limit of normal value 2 Patients with multiple or above), kidney disease (patients with blood creatinine exceeding the upper limit of normal value), diabetes mellitus requiring insulin injection or poor blood glucose control (fasting blood glucose >= 10mmol / L), coagulation dysfunction (thrombocytopenia, hemophilia, etc.). 5) Patients with skin defects or ulcers around the affected knee joint. 6) The deformity of genu varus > 10 degrees, genu valgus > 20 degrees and joint space disappeared. 7) Patients who have taken glucocorticoids or participated in clinical trials of other drugs within one month before this trial. 8) The patients who were treated in the first 3 months of this trial included intra-articular medication, intra-articular irrigation, and arthroscopic surgery. 9) People who are known to be allergic to the drug components related to this test. 10) Other subjects judged by the researchers were not suitable for inclusion.

研究实施时间:

Study execute time:

From 2020-05-15

To      2023-05-15

征募观察对象时间:

Recruiting time:

From 2020-05-15

To      2023-05-15

干预措施:

Interventions:

组别:

单纯针灸治疗组

样本量:

70

Group:

Acupuncture group

Sample size:

干预措施:

针灸治疗

干预措施代码:

Intervention:

Treatment with Acupuncture

Intervention code:

组别:

联合疗法组

样本量:

70

Group:

Combined therapy group

Sample size:

干预措施:

针灸、中药熏洗、中药蜡疗3种疗法同时治疗

干预措施代码:

Intervention:

Treatment with Acupuncture, Chinese herbal fumigation and Chinese herbal wax therapy simultaneously

Intervention code:

样本总量 Total sample size : 140

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

陕西

市(区县):

咸阳

Country:

China

Province:

Shaannxi

City:

Xianyang

单位(医院):

陕西中医药大学附院医院

单位级别:

三级甲等

Institution/hospital:

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

SF-36生活质量评分、六分钟步行距离、20米步行时间基线与第24周的差值以及全器官磁共振成像评分系统(WORMS)评分、骨标志物6项数值以及膝关节B超检查包括髌上囊积液 、滑膜厚度、股骨软骨厚度及股骨软骨下骨质破坏程度的变化情况

指标类型:

次要指标

Outcome:

SF-36 quality of life score, six minute walking distance, the difference between the baseline and the 24th week of 20 meter walking time, worms score, six values of bone markers and B-ultrasound examination of knee joint, including the changes of hydrops of suprapatellar capsule, thickness of synovium, thicknes

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基线与治疗24周WOMAC关节功能评分差值

指标类型:

主要指标

Outcome:

Difference of WOMAC joint function score between baseline and 24 weeks ± 4 days

Type:

Primary indicator

测量时间点:

基线与治疗后24周

测量方法:

WOMAC评分量表

Measure time point of outcome:

baseline and 24 weeks

Measure method:

WOMAC index

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood sample

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:

正在进行

Recruiting

年龄范围:

最小 40
Min age years
最大 -
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):

采用SAS proc plan程序生成随机数字序列,并根据序列将受试者分为联合治疗组和单纯针灸组。

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

According to the random number sequence, the subjects were divided into the combined treatment group and the simple acupuncture group.

盲法:

未说明

Blinding:

Not stated

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):

试验结束后提交至该网站

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

Submit to this website after finishing study

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:

采用CRF表收集数据

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

Data collection was conducted by CRF

数据管理委员会:

Data Managemen Committee:

No

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
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