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基于CT三维重建探讨针灸联合关节错缝术对膝骨性关节炎关节功能的调节作用效果

注册号：

Registration number：

ITMCTR2024000885

最近更新日期：

Date of Last Refreshed on：

2024-12-28

注册时间：

Date of Registration：

2024-12-28

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于CT三维重建探讨针灸联合关节错缝术对膝骨性关节炎关节功能的调节作用效果

Public title：

The Effect of Acupuncture Combined with Joint Dislocation on Joint Function of Knee Osteoarthritis Based on CT Three-Dimensional Reconstruction

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于CT三维重建探讨针灸联合关节错缝术对膝骨性关节炎关节功能的调节作用效果

Scientific title：

The Effect of Acupuncture Combined with Joint Dislocation on Joint Function of Knee Osteoarthritis Based on CT Three-Dimensional Reconstruction

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：

何颖

研究负责人：

童娟

Applicant：

He Ying

Study leader：

Tong Juan

申请注册联系人电话：

Applicant telephone：

13422068176

研究负责人电话：

Study leader's telephone：

13826203550

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：

532937038@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1160739011@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：

广州医科大学附属第一医院

研究负责人通讯地址：

广州医科大学附属第一医院

Applicant address：

The First Affiliated Hospital of Guangzhou Medical University

Study leader's address：

The First Affiliated Hospital of Guangzhou Medical University

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：

广州医科大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Guangzhou Medical University

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：

ES-2024-049-03

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

广州医科大学附属第一医院科研项目审查伦理委员会

Name of the ethic committee：

Ethics Committee of Research Project Review of the First Affiliated Hospital of Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024/10/15 0:00:00

伦理委员会联系人：

张晓露

Contact Name of the ethic committee：

Zhang Xiaolu

伦理委员会联系地址：

广州医科大学附属第一医院

Contact Address of the ethic committee：

The First Affiliated Hospital of Guangzhou Medical University

伦理委员会联系人电话：

Contact phone of the ethic committee：

020-81566265

伦理委员会联系人邮箱：

Contact email of the ethic committee：

gyfyky_ec@163.com

研究实施负责（组长）单位：

广州医科大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广东省广州市越秀区沿江路151号

Primary sponsor's address：

151 Yanjiang Road, Yuexiu District, Guangzhou City, Guangdong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州医科大学附属第一医院

具体地址：

广东省广州市越秀区沿江路151号

Institution
hospital：

The First Affiliated Hospital of Guangzhou Medical University

Address：

151 Yanjiang Road, Yuexiu District, Guangzhou City, Guangdong Province

经费或物资来源：

广州医科大学科研能力提升计划重大临床研究项目

Source(s) of funding：

Major Clinical Research Project of Guangzhou Medical University's Research Capability Enhancement Program

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：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

1、研究针灸联合关节错缝术疗法对膝骨性关节炎治疗效果； 2、运用CT三维成像技术，评估针灸联合关节错缝术疗法对膝骨性关节炎患者膝关节屈曲15°及50°状态下股骨滑车角（FTA）、髌骨倾斜角（PTA）、外侧髌股角（LPTA）、和谐角（CA）及髌股指数（PFI）的调节效果，探讨方案对膝骨性关节炎患者膝內骨间距的调整作用及关节功能的改善效果； 3、运动步态分析技术，探讨针灸联合关节错缝术疗法对膝骨性关节炎患者日常活动中的下肢关节运动学（步行周期中的步速、步长、跨步长和步宽值），与关节载荷的影响及临床意义，明确治疗技术对膝关节活动功能的调节作用 4、确立膝骨性关节炎早、中期防治中西医联合方案。

Objectives of Study：

1. To study the effect of acupuncture combined with joint dislocation on KOA. 2. To evaluating the adjustment effects of acupuncture combined with joint dislocation on femoral trochlear angle (FTA) patellar inclination angle (PTA) lateral patellofemoral angle (LPTA) harmonious angle (CA) and patellofemoral index (PFI) in patients with KOA under 15° and 50° knee flexion by CT three-dimensinal imaging. To investigate the effect of this treatment protocol on the adjustment of intra-knee bone spacing and the improvement of joint function in patients with KOA. 3. To explore the influence and clinical significance of acupuncture combined with joint dislocation therapy on lower limb joint kinematics (step speed step length stride length and step width in walking cycle) and joint load in patients with KOA during daily activities by kinematic gait analysis technology and to clarify the adjustment effect of the treatment protocol on knee joint activity function. 4. To establish the early and middle treatment of traditional Chinese and western medicine combined program on KOA.

药物成份或治疗方案详述：

1.研究对象 符合纳入标准的KOA患者，共约110例，另选取符合膝骨性关节炎诊断标准的无症状患者30例。 2.研究流程 本研究为随机、单盲对照干预性研究。广州医科大学附属第一医院中医针灸专业组全面负责本方案的组织和实施工作。采用随机对照试验将患者分为两组，其中针灸+关节错缝术+玻璃酸钠组55例，对照组为安慰针+关节错缝术+玻璃酸钠组55例，另选取符合膝骨性关节炎诊断标准的无症状患者30例。所有患者均需两组治疗均5天一次，5次为一疗程，要求在4周内完成所有治疗。 3.治疗方案 （1）针灸法+关节错缝术+玻璃酸钠注射液组： 针灸疗法：穴位选取：患侧内、外膝眼，梁丘，阴陵泉，曲泉，使用治疗针针刺腧穴。治疗针（规格0.40×25mm，无锡佳健医疗器械股份有限公司）与平时所用的毫针一样，针尖锐利，可刺入皮下，外附塑料管套及硅胶底座（DONGBANGACUPUNCTURE，INC）固定针身并作掩饰。受试者取仰卧位，腧穴以碘附消毒，消毒后在相应穴位固定好管套及底座，毫针通过管套直刺入皮下，进针深度为1-1.5cm，不行针。针刺后，在每个腧穴针柄上插入1厘米长左右的艾条并点燃，待艾条燃尽约20min后可出针。出针时，先拔出针，采取适当体位遮挡受试者视线，迅速将针放入有遮盖的针盒内，然后再去掉塑料管套及固定底座，最后用消毒棉签适当按压。 关节错缝术：针刺对患者行放松手法后，运用按揉拿等手法放松膝关节周围软组织，左右上下松解髌周黏连组织，治疗20min，手法松解时嘱患者双手抓住床沿，后其中一名施术者根据髌骨旋转情况按压髌骨向内（外）斜下45度推动，另一名施术者向小腿方向做直拉及下肢反方向旋转，操作要求两位术者同时用力，术中可以听见关节松解弹响声，术毕屈伸膝关节3次，治疗时间10min。 玻璃酸钠注射：分别在患处膝关节髌下内侧及髌上外出交替在关节腔内注射玻璃酸钠注射液2.5ml，一周1次，5次为一疗程。 治疗顺序：先进行针灸治疗后，再进行玻璃酸钠注射治疗，最后进行关节错缝术治疗。 （2）安慰针+关节错缝术+玻璃酸钠注射液组： 安慰针：安慰针（规格：0.40×25mm，苏州市华伦医疗用品有限公司）外表与治疗针相同，但针尖钝平，不刺入皮下（作用原理同Streitberger安慰针，Streitberger安慰针是一种非穿透性安慰针，在国际上常用于针刺疗效研究的 单盲试验中[10-13]），外亦附有塑料管套及硅胶底座（DONGBANGACUPUNCTURE， INC）。取穴、针刺及出针均同针灸组。针刺后，在每个腧穴针柄上插入1厘米长左右的艾条但不点燃，再加TDP灯照射患膝，留针20min后出针。 关节错缝术：同上 玻璃酸钠注射：同上 治疗顺序：同上 两组治疗均5天一次，5次为一疗程，要求在4周内完成所有治疗。

Description for medicine or protocol of treatment in detail：

1. Research object About 110 KOA patients met the inclusion criteria and an additional 30 asymptomatic patients who met the diagnostic criteria for KOA were selected. 2. Research process This study is a randomized single blind controlled intervention study. The TCM acupuncture and moxibustion Professional Group of the First Affiliated Hospital of Guangzhou Medical University is fully responsible for the organization and implementation of this scheme. Randomized controlled trial was used to divide the patients into two groups including 55 cases in the acupuncture +joint dislocation +sodium hyaluronate injection group and 55 cases in the control group of comfort acupuncture+joint dislocation +sodium hyaluronate injection group and 30 asymptomatic patients who met the diagnostic criteria of KOA. All patients require two sets of treatment once every 5 days with 5 sessions as one course of treatment and are required to complete all treatments within 4 weeks. 3. Treatment plan (1) Acupuncture +joint dislocation+sodium hyaluronate injection group: Acupuncture and moxibustion therapy: Acupoint selection: the affected side's inner and outer knee eyes Liangqiu Yinling Spring Qu Spring and acupuncture points with therapeutic needles. The therapeutic needle (specification 0.40 × 25mm Wuxi Jiajian Medical Equipment Co. Ltd.) is the same as the commonly used filiform needle with a sharp tip that can penetrate subcutaneously. It is attached with a plastic tube sleeve and a silicone base (DONGBANGATUPUNCURE INC) to fix the needle body and conceal it. The subject is placed in a supine position and the acupoints are disinfected with iodine. After disinfection the tube sleeve and base are fixed at the corresponding acupoints and a needle is inserted directly into the subcutaneous tissue through the tube sleeve at a depth of 1-1.5cm. No needle is allowed. After needling insert a 1 centimeter long moxa stick into the handle of each acupoint and ignite it. After the moxa stick burns out for about 20 minutes the needle can be removed. When removing the needle first pull out the needle take an appropriate position to block the subject's line of sight quickly place the needle into the covered needle box then remove the plastic tube cover and fixed base and finally press it appropriately with a disinfectant cotton swab. Joint Dislocation: After performing a relaxation technique on the patient with acupuncture the soft tissue around the knee joint is relaxed using techniques such as pressing kneading and grasping. The adhesive tissue around the patella is loosened left and right up and down and treated for 20 minutes. During the technique the patient is instructed to grasp the edge of the bed with both hands. One of the surgeons then presses the patella inward (outward) at a 45 degree angle according to the rotation of the patella while the other surgeon performs a straight pull towards the lower leg and a reverse rotation of the lower limb. The operation requires both surgeons to exert force simultaneously and a joint release sound can be heard during the operation. The knee joint is flexed and extended three times and the treatment time is 10 minutes. Sodium hyaluronate injection: Inject 2.5ml of sodium hyaluronate injection alternately into the joint cavity on the medial side below the patella and on the lateral side above the patella at the affected knee joint once a week with 5 times as one course of treatment. Treatment sequence: acupuncture and moxibustion treatment first then sodium hyaluronate injection treatment and finally joint dislocation suture treatment. (2) Comfort acupuncture+joint dislocation +sodium hyaluronate injection group: Comfort needle: Comfort needle (specification: 0.40 × 25mm Suzhou Hualun Medical Products Co. Ltd.) has the same appearance as a therapeutic needle but the needle tip is blunt and flat and does not penetrate the subcutaneous tissue (the principle of action is the same as Streitberger Comfort Needle which is a non penetrating comfort needle commonly used in international acupuncture efficacy research) In single blind trials plastic tube sleeves and silicone bases were also attached externally (DONGBANGATUPUNCURE INC） The acupoint selection acupuncture and needling out were the same as those in the acupuncture and moxibustion group. After acupuncture insert a 1 centimeter long moxa stick into the handle of each acupoint but do not ignite it. Then apply TDP light to the affected knee and leave the needle for 20 minutes before removing it. Joint dislocation: Same as above Sodium hyaluronate injection: Same as above Treatment sequence: Same as above Both groups of treatments are administered once every 5 days with 5 sessions constituting one course of treatment. All treatments are required to be completed within 4 weeks.

纳入标准：

（1）符合膝骨关节炎诊断标准，以主诉疼痛和关节活动障碍的患者为观察对象；（2）近3个月或以上膝关节疼痛病史（3）纳入时VAS≥3分；（4）年龄介于40-80岁之间；（5）近1个月内未接受过针灸推拿治疗。

Inclusion criteria

(1)Patients who meet the diagnostic criteria for knee osteoarthritis and complain of pain and joint movement disorders were observed. (2)History of knee pain in the past 3 months or more. (3)VAS score ≥3. (4)Age between 40 and 80 years old. (5)Have not received acupuncture and massage treatment in the past 1 month.

排除标准：

（1）排除膝关节感染性、恶性及自身免疫性疾病所导致的疼痛，先天性膝关节畸形及重度膝骨性关节炎；（2）合并严重心、肝、肾、脑血管、肿瘤疾病等，研究者认为不适合参加本研究；（3）久病体弱、严重神经官能症、痴呆、妊娠或哺乳妇女；（4）白血病、血小板减少等有出血倾向者；（5）严重的或全身性皮肤疾病者。

Exclusion criteria：

(1) Pain caused by infectious malignant and autoimmune diseases of the knee congenital knee deformity and severe knee osteoarthritis.(2) Patients with severe heart liver kidney cerebrovascular and tumor diseases were not considered suitable for participation in this study. (3) Chronically weak severe neurological disorders dementia pregnant or nursing women. (4) Patients with bleeding tendency such as leukemia and thrombocytopenia. (5) Patients with severe or systemic skin diseases.

研究实施时间：

Study execute time：

从From 2024-06-01

至To      2027-05-31

征募观察对象时间：

Recruiting time：

从From 2025-01-01

至To      2027-03-31

干预措施：

Interventions：

组别：

无症状受试组

样本量：

30

Group：

no symptom group

Sample size：

干预措施：

不进行任何治疗

干预措施代码：

Intervention：

no treatment

Intervention code：

组别：

安慰针+关节错缝术+玻璃酸钠组

样本量：

55

Group：

comfort acupuncture+joint dislocation+sodium hyaluronate injection group

Sample size：

干预措施：

安慰针+关节错缝术+玻璃酸钠注射液注射

干预措施代码：

Intervention：

comfort acupuncture+joint dislocation+sodium hyaluronate injection

Intervention code：

组别：

针灸+关节错缝术+玻璃酸钠组

样本量：

55

Group：

acupuncture+joint dislocation+sodium hyaluronate injection group

Sample size：

干预措施：

针灸+关节错缝术+玻璃酸钠注射液注射

干预措施代码：

Intervention：

acupuncture+joint dislocation+sodium hyaluronate injection

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)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州医科大学附属第一医院

单位级别：

三级甲等医院

Institution/hospital：

The First Affiliated Hospital of Guangzhou Medical University

Level of the institution：

tertiary hospital

测量指标：

Outcomes：

指标中文名：

步态分析试验

指标类型：

次要指标

Outcome：

Kinematic gait analysis

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

CT检查

指标类型：

次要指标

Outcome：

CT Imaging

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

关节活动度

指标类型：

次要指标

Outcome：

Range of motion

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

膝关节结构和功能评分

指标类型：

主要指标

Outcome：

Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC

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：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 40 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）：

统计人员利用 SPSS 软件（SPSS, version 22.0, SPSS Inc., Chicago, IL, USA）产生随机数字表，根据随机数字表进行分组，将受试者分为针灸+关节错缝术+玻璃酸钠注射液组、安慰针+关节错缝术+玻璃酸钠注射液组。受试者顺序号和分组结果产生后装进不透光的信封，信封密封后在封面标记序号，按照序号依次纳入符合入组标准的受试者。

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

Statisticians used SPSS software (SPSS version 22.0 SPSS Inc. Chicago IL USA) to generate a random number table. According to the random number table the subjects were divided into acupuncture+joint dislocation+sodium hyaluronate injection group and comfort acupuncture+joint dislocation+sodium hyaluronate injection group. The subject sequence number and grouping results are placed in opaque envelopes with serial numbers on the cover. Subjects who meet the inclusion criteria are included in order of their serial numbers.

盲法：

Blinding：

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）：

日期：2027.06.01；方式：采用网络平台：国际传统医学临床注册平台http://itmctr.ccebtcm.org.cn/

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

online platform:http://itmctr.ccebtcm.org.cn/

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：

数据采集和管理采用病例记录表

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

Use CRF to collect and manage data.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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