ChiCTR2400090897 版本V1.0 版本创建时间2024/10/15 10:52:04 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400090897 

最近更新日期：

Date of Last Refreshed on：

 2024-10-15 10:52:00 

注册时间：

Date of Registration：

 2024-10-15 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

重复外周磁刺激联合FM?治疗膝骨关节炎：一项临床随机对照试验

Public title：

Repeated peripheral magnetic stimulation combined with FM? for knee osteoarthritis: a clinical randomized controlled trial

注册题目简写：

重复外周磁刺激联合FM?治疗KOA临床随机对照试验

English Acronym：

Repeated randomized controlled clinical trial of peripheral magnetic stimulation combined with FM? for knee osteoarthritis

研究课题的正式科学名称：

重复外周磁刺激联合FM?治疗膝骨关节炎：一项临床随机对照试验

Scientific title：

Repeated peripheral magnetic stimulation combined with FM? for knee osteoarthritis: a clinical randomized controlled trial

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：

谢晨 

研究负责人：

张忠国 

Applicant：

Xie Chen 

Study leader：

Zhang Zhongguo 

申请注册联系人电话：

Applicant telephone：

 +86 150 8390 9753

研究负责人电话：

Study leader's
telephone：

+86 152 7971 8924

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：

 1589361134@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 874953314@qq.com

申请单位网址(自愿提供)：

Applicant 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：

江西省赣州市章贡区赣南医科大学黄金校区

研究负责人通讯地址：

江西省赣州市兴国县兴国中医院

Applicant address：

Gold Campus, Gannan Medical University, Zhanggong District, Ganzhou City, Jiangxi Province

Study leader's address：

Xingguo Hospital of Traditional Chinese Medicine, Xingguo County, Ganzhou City, Jiangxi Province

申请注册联系人邮政编码：

Applicant postcode：

 341000

研究负责人邮政编码：

Study leader's postcode：

 341000

申请人所在单位：

赣南医科大学

Applicant's institution：

Gannan Medical University

研究负责人所在单位：

兴国县中医院

Affiliation of the Leader：

Xingguo Hospital of Traditional Chinese Medicine

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024LL3-20

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

兴国县中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Xingguo County Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-05 00:00:00

伦理委员会联系人：

钟南海

Contact Name of the ethic committee：

Zhong Nanhai

伦理委员会联系地址：

江西省赣州市兴国县潋江镇兴国县中医院

Contact Address of the ethic committee：

Xingguo Hospital of Traditional Chinese Medicine, Xingguo Town, Xingguo County, Ganzhou City, Jiangxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 137 0702 2778

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 xgxzyy@163.com

研究实施负责（组长）单位：

兴国县中医院

Primary sponsor：

Xingguo Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

江西省赣州市兴国县潋江镇兴国县中医院

Primary sponsor's address：

Xingguo Hospital of Traditional Chinese Medicine, Xingguo Town, Xingguo County, Ganzhou City, Jiangxi 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)：

江西

市(区县)：

兴国

Country：

China

Province：

Jiangxi

City：

Xingguo

单位(医院)：

兴国县中医院

具体地址：

江西省赣州市兴国县潋江镇兴国县中医院

Institution
hospital：

Xingguo Hospital of Traditional Chinese Medicine

Address：

Xingguo Hospital of Traditional Chinese Medicine, Xingguo Town, Xingguo County, Ganzhou City, Jiangxi Province

国家：

中国

省(直辖市)：

江西

市(区县)：

赣州

Country：

China

Province：

Jiangxi

City：

Ganzhou

单位(医院)：

赣南医科大学

具体地址：

江西省赣州市章贡区赣南医科大学黄金校区

Institution
hospital：

Gannan Medical University

Address：

Xingguo Hospital of Traditional Chinese Medicine, Xingguo Town, Xingguo County, Ganzhou City, Jiangxi Province

经费或物资来源：

赣南医科大学2024年研究生创新专项资金项目立项

Source(s) of funding：

Gannan Medical University 2024 Graduate Student Innovation special fund project

研究疾病：

膝骨关节炎  

Target disease：

Knee osteoarthritis

研究疾病代码：

M17

Target disease code：

M17

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本次研究的主要目的是系统评估rPMS结合FM?治疗KOA的疗效和安全性。 KOA是一种多发常见的慢性病变，探寻一种绿色安全有效的治疗方法一直以来是业界研究的热点和方向。目前少有研究将rPMS与FM?这两种治疗方法联合使用治疗KOA以及探究两者联合运用提升疗效的潜在协同机制。 我们通过fNIRS探讨健康人群与KOA患者不同脑区激活模式差异，以寻找新的中枢干预靶点，探讨fNIRS与常规评价指标直接的关联性，可以挖掘fNIRS对于KOA患者的评估价值。本研究还应用sEMG观察分析KOA患者肌肉肌电信号，并对特定的肌电特征和临床指标进行相关性分析，旨在为临床评估和治疗提供参考。未来有望在临床推广作为治疗的一种较好治疗方案供患者和临床医生选择。  

Objectives of Study：

The primary objective of this study was to systematically evaluate the efficacy and safety of rPMS combined with FM? in the treatment of KOA. KOA is a kind of common chronic disease, and seeking a green, safe and effective treatment method has always been the focus and direction of industry research. There are few studies combining rPMS and FM? for the treatment of KOA and exploring the potential synergistic mechanisms by which the combination of the two treatments improves outcomes. We used fNIRS to explore the differences in activation patterns of different brain regions between healthy people and KOA patients, so as to find new central intervention targets and explore the direct correlation between fNIRS and conventional evaluation indicators, which can explore the evaluation value of fNIRS for KOA patients. In this study, sEMG observation was also used to analyze muscle electromyography signals in KOA patients, and correlation analysis was performed for specific EMG features and clinical indicators, aiming to provide references for clinical evaluation and treatment. In the future, it is expected to be promoted as a better treatment plan for patients and clinicians to choose.

药物成份或治疗方案详述：

在研究前，G* Power 3.1.9.7根据以往rPMS治疗下背痛的研究结果估计样本量，获得80%的幂，α风险= 0.05，还考虑存在约20%的脱落率，因此我们计划招募患者36名，分为3组，每组12例。分别进行3种不同的干预方式。比较患者的一般资料无统计学差异，具有可比性。 随机化用SPSS 27.0软件对患者数据进行盲化，按照招募的先后顺序，得到1~36个序列号，然后由RVUNIFORM （0、1）在计算机中产生的随机数，与患者的序列号进行逐个匹配。 试验组1：FM?组 该组患者只接受FM?治疗，没有rPMS的介入。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。 试验组2：rPMS组 该组患者仅接受rPMS治疗，不包括FM?。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。 试验组3：联合治疗组 该组患者接受同时进行rPMS和FM?的联合治疗。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。 干预方法：（1）FM?组：选取AN-GE（大腿中部、股直肌外侧）、AN-TA（小腿中间、胫前肌肌腹上）、RE-GE（大腿后部中间、股二头肌中部）、RE-TA（外侧腓肠肌的肌腱移行处）、LA-GE（大腿外侧中间、髂胫束上靠近股二头肌短头起点）五个筋膜点进行筋膜手法的按压和摩擦治疗。每个点作用6 min左右，每次治疗30 min，每周5次，连续2周。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。将表面肌电的电极放置于股四头肌表面，使用医用胶带进行固定。电极的放置位置如下：股外侧肌（髌骨外侧缘以上15cm处肌腹隆起）；股直肌（髂前上棘与髌骨上缘连线中点）；股内侧肌（位于 髌骨内侧缘以上5cm处的肌腹隆起）。臀大肌放置位置：电极需要放置在骶骨和大转子之间50%的线上。这个位置对应于臀部中间最突出的位置，远高于大转子可见的凸起。方向：从髂后上棘到大腿后侧中间的直线方向。 （2）rPMS组：治疗选取的位置为上述FM? 5个治疗点，加上患者感受最疼痛的点，共6个，治疗频率采用20Hz-rPMS为每点3分钟，30次收缩，每次10秒，每次收缩间隔30秒，共进行6000次刺激。强度设定在最大刺激器输出的35～40%之间。每周5次，连续2周。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。电极的放置位置如下：股外侧肌（髌骨外侧缘以上15cm处肌腹隆起）；股直肌（髂前上棘与髌骨上缘连线中点）；股内侧肌（位于 髌骨内侧缘以上5cm处的肌腹隆起）。臀大肌放置位置：电极需要放置在骶骨和大转子之间50%的线上。这个位置对应于臀部中间最突出的位置，远高于大转子可见的凸起。方向：从髂后上棘到大腿后侧中间的直线方向。 （3）联合治疗组：患者先进行 rPMS治疗，治疗部位、强度、频率与rPMS组相同。休息10～15分钟后进行FM?治疗，治疗部位、强度、频率与FM?组相同，每周5次，连续2周。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。电极的放置位置如下：股外侧肌（髌骨外侧缘以上15cm处肌腹隆起）；股直肌（髂前上棘与髌骨上缘连线中点）；股内侧肌（位于 髌骨内侧缘以上5cm处的肌腹隆起）。臀大肌放置位置：电极需要放置在骶骨和大转子之间50%的线上。这个位置对应于臀部中间最突出的位置，远高于大转子可见的凸起。方向：从髂后上棘到大腿后侧中间的直线方向。 

Description for medicine or protocol of treatment in detail：

Before the study, G* Power 3.1.9.7 estimated the sample size according to the results of previous studies on rPMS in the treatment of low back pain, and obtained a power of 80%, α risk = 0.05, and a shedding rate of about 20%. Therefore, we planned to recruit 36 patients and divided them into 3 groups with 12 cases in each group. Three different intervention methods were performed. There was no statistical difference in the general data of the compared patients, which was comparable. SPSS 27.0 software was used to blind patient data, and 1~36 serial numbers were obtained according to the order of recruitment, and then random numbers generated by RVUNIFORM (0, 1) in the computer were matched with patient serial numbers one by one. Test group 1: FM? group This group of patients received only FM? therapy without rPMS intervention. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment. Test group 2: rPMS group This group of patients received rPMS only, excluding FM?. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment. Trial group 3: Combined treatment group This group of patients received a combination of rPMS and FM?. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment. Intervention methods: (1) FM? group: Five fascia points (AN-GE (middle thigh, lateral femoris rectus), AN-TA (middle calf, anterior tibial muscle), RE-GE (middle thigh, medial biceps femoris), RE-TA (tendon migration of lateral gastrocnemius muscle), LA-GE (middle thigh, iliotibial band near the starting point of short head of biceps femoris) were selected for fascia manipulation Pressure and friction treatment. Each point was treated for about 6 minutes, and each treatment was treated for 30 minutes, 5 times a week for 2 consecutive weeks. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment. The surface EMG electrode was placed on the surface of the quadriceps muscle and fixed with medical tape. The position of the electrode is as follows: lateral femoral muscle (muscle abdominal bulge 15cm above the lateral margin of the patella); Rectus femoris (midpoint of the line between the anterior superior spine of iliac and the upper margin of patella); The vastus medialis (the abdominal bulge of the muscle located 5cm above the medial margin of the patella). Gluteus maximus placement: The electrodes need to be placed on the 50% line between the sacrum and the greater trochanter. This position corresponds to the most prominent position in the middle of the hip, well above the visible bulge of the greater trochanter. Direction: Straight direction from the posterior superior spine of the iliac to the middle of the posterior thigh. (2) rPMS group: The treatment locations were the above 5 FM? treatment points, plus the point where the patient felt the most pain, a total of 6. The treatment frequency was 20Hz-rPMS: 3 minutes per point, 30 contractions, each 10 seconds, each contraction interval of 30 seconds, and a total of 6000 stimuli were performed. The intensity is set between 35 and 40% of the maximum stimulator output. Five times a week for two weeks. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment. The position of the electrode is as follows: lateral femoral muscle (muscle abdominal bulge 15cm above the lateral margin of the patella); Rectus femoris (midpoint of the line between the anterior superior spine of iliac and the upper margin of patella); The vastus medialis (the abdominal bulge of the muscle located 5cm above the medial margin of the patella). Gluteus maximus placement: The electrodes need to be placed on the 50% line between the sacrum and the greater trochanter. This position corresponds to the most prominent position in the middle of the hip, well above the visible bulge of the greater trochanter. Direction: Straight direction from the posterior superior spine of the iliac to the middle of the posterior thigh. (3) Combined treatment group: Patients received rPMS treatment first, and the treatment site, intensity, and frequency were the same as those in rPMS group. After rest for 10 to 15 minutes, FM? therapy was performed at the same site, intensity, and frequency as FM? group, 5 times a week for 2 consecutive weeks. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment. The position of the electrode is as follows: lateral femoral muscle (muscle abdominal bulge 15cm above the lateral margin of the patella); Rectus femoris (midpoint of the line between the anterior superior spine of iliac and the upper margin of patella); The vastus medialis (the abdominal bulge of the muscle located 5cm above the medial margin of the patella). Gluteus maximus placement: The electrodes need to be placed on the 50% line between the sacrum and the greater trochanter. This position corresponds to the most prominent position in the middle of the hip, well above the visible bulge of the greater trochanter. Direction: Straight direction from the posterior superior spine of the iliac to the middle of the posterior thigh. 

纳入标准：

膝骨关节炎患者纳入标准：①年龄为18-80岁；②影像学或关节镜诊断的单侧KOA患者；③Kellgren-lawrenceRating III级(含)以下；④视觉模拟评分法(Visual analogue scale ，VAS)评分大于3分；⑤认知功能正常，无颅脑损伤、脑血管疾病、癫痫等并发疾病，无颅脑手术史；⑥体内无心脏起搏器和植入支架；⑦自愿接受本方案治疗，⑧签署知情同意书。

Inclusion criteria

Inclusion criteria for patients with knee osteoarthritis: ① Age 18-80 years old; Unilateral KOA patients diagnosed by imaging or arthroscopy; (3) Kellgren-lawrenceRating Level III (inclusive) or below; (4) Visual analogue scale (VAS) score is greater than 3 points; ⑤ Normal cognitive function, no craniocerebral injury, cerebrovascular disease, epilepsy and other concurrent diseases, no history of craniocerebral surgery; ⑥ No pacemaker or stent implanted in the body; ⑦ Voluntarily accept the treatment program, ⑧ sign the informed consent.

排除标准：

排除标准：①患风湿或者类风湿疾病、严重骨质疏松的患者；②有认知障碍，或者无法读写或者理解文字的患者；③妊娠或哺乳期妇女；④活动性肿瘤，活动性炎症；⑤患者口服镇痛等药物；使用过激素治疗；⑥有癫痫病史及癫痫病家族史的患者；⑦头颅内置有金属异物、带心脏起搏器者、心脏支架者、有耳蜗植入物者，有颅内压增高者。

Exclusion criteria：

Exclusion criteria: ① Patients with rheumatism or rheumatoid disease, severe osteoporosis; Patients with cognitive impairment, or inability to read, write, or understand text; Pregnant or lactating women; ④ Active tumor, active inflammation; (5) Oral analgesia and other drugs; Used hormone therapy; ⑥ Patients with a history of epilepsy and a family history of epilepsy; ⑦ There are metal foreign bodies in the skull, people with cardiac pacemakers, heart stents, people with cochlear implants, and people with increased intracranial pressure.

研究实施时间：

Study execute time：

从 From 2024-09-10 00:00:00至 To 2026-09-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-10 00:00:00 至 To 2025-09-10 00:00:00

干预措施：

Interventions：

组别：

FM组

样本量：

 12

Group：

FM group

Sample size：

干预措施：

该组患者只接受FM治疗，没有rPMS的介入。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。

干预措施代码：

Intervention：

This group of patients received only FM therapy without rPMS intervention. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment.

Intervention code：

组别：

rPMS组

样本量：

 12

Group：

rPMS group

Sample size：

干预措施：

该组患者仅接受rPMS治疗，不包括FM。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。

干预措施代码：

Intervention：

This group of patients received rPMS only, excluding FM. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment.

Intervention code：

组别：

联合治疗组

样本量：

 12

Group：

Combined treatment group

Sample size：

干预措施：

该组患者接受同时进行rPMS和FM的联合治疗。治疗前后通过fNIRS监测脑血氧含量指标及使用sEMG测量患者表面肌电活动。

干预措施代码：

Intervention：

This group of patients received a combination of rPMS and FM. Cerebral blood oxygen content was measured by fNIRS and surface myoelectric activity was measured by sEMG before and after treatment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江西 

市(区县)：

 兴国 

Country：

China

Province：

Jiangxi

City：

Xingguo

单位(医院)：

 兴国县中医院 

单位级别：

 二甲 

Institution
hospital：

Xingguo County Hospital of Traditional Chinese Medicine

Level of the institution：

Secondary A

测量指标：

Outcomes：

指标中文名：

功能性近红外光谱成像技术

指标类型：

次要指标

Outcome：

Functional near infrared spectroscopy

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

测量患者运动区佩戴头上

Measure time point of outcome：

Before and after treatment

Measure method：

Measure the patient's movement area worn on the head

指标中文名：

表面肌电图

指标类型：

主要指标

Outcome：

Surface electromyography

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

测量患者肌肉功能贴附在肌肉上

Measure time point of outcome：

Before and after treatment

Measure method：

Measuring the patient's muscle function is attached to the muscle

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

在研究前，G* Power 3.1.9.7根据以往rPMS治疗下背痛的研究结果估计样本量，获得80%的幂，α风险= 0.05，还考虑存在约20%的脱落率，因此我们计划招募患者36名，分为3组，每组12例。分别进行3种不同的干预方式。比较患者的一般资料无统计学差异，具有可比性。 由研究者谢晨随机化用SPSS 27.0软件对患者数据进行盲化，按照招募的先后顺序，得到1~36个序列号，然后由RVUNIFORM （0、1）在计算机中产生的随机数，与患者的序列号进行逐个匹配。

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

Before the study, G* Power 3.1.9.7 estimated the sample size according to the results of previous studies on rPMS in the treatment of low back pain, and obtained a power of 80%, α risk = 0.05, and a shedding rate of about 20%. Therefore, we planned to recruit 36 patients and divided them into 3 groups with 12 cases in each group. Three different intervention methods were performed. There was no statistical difference in the general data of the compared patients, which was comparable. The researcher Xie Chen randomized the patient data by using SPSS 27.0 software. According to the order of recruitment, 1~36 serial numbers were obtained, and then the random numbers generated by RVUNIFORM (0, 1) in the computer were matched with the serial numbers of patients one by one.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

单盲：仅参与者不知道自己被分配到哪个组（如治疗组或对照组），而研究者和数据分析师是知情的。因研究者要参与治疗患者工作，所以无法进行双盲。

Blinding：

Single Blind: Only the participants do not know which group they are assigned to (such as the treatment or control group), and the researcher and data analyst are informed. Double blindness is not possible because researchers are involved in treating patients.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

临床试验公共管理平台 (http://www.medresman.org.cn/login.aspx)

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

ResMan (http://www.medresman.org.cn/login.aspx)

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 Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-10-15 10:52:00