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Clinical Efficacy of Filiform-heated Needling Combined with Heat-Sensitive Moxibustion in the Treatment of Knee Osteoarthritis and Its Mechanistic Impact on CRP and IL-6

注册号：

Registration number：

ITMCTR2025001505

最近更新日期：

Date of Last Refreshed on：

2025-07-28

注册时间：

Date of Registration：

2025-07-28

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

毫火针联合热敏灸治疗膝骨关节炎的临床疗效及对CRP、IL-6影响的机制研究

Public title：

Clinical Efficacy of Filiform-heated Needling Combined with Heat-Sensitive Moxibustion in the Treatment of Knee Osteoarthritis and Its Mechanistic Impact on CRP and IL-6

注册题目简写：

English Acronym：

研究课题的正式科学名称：

毫火针联合热敏灸治疗膝骨关节炎的临床疗效及对CRP、IL-6影响的机制研究

Scientific title：

Clinical Efficacy of Filiform-heated Needling Combined with Heat-Sensitive Moxibustion in the Treatment of Knee Osteoarthritis and Its Mechanistic Impact on CRP and IL-6

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：

杨琪琪

研究负责人：

张玉

Applicant：

Yang Qiqi

Study leader：

Zhang Yu

申请注册联系人电话：

Applicant telephone：

13476157847

研究负责人电话：

Study leader's telephone：

15956881705

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：

821920266@qq.com

研究负责人电子邮件：

Study leader's E-mail：

13476157847@126.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：

安徽中医药大学第二附属医院,安徽省合肥市庐阳区寿春路300号‌‌,230061

研究负责人通讯地址：

阜阳市中医医院,安徽省阜阳市,236032,阜阳市颍州区中清路286号

Applicant address：

Chinese Medicine Hefei Anhui Province 230061 China

Study leader's address：

Fuyang Traditional Chinese Medicine Hospital 286 Zhongqing Road Yingzhou District Fuyang Anhui Province 236032 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：

安徽中医药大学第二附属医院

Applicant's institution：

Second Affiliated Hospital of Anhui University of 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：

2024fyszyyy014

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：

阜阳市中医医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Fuyang Traditional Chinese Medicine Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/12/3 0:00:00

伦理委员会联系人：

朱广宝

Contact Name of the ethic committee：

Zhu Guangbao

伦理委员会联系地址：

阜阳市中医医院,安徽省阜阳市,236032,阜阳市颍州区中清路286号

Contact Address of the ethic committee：

Fuyang Traditional Chinese Medicine Hospital 286 Zhongqing Road Yingzhou District Fuyang Anhui Province 236032 China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 158 5558 7273

伦理委员会联系人邮箱：

Contact email of the ethic committee：

642138835@qq.com

研究实施负责（组长）单位：

阜阳市中医医院

Primary sponsor：

Fuyang Traditional Chinese Medicine Hospital

研究实施负责（组长）单位地址：

阜阳市中医医院,安徽省阜阳市颍州区中清路286号

Primary sponsor's address：

Fuyang Traditional Chinese Medicine Hospital 286 Zhongqing Road Yingzhou District Fuyang Anhui Province 236032 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)：

安徽省

市(区县)：

阜阳市

Country：

China

Province：

Anhui

City：

单位(医院)：

阜阳市中医医院

具体地址：

安徽省阜阳市颍州区中清路286号

Institution
hospital：

Fuyang Traditional Chinese Medicine Hospital

Address：

286 Zhongqing Road Yingzhou District Fuyang Anhui Province 236032 China

经费或物资来源：

阜阳市重点研究与开发计划项目（FK20245541）

Source(s) of funding：

Fuyang City Key Research and Development Plan Project (FK20245541)

研究疾病：

膝骨关节炎

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

通过随机对照研究评价毫火针联合热敏灸治疗膝骨关节炎的有效性、安全性及起效机制，为临床治疗该病提供新的思路和手段。

Objectives of Study：

To investigate the efficacy safety and mechanisms of action of fire needling combined with heat-sensitive moxibustion in the treatment of knee osteoarthritis.

药物成份或治疗方案详述：

1. 试验组：采用毫火针和热敏灸联合治疗 （1）毫火针治疗 ①材料准备：一次性使用无菌针灸针：规格：0.30×40mm；生产厂家：苏州医疗用品厂生产；商品名：悦臻牌。 ②取穴：阿是穴。采用双手触诊法，以手拇指为主，其他四指为辅，浅、中、深层以循、按、触、摸、切、推、拨等多种手法进行检查，并配合膝关节的被动或主动运动；以膝关节为中心及起点循经筋循行按次序诊察；结合手下触感与受试者反应，手下有结节、条索处或受试者有明显疼痛处均为阳性反应点，做好标记，确定阿是穴位置。 ③操作：受试者取仰卧位，在患侧膝盖下铺垫一块有柔性的松软垫，使得膝关节微微屈曲120度。先定位好针刺点，并用无菌医用皮肤记号笔点于预测穴位上，穴位周围予碘伏消毒，操作者同时左手使用止血钳夹95％酒精棉球并点燃，右手持毫火针针柄，在针尖距离每个预刺穴位上方约10cm处，在距离火焰外灼热热点处，倾斜约45°将针身的前中段烧红，迅速垂直点剌所选穴位（注意烧针的长度一定要大于点刺的深度），疾进疾出点刺，时间控制在0.5秒内，点刺的控制深度范围可以根据每位病人：点刺穴位位置所在的不同部位和根据病人自身体质而进行选择，控制深度范围一般为0.2-0.5cm。 ④治疗疗程：每周3次，6次1个疗程，总共1个疗程。 （2）热敏灸治疗 ①材料准备：热敏灸艾灸：规格：22mm×120mm，22g；生产批号：赣药制字Z20090358；生产厂家：江西中医药大学附属医院。 ②取穴：操作前进行热敏灸灸感宣教，然后点燃艾条，运用温和灸法在受试者患膝关节热敏腧穴高发区域内（内、外膝眼等），距离皮肤 5cm施行热敏灸操作，先行回旋灸2min使皮肤潮红迅速升温，温热局部气血，询问患者灸温是否合适，继用雀啄灸2min进行强温热刺激加强敏化，循经往返灸2min激发经气以经络感传，让患者保持安静认真感觉，询问患者是否出现灸感，若灸感稳定再施以温和灸保持灸感，激发感传。在艾灸过程中，当询问到患者身体出现灸感，就用记号笔在产生感觉的部位进行标记拍照，并在灸感记录表上填写，该记录的穴位区域就是热敏灸治疗施灸部位。 ③操作：对准做好记录的部位，采用温和悬灸的方法，距皮肤表面约5cm左右，以受试者局部温热舒适为度。 ④治疗疗程：每天1次，每次30分钟，10次为1个疗程，共治疗1个疗程。 2. 对照组：仅采用热敏灸治疗，治疗方法和疗程同试验组。

Description for medicine or protocol of treatment in detail：

1. Intervention Group: Combined Treatment with Fire Needling and Heat-Sensitive Moxibustion (1) Fire Needling Treatment ① Materials Preparation: Sterile disposable acupuncture needles specification: 0.30 × 40 mm; Manufacturer: Suzhou Medical Supplies Factory; Brand name: Yuezhen. ② Acupoint Selection: Ashi points. The bilateral palpation method is adopted with the thumb as the main probing finger and the other four fingers as auxiliaries. Superficial middle and deep layers are examined using various techniques including tracing pressing touching palpating slicing pushing and plucking combined with passive or active movements of the knee joint. Starting from and centering on the knee joint the examination follows the meridian-muscle pathway. Points with palpable nodules or cords under the fingers or areas causing obvious pain for the subject are identified as positive reaction points and marked as Ashi points. ③ Procedure: The subject is placed in a supine position with a soft cushion under the affected knee allowing the knee joint to flex slightly to about 120 degrees. After locating the selected needle insertion points they are marked using a sterile medical skin marker. The surrounding area is disinfected with povidone-iodine. The operator holds a hemostat with a cotton ball soaked in 95% alcohol in the left hand and ignites it. Holding the needle handle in the right hand the fire needle is heated at a 45° angle to the flame about 10 cm above the marked point until the front to mid-portion of the needle body turns red-hot (ensure the heated length exceeds the desired insertion depth). Then the needle is swiftly inserted and withdrawn vertically into the selected point within 0.5 seconds. The insertion depth can be adjusted based on the location of the point and the patient's constitution typically ranging from 0.2 to 0.5 cm. ④ Treatment Course: Three times per week 6 sessions per course with a total of 1 course. (2) Heat-Sensitive Moxibustion Treatment ① Materials Preparation: Heat-sensitive moxa sticks specification: 22 mm × 120 mm 22 g; Batch number: Gan Yao Zhi Zi Z20090358; Manufacturer: Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine. ② Acupoint Selection: Before treatment patients receive moxibustion sensation education. After igniting the moxa stick mild moxibustion is performed 5 cm above the skin over the high-frequency heat-sensitive acupoint areas of the affected knee (e.g. medial and lateral Xiyan). First circular moxibustion is applied for 2 minutes to warm and redden the skin promoting local qi and blood circulation. Patients are asked whether the temperature is appropriate. Then pecking moxibustion is applied for another 2 minutes to enhance thermal stimulation and sensitivity. Following this reciprocal moxibustion is applied along the meridians for 2 minutes to stimulate qi movement and meridian sensation. Patients are encouraged to stay calm and focus on their sensations. Once stable moxibustion sensations (moxa-response) appear mild moxibustion is continued to maintain and enhance the sensation. The locations where patients experience moxa-response are marked and photographed and the corresponding regions are recorded as treatment sites on the moxibustion sensation recording form. ③ Procedure: Target the marked regions using mild suspended moxibustion maintaining a distance of approximately 5 cm from the skin surface with the warmth adjusted to a comfortable level for the patient. ④ Treatment Course: Once daily 30 minutes per session 10 sessions per course with a total of 1 course. 2. Control Group: Only heat-sensitive moxibustion is applied with the same treatment method and duration as in the intervention group.

纳入标准：

（1）符合上述KOA诊断标准； （2）年龄45-65岁之间，男女不限； （3）Kellgren-Lawrence影像分级属于II级或III级（轻或中度））； （4）过去一周膝关节疼痛数据评分（NRS）≥4； （5）自愿参加，签署知情同意书。

Inclusion criteria

(1) Meeting the above diagnostic criteria for KOA; (2) Aged between 40 and 65 years with no gender restriction; (3) Kellgren-Lawrence imaging grade of II or III (mild to moderate); (4) Knee pain score (NRS) ≥ 4 in the past week; (5) Willing to participate and signing an informed consent form.

排除标准：

（1）有膝关节手术史或正在等待膝关节手术（膝关节置换或膝关节镜手术）； （2）评价关节1年之内有关节镜检查史、近6个月有关节腔注射史； （3）其他疾病引起的膝部疼痛（如关节游离体、关节腔严重积液、感染、恶性肿瘤、自身免疫疾病、外伤、骨折、痛风等） （4）凝血功能障碍（如血友病等），消化道溃疡或活动性出血者； （5）对艾叶过敏者； （6）受试者有重大疾病史、头颅外伤史、神经精神系统疾病史及其它可能影响大脑活动的疾病； （7）备孕、妊娠期及哺乳期妇女； （8）近1个月内接受推拿或针灸治疗者； （9）近3个月内参加其他临床研究者。

Exclusion criteria：

(1) History of knee surgery or currently awaiting knee surgery (knee replacement or arthroscopy); (2) History of arthroscopy within the past year or intra-articular injections within the past six months; (3) Knee pain caused by other conditions (e.g. loose bodies severe joint effusion infection malignancy autoimmune diseases trauma fractures gout etc.); (4) Coagulation disorders (e.g. hemophilia) gastrointestinal ulcers or active bleeding; (5) Allergy to mugwort; (6) History of major illnesses cranial trauma neurological or psychiatric disorders or other conditions that may affect brain function; (7) Women who are planning to conceive pregnant or breastfeeding; (8) Receipt of massage or acupuncture treatment within the past month; (9) Participation in other clinical studies within the past three months.

研究实施时间：

Study execute time：

从From 2025-08-01

至To      2027-07-31

征募观察对象时间：

Recruiting time：

从From 2025-08-01

至To      2026-07-31

干预措施：

Interventions：

组别：

试验组

样本量：

53

Group：

Intervention group

Sample size：

干预措施：

毫火针联合热敏灸

干预措施代码：

Intervention：

Filiform-heated Needling Combined with Heat-Sensitive Moxibustion

Intervention code：

组别：

对照组

样本量：

53

Group：

Control group

Sample size：

干预措施：

热敏灸

干预措施代码：

Intervention：

Heat-sensitive moxibustion

Intervention code：

样本总量 Total sample size ： 106

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

安徽省

市(区县)：

阜阳市

Country：

China

Province：

Anhui Province

City：

Fuyang Citu

单位(医院)：

阜阳市中医医院

单位级别：

三甲

Institution/hospital：

Fuyang Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

安徽省

市(区县)：

合肥市

Country：

China

Province：

Anhui Province

City：

Hefei Citu

单位(医院)：

安徽中医药大学第二附属医院

单位级别：

三甲

Institution/hospital：

Second Affiliated Hospital of Anhui University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛数字评分法

指标类型：

主要指标

Outcome：

Numerical Rating Scale

Type：

Primary indicator

测量时间点：

第0周、第2周、第4周、第8周、第16周、第24周

测量方法：

采用疼痛数字评分法（Numerical Rating Scale，NRS）评估膝关节的疼痛程度，受试者被要求对过去24小时内KOA疼痛进行评分，分数越高，表示受试者的疼痛越严重。

Measure time point of outcome：

Week 0, Week 2, Week 4, Week 8, Week 16, Week 24

Measure method：

The Numerical Rating Scale (NRS) was used to assess the level of knee pain. Participants were asked to rate their KOA-related pain over the past 24 hours, with higher scores indicating more severe pain.

指标中文名：

膝骨关节炎指数量表

指标类型：

次要指标

Outcome：

Western Ontario and McMaster Universities Osteoarthritis Index

Type：

Secondary indicator

测量时间点：

第0周、第2周、第4周、第8周、第16周、第24周

测量方法：

膝骨关节炎指数（Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC）量表：由三个亚量表组成，包括疼痛亚表、僵硬亚表和功能亚表。评分越高，表示受试者疼痛、僵硬、功能障碍的程度越高。

Measure time point of outcome：

Week 0, Week 2, Week 4, Week 8, Week 16, Week 24

Measure method：

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of three subscales: pain, stiffness, and physical function. Higher scores indicate greater levels of pain, stiffness, and functional impairment in the participants.

指标中文名：

膝关节关节腔内积液厚度及滑膜厚度

指标类型：

次要指标

Outcome：

Thickness of intra-articular effusion and synovial membrane of the knee joint

Type：

Secondary indicator

测量时间点：

第0周、第2周

测量方法：

膝关节关节腔内积液厚度及滑膜厚度：在专业超声科医师的指导下，在第0周和第2周采用肌骨超声仪器（品牌名称：SIEMENS；型号：出厂编号：219337；探头型号：高频9L4）测量患者积液厚度及滑膜厚度。

Measure time point of outcome：

Week 0, Week 2

Measure method：

Intra-articular effusion thickness and synovial thickness of the knee joint were measured using a musculoskeletal ultrasound device (Brand: SIEMENS; Serial Number: 219337; Probe Model: High-frequency 9L4) under the guidance of a professional ultrasound physician at Week 0 and Week 2.

指标中文名：

C反应蛋白

指标类型：

次要指标

Outcome：

C-reactive protein

Type：

Secondary indicator

测量时间点：

第0周、第2周

测量方法：

采集患者晨起空腹静脉血3 mL，以3,000 r/min离心10 min（离心半径10 cm），离心后分离血清用于生物标志物检测。采用酶联免疫吸附测定法（ELISA）检测患者外周血CRP水平。

Measure time point of outcome：

Week 0, Week 2

Measure method：

A 3 mL sample of fasting venous blood was collected from each patient in the morning. The samples were centrifuged at 3,000 r/min for 10 minutes (centrifugal radius: 10 cm), and the serum was separated for biomarker analysis. The level of C-reactive protein (CRP) in peripheral blood was measured using enzyme-linked immunosorbent assay (ELISA).

指标中文名：

白介素6

指标类型：

次要指标

Outcome：

IL-6

Type：

Secondary indicator

测量时间点：

第0周、第2周

测量方法：

采集患者晨起空腹静脉血3 mL，以3,000 r/min离心10 min（离心半径10 cm），离心后分离血清用于生物标志物检测。采用酶联免疫吸附测定法（ELISA）检测患者外周血IL-6水平。

Measure time point of outcome：

Week 0, Week 2

Measure method：

A 3 mL sample of fasting venous blood was collected from each patient in the morning. The samples were centrifuged at 3,000 r/min for 10 minutes (centrifugal radius: 10 cm), and the serum was separated for biomarker analysis. The level of interleukin-6 (IL-6) in peripheral blood was measured using enzyme-linked immunosorbent assay (ELISA).

指标中文名：

临时止痛药情况

指标类型：

次要指标

Outcome：

Usage of temporary analgesics

Type：

Secondary indicator

测量时间点：

第0周、第2周、第4周、第8周、第16周、第24周

测量方法：

受试者疼痛较重，难以忍受时联系研究者，申请口服非甾体类抗炎药物进行临时止痛治疗。研究者详细记录受试者服用药物原因，用药名称及剂量，服药及停药时间等，计算临时止痛药用药人数比例。

Measure time point of outcome：

Week 0, Week 2, Week 4, Week 8, Week 16, Week 24

Measure method：

When participants experienced severe and intolerable pain, they were instructed to contact the investigators to request temporary pain relief with oral nonsteroidal anti-inflammatory drugs (NSAIDs). Investigators documented in detail the reason for medication use, drug name, dosage, as well as the start and stop time of administration. The proportion of participants who used temporary analgesics was then calculated.

指标中文名：

针灸不良反应

指标类型：

副作用指标

Outcome：

Adverse Reactions to Acupuncture and Moxibustion:

Type：

Adverse events

测量时间点：

第0周-第2周每次治疗后

测量方法：

针灸医师记录针刺及艾灸过程中出现的不良反应，如皮下血肿、出血、灼伤、水泡、皮肤过敏等。

Measure time point of outcome：

After each treatment from Week 0 to Week 2

Measure method：

The acupuncturist records any adverse reactions during acupuncture and moxibustion, such as subcutaneous hematoma, bleeding, burns, blisters, and skin allergies.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

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 45 岁
Min age years
最大 65 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）：

随机序列由一名不参与本研究的统计人员应用Stata14.0软件生成和保存将符合纳入排除标准的 KOA 受试者随机分为试验组和对照组，每组各 53例。

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

The random sequence was generated and saved using Stata 14.0 software by a statistician who was not involved in this study. Eligible KOA participants meeting the inclusion and exclusion criteria were randomly assigned to either the intervention group or the control group with 53 participants in each group.

盲法：

本研究对结局评价者、统计分析人员设盲。用字母A和B代替分组情况，以保证结局评价者和统计人员无法判断患者所接受的干预方式。由于针灸方式本身操作的特性，本试验无法对针灸医师设盲，在试验期间，针灸医生被要求不可于患者进行过多的交流。

Blinding：

In this study outcome evaluators and statistical analysts were blinded. Group assignments were replaced with letters A and B to ensure that the evaluators and analysts could not determine the type of intervention received by the patients. Due to the operational characteristics of acupuncture it was not possible to blind the acupuncturists. During the trial acupuncturists were instructed to minimize communication with the patients.

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）：

不共享

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

No

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：

病例记录表和电子采集

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

Case Record Form CRF and Electronic Data Capture

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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