中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600126179
最近更新日期： Date of Last Refreshed on：	2026-06-04 16:39:11
注册时间： Date of Registration：	2026-06-04 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	不同热效应强度电容-电阻式能量转移疗法对肘屈肌离心运动后肌肉功能恢复的影响：一项随机对照试验
Public title：	Effects of different thermal intensities of capacitive-resistive electric transfer therapy on muscle function recovery after elbow flexor eccentric exercise: a randomized controlled trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	不同热效应强度电容-电阻式能量转移疗法对肘屈肌离心运动后肌肉功能恢复的影响：一项随机对照试验
Scientific title：	Effects of different thermal intensities of capacitive-resistive electric transfer therapy on muscle function recovery after elbow flexor eccentric exercise: a 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：	陈建欣	研究负责人：	杨劲峰
Applicant：	Chen Jianxin	Study leader：	Yang Jinfeng
申请注册联系人电话： Applicant telephone：	+86 132 4294 6566	研究负责人电话： Study leader's telephone：	+86 158 8369 0066
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：	jascjx@163.com	研究负责人电子邮件： Study leader's E-mail：	yangjinfeng@cdsu.edu.cn
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：	四川省成都市东部新区环湖北路1942号	研究负责人通讯地址：	四川省成都市东部新区环湖北路1942号
Applicant address：	No.1942, Huanhu North Road, Eastern New District, Chengdu City, Sichuan Province	Study leader's address：	No.1942, Huanhu North Road, Eastern New District, Chengdu City, Sichuan 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：	成都体育学院
Applicant's institution：	chengdu sport university
研究负责人所在单位：	成都体育学院
Affiliation of the Leader：	chengdu sport university

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：	成体伦理 2026 (161)号	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：	成都体育学院伦理委员会
Name of the ethic committee：	Ethics Committee of Chengdu Sport University
伦理委员会批准日期： Date of approved by ethic committee：	2026-05-08 00:00:00
伦理委员会联系人：	杨劲峰
Contact Name of the ethic committee：	Yangjinfeng
伦理委员会联系地址：	四川省成都市东部新区环湖北路1942号
Contact Address of the ethic committee：	No.1942, Huanhu North Road, Eastern New District, Chengdu City, Sichuan Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 158 8369 0066	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：

成都体育学院

Primary sponsor：

chengdu sport university

研究实施负责（组长）单位地址：

四川省成都市东部新区环湖北路1942号

Primary sponsor's address：

No.1942, Huanhu North Road, Eastern New District, Chengdu City, Sichuan 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)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	成都体育学院	具体地址：	四川省成都市东部新区环湖北路1942号
Institution hospital：	chengdu sport university	Address：	No.1942, Huanhu North Road, Eastern New District, Chengdu City, Sichuan Province

经费或物资来源：

自筹

Source(s) of funding：

self funding

研究疾病：

运动性肌肉损伤

Target disease：

exercise induced muscle damage

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

本研究拟采用随机对照试验设计，观察不同热效应强度电容-电阻式能量转移疗法对肘屈肌离心运动后肌肉功能相关指标恢复的影响，包括最大自主等长收缩力矩、肌肉酸痛，及无痛关节活动度。探讨电容-电阻式能量转移疗法在统一CAP模式（作用于肌腹）下，不同输出强度所产生的非热效应或温热效应是否对运动后肌肉功能的恢复产生不同影响，为运动后肌肉损伤和延迟性肌肉酸痛的物理治疗参数选择提供依据。

Objectives of Study：

This study adopts a randomized controlled trial design to investigate the effects of different thermal intensity levels in capacitive-resistive energy transfer therapy on the recovery of muscle function-related parameters following eccentric elbow flexion exercise, including maximal voluntary isometric contraction torque, muscle soreness, and pain-free joint range of motion.This study investigates whether the non-thermal or thermal effects generated by different output intensities of capacitive-resistive energy transfer therapy under the unified CAP mode (acting on muscle fibers) exert distinct impacts on post-exercise muscle function recovery, thereby providing a basis for selecting appropriate physiotherapy parameters for post-exercise muscle injuries and delayed-onset muscle soreness.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Subjects meeting the following criteria are proposed for inclusion:
1. Healthy adults aged 18–35 years, regardless of gender.
2. No regular upper limb resistance training experience in the past 12 weeks.
3. No history of musculoskeletal injuries to the elbow, shoulder, wrist, or upper limbs within the past 6 months.
4. Able to understand the research protocol and voluntarily sign the informed consent form.
5. Able to collaborate in performing isokinetic centrifugation exercises, continuous interventions, and follow-up measurements.
6. During the study period, participants agreed to avoid additional upper limb resistance training, strenuous exercise, massage, thermotherapy, cryotherapy, analgesics, or any other interventions that may interfere with recovery.
7. Female subjects must have a relatively regular menstrual cycle and agree to report the phase of their menstrual cycle in the study records; baseline testing and centrifugal exercise-induced tests should preferably be conducted during the early follicular phase (i.e., days 2–7 of menstruation) .

排除标准：

1. 既往存在上肢骨折、肌腱损伤、神经损伤、严重肌肉拉伤或手术史。 2. 存在影响上肢运动功能的神经系统疾病、肌肉疾病或风湿免疫疾病。 3. 存在心血管疾病、严重代谢性疾病、未控制的高血压或其他不适合完成高强度离心运动的情况。 4. 近期存在急性炎症、感染、发热或全身不适。 5. 研究前7天内服用非甾体抗炎药、镇痛药、肌肉松弛剂或其他可能影响疼痛和炎症反应的药物。 6. 研究前48–72h内进行过剧烈上肢运动、抗阻训练、按摩、热疗、冷疗或其他恢复干预。 7. 皮肤存在破损、皮炎、感染、感觉障碍或对导电介质过敏。 8. 体内植入心脏起搏器、金属内固定物或其他不适宜接受射频/电疗干预的植入装置。 9. 妊娠期、哺乳期或备孕期女性。 10. 女性受试者存在月经周期明显不规律、痛经严重影响运动表现，或近期使用可能显著改变激素水平的药物且无法稳定控制者。

Exclusion criteria：

1. History of upper limb fractures, tendon injuries, nerve injuries, severe muscle strains, or surgical interventions. 2. Presence of neurological disorders, muscular diseases, or rheumatic/immune diseases that affect upper limb motor function. 3. Presence of cardiovascular diseases, severe metabolic disorders, uncontrolled hypertension, or other conditions that make high-intensity eccentric exercise unsuitable. 4. Recent presence of acute inflammation, infection, fever, or general malaise. 5. Do not take nonsteroidal anti-inflammatory drugs, analgesics, muscle relaxants, or any other medications that may affect pain and inflammatory responses within 7 days prior to the study. 6. Engaged in intense upper limb exercise, resistance training, massage, thermotherapy, cryotherapy, or other recovery interventions within 48–72 hours prior to the study. 7. Presence of skin lesions, dermatitis, infection, sensory impairment, or allergy to conductive materials. 8. Implantation of a cardiac pacemaker, metallic internal fixation devices, or other implantable devices unsuitable for radiofrequency/electrical therapy intervention. 9. Women during pregnancy, lactation, or preconception period. 10. Female subjects with significantly irregular menstrual cycles, dysmenorrhea severely affecting athletic performance, or recent use of medications that may substantially alter hormone levels without achieving stable control.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2026-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-05 00:00:00 至 To 2026-06-25 00:00:00

干预措施：

Interventions：

组别：	假治疗组	样本量：	10
Group：	Sham group	Sample size：	10
干预措施：	试者采取与其他组相同体位，治疗师涂抹导电介质，放置电极和回流板，并按照相同路径在肘屈肌区域移动治疗电极。设备处于开机或模拟运行状态，但不输出有效射频能量，或输出被设定为无治疗效应水平。治疗时间与真实干预组一致。	干预措施代码：
Intervention：	The subject assumes the same positioning as in other groups. The therapist applies a conductive medium, places electrodes and a return plate, and moves the therapeutic electrodes along the same pathway over the elbow flexor region.The device is in powered-on or simulated operation mode but does not emit effective radiofrequency energy, or the output is set at a level with no therapeutic effect.The treatment duration was consistent with that of the actual intervention group.	Intervention code：

组别：	非热剂量CAP-CRET组	样本量：	10
Group：	Non-thermal dose group for CAP-CRET	Sample size：	10
干预措施：	采用CAP模式进行低功率电容-电阻式能量转移干预。治疗过程中受试者应无明显温热感或仅有极轻微温热感。控制标准：主观温热感：0–2/10；不出现明显皮肤发热、灼热或不适；记录治疗前后皮肤温度，皮温升高控制在较低范围。	干预措施代码：
Intervention：	The CAP mode was employed for low-power capacitive-resistive energy transfer intervention.During the treatment, the subject should not experience any significant sensation of warmth or should only experience an extremely mild sensation of warmth.Control criteria: Subjective warmth sensation: 0–2/10; no significant skin heat, burning sensation, or discomfort is observed; record skin temperature before and after treatment, ensuring the increase in skin temperature remains within a low range.	Intervention code：

组别：	温热剂量CAP-CRET组	样本量：	10
Group：	Warm-dose group: CAP-CRET	Sample size：	10
干预措施：	采用CAP模式进行中等功率电容-电阻式能量转移干预。治疗过程中产生稳定、舒适、可耐受的温热感。控制标准：主观温热感：4–6/10；不出现灼热、刺痛或疼痛加重；如温热感≥7/10或受试者出现不适，立即降低强度或暂停干预；记录治疗前后皮肤温度。	干预措施代码：
Intervention：	The CAP mode was employed for medium-power capacitive-resistive energy transfer intervention.During the treatment, a stable, comfortable, and well-tolerated warm sensation is experienced.Control criteria: Subjective warmth sensation: 4–6/10; no burning, tingling, or aggravated pain occurs; if the warmth sensation ≥7/10 or the subject experiences discomfort, immediately reduce the intensity or suspend the intervention; record skin temperature 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)：	四川	市(区县)：
Country：	China	Province：	sichuan	City：
单位(医院)：	成都体育学院	单位级别：	无
Institution hospital：	chengdu sport university	Level of the institution：	N/A

测量指标：

Outcomes：

指标中文名：	最大自主等长收缩力矩	指标类型：	主要指标
Outcome：	Maximum isometric contraction torque	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	VAS疼痛评分	指标类型：	次要指标
Outcome：	VAS Pain Score	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无痛关节活动度	指标类型：	主要指标
Outcome：	Painless joint range of motion	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：

标本中文名：	无	组织：
Sample Name：	N/A	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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	35	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）：

本研究采用区组随机法将受试者按 1:1:1比例分配至假治疗组、非热剂量CAP-CRET组，及温热剂量CAP-CRET组。随机序列由一名不参与受试者招募、干预实施、结局评估和统计分析的独立研究人员使用R统计软件生成。由于本研究为三组设计，区组大小设置为3，并采用随机区组大小，以减少分组可预测性。考虑到本研究纳入男女受试者，性别可能影响疼痛敏感性和肌肉功能恢复反应，将采用按性别分层的区组随机法，即男性和女性分别生成随机序列，以保证三组中男女比例尽量均衡。随机分组结果采用连续编号、不透明、密封信封保存。受试者完成基线测试并确认入组后，由治疗师或指定研究人员按编号依次开启信封获取分组信息。结局评估人员、受试者和统计分析人员均不接触随机分组表。

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

In this study, subjects were randomly assigned using a block randomization method in a 1:1:1 ratio to the placebo treatment group, the non-heated dose CAP-CRET group, and the heated dose CAP-CRET group.The random sequences were generated by an independent researcher who was not involved in subject recruitment, intervention delivery, outcome assessment, or statistical analysis, using the R statistical software.Since this study employs a three-group design, the block size was set to 3 with randomization to reduce group predictability.Given that this study included both male and female participants, gender may influence pain sensitivity and muscle function recovery responses. Therefore, a gender-stratified block randomization method will be employed, with separate random sequences generated for males and females to ensure an approximately balanced gender distribution across all three groups.The results of random grouping were stored in continuously numbered, opaque, sealed envelopes.After participants complete the baseline assessment and confirm enrollment, the therapist or designated researcher opens envelopes in numerical order to retrieve group assignment information.Neither the outcome evaluators, participants, nor the statistical analysts had access to the randomization table.

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：	盲法采用受试者、结局评估者和统计分析者盲法。 1. 受试者盲法：受试者不知道自己接受假治疗、非热剂量治疗或温热剂量治疗。治疗时设备屏幕和参数不向受试者显示。 2. 评估者盲法：负责肌力、疼痛和关节活动度测量的研究人员不参与治疗过程，不知道受试者分组。 3. 统计分析者盲法：数据分析前将三组编码为A、B、C，统计人员在不知晓具体分组含义的情况下完成主要分析。 4. 治疗师盲法限制：治疗师因需设置设备参数和控制输出强度，无法实施盲法，但治疗师不参与结局评估、数据录入和统计分析。
Blinding：	blind method Blinding was implemented for subjects, outcome assessors, and statistical analysts. 1. Blinding of subjects: Subjects were unaware whether they received placebo treatment, non-therapeutic dose treatment, or therapeutic dose treatment.During treatment, the device screen and parameters are not displayed to the subject. 2. Blinded assessment: The researchers responsible for measuring muscle strength, pain, and joint range of motion do not participate in the treatment process and are unaware of the subjects' grouping assignments. 3. Blinded method for statistical analysts: Prior to data analysis, the three groups were coded as A, B, and C; statisticians conducted the primary analysis without knowledge of the specific group assignments. 4. Limitations of the therapist-blind method: Therapists cannot implement a blind protocol due to the need to configure device parameters and control output intensity; however, they do not participate in outcome evaluation, data entry, or statistical analysis.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	在项目结束后通过ResMan共享，网址为国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Share on China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)
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：	本研究数据采集主要由专人进行纸质记录，保存于研究者处。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The data collection of this study is mainly carried out by special personnel for paper records, which are kept at the researcher's office.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-06-04 16:39:05