ChiCTR2300074662 版本V1.1 版本创建时间2023/12/28 23:15:12 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：

 ChiCTR2300074662 

最近更新日期：

Date of Last Refreshed on：

 2023-08-11 16:05:52 

注册时间：

Date of Registration：

 2023-08-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经筋理论诊疗非特异性慢性颈痛伴功能障碍的临床疗效观察

Public title：

Clinical observation on the therapeutic effect of the meridian theory in the diagnosis and treatment of non-specific chronic neck pain with dysfunction

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经筋理论诊疗非特异性慢性颈痛伴功能障碍的临床疗效观察

Scientific title：

Clinical observation on the therapeutic effect of the meridian theory in the diagnosis and treatment of non-specific chronic neck pain with dysfunction

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：

陈沁涛 

研究负责人：

李江山 

Applicant：

Qintao Chen 

Study leader：

Jiangshan Li 

申请注册联系人电话：

Applicant telephone：

 +86 157 0079 2616

研究负责人电话：

Study leader's
telephone：

+86 137 0731 5642

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：

 429587419@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 001316@hnucm.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：

湖南省长沙市开福区蔡锷北路233号

研究负责人通讯地址：

湖南省长沙市开福区蔡锷北路233号

Applicant address：

233 CAI'e Road North,Kaifu District,Changsha,Hunan,China

Study leader's address：

233 CAI'e Road North,Kaifu District,Changsha,Hunan,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：

湖南中医药大学第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Hunan University of Chinese Medicine

研究负责人所在单位：

湖南中医药大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Hunan University of 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：

 2023-KY-027

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：

湖南中医药大学第二附属医院伦理委员会

Name of the ethic committee：

The Ethics Committee of the Second Affiliated Hospital of the Hunan University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-14 00:00:00

伦理委员会联系人：

杨声辉

Contact Name of the ethic committee：

Shenghui Yang

伦理委员会联系地址：

湖南省长沙市开福区蔡锷北路233号

Contact Address of the ethic committee：

233 CAI'e Road North,Kaifu District,Changsha,Hunan,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8491 7719

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：

湖南中医药大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Hunan University of Chinese Medicine

研究实施负责（组长）单位地址：

湖南省长沙市开福区蔡锷北路233号

Primary sponsor's address：

233 CAI'e Road North,Kaifu District,Changsha,Hunan,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)：

湖南省

市(区县)：

长沙市

Country：

China

Province：

Hunan province

City：

Changsha

单位(医院)：

湖南中医药大学第二附属医院

具体地址：

湖南省长沙市开福区蔡锷北路233号

Institution
hospital：

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Address：

233 CAI'e Road North,Kaifu District,Changsha,Hunan,China

经费或物资来源：

湖南省科技创新计划资助（2022RC1221）

Source(s) of funding：

Funded by Hunan Science and Technology Innovation program（2022RC1221）

研究疾病：

非特异性慢性颈痛  

Target disease：

Nonspecific chronic neck pain

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：

本试验的目的是评估经筋远端推拿是否对功能障碍具有更为显著的疗效。本研究将为临床医生和利益相关者提供急需的知识，为伴有功能障碍的非特异性慢性颈痛患者提供补充和替代治疗。  

Objectives of Study：

The aim of this study was to assess whether distal jingjin massage has a more significant effect on functional disorders. This study will provide much-needed knowledge for clinicians and stakeholders to provide complementary and alternative therapies for patients with nonspecific chronic neck pain with functional impairment.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①以颈痛症状病程至少3个月但不超过2年； ②疼痛发作时间超过30分钟，每月至少发生一次； ③招募时通过视觉模拟量表(VAS)测量的疼痛强度超过3分； ④颈椎活动时感到疼痛，或颈部活动受限； ⑤年龄20-60岁，男女不限； ⑥能够并愿意服从干预和随访评估； ⑦同意在治疗期间不接受其他相关治疗(包括肌松药)； ⑧能够提供书面知情同意书； ⑨招募前7天内未接受按摩或其他相关治疗

Inclusion criteria

① The course of neck pain symptoms should be at least 3 months but not more than 2 years; ② Pain attacks lasting for more than 30 minutes, occurring at least once a month; ③ The pain intensity measured through the Visual Analog Scale (VAS) during recruitment exceeded 3 points; ④ Feeling pain during cervical movement or limited neck movement; ⑤ Age range from 20 to 60 years old, regardless of gender; ⑥ Able and willing to comply with interventions and follow-up evaluations; ⑦ Agree not to receive other related treatments (including muscle relaxants) during the treatment period; ⑧ Able to provide written informed consent; ⑨ Did not receive massage or other related treatment within 7 days before recruitment

排除标准：

①有伴神经症状的颈椎间盘突出史;颈部创伤；外科颈部骨折；脊柱疾病；感染性炎症性自身免疫性疾病；先天性椎体畸形；或者压缩性骨折； ②有严重的原发病，如心脑血管、肝、肾疾病； ③由于与严重神经症或痴呆相关的精神或心理障碍，无法沟通或自我照顾； ④孕妇或哺乳期妇女； ⑤局部皮肤损伤； ⑥没有在规定的时间内坚持治疗； ⑦参与其他临床试验； ⑧使用任何其他治疗方法(药物或非药物)

Exclusion criteria：

① Have a history of cervical disc herniation with neurological symptoms; Neck trauma; Surgical neck fracture; Spinal diseases; Infectious inflammatory autoimmune diseases; Congenital vertebral malformation; Or compression fractures; ② There are serious primary diseases, such as cardiovascular, cerebrovascular, liver, and kidney diseases; ③ Unable to communicate or take care of oneself due to mental or psychological disorders related to severe neurosis or dementia; ④ Pregnant or lactating women; ⑤ Local skin damage; ⑥ Failure to adhere to treatment within the prescribed time frame; ⑦ Participate in other clinical trials; ⑧ Use any other treatment method (medication or non medication)

研究实施时间：

Study execute time：

从 From 2023-08-13 00:00:00至 To 2024-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-13 00:00:00 至 To 2024-03-31 00:00:00

干预措施：

Interventions：

组别：

足太阳对照组

样本量：

 80

Group：

Zu Taiyang Control Group

Sample size：

干预措施：

对照组：受试者取仰卧位，治疗师按揉受试者阳池、天井穴处各5分钟，以出现酸麻胀痛感受试者能耐受为度，并嘱受试者放松调整呼吸，接着治疗师将弹拨手少阳天井至阳池循行路线10分钟。整个治疗共20min。

干预措施代码：

Intervention：

The subjects were placed in supine position, and the therapist massaged the Yang Chi and Tian Jing acupoints for 5 minutes, to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing, then the therapist will pluck hand Tian Jing to Yangchi to follow the route for 10 minutes. The whole treatment lasted 20 min.

Intervention code：

组别：

足太阳干预组

样本量：

 80

Group：

Zu Taiyang Intervention Group

Sample size：

干预措施：

试验组：受试者取俯卧位，治疗师按揉受试者昆仑、委中穴处各5分钟，以出现酸麻胀痛感受试者能耐受为度，并嘱受试者放松调整呼吸，接着治疗师将弹拨足太阳昆仑至委中循行路线10分钟。整个治疗共20min。

干预措施代码：

Intervention：

The subjects were placed in supine position, and the therapist massaged the Kun Lun and Wei Zhong acupoints for 5 minutes, to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing, then the therapist will pluck hand Kun Lun to Wei Zhong to follow the route for 10 minutes. The whole treatment lasted 20 min.

Intervention code：

组别：

手太阳对照组

样本量：

 80

Group：

Shou Taiyang Control Group

Sample size：

干预措施：

对照组：①左后侧屈旋转：患者为坐位，施术者立于患者头部右后方。右手托于患者下颔部，左手置于枕后部，两手协同施力后伸，分别缓慢的渐进的将患者颈部向左后侧屈45度方向后，再左右手作相反方向操作旋转，右手向右后方向，左手向左前方向旋转（1min30s）。每次增加患者颈部左后侧屈旋转的最大耐受度，单次保持20s，之后缓慢回复至中立位（10s），共需2min，共操作5次。②右后侧屈旋转：患者坐位，施术者立患者头部左后方。左手托于患者下颔部，右手置于枕后部，先两手协同施力后伸，再缓慢的渐进的将患者颈部向右后侧屈45度方向后，再左右手作相反方向操作旋转，右手向右前方向，左手向左后方向旋转（1min30s）。每次增加患者颈部右后侧屈旋转的最大耐受度，单次保持20s，之后缓慢回复至中立位（10s），共需2min，共操作5次。 治疗的强度水平基于体格检查和治疗师的临床经验，以及与每位研究参与者的仔细沟通。每组治疗各20min。

干预措施代码：

Intervention：

① Left posterior flexion and rotation: The patient is in a sitting position, and the performer is standing at the right rear of the patient's head. Hold the right hand on the patient's chin, place the left hand behind the pillow, and extend the neck slowly and gradually to the left and back by 45 degrees. Then, rotate the left and right hands in the opposite direction. Rotate the right hand to the right back direction and the left hand to the left front direction (1 minute, 30 seconds). Increase the maximum tolerance of the patient's left posterior neck flexion and rotation each time, maintain it for 20 seconds, and then slowly return to the neutral position (10 seconds), which takes a total of 2 minutes and is performed 5 times. ② Right posterior flexion and rotation: The patient is seated, and the performer stands behind the left side of the patient's head. Place the left hand on the patient's chin and the right hand behind the pillow. First, apply force together with both hands and extend. Then slowly and gradually bend the patient's neck to the right and back 45 degrees, and then rotate the left and right hands in the opposite direction. Rotate the right hand to the front right and the left hand to the back left (1 minute, 30 seconds). Increase the maximum tolerance of the patient's right posterior neck flexion and rotation each time, maintain it for 20 seconds, and then slowly return to the neutral position (10 seconds), which takes a total of 2 minutes and is performed 5 times. The intensity level of treatment is based on physical examination and clinical experience of the therapist, as well as careful communication with each study participant. Each group was treated for 20 minutes.

Intervention code：

组别：

手太阳干预组

样本量：

 80

Group：

Shou Taiyang Intervention Group

Sample size：

干预措施：

试验组：患者坐位，治疗师按揉受试者患侧阳谷、小海穴处各5分钟，以出现酸麻胀痛感受试者能耐受为度，并嘱受试者放松调整呼吸，接着治疗师将弹拨手太阳小肠经在前臂部（腕关节至肘关节）循行路线10分钟。整个治疗共20min。

干预措施代码：

Intervention：

The subjects were placed in supine position, and the therapist massaged the Yang Gu and Xiao Hai acupoints for 5 minutes, to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing, then the therapist will pluck hand Yang Gu to Xiao Hai to follow the route for 10 minutes. The whole treatment lasted 20 min.

Intervention code：

组别：

足少阳对照组

样本量：

 80

Group：

Zu Shaoyang Control Group

Sample size：

干预措施：

对照组：受试者取仰卧位，治疗师按揉受试者阳池、天井穴处各5分钟，以出现酸麻胀痛感受试者能耐受为度，并嘱受试者放松调整呼吸，接着治疗师将弹拨手少阳天井至阳池循行路线10分钟。整个治疗共20min。

干预措施代码：

Intervention：

The subjects were placed in supine position, and the therapist massaged the Yang Chi and Tian Jing acupoints for 5 minutes, to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing, then the therapist will pluck hand Tian Jing to Yangchi to follow the route for 10 minutes. The whole treatment lasted 20 min.

Intervention code：

组别：

足少阳干预组

样本量：

 80

Group：

Zu Shaoyang Intervention Group

Sample size：

干预措施：

试验组：受试者取仰卧位，治疗师按揉受试者丘墟、阳陵泉穴处各5分钟，以出现酸麻胀痛感受试者能耐受为度，并嘱受试者放松调整呼吸，接着治疗师将弹拨丘墟至阳陵泉循行路线10分钟。整个治疗共20min。

干预措施代码：

Intervention：

The subjects were placed in supine position, and the therapist massaged the Qiu Xu and Yang Chi acupoints for 5 minutes, to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing, then the therapist will pluck hand Qiu Xu to Yang Chi to follow the route for 10 minutes. The whole treatment lasted 20 min.

Intervention code：

组别：

足少阴对照组

样本量：

 80

Group：

Zu Shaoyin Control Group

Sample size：

干预措施：

对照组：第一步，软组织放松：治疗师指示患者俯卧，自然放松身心。非特异性慢性颈部疼痛状况将在治疗前通过姿势和触诊评估仔细检查。治疗师将通过按压捏合操作放松颈部和肩部的软组织和僵硬肌肉5分钟。然后，治疗师将使用他的手掌轻轻地滚动斜方肌放松背部区域5分钟。这一步的目的是解决粘连并增加全身循环。共10分钟。第二步穴位按压，治疗师将按压并揉捏风池，肩井和肩中俞各5分钟。使用的力量取决于患者的得气感觉，通常被描述为钝痛，沉重，麻木或酸痛。第三步拉伸，缓慢应用按揉穴位治疗，并且在不引起患者疼痛的情况下进行。患侧上斜方肌的被动拉伸也进行了1分20秒（缓慢拉伸至最大幅度，并保持15秒，之后缓慢回复至中立位，共需20秒，共操作3次，每次间隔10秒）。

干预措施代码：

Intervention：

Step 1, soft tissue relaxation: The therapist instructs the patient to lie down and naturally relax their body and mind. Non specific chronic neck pain will be carefully examined through posture and palpation assessment before treatment. The therapist will relax the soft tissues and stiff muscles of the neck and shoulders through compression and kneading operations for 5 minutes. Then, the therapist will use his palm to gently roll the trapezius muscle to relax the back area for 5 minutes. The purpose of this step is to solve adhesions and increase systemic circulation. A total of 10 minutes. The second step is to press the acupoints, and the therapist will press and knead Feng Chi, Jian jing, and Jian Zhongshu for 5 minutes each. The strength used depends on the patient's sense of qi acquisition, which is usually described as dull pain, heaviness, numbness, or soreness. The third step is to stretch, slowly apply massage to the acupoints for treatment, and proceed without causing pain to the patient. The passive stretching of the affected superior trapezius muscle was also performed for 1 minute and 20 seconds (slowly stretching to the maximum amplitude, holding for 15 seconds, and then slowly returning to the neutral position, taking a total of 20 seconds, with a total of 3 operations, each with an interval of 10 seconds).

Intervention code：

组别：

足少阴干预组

样本量：

 80

Group：

Zu Shaoyin Intervention Group

Sample size：

干预措施：

试验组：受试者取俯卧位，治疗师按揉受试者太溪、筑宾、阴谷穴处各5分钟，以出现酸麻胀痛感受试者能耐受为度，并嘱受试者放松调整呼吸，接着治疗师将弹拨太溪至阴谷循行路线10分钟。整个治疗共25min。

干预措施代码：

Intervention：

The subjects were placed in prone position, and the therapist massaged the Tai Xi,Zhu Bin and Yin Gu acupoints for 5 minutes, to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing, then the therapist will pluck hand Tai Xi to Yin Gu to follow the route for 10 minutes. The whole treatment lasted 25 min.

Intervention code：

组别：

序贯试验组

样本量：

 10

Group：

Sequential test group

Sample size：

干预措施：

足少阴经筋：操作者用拇指点按受试者太溪及阴谷（各3分钟，共6分钟），以出现酸麻胀痛感受试者能耐受为度，并嘱受试者放松调整呼吸。整个推拿治疗共6min，治疗一次。 足厥阴经筋：操作者用拇指点按受试者中封及曲泉（各3分钟，共6分钟），以出现酸麻胀痛感患者能耐受为度，并嘱受试者放松调整呼吸。整个推拿治疗共 6min，治疗一次。 每位患者入组当日均接受2种治疗。具体患者先接受何组治疗，由随机决定。

干预措施代码：

Intervention：

Zu Shaoyin muscle region：The therapist massaged the Tai Xi and Yin Gu acupoints (3 minutes each, 6 minutes in total), to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing. Zu Jueyin muscle region：The therapist massaged the Zhong Feng and Qu Quan acupoints (3 minutes each, 6 minutes in total), to the extent that the subjects could tolerate the sensation of soreness, numbness and pain, and instructed the subjects to relax and adjust their breathing. Each patient received 2 treatments on the day of admission. Which group of patients received treatment first was decided by randomization.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 长沙市 

Country：

China

Province：

Hunan province

City：

Changsha

单位(医院)：

 湖南中医药大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

颈椎关节活动度

指标类型：

主要指标

Outcome：

Cervical joint range of motion

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

颈椎功能障碍指数量表

指标类型：

次要指标

Outcome：

Neckdisabilityindex,NDI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉模拟评分量表

指标类型：

次要指标

Outcome：

Visual analogue scale，VAS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

数字触诊仪

指标类型：

次要指标

Outcome：

MyotonPRO

Type：

Secondary 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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 60 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）：

在招募之前将生成连续数字列表（从1-160），并且这些数字中的每一个将被随机分配到两个研究组（对照组、干预组）中的一个。随机化列表由Excel生成。

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

A list of consecutive numbers (from 1 to 160) is generated prior to recruitment, and each of these numbers will be randomly assigned to one of the two study groups (control, intervention) . The randomization list is generated by Excel.

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：

患者将被告知他们将接受的治疗类型。治疗师将知道分配情况，以便他们应该学习如何与患者沟通以确保治疗的盲法。为了降低偏倚风险，评估人员，数据管理人员和统计人员将不知道结果评估程序和数据分析中的小组任务。

Blinding：

Patients will be told the type of treatment they will receive. Therapists will know the assignments so that they should learn how to communicate with patients to ensure treatment blindness. To reduce the risk of bias, evaluators, data managers, and statisticians will be unaware of the results assessment procedures and team assignments in data analysis.

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）：

以论文形式公开

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

public paper

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：

CRF

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

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：

  2023-08-11 16:05:45