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Effect of acupuncture (head acupuncture, matrix acupuncture and 'Shanyin' point) combined with bladder function training in the treatment of Neurogenic bladder in patients with spinal cord injury

注册号：

Registration number：

ITMCTR1900002419

最近更新日期：

Date of Last Refreshed on：

2019-06-23

注册时间：

Date of Registration：

2019-06-23

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

针刺（头针、矩阵针法及“三阴穴”）联合膀胱功能训练治疗脊髓损伤患者神经源性膀胱的影响

Public title：

Effect of acupuncture (head acupuncture, matrix acupuncture and 'Shanyin' point) combined with bladder function training in the treatment of Neurogenic bladder in patients with spinal cord injury

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺（头针、矩阵针法及“三阴穴”）联合膀胱功能训练治疗脊髓损伤患者神经源性膀胱的影响

Scientific title：

Effect of acupuncture (head acupuncture, matrix acupuncture and 'Shanyin' point) combined with bladder function training in the treatment of Neurogenic bladder in patients with spinal cord injury

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：

ChiCTR1900024034 ; ChiMCTR1900002419

申请注册联系人：

张丽蓉

研究负责人：

寄婧

Applicant：

Zhang lirong

Study leader：

Ji Jing

申请注册联系人电话：

Applicant telephone：

+86 18193630535

研究负责人电话：

Study leader's telephone：

+86 13893492385

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：

1334894283@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2472770527@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：

甘肃省兰州市七里河区瓜州路418号

研究负责人通讯地址：

甘肃省兰州市七里河区瓜州路418号

Applicant address：

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, China

Study leader's address：

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, China

申请注册联系人邮政编码：

Applicant postcode：

730050

研究负责人邮政编码：

Study leader's postcode：

730050

申请人所在单位：

甘肃省中医院

Applicant's institution：

Gansu Provincial Hospital of TCM

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：

FJ/04-IRB/C/018/-V3.0

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：

甘肃省中医院伦理委员会

Name of the ethic committee：

Ethics committee of Gansu Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2019/5/9 0:00:00

伦理委员会联系人：

李玉梅

Contact Name of the ethic committee：

LIyumei

伦理委员会联系地址：

甘肃省兰州市七里河区瓜州路418号

Contact Address of the ethic committee：

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 17793195736

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2650187322@qq.com

研究实施负责（组长）单位：

甘肃省中医院

Primary sponsor：

Gansu Provincial Hospital of TCM

研究实施负责（组长）单位地址：

甘肃省兰州市七里河区瓜州路418号

Primary sponsor's address：

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, 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)：

甘肃省

市(区县)：

兰州市

Country：

China

Province：

Gansu

City：

Lanzhou

单位(医院)：

甘肃省中医院

具体地址：

甘肃省兰州市七里河区瓜州路418号

Institution
hospital：

Gansu Provincial Hospital of TCM

Address：

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, China

经费或物资来源：

甘肃省中医药管理局项目

Source(s) of funding：

Gansu traditional Chinese medicine administration project

研究疾病：

神经源性膀胱

研究疾病代码：

Target disease：

neurogenic bladder

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：

其它

Others

研究目的：

观察针刺（头针、矩阵针法及“三阴穴”）联合膀胱功能训练治疗脊髓损伤患者神经源性膀胱的影响以两组患者治疗前后膀胱功能积分、膀胱残余尿量和膀胱容量的变化为观察指标，以规范观察针刺（头针、矩阵针法及“三阴穴”）联合膀胱功能训练在神经源性膀胱的实验研究阶段拓展到临床应用，并能够将这项无创、成本低、实用性强、有效性和安全性高的技术在基层推广，让广大脊髓损伤后神经源性膀胱功能障碍患者的困扰减轻并从中受益。

Objectives of Study：

Observation acupuncture (head needle stitch, matrix and the "three Yin cave") with bladder function training therapy of spinal cord injury patients with neurogenic bladder effects in two groups before and after treatment in patients with bladder function integral, bladder residual urine volume and the change of the bladder capacity as observation indexes, to regulate observation acupuncture (head needle stitch, matrix and the "three Yin cave") joint bladder function training in experimental research stage of neurogenic bladder to expand into clinical applications, and to the noninvasive, low cost, strong practicability, effectiveness and safety of high technology in the grass-roots promotion, let the masses of neurogenic bladder dysfunction after spinal cord injury patients with ease and benefit from it.

药物成份或治疗方案详述：

1 对照组 采用康复治疗方案进行积极干预，进行间歇导尿及常规膀胱功能训练：（1）间歇导尿：定时饮水，每隔4～6 h用一次性导尿管导尿1次，在每次导尿前行膀胱功能训练辅助排尿。自动排尿间隔每次大于2 h或者排尿后残余尿量小于100 ml，膀肌容量在250 ml以上，且无感染时可终止导尿；（2）膀胱功能训练：采用激发技术在小腹周围某一点轻轻叩击或挤压膀胱，拍打大腿内侧，轻轻拉扯阴毛，挠脚心，听流水声，手法排尿（按摩膀胱区、Valsalva屏气法和耻骨上叩击法）、盆底肌锻炼。每天治疗1次，每周治疗7天，共治疗4周。 2 治疗组 在对照组疗法的基础上同时加针刺[头针、矩阵针法及“三阴穴”治疗。矩阵针法取穴：第一组：百会,百会穴属督脉，别名“三阳五会”，百脉于此交会，能通阳化气行水、四神聪（平刺）在临床应用十分广泛，可以醒脑开窍，镇静安神，改善患者睡眠质量，提高免疫力；双侧眉冲、曲差、五处、承光（斜刺）易可通经理气、调补肾气，促进肾和膀胱对水液的气化固摄；神阙1（单穴隔姜灸）、合谷（双）2、太冲（双）3；第二组：关元（单）1、气海（单）2、中极（单）3、水道（双）4、大巨（双）5、归来（双）6；第三组：“三阴穴”取穴：夹阴1（左侧腹股沟中点，股动脉搏动处内侧缘）、夹阴2（右侧腹股沟中点，股动脉搏动处内侧缘）、夹阴3（前正中线上，曲骨穴直上0.5寸（改为mm或cm表示）。针刺方式（按一到三组的顺序依次施以针灸之术，每组腧穴右下部标记的数字即为该腧穴针灸时的顺序、双穴遵循先左后右的顺序）。神阙穴采用隔姜灸法，选用厚约3～5 mm左右大小刚好覆盖神阙穴的新鲜生姜，中间用毫针散在刺部分小孔，艾柱底大小以稍小于生姜片大小为度，每次灸3～5壮；其余十四经穴使用华佗牌（规格：0.30×40 mm）毫针垂直刺入皮肤，得气后以右手拇指向前，食指向后轻轻捻转针柄，使针旋转约180°，以手下粘滞沉紧为度。三阴穴[52]均采用规格为0.30×75 mm华佗牌毫针，夹阴1和夹阴2避开股动脉，沿股动脉巡行方向向会阴部针刺，以针感传导到会阴部或手下粘滞沉紧为度；夹阴3待患者排尿或导尿后斜刺向会阴部，以针感传导到会阴部或手下粘滞沉紧为度（注：患者因脊髓损伤的缘故，部分腧穴无任何针感，针刺以施术者手下粘滞沉紧为度）。以上腧穴每日针灸治疗两次，治疗中间时间间隔为6 h左右，8日为一疗程，中间休息2天，连续治疗3个疗程后统计疗效。

Description for medicine or protocol of treatment in detail：

1. control group: (1) intermittent catheterization: regular drinking water, one-time urinary catheter catheterization every 4 to 6 hours, assisted by bladder function training before each catheterization.Automatic urination interval is more than 2 h at a time, or residual urine volume after urination is less than 100 ml, bladder muscle capacity is more than 250 ml, and catheterization can be terminated when there is no infection; (2) bladder function training: tap or squeeze the bladder at a certain point around the lower abdomen with stimulation technology, pat the inner thigh, gently pull pubic hair, scratch the heart of the foot, listen to the sound of running water, urinate by hand (massage the bladder area, Valsalva breath-holding method and pubic suprapulophal percussion method), pelvic floor muscle exercise.Treatment was performed once a day for 7 days a week for a total of 4 weeks. 2. treatment group: Plus acupuncture at the same time in the control group therapy on the basis of [head needle stitch, matrix and the "three Yin cave" treatment. Matrix stitch find: in the first group: the will, the will den du meridian, alias "three Yang five", lotaustralin in this intersection, tong Yang gas lines of water, four god astute (flat) and they are widely used in clinical can wake the brain begin to understand, tranquilize mind, improve sleep quality, enhance immunity; bilateral eyebrow rushed, stuffy nose, five, chengguang (oblique) easy to menstruation and qi, kidney qi, promoting kidney and bladder of water gasification is taken; CV 8 1 (single cavity ginger moxibustion) insulation, li4 (double) 2, lr 3 (double) 3; the second group:Guan yuan (single) 1, qi hai (single) 2, middle pole (single) 3, channel (double) 4, big giant (double) 5, return (double) 6;Clamp Yin 1 (the left groin midpoint, shares pulses at the inside edge), clip Yin 2 (right groin midpoint, femoral artery pulse inside edge), clip Yin 3 (online, before the middle of symphysis pubis hole straight on a 0.5 -inch (mm or cm). Acupuncture methods (according to one to three groups in the order to acupuncture, acupuncture points in each group at tag number is the order of the acupuncture at acupoints, double holes follow left right after the first order). CV 8 point with ginger moxibustion, choose thick about 3 ~ 5 mm size cover CV 8 point of fresh ginger, with filiform needle in middle part of the hole,The size of the bottom of aizhu is slightly smaller than that of ginger slices, and the moxibustion is 3-5 strong each time; the other 14 meridian points are treated with huatuo brand (specifications:0.30 x 40 mm) filiform needle vertical Pierce the skin, after qi forward with your right thumb, index finger gently turning back the needle handle, make needle rotate 180 °, with viscous heavy under tight degrees. Three Yin cave [52] all the specifications of 0.30 x 75 mm hua tuo card insertion, clamp and Yin Yin 1 2 to avoid femoral artery, the femoral artery over all the direction to the perineum acupuncture, with needle feeling conduct perineum or for viscous heavy under tight degree; clip Yin 3 after micturition or urethral catheterization in patients with inclined stab to the perineum, with needle feeling conduct perineum or viscous heavy under tight for degrees (note:Acupuncture and moxibustion at the above acupoints were performed twice a day, with an interval of about 6 h, 8 days for a course of treatment, 2 days for rest, and 3 consecutive treatment courses for statistical efficacy.

纳入标准：

（1）SCI诊断符合美国脊柱损伤学会2013年标准（ASIA，2013年）及脊髓损伤后神经源性膀胱的诊断标准； （2）年龄16至65岁,脊髓休克期已过，处于恢复期患者，意识清醒，生命体征平稳，无严重合并症； （3）不完全性脊髓损伤患者； （4）留置尿管已拔除，患者均有不同程度的尿潴留，主要表现为膀胱胀满而无法排尿或尿频、尿不尽，下腹胀满不适Ｂ超检,查残余尿量＞100ｍＬ。 （5）同意参加临床试验并签署知情同意书。 凡同时符合上述5条者，均可纳入临床研究。

Inclusion criteria

(1) SCI diagnosis conforms to the 2013 standard of the American spinal injury society (ASIA, 2013) and the diagnosis standard of neurogenic bladder after spinal cord injury; (2) patients aged from 16 to 65 years old, past the stage of spinal shock, in the recovery stage, conscious, stable vital signs, no serious complications; (3) patients with incomplete spinal cord injury; (4) the indwelling catheter has been removed, and all patients have urinary retention of different degrees, mainly manifested as full bladder and inability to urinate, frequent urination and insufficient urine, and full abdominal distension and discomfort. (5) agree to participate in the clinical trial and sign the informed consent. Those who also meet the above five criteria can be included in clinical studies

排除标准：

（1）脊髓损伤急性期； （2）完全性脊髓损伤； （3）生命体征不稳定； （4）伴有严重心、脑、肺等重要脏器疾患； （5）合并水电解质、酸碱平衡紊乱； （6）既往有严重肾脏疾患或前列腺疾患； （7）合并严重肾积水、膀胱造瘘术、尿道前括约肌切开术及严重的排尿植物神经系统过反射等疾患； （8）合并严重泌尿系统感染； （9）针刺部位皮肤感染者、有晕针史患者； （10）患者依从性、配合度欠佳； （11）未完成本方案所规定的疗程中途退出或治疗前后数据资料不全者。标准：如果尿常规出现白细胞或脓细胞 ＞3 个／ＨＰ、普通细菌培养 ＞1×105／ｍＬ 者为尿路感染，应用抗生素治疗1周感染未控制者。

Exclusion criteria：

(1) acute stage of spinal cord injury; (2) complete spinal cord injury; (3) unstable vital signs; (4) accompanied by serious heart, brain, lung and other important organ diseases; (5) water electrolyte, acid-base balance disorder; (6) previous severe kidney disease or prostate disease; (7) combined with severe hydronephrosis, cystostomy, anterior urethral sphincterotomy and severe urinary vegetative nervous system overreflex; (8) severe urinary tract infection; (9) patients with skin infection at the acupuncture site or with a history of needle sickness; (10) poor compliance and cooperation; (11) withdrawal from the course of treatment or incomplete data before and after treatment as stipulated in the plan of unfinished cost.Standard: urinary tract infection was defined as 3 > / HP white blood cells or pus cells in urine routine and 1×10^5/mL > culture of common bacteria, and antibiotics were applied to treat the untreated infection for 1 week.

研究实施时间：

Study execute time：

从From 2019-06-21

至To      2020-12-31

征募观察对象时间：

Recruiting time：

从From 2019-06-21

至To      2020-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

膀胱功能训练

干预措施代码：

Intervention：

bladder function training

Intervention code：

组别：

试验组

样本量：

30

Group：

Experimental group

Sample size：

干预措施：

针刺（头针、矩阵针法及“三阴穴”）联合膀胱功能训练

干预措施代码：

Intervention：

acupuncture (head acupuncture, matrix acupuncture and 'Shanyin' point) combined with bladder function training

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

甘肃省

市(区县)：

兰州市

Country：

China

Province：

Gansu

City：

Lanzhou

单位(医院)：

甘肃省中医院

单位级别：

三级甲等医院

Institution/hospital：

Gansu Provincial Hospital of TCM

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

膀胱功能积分、FIM功能独立性量表

指标类型：

主要指标

Outcome：

Bladder function score and FIM function independence scale

Type：

Primary indicator

测量时间点：

饮水后3-4h

测量方法：

残余尿量测定及尿流率、膀胱压力测定

Measure time point of outcome：

3-4 h after drinking water

Measure method：

residual urine volume, urine flow rate and bladder pressure were measured

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液

组织：

膀胱

Sample Name：

urine

Tissue：

bladder

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 16 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）：

按研究纳入标准分为治疗组及对照组，各组30例，共60例

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

According to the study inclusion criteria, 30 patients in each group were divided into treatment group and control group, with a total of 60 cases

盲法：

未说明

Blinding：

Not stated

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）：

2021年以论文数据形式显示

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

2021 is shown in the form of paper data

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：

康复评定量表及残余尿量

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

Rehabilitation assessment scale and residual urine volume

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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