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臂丛麻醉下手法松解术治疗冻结肩的临床研究

注册号：

Registration number：

ITMCTR2200006033

最近更新日期：

Date of Last Refreshed on：

2022-05-24

注册时间：

Date of Registration：

2022-05-24

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

臂丛麻醉下手法松解术治疗冻结肩的临床研究

Public title：

Clinical study on the treatment of frozen shoulder by manipulation under brachial plexus anesthesia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

臂丛麻醉下手法松解术治疗冻结肩的临床研究

Scientific title：

Clinical study on the treatment of frozen shoulder by manipulation under brachial plexus anesthesia

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：

ChiCTR2200060269 ; ChiMCTR2200006033

申请注册联系人：

王翔

研究负责人：

王翔

Applicant：

Wang xiang

Study leader：

Wang xiang

申请注册联系人电话：

Applicant telephone：

13816985219

研究负责人电话：

Study leader's telephone：

13816985219

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：

w8x@163.com

研究负责人电子邮件：

Study leader's E-mail：

w8x@163.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：

上海市黄浦区普安路185号曙光医院骨伤科

研究负责人通讯地址：

上海市黄浦区普安路185号曙光医院骨伤科

Applicant address：

Department of Orthopedics and Traumatology, Shuguang Hospital, 185 Puan Road, Huangpu District, Shanghai

Study leader's address：

Department of Orthopedics and Traumatology, Shuguang Hospital, 185 Puan Road, Huangpu District, Shanghai

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：

上海中医药大学附属曙光医院

Applicant's institution：

Shuguang Hospital affiliated to Shanghai University of Traditional 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：

ChiECRCT20200121

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

中国注册临床试验伦理审查委员会

Name of the ethic committee：

China Ethics Committee of Registering Clinical Trials

伦理委员会批准日期：

Date of approved by ethic committee：

2020/5/21 0:00:00

伦理委员会联系人：

吴莼

Contact Name of the ethic committee：

Wu Chun

伦理委员会联系地址：

四川大学华西医院、中国四川省成都市国学巷37号行政楼八角亭2902室

Contact Address of the ethic committee：

West China Hospital of Sichuan University, Room 2902, Bajiao Pavilion, Administration Building no. 37, Guoxue Lane, Chengdu, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

上海中医药大学附属曙光医院

Primary sponsor：

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市黄浦区普安路185号曙光医院骨伤科

Primary sponsor's address：

Department of Orthopedics and Traumatology, Shuguang Hospital, 185 Puan Road, Huangpu District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属曙光医院

具体地址：

上海市黄浦区普安路185号曙光医院骨伤科

Institution
hospital：

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Address：

Department of Orthopedics and Traumatology, Shuguang Hospital, 185 Puan Road, Huangpu District, Shanghai

经费或物资来源：

上海市卫生和计划生育委员会

Source(s) of funding：

Shanghai Municipal Health and Family Planning Commission

研究疾病：

冻结肩

研究疾病代码：

Target disease：

Frozen Shoulder

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：

通过随机、对照的临床设计，观察臂丛麻醉下手法松解术对冻结肩患者的治疗作用，从而客观评价臂丛麻醉下手法松解术的临床疗效，为该治疗方案的临床应用提供客观的临床依据。

Objectives of Study：

Through a randomized, controlled clinical design, the therapeutic effect of manipulation under brachial plexus anesthesia on patients with Frozen Shoulder was observed, so as to objectively evaluate the clinical efficacy of manipulation under brachial plexus anesthesia, providing objective clinical basis for the clinical application of this treatment plan.

药物成份或治疗方案详述：

一、试验组 本操作由经严格培训过的高年资临床医师在手术室进行，以确保操作安全、无菌，术前患者需禁食禁水至少6小时，术中患者低流量持续吸氧（2-2.5L/min），并开放静脉输液通道，心电监护实时监测患者的生命体征。 （1）臂丛麻醉：患者取仰卧位，头偏向健侧，颈肩部垫一软薄枕，以充分暴露麻醉穿刺部位，常规消毒后，超声引导下定位胸锁乳突肌和前中斜角肌所形成的肌间沟，以此为进针点，注入罗哌卡因75mg/10ml+2%利多卡因10ml阻滞臂丛神经。15-20min待麻醉充分后开始进行手法松解。 （2）手法松解术： ①患者取仰卧位，术者立于患者患侧，将患肢前屈上举至180°，操作过程中一手持患侧肘部，一手置于患者腋窝处的肱骨上端近肱骨头处，以防肩关节脱位，重复三遍，可以听到或者手下感到粘连松解的声音或感觉。 ②外展上举患者患肢至180°，同样注意保护肱骨头，以防脱位，重复三遍。 ③前屈患侧肩关节90°，屈肘，内收患侧肩关节45°，重复三遍，可以听到或者手下感到粘连松解的声音或感觉。 ④外展45°肘关节伸直位，内旋、外旋患肩，重复三遍。 ⑤患者健侧卧位，后伸内旋屈肘，使患者的手指至少可触及健侧肩胛骨，重复三遍。术毕，患肢固定保护。 注：操作过程中注意加强与患者的沟通交流，密切关注患者的生命体征。应手法轻柔，避免操作不当造成骨折等并发症可能，松解后可予冰敷以减少出血和消肿。 二、对照组 选用塞来昔布胶囊（规格：200mg/粒；厂家：辉瑞制药有限公司；国药准字：J 20140072），患者需每天1次，每次1粒口服，连续服用12天，不能自行调整用量，用药期间若出现任何不适，即停药。试验期间不得同时使用其他止痛作用的药物。 三、功能锻炼 两组均于治疗开始后第一天开始进行功能锻炼，其中患者首次功能锻炼需在经统一严格培训过的门诊医师的指导下进行，直到患者及陪同的家属均掌握正确的功能锻炼方法，陪同家属可录制相关视频，初期家属可协助并监督患者进行功能锻炼。定期对患者进行随访，以确保锻炼姿势的规范、正确性。具体方法如下： ①爬墙训练：患者面对墙壁直立，双脚分开，与肩同宽，双脚脚尖顶住墙壁，患侧五指张开扶在墙上，沿墙壁缓慢用力上举，在疼痛可承受范围内，可由健肢辅助患肢逐渐向上抬高，或他人于患者身后推举患侧肩胛骨以促使患肢上举至极限位置。 ②搭肩训练：患侧肘关节屈曲，尽量贴于胸壁，在疼痛可承受范围内，健侧手掌逐渐上推患侧肘关节，使患侧手搭于健侧肩关节。 ③提手后拉：患者取坐位或直立位，患侧手置于背后，掌心向后，在疼痛可承受范围内，患肢逐渐内收、上提，健侧手可拉患侧手帮助其达到极限位置。 注：待患者疼痛缓解后，反复上述动作。每天3次，每次3组。

Description for medicine or protocol of treatment in detail：

I. Experimental group This operation was performed by highly trained and experienced clinicians in the operating room to ensure safety and aseptic operation. Patients were required to fast and keep water for at least 6 hours before surgery. During the operation, patients continued oxygen inhalation at low flow rate (2-2.5L/min), intravenous infusion channels were opened, and patients' vital signs were monitored by ecg monitoring in real time. (1) Brachial plexus anesthesia: the patient was placed in supine position with the head on the healthy side and a soft and thin pillow on the neck and shoulder to fully expose the anesthesia puncture site. After routine disinfection, the intermuscular groove formed by the sternocleidomastoid muscle and the anterior middle scalenus muscle was located under the guidance of ultrasound, which was used as the injection point. Ropivacaine 75mg/10ml+2% lidocaine 10ml were injected to block the brachial plexus nerve. 15-20min after full anesthesia, manual release was performed. (2) Manipulation: ①the patient supine position, the operator in the patient side, the affected limb flexion upward to 180°, the operation process in hand side elbow, hand placed in the patient's axilla at the upper end of the humerus near the humerus head, in order to prevent shoulder dislocation, repeat three times, you can hear or feel the voice or feeling of adhesion release. ② Abduction of the patient's affected limb to 180°, also pay attention to protect the humeral head, to prevent dislocation, repeat three times. ③ The anterior flexion side shoulder joint 90°, elbow flexion, adduction side shoulder joint 45°, repeat three times, you can hear or feel the sound or feeling of adhesion release. ④ Extend the elbow at 45°, rotate the affected shoulder inside and outside, repeat three times. ⑤ The patient is in lateral decubitus position, with elbow flexion after extension, so that the patient's fingers can touch at least the shoulder blade on the healthy side, repeat three times. After the operation, the limb was fixed and protected. Note: During the operation, pay attention to strengthen communication with the patient and pay close attention to the patient's vital signs. It should be handled gently to avoid possible complications such as fracture caused by improper operation. After release, ice can be applied to reduce bleeding and reduce swelling. II. Control group Celecoxib capsule (specification: 200mg/ tablet; Manufacturer: Pfizer Inc. National Drug approval word: J 20140072), the patient needs to take 1 pill orally once a day for 12 consecutive days without adjusting the dosage. If any discomfort occurs during the medication, the drug will be stopped. Other analgesic drugs shall not be used at the same time during the test. III. Functional exercise Both groups after treatment began, the first day to the patients with functional exercise for the first time in the unified strictly trained under the guidance of clinic doctors, until the patients and the accompanying family members are the right functional exercise method, accompanying family members can be related video recording, the early family member can assist and supervise the patients with functional exercise. Follow up patients regularly to ensure the standard and correctness of exercise posture. Specific methods are as follows: ①Climbing training: Patients facing the wall upright, feet apart, and shoulder are the same as wide, double foot toe against the wall, side before hand on the wall, along the wall slowly lift on hard, within the scope of the pain can afford, but by the healthy limb assistant limb gradually upward, or others behind in the patients with elevated risk of side shoulder blades to encourage lift on limb to limit position. ②Shoulder training: the affected elbow flexion, as far as possible on the chest wall, in the pain tolerance range, the healthy side of the hand gradually push the affected elbow, so that the affected hand on the healthy side of the shoulder joint. ③Hand after pulling: the patient takes a sitting or upright position, the affected hand is placed behind the back, the palm is backward, in the pain tolerance range, the affected limb gradually adduction, lifting, the healthy hand can pull the affected hand to help it reach the limit position. Note: Repeat the above actions after the patient's pain is relieved. Three groups, three times a day.

纳入标准：

（1）年龄在40岁至70岁之间； （2）符合冻结肩的诊断标准，肩关节活动明显受限； （3）治疗前拍摄肩关节MRI排除肩周肌腱、韧带断裂、肩袖损伤、肿瘤等其他关节内或器质性病变； （4）门诊复查3个月以上，并坚持功能锻炼者。

Inclusion criteria

(1) Aged between 40 and 70; (2) In line with the diagnostic criteria of Frozen Shoulder, shoulder joint activity was significantly limited; (3) Before treatment, MRI of shoulder joint was taken to exclude perishoulder tendon and ligament rupture, rotator cuff injury, tumor and other intraarticular or organic lesions; (4) Outpatient review for more than 3 months and insist on functional exercise.

排除标准：

具有下列情况之一者，不能纳入本次试验： （1）不符合纳入标准者； （2）对麻醉药物过敏者； （3）因颈椎病、某些结缔组织疾病以及肩周烧烫伤后皮肤明显挛缩所导致的以肩痛及活动障碍症状为主的疾患； （4）合并有严重的心、肝、肾、血液等内科系统疾病； （5）存在抑郁、狂躁等精神、心理类疾病； （6）麻醉穿刺部位皮肤存在破损、溃烂或感染等现象，有长期发热症状的患者； （7）妊娠期，哺乳期妇女； （8）不接受观察，不愿治疗者； （9）目前正在参加其他临床试验者； （10）研究者认为不适合加入本研究或进行治疗的其他情况。

Exclusion criteria：

In any of the following circumstances, it cannot be included in this test: (1) Those who do not meet the inclusion criteria; (2) allergic to narcotic drugs; (3) shoulder pain and mobility disorders mainly caused by cervical spondylosis, some connective tissue diseases and obvious skin contracture after burns and scalds around the shoulder; (4) complicated with serious heart, liver, kidney, blood and other internal diseases; (5) the existence of depression, mania and other mental and psychological diseases; (6) Patients with long-term fever and skin damage, ulceration or infection at the anesthesia puncture site; (7) Pregnant women and lactating women; (8) those who refuse observation or treatment; (9) currently participating in other clinical trials; (10) Other conditions that the investigator considers inappropriate for inclusion in this study or treatment.

研究实施时间：

Study execute time：

从From 2019-06-01

至To      2020-12-31

征募观察对象时间：

Recruiting time：

从From 2019-06-01

至To      2020-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

68

Group：

The control group

Sample size：

干预措施：

塞来昔布联合功能锻炼

干预措施代码：

Intervention：

Celecoxib combined with functional exercise

Intervention code：

组别：

试验组

样本量：

68

Group：

Experimental group

Sample size：

干预措施：

臂丛麻醉下手法松解术联合功能锻炼

干预措施代码：

Intervention：

Manual release under brachial plexus anesthesia combined with functional exercise

Intervention code：

样本总量 Total sample size ： 136

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属曙光医院

单位级别：

三级甲等

Institution/hospital：

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Third rate

测量指标：

Outcomes：

指标中文名：

肩关节活动度（包括前屈、后伸、外展、外旋、后伸内旋）

指标类型：

次要指标

Outcome：

Range of motion of shoulder joint(including flexion, extension, abduction, pronation, extension and internal pronation)

Type：

Secondary indicator

测量时间点：

治疗前、治疗后1天、2周、4周、12周

测量方法：

门诊随访

Measure time point of outcome：

Before treatment, 1 day, 2 weeks, 4 weeks, 12 weeks after treatment

Measure method：

Outpatient follow-up

指标中文名：

“简式Mcgill”疼痛评分量表

指标类型：

次要指标

Outcome：

"Simple Mcgill" pain Scale

Type：

Secondary indicator

测量时间点：

治疗前、治疗后1天、2周、4周、12周

测量方法：

门诊随访

Measure time point of outcome：

Before treatment, 1 day, 2 weeks, 4 weeks, 12 weeks after treatment

Measure method：

Outpatient follow-up

指标中文名：

Constant-Murley 肩关节功能评分

指标类型：

主要指标

Outcome：

Constant-Murley shoulder function score

Type：

Primary indicator

测量时间点：

治疗前、治疗后1天、2周、4周、12周

测量方法：

门诊随访

Measure time point of outcome：

Before treatment, 1 day, 2 weeks, 4 weeks, 12 weeks after treatment

Measure method：

Outpatient follow-up

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

no

Tissue：

no

人体标本去向

使用后销毁

说明

无

Fate of sample 

Destruction after use

Note：

no

征募研究对象情况：

结束

Completed

年龄范围：

最小 40 岁
Min age years
最大 70 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）：

通过统计软件SPSS 25.0产生随机数字，将所有符合入组条件的冻结肩患者，随机分为试验组（臂丛麻醉下手法松解术+功能锻炼）、对照组（塞来昔布＋功能锻炼）。

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

Statistical software SPSS 25.0 was used to generate random numbers, and all eligible patients with Frozen Shoulder were randomly divided into experimental group (manipulation under brachial plexus anesthesia + functional exercise) and control group (celecoxib + functional exercise).

盲法：

本研究的随机分组方案由负责受试者招募和分配的临床研究人员负责；受试者对具体的分组情况不知情；结果评估人员、数据收集人员以及统计学家在研究过程中对两组的分配情况不知情。

Blinding：

The randomization protocol for this study was carried out by the clinical investigator responsible for the recruitment and assignment of subjects; Subjects are not aware of the specific grouping; Results evaluators, data collectors, and statisticians were unaware of the allocation of the two groups during the study.

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）：

病例报告表

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

Case report form

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：

病例报告表

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

Case report form

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）：

暂无

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

/

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