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COMPARATIVE EFFICACY OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT NEUROMOBILIZATION IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE CARPAL TUNNEL SYNDROME
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注册号：

Registration number：

 ChiCTR1800019908 

最近更新日期：

Date of Last Refreshed on：

 2018-12-08 10:26:29 

注册时间：

Date of Registration：

 2018-12-08 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

COMPARATIVE EFFICACY OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT NEUROMOBILIZATION IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE CARPAL TUNNEL SYNDROME

Public title：

COMPARATIVE EFFICACY OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT NEUROMOBILIZATION IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE CARPAL TUNNEL SYNDROME

注册题目简写：

English Acronym：

研究课题的正式科学名称：

COMPARATIVE EFFICACY OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT NEUROMOBILIZATION IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE CARPAL TUNNEL SYNDROME

Scientific title：

COMPARATIVE EFFICACY OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT NEUROMOBILIZATION IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE CARPAL TUNNEL SYNDROME

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：

Muhammad Junaid Ijaz 

研究负责人：

Muhammad Junaid Ijaz 

Applicant：

Muhammad Junaid Ijaz 

Study leader：

Muhammad Junaid Ijaz 

申请注册联系人电话：

Applicant telephone：

 +92 3344021312

研究负责人电话：

Study leader's
telephone：

+92 3344021312

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：

 junaid_gondal92@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 junaid_gondal92@yahoo.com

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：

巴基斯坦拉合尔大学麦沃医院理疗科

研究负责人通讯地址：

巴基斯坦拉合尔大学麦沃医院理疗科

Applicant address：

Department of Physiotherapy, Mayo Hospital, Lahore, Pakistan

Study leader's address：

Department of Physiotherapy Mayo Hospital Lahore, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 54000

研究负责人邮政编码：

Study leader's postcode：

 54000

申请人所在单位：

巴基斯坦拉合尔大学麦沃医院

Applicant's institution：

Mayo Hospital Lahore

研究负责人所在单位：

巴基斯坦拉合尔大学麦沃医院

Affiliation of the Leader：

Mayo Hospital Lahore

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：

 IRB-UOL-FAHS/00238-IV

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：

INSTITUTIONAL REVIEW BOARD

Name of the ethic committee：

INSTITUTIONAL REVIEW BOARD

伦理委员会批准日期：

Date of approved by ethic committee：

 2016-08-02 00:00:00

伦理委员会联系人：

Prof. Dr. Syed Amir Gilani

Contact Name of the ethic committee：

Prof. Dr. Syed Amir Gilani

伦理委员会联系地址：

UNIVERSITY INSTITUTE OF PHYSICAL THERAPY, UNIVERSITY OF LAHORE, 1-KM DEFENCE ROAD LAHORE, PAKISTAN.

Contact Address of the ethic committee：

UNIVERSITY INSTITUTE OF PHYSICAL THERAPY, UNIVERSITY OF LAHORE, 1-KM DEFENCE ROAD LAHORE, PAKISTAN.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 42 111-865-865

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：

Muhammad Junaid Ijaz

Primary sponsor：

Muhammad Junaid Ijaz

研究实施负责（组长）单位地址：

巴基斯坦拉合尔大学麦沃医院理疗科

Primary sponsor's address：

Department of Physiotherapy Mayo Hospital Lahore

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

旁遮普

市(区县)：

拉合尔

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

拉合尔大学麦沃医院

具体地址：

巴基斯坦拉合尔大学麦沃医院

Institution
hospital：

University of Lahore

Address：

University Institute of Physical Therapy, University of Lahore, Lahore, Pakistan

经费或物资来源：

Self Financed

Source(s) of funding：

Self Financed

研究疾病：

Carpal Tunnel Syndrome  

Target disease：

Carpal Tunnel Syndrome

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：

The primary objectiveof this study is: 1. To determine the comparative efficacy of routine physical therapy with and withoutNeuromobilization in the treatment of patients with mild to moderate carpal tunnel syndrome on pain intensity, handgrip strength, and range of motion and functional status in patients of carpal tunnel syndrome. The secondary objectives are: 1. To measure the sensory and motor delay responses using Electroneuromyography in Carpal Tunnel Syndrome patients before and after the treatment in both groups; 2. To determine the relationship between pain intensity and nerve conduction study results; 3. To determine the neurological relationshipbetween symptoms and functional status of the hand.  

Objectives of Study：

The primary objectiveof this study is: 1. To determine the comparative efficacy of routine physical therapy with and withoutNeuromobilization in the treatment of patients with mild to moderate carpal tunnel syndrome on pain intensity, handgrip strength, and range of motion and functional status in patients of carpal tunnel syndrome. The secondary objectives are: 1. To measure the sensory and motor delay responses using Electroneuromyography in Carpal Tunnel Syndrome patients before and after the treatment in both groups; 2. To determine the relationship between pain intensity and nerve conduction study results; 3. To determine the neurological relationshipbetween symptoms and functional status of the hand.

药物成份或治疗方案详述：

Patients will be selected according to exclusion and inclusion criteria. Patients will be selected from the Mayo Hospital, Lahore. The study will include the qualified physiotherapist, the assessor, the Biostatistician and the Neurologist. The patients will be diagnosed on Electrophysiological basis, for that NCS with EMG will be carried out by neurologist. Physiotherapists through Physical and Electrophysiological means further assess the patients after diagnosis for severity. Physical assessment will be made through Phalens, reverse Phalens and Tinel’s tests.Informed consent form will be taken from selected patients. Numeric Pain rating scale, Manual muscle testing for strength, Goniometer for range of motions (Unaffected side will be considered as normal or standard. So, ROM and Muscle strength will be calculated by comparing with standard) and Boston carpal tunnel syndrome questionnaire for functional limitation will be measured. Patients will be divided into two groups randomly, Group 1 will be control group and Group 2 will be experimental group. Group 1 will receive conservative treatment including Ultrasound therapy two days a week for 6 weeks, using pulsed mode 0.8W/cm2 and frequency 1MHz(42), Wrist Splinting and Tendon gliding exercises, while Group 2 will receive conservative treatment include Ultrasound, Splinting and Tendon gliding exercises as well as Neuromobilization technique. The Neuromobilization technique will includepassive Neuromobilization techniques and functional self-exercises. Patients will be treated by physical therapist as 2 sessions a week upto 6 weeks for 3 months follow up period. Clinical findings will be taken before the first treatment session, after 3-week treatment period and then after six weeks on specially designed questionnaire. To check the effectiveness of Neuromobilization, NCS with EMG will be performed again at the end of study. 

Description for medicine or protocol of treatment in detail：

Patients will be selected according to exclusion and inclusion criteria. Patients will be selected from the Mayo Hospital, Lahore. The study will include the qualified physiotherapist, the assessor, the Biostatistician and the Neurologist. The patients will be diagnosed on Electrophysiological basis, for that NCS with EMG will be carried out by neurologist. Physiotherapists through Physical and Electrophysiological means further assess the patients after diagnosis for severity. Physical assessment will be made through Phalens, reverse Phalens and Tinels tests.Informed consent form will be taken from selected patients. Numeric Pain rating scale, Manual muscle testing for strength, Goniometer for range of motions (Unaffected side will be considered as normal or standard. So, ROM and Muscle strength will be calculated by comparing with standard) and Boston carpal tunnel syndrome questionnaire for functional limitation will be measured. Patients will be divided into two groups randomly, Group 1 will be control group and Group 2 will be experimental group. Group 1 will receive conservative treatment including Ultrasound therapy two days a week for 6 weeks, using pulsed mode 0.8W/cm2 and frequency 1MHz(42), Wrist Splinting and Tendon gliding exercises, while Group 2 will receive conservative treatment include Ultrasound, Splinting and Tendon gliding exercises as well as Neuromobilization technique. The Neuromobilization technique will includepassive Neuromobilization techniques and functional self-exercises. Patients will be treated by physical therapist as 2 sessions a week upto 6 weeks for 3 months follow up period. Clinical findings will be taken before the first treatment session, after 3-week treatment period and then after six weeks on specially designed questionnaire. To check the effectiveness of Neuromobilization, NCS with EMG will be performed again at the end of study. 

纳入标准：

Inclusion criteria

排除标准：

1. Patients diagnosed with any systemic or musculoskeletal pathology of involved extremity;
2. Patients diagnosed with chronic carpal tunnel syndrome for more than two months;
3. Patients having as SEVERE to EXTREME findings of Carpal Tunnel Syndrome on Electroneuromyography;
4. Anyprevious surgery or corticosteroid injection treatment of Carpal Tunnel Syndrome;
5. Patients suffering from recurrent Carpal Tunnel Syndrome;
6. Any sensory or motor deficit in the ulnar or radial nerve was present;
7. Median nerve involvement at elbow or shoulder level.

Exclusion criteria：

1. Patients diagnosed with any systemic or musculoskeletal pathology of involved extremity;
2. Patients diagnosed with chronic carpal tunnel syndrome for more than two months;
3. Patients having as SEVERE to EXTREME findings of Carpal Tunnel Syndrome on Electroneuromyography;
4. Anyprevious surgery or corticosteroid injection treatment of Carpal Tunnel Syndrome;
5. Patients suffering from recurrent Carpal Tunnel Syndrome;
6. Any sensory or motor deficit in the ulnar or radial nerve was present;
7. Median nerve involvement at elbow or shoulder level.

研究实施时间：

Study execute time：

从 From 2016-09-05 00:00:00至 To 2018-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-03-06 00:00:00 至 To 2018-03-01 00:00:00

干预措施：

Interventions：

组别：

CONSERVATIVE

样本量：

 33

Group：

CONSERVATIVE

Sample size：

干预措施：

ULTRASOUND WITH TENDION GLIDING WRIST SPLINTING

干预措施代码：

Intervention：

ULTRASOUND WITH TENDION GLIDING WRIST SPLINTING

Intervention code：

组别：

NEUROMOBILIZATION

样本量：

 33

Group：

NEUROMOBILIZATION

Sample size：

干预措施：

ADDITIONAL MEDIAN NERVE MOBILIZATION

干预措施代码：

Intervention：

ADDITIONAL MEDIAN NERVE MOBILIZATION

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 拉合尔 

Country：

PAKISTAN

Province：

PUNJAB

City：

LAHORE

单位(医院)：

 拉合尔大学麦沃医院 

单位级别：

 三级医院 

Institution
hospital：

MAYO HOSPITAL LAHORE

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

SYMPTOMS SEVERITY INDEX

指标类型：

主要指标

Outcome：

SYMPTOMS SEVERITY INDEX

Type：

Primary indicator

测量时间点：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

测量方法：

Boston Carpal Tunnel Syndrome Questionnaire

Measure time point of outcome：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

Measure method：

Boston Carpal Tunnel Syndrome Questionnaire

指标中文名：

FUNCTIONAL STATUS INDEX

指标类型：

主要指标

Outcome：

FUNCTIONAL STATUS INDEX

Type：

Primary indicator

测量时间点：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

测量方法：

Boston Carpal Tunnel Syndrome Questionnaire

Measure time point of outcome：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

Measure method：

Boston Carpal Tunnel Syndrome Questionnaire

指标中文名：

PAIN

指标类型：

主要指标

Outcome：

PAIN

Type：

Primary indicator

测量时间点：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

测量方法：

Numeric Rating Pain Scale

Measure time point of outcome：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

Measure method：

Numeric Rating Pain Scale

指标中文名：

RANGE OF MOTION

指标类型：

次要指标

Outcome：

RANGE OF MOTION

Type：

Secondary indicator

测量时间点：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

测量方法：

Goniometer

Measure time point of outcome：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

Measure method：

Goniometer

指标中文名：

MUSCLE STRENGTH

指标类型：

次要指标

Outcome：

MUSCLE STRENGTH

Type：

Secondary indicator

测量时间点：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

测量方法：

Manual Muscle testing

Measure time point of outcome：

PRETREATMENT, AFTER 3RD AND 6TH WEEK

Measure method：

Manual Muscle testing

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 21 岁 years
最大 Max age 45 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

The patients will be screened by an independent assessor and randomly allocated into either an experimental group or control group. Randomization will be stratified by another person and severity using randomly permuted blocks of four or six patients. The allocation sequence will be computer-generated before the en

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

The patients will be screened by an independent assessor and randomly allocated into either an experimental group or control group. Randomization will be stratified by another person and severity using randomly permuted blocks of four or six patients. The allocation sequence will be computer-generated before the en

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：

Not stated

Blinding：

Not stated

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）：

Individual participant data will be provided on request after approval from Institutional Review Board. For that an email can be sent to Prof. Dr Syed Amir Gillani at profgilani@gmail.com

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

Individual participant data will be provided on request after approval from Institutional Review Board. For that an email can be sent to Prof. Dr Syed Amir Gillani at profgilani@gmail.com

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：

无/No

注册人：

Name of Registration：

  2018-12-08 10:26:29
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