今天是:2020-06-06 星期六

COMPARISON OF EFFECTIVENESS OF MEDIAN NERVE NEURODYNAMIC MOBILIZATION VERSUS CARPAL BONE MOBILIZATION ON PAIN, SYMPTOM SEVERITY AND FUNCTIONAL STATUS IN CARPAL TUNNEL SYNDROME
下载XML文档

注册号:

Registration number:

ChiCTR1800017905 

最近更新日期:

Date of Last Refreshed on:

2018-08-20 

注册时间:

Date of Registration:

2018-08-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

COMPARISON OF EFFECTIVENESS OF MEDIAN NERVE NEURODYNAMIC MOBILIZATION VERSUS CARPAL BONE MOBILIZATION ON PAIN, SYMPTOM SEVERITY AND FUNCTIONAL STATUS IN CARPAL TUNNEL SYNDROME 

Public title:

COMPARISON OF EFFECTIVENESS OF MEDIAN NERVE NEURODYNAMIC MOBILIZATION VERSUS CARPAL BONE MOBILIZATION ON PAIN, SYMPTOM SEVERITY AND FUNCTIONAL STATUS IN CARPAL TUNNEL SYNDROME 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

COMPARISON OF EFFECTIVENESS OF MEDIAN NERVE NEURODYNAMIC MOBILIZATION VERSUS CARPAL BONE MOBILIZATION ON PAIN, SYMPTOM SEVERITY AND FUNCTIONAL STATUS IN CARPAL TUNNEL SYNDROME 

Scientific title:

COMPARISON OF EFFECTIVENESS OF MEDIAN NERVE NEURODYNAMIC MOBILIZATION VERSUS CARPAL BONE MOBILIZATION ON PAIN, SYMPTOM SEVERITY AND FUNCTIONAL STATUS IN 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 Asad Chaudhary 

研究负责人:

Muhammad Asad Chaudhary 

Applicant:

Muhammad Asad Chaudhary 

Study leader:

Muhammad Asad Chaudahry 

申请注册联系人电话:

Applicant telephone:

+923 0 04706509 

研究负责人电话:

Study leader's telephone:

+923 0 04706509 

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:

asadchaudhary97@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

asadchaudhary97@gmail.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:

House No 76 Street No. 1 Main Bazar Gunj Mughalpura Lahore, Pakistan. 

研究负责人通讯地址:

House No 76 Street No. 1 Main Bazar Gunj Mughalpura Lahore, Pakistan. 

Applicant address:

House No 76 Street No. 1 Main Bazar Gunj Mughalpura Lahore, Pakistan. 

Study leader's address:

House No 76 Street No. 1 Main Bazar Gunj Mughalpura 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:

5400 

申请人所在单位:

District Head Quarter Hospital, Narowal, Pakistan 

Applicant's institution:

District Head Quarter Hospital, Narowal, Pakistan 

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:

400865 

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:

Board of Advanced Studies and Research 

Name of the ethic committee:

Board of Advanced Studies and Research 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-05-15 

伦理委员会联系人:

Dr. Atif Dastagir 

Contact Name of the ethic committee:

Dr. Atif Dastagir 

伦理委员会联系地址:

Riphah College of Rehabilitation Sciences, Riphah International University, Lahore Campus. 

Contact Address of the ethic committee:

Riphah College of Rehabilitation Sciences, Riphah International University, Lahore Campus. 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+923 2 24411000 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

atif.dustgir@riphah.edu.pk 

研究实施负责(组长)单位:

Riphah International University, Pakistan 

Primary sponsor:

Riphah International University, Pakistan 

研究实施负责(组长)单位地址:

House No 76 Street No. 1 Main Bazar Gunj Mughalpura Lahore, Pakistan. 

Primary sponsor's address:

House No 76 Street No. 1 Main Bazar Gunj Mughalpura Lahore, Pakistan. 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

Pakistan

省(直辖市):

Punjab

市(区县):

Lahore

Country:

Pakistan

Province:

Punjab

City:

Lahore

单位(医院):

Riphah International University, Lahore Campus

具体地址:

28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath Lahore. Pakistan

Institution
hospital:

Riphah International University, Lahore Campus

Address:

28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath 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:

研究目的:

To determine the effectiveness of median nerve mobilization vs. carpal bone mobilization in reducing pain & symptom severity and improving functional status in subjects with carpal tunnel syndrome 

Objectives of Study:

To determine the effectiveness of median nerve mobilization vs. carpal bone mobilization in reducing pain & symptom severity and improving functional status in subjects with carpal tunnel syndrome 

药物成份或治疗方案详述:

Group A: Carpal bone Mobilization Positioning for scaphoid: 1. The patient will be placed in a sitting position with the ventral aspect of the forearm on the table and the and off the table. 2. If conservative techniques is indicated, the radiocarpal and ulnocarpal jointswere in the resting position. If more aggressive techniques is indicated, they will approximating the restricted range. 3. The clinician will be facing the radiocarpal and ulnocarpal joints. 4. The stabilizing hand grip the distal radius with the thumb on the dorsal surface and the index finger on the ventral surface. 5. Additional stabilization can be achieved by holding the patients hand against the clinicians trunk. 6. The manipulating hand grip the proximal and distal carpal bone with the thumb on the dorsal surface and the index finger on the volar surface. Procedures: 1. The stabilizing hand will hold the radius in position. 2. The manipulating hand will glide the scaphoid in a volar and dorsal direction on the radius. Positioning for hammate: 1. The patient will be sitting with the ventral aspect of the forearm on the table and the hand off the table. 2. The mid carpal joints will be in the resting position if conservative techniques are indicated or approximating the restricted range if more aggressive techniques are indicated. 3. The clinician will be facing the midcarpal joint. 4. The stabilizing hand will grip the proximal carpal bone with the thumb on the dorsal surface and the index finger on the ventral surface. 5. Additional stabilization can be achieved by holding the patients hand against the clinicians trunk. 6. The manipulating hand will grip the distal carpal bone with the thumb on the dorsal surface and the index finger on the volar surface. Procedure: 1. The stabilizing hand holds the proximal carpal bone in position. 2. The manipulating hand glides the hamate in a volar and dorsal direction on the triquetrum.(16) Group B: Median Nerve Neurodynamic mobilization The nerve gliding exercises target the median nerve and will be performed as follows: 1. shoulder girdle depression, 2. gleno-humeral abduction and lateral rotation, 3. supination of the forearm, wrist, thumb and fingers extension 4. From that position, concurrent elbow flexion and wrist extension will be alternated with concurrent elbow extension and wrist flexion. Speed and amplitude of movement will be adjusted to avoid pain during the intervention 

Description for medicine or protocol of treatment in detail:

Group A: Carpal bone Mobilization Positioning for scaphoid: 1. The patient will be placed in a sitting position with the ventral aspect of the forearm on the table and the and off the table. 2. If conservative techniques is indicated, the radiocarpal and ulnocarpal jointswere in the resting position. If more aggressive techniques is indicated, they will approximating the restricted range. 3. The clinician will be facing the radiocarpal and ulnocarpal joints. 4. The stabilizing hand grip the distal radius with the thumb on the dorsal surface and the index finger on the ventral surface. 5. Additional stabilization can be achieved by holding the patients hand against the clinicians trunk. 6. The manipulating hand grip the proximal and distal carpal bone with the thumb on the dorsal surface and the index finger on the volar surface. Procedures: 1. The stabilizing hand will hold the radius in position. 2. The manipulating hand will glide the scaphoid in a volar and dorsal direction on the radius. Positioning for hammate: 1. The patient will be sitting with the ventral aspect of the forearm on the table and the hand off the table. 2. The mid carpal joints will be in the resting position if conservative techniques are indicated or approximating the restricted range if more aggressive techniques are indicated. 3. The clinician will be facing the midcarpal joint. 4. The stabilizing hand will grip the proximal carpal bone with the thumb on the dorsal surface and the index finger on the ventral surface. 5. Additional stabilization can be achieved by holding the patients hand against the clinicians trunk. 6. The manipulating hand will grip the distal carpal bone with the thumb on the dorsal surface and the index finger on the volar surface. Procedure: 1. The stabilizing hand holds the proximal carpal bone in position. 2. The manipulating hand glides the hamate in a volar and dorsal direction on the triquetrum.(16) Group B: Median Nerve Neurodynamic mobilization The nerve gliding exercises target the median nerve and will be performed as follows: 1. shoulder girdle depression, 2. gleno-humeral abduction and lateral rotation, 3. supination of the forearm, wrist, thumb and fingers extension 4. From that position, concurrent elbow flexion and wrist extension will be alternated with concurrent elbow extension and wrist flexion. Speed and amplitude of movement will be adjusted to avoid pain during the intervention 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. Age 25-55 years. 2. Both male and female patients diagnosed with CTS; 3. Patients with positive phalen's test, positive tinel's test and positive upper limb tension test for median nerve; 4. Patient's having median nerve latencies above 4ms. 

Inclusion criteria

1. Age 25-55 years. 2. Both male and female patients diagnosed with CTS; 3. Patients with positive phalen's test, positive tinel's test and positive upper limb tension test for median nerve; 4. Patient's having median nerve latencies above 4ms. 

排除标准:

1. Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis,HTN, prolonged history of steroid use, etc); 2. Patients with double crush syndrome, cervical or thoracic origin of symptoms, scaphoid instability, shoulder injuries, recent fractures and crush injuries, hypermobile joints, pregnancy and women undergoing hormone replacement therapy; 3. Evidence of central nervous system involvement; 4. Patients who requested to leave the study and history of other treatments including local corticosteroid and using of physical modalities and physiotherapy injection and splint in 3 months ago; 5. Any sensory and/or motor deficit in either ulnar or radial nerve. 

Exclusion criteria:

1. Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis,HTN, prolonged history of steroid use, etc); 2. Patients with double crush syndrome, cervical or thoracic origin of symptoms, scaphoid instability, shoulder injuries, recent fractures and crush injuries, hypermobile joints, pregnancy and women undergoing hormone replacement therapy; 3. Evidence of central nervous system involvement; 4. Patients who requested to leave the study and history of other treatments including local corticosteroid and using of physical modalities and physiotherapy injection and splint in 3 months ago; 5. Any sensory and/or motor deficit in either ulnar or radial nerve. 

研究实施时间:

Study execute time:

From2018-08-01To 2018-11-30 

干预措施:

Interventions:

组别:

Group 1

样本量:

30

Group:

Group 1

Sample size:

干预措施:

Carpal Bone Mobilization

干预措施代码:

Intervention:

Carpal Bone Mobilization

Intervention code:

组别:

Group 2

样本量:

30

Group:

Group 2

Sample size:

干预措施:

Median Nerve Neurodynamic Mobilization

干预措施代码:

Intervention:

Median Nerve Neurodynamic Mobilization

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

Pakistan 

省(直辖市):

Punjab 

市(区县):

Lahore 

Country:

Pakistan 

Province:

Punjab 

City:

Lahore 

单位(医院):

District Head Quarter Hospital, Narowal, Pakistan 

单位级别:

Secondary Care Hospital 

Institution
hospital:

District Head Quarter Hospital, Narowal, Pakistan  

Level of the institution:

Secondary Care Hospital 

国家:

Pakistan 

省(直辖市):

Punjab 

市(区县):

Lahore 

Country:

Pakistan 

Province:

Punjab 

City:

Lahore 

单位(医院):

Mayo Hospital Lahore 

单位级别:

Tertiary Care Hospital 

Institution
hospital:

Mayo Hospital Lahore  

Level of the institution:

Tertiary Care Hospital 

测量指标:

Outcomes:

指标中文名:

Boston Carpal Tunnel Questionnaire

指标类型:

主要指标 

Outcome:

Boston Carpal Tunnel Questionnaire

Type:

Primary indicator 

测量时间点:

Pretreatment, after 3 weeks, after 6 weeks

测量方法:

subjective questionnaire

Measure time point of outcome:

Pretreatment, after 3 weeks, after 6 weeks

Measure method:

subjective questionnaire

指标中文名:

Numeric rating pain scale

指标类型:

主要指标 

Outcome:

Numeric rating pain scale

Type:

Primary indicator 

测量时间点:

Pretreatment, after 3 weeks, after 6 weeks

测量方法:

Subjective

Measure time point of outcome:

Pretreatment, after 3 weeks, after 6 weeks

Measure method:

Subjective

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 25 years
最大 Max age 55 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):

The patients will be asked to choose a token from the a box on which group of patient will be mentioned. Box will be filled with equal number of tokens for both groups to ensure equal sample size. None of the patients will be aware of the subgroup they will have

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

The patients will be asked to choose a token from the a box on which group of patient will be mentioned. Box will be filled with equal number of tokens for both groups to ensure equal sample size. None of the patients will be aware of the subgroup they will have

盲法:

Blinding:

Patients will be kept unaware of their study group as allocation will be concealed. Physiotherapist who will be treating, examining patient and taking data for outcome measures before, during and after the treatment will be kept unaware of the patient as treatment will be given by two different therapists in two different rooms and both will be kept unaware of the other treatment protocol.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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 Board of Advanced Studies and Research only. For that an email can be sent to Dr. Atif Dastgir on atif.dustgir@riphah.edu.pk

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 Board of Advanced Studies and Research only. For that an email can be sent to Dr. Atif Dastgir on atif.dustgir@riphah.edu.pk

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

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-08-20
返回列表